PB 20 of 2014
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No. 3)
 
National Health Act 1953
___________________________________________________________________________
 
 
I, KIM BESSELL, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the
National Health Act 1953.
Dated   28 March 2014
 
 
 
 
 
 
 
 
 
 
 
 
 
 
KIM BESSELL
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________________
 
 
1       Name of Instrument
 
(1)                This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No.3).
 
(2)                This Instrument may also be cited as PB 20 of 2014.
 
2              Commencement
This Instrument commences on 1 April 2014.
3              Amendments to PB 116 of 2010
Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).
 
 
Schedule 1       Amendments
[1]           Division 1, Section 4, definition for CAR drug
insert after existing text:
          Note: For the drug infliximab, a non-CAR HSD pharmaceutical benefit also applies.  
[2]           Schedule 1, entry for Abacavir in each of the forms: Tablet 300 mg (as sulfate); and Oral solution 20 mg (as sulfate) per mL, 240 mL
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589                  substitute:      C4454  C4455  C4469  C4512
[3]           Schedule 1, entry for Abacavir with Lamivudine
omit from the column headed “Circumstances”:            C3590  C3591  C3592  C3593                   substitute:      C4505  C4527  C4528  C4538
[4]           Schedule 1, entry for Abacavir with Lamivudine and Zidovudine
omit from the column headed “Circumstances”:            C3979  C3980  C3981  C3982                   substitute:      C4472  C4480  C4495  C4523
[5]           Schedule 1, entry for Adalimumab in each of the forms: Injection 20 mg in 0.4 mL pre-filled syringe; Injection 40 mg in 0.8 mL pre-filled syringe; and Injection 40 mg in 0.8 mL pre-filled pen
omit from the column headed “Circumstances”:            C3527  C3529  C3798  C3799                   substitute:      C4464  C4465  C4491  C4500  C4546
[6]           Schedule 1, entry for Atazanavir in each of the forms: Capsule 100 mg (as sulfate); Capsule 150 mg (as sulfate); Capsule 200 mg (as sulfate); and Capsule 300 mg (as sulfate)
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589                   substitute:      C4454  C4455  C4469  C4512
[7]           Schedule 1, entry for Didanosine in each of the forms: Capsule 125 mg (containing enteric coated beadlets); Capsule 200 mg (containing enteric coated beadlets); Capsule 250 mg (containing enteric coated beadlets); and Capsule 400 mg (containing enteric coated beadlets)
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589                   substitute:      C4454  C4455  C4469  C4512
[8]           Schedule 1, after entry for Didanosine
insert: 
Dolutegravir
Tablet 50mg (as sodium)
Oral
Tivicay
 
VI
EMP
C4454 C4455
C4469 C4512
 
60
5
D
[9]           Schedule 1, entry for Doxorubicin-Pegylated Liposomal
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Liposomal Doxorubicin SUN
ZF
EMP
C1828 C1829 C3348 C3349
 
4
5
D
 
[10]         Schedule 1, entry for Efavirenz in each of the forms: Tablet 200 mg; Tablet 600 mg; and Oral solution 30 mg per mL, 180 mL
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589      substitute:      C4454  C4455  C4469  C4512
[11]         Schedule 1, entry for Emtricitabine in the form Capsule 200 mg
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589                   substitute:      C4454  C4455  C4469  C4512
[12]         Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
omit from the column headed “Circumstances”:            C3531  C3800  C3801                     substitute:      C4459  C4461  C4486  C4487  C4540
[13]         Schedule 1, entry for Etanercept in the each of the forms: Injections 50 mg in 1 mL single use pre-filled syringes, 4; and Injection 50 mg in 1 mL single use auto-injector, 4
omit from the column headed “Circumstances”:            C3802             substitute:      C4459  C4484 
[14]         Schedule 1, entry for Fosamprenavir in each of the forms: Tablet 700 mg (as calcium); and Oral liquid 50 mg (as calcium) per mL, 225 mL
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589                   substitute:      C4454  C4455  C4469  C4512
[15]         Schedule 1, entry for Indinavir
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589                   substitute:      C4454  C4455  C4469  C4512
[16]         Schedule 1, entry for Infliximab
substitute:

Infliximab
Powder for I.V. infusion 100 mg
Injection
Remicade
JC
EMP
C2996 C2999 C3002 C3004 C3005 C3008 C3259 C3262 C3492 C3513 C3585 C3691 C3693 C3710 C3803 C3804 C3805 C3806 C3807 C3808 C3809 C3810 C3811 C3812 C3813 C3814 C3815 C3816 C3817 C3818 C3819 C3820 C4524 C4535
P2996 P2999 P3002 P3004 P3005 P3008 P3259 P3262 P3492 P3513 P3585 P3691 P3693 P3710 P3803 P3804 P3805 P3806 P3807 P3808 P3809 P3810 P3811 P3812 P3813 P3814 P3815 P3816 P3817 P3818 P3819 P3820
See Note 1
See Note 2
D

 
 
 
 
 
 
C2996 C2999 C3002 C3004 C3005 C3008 C3259 C3262 C3492 C3513 C3585 C3691 C3693 C3710 C3803 C3804 C3805 C3806 C3807 C3808 C3809 C3810 C3811 C3812 C3813 C3814 C3815 C3816 C3817 C3818 C3819 C3820 C4524 C4535
P4535
1
1
D

 
 
 
 
 
 
C2996 C2999 C3002 C3004 C3005 C3008 C3259 C3262 C3492 C3513 C3585 C3691 C3693 C3710 C3803 C3804 C3805 C3806 C3807 C3808 C3809 C3810 C3811 C3812 C3813 C3814 C3815 C3816 C3817 C3818 C3819 C3820 C4524 C4535
P4524
5
1
D

[17]         Schedule 1, entry for Lamivudine in each of the forms: Tablet 150 mg; and Tablet 300 mg
omit from the column headed “Circumstances” (in all instances):      C3586  C3587  C3588  C3589                   substitute:          C4454  C4455  C4469  C4512
[18]         Schedule 1, entry for Lamivudine in the form Oral solution 10 mg per mL, 240 mL
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589                   substitute:      C4454  C4455  C4469  C4512
[19]         Schedule 1, entry for Lamivudine with Zidovudine
omit from the column headed “Circumstances”(twice occurring):      C3586  C3587  C3588  C3589                   substitute:          C4454  C4455  C4469  C4512
 
[20]         Schedule 1, entry for Lopinavir with Ritonavir in each of the forms: Tablet 100 mg-25 mg; Tablet 200 mg-50 mg; and Oral liquid 400 mg-100 mg per 5 mL, 60 mL
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589      substitute:      C4454  C4455  C4469  C4512
[21]         Schedule 1, entry for Nevirapine in the form Tablet 200 mg
omit from the column headed “Circumstances”(in all instances):       C3586  C3587  C3588  C3589                   substitute:          C4454  C4455  C4469  C4512
[22]         Schedule 1, entry for Nevirapine in the form Tablet 400 mg (extended release)
omit from the column headed “Circumstances”:            C3587  C3589  C3994  C3995                   substitute:      C4454  C4460  C4469  C4526
[23]         Schedule 1, entry for Nevirapine in the form Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL
omit from the column headed “Circumstances”:            C3586  3587  3588  3589               substitute:      C4454  C4455  C4469  C4512
[24]         Schedule 1, entry for Raltegravir in the form Tablet 400 mg (as potassium)
omit from the column headed “Circumstances”:         C3586  C3587  C3588  C3589                  substitute:      C4454  C4455  C4469  C4512
[25]         Schedule 1, entry for Rilpivirine in the form Tablet 25 mg (as hydrochloride)
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589      substitute:      C4454  C4455  C4469  C4512
[26]         Schedule 1, entry for Ritonavir in each of the forms: Tablet 100 mg; and Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589      substitute:      C4454  C4455  C4469  C4512
[27]         Schedule 1, entry for Saquinavir
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589      substitute:      C4454  C4455  C4469  C4512
[28]         Schedule 1, entry for Stavudine in each of the forms: Capsule 20 mg; Capsule 30 mg; and Capsule 40 mg
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589      substitute:      C4454  C4455  C4469  C4512
[29]         Schedule 1, entry for Tenofovir
omit all codes from the column headed “Circumstances” and substitute:     
C4454  C4455  C4469  C4476  C4489  C4490  C4499  C4509  C4510  C4512  C4544  C4545
[30]         Schedule 1, entry for Tenofovir with Emtricitabine
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589      substitute:      C4454  C4455  C4469  C4512
[31]         Schedule 1, entry for Tenofovir with emtricitabine and efavirenz
omit from the column headed “Circumstances”:            C3983  C3984  C3985  C3986      substitute:      C4470  C4494  C4522  C4533
 
[32]         Schedule 1, entry for Tenofovir with Emtricitabine and Rilpivirine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and rilpivirine 25 mg (as hydrochloride)
omit from the column headed “Circumstances”:            C3983  C3984  C3985  C3986      substitute:      C4470  C4494  C4522  C4533
[33]         Schedule 1, entry for Tociluzumab in each of the forms: Concentrate for injection 80 mg in 4 mL; Concentrate for injection 200 mg in 10 mL; and Concentrate for injection 400 mg in 20 mL
insert in numerical order following existing codes in the column headed “Circumstances”:         
C4453  C4466  C4493  C4497  C4502  C4508 C4515 C4521 C4541 C4542
[34]         Schedule 1, entry for Zidovudine in each of the forms: Capsule 100 mg; Capsule 250 mg; and Syrup 10 mg per mL, 200 mL
omit from the column headed “Circumstances”:            C3586  C3587  C3588  C3589      substitute:      C4454  C4455  C4469  C4512
[35]         Schedule 3, entry for Abacavir
substitute:
Abacavir
C4454
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[36]         Schedule 3, entry for Abacavir with Lamivudine
substitute:
Abacavir with Lamivudine
C4505
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures


 
C4527
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4527


 
C4528
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4528


 
C4538
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures


[37]         Schedule 3, entry for Abacavir with Lamivudine and Zidovudine
substitute:
Abacavir with Lamivudine and Zidovudine
C4472 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures


 
C4480 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4480


 
C4495 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4495


 
C4523
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures


[38]         Schedule 3, entry for Adalimumab
substitute:
Adalimumab
 
C4464 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — initial treatment (new patient or patient recommencing treatment after a break of more than 12 months)
Patient must have severe active juvenile idiopathic arthritis; AND
Patient must have received no prior PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition; OR
Patient must not have received PBS-subsidised treatment with adalimumab, etanercept or tocilizumab for this condition in the previous 12 months; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or (ii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age and a parent or authorised guardian must have signed a patient acknowledgement.
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; OR
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form; and
(3) an acknowledgement signed by a parent or authorised guardian.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide sufficient for two doses. Up to a maximum of 3 repeats will be authorised.
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle. A patient may re-trial adalimumab after a minimum of 12 months have elapsed between the date the last PBS-subsidised bDMARD was stopped and the date of the first application under a new treatment cycle.
Compliance with modified Authority Required procedures

 
C4465 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — continuing treatment
Patient must have a documented history of severe active juvenile idiopathic arthritis; AND
Patient must have demonstrated an adequate response to treatment with adalimumab; AND
Patient must have received adalimumab as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide sufficient for two doses. Up to a maximum of 5 repeats will be authorised.
All applications for continuing treatment with adalimumab must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with adalimumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with adalimumab.
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle.
Compliance with modified Authority Required procedures

 
C4491
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — initial treatment 1 (new patient or patient recommencing treatment after a break of more than 12 months) or Initial 2 (change or recommencement of treatment after break of less than 12 months) – balance of supply
Patient must have received insufficient adalimumab therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient adalimumab therapy under the Initial 2 (change or recommencement of treatment after break of less than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
 
Compliance with modified Authority Required procedures

 
C4500
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — continuing treatment – balance of supply
Patient must have received insufficient adalimumab therapy under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
 
Compliance with modified Authority Required procedures

 
C4546
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — initial treatment 2 (change or recommencement of treatment after break of less than 12 months)
Patient must have a documented history of severe active juvenile idiopathic arthritis; AND
Patient must have received prior PBS-subsidised treatment with adalimumab, etanercept or tocilizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with adalimumab for this condition in the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide sufficient for two doses. Up to a maximum of 3 repeats will be authorised.
Applications for a patient who has received PBS-subsidised treatment with adalimumab in this treatment cycle and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised adalimumab treatment was approved under either of the Initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised adalimumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with adalimumab.
If a patient fails to respond to PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Compliance with modified Authority Required procedures

 
[39]         Schedule 3, entry for Atazanavir
substitute:
Atazanavir
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[40]         Schedule 3, entry for Didanosine
substitute:
Didanosine
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[41]         Schedule 3, after entry for Didanosine
insert:
Dolutegravir
C4454
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


 
[42]         Schedule 3, entry for Efavirenz
substitute:
Efavirenz
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[43]         Schedule 3, entry for Emtricitabine
substitute:
Emtricitabine
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[44]         Schedule 3, entry for Etanercept
substitute:
Etanercept
C4459 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — continuing treatment – balance of supply
Patient must have received insufficient etanercept therapy under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Compliance with modified Authority Required procedures

 
C4461 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis—initial treatment 1 (new patient or patient recommencing treatment after a break of more than 12 months)
Patient must have severe active juvenile idiopathic arthritis; AND
Patient must have received no prior PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition; OR
Patient must not have received PBS-subsidised treatment with adalimumab, etanercept or tocilizumab for this condition in the previous 12 months; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or (ii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age and a parent or authorised guardian must have signed a patient acknowledgement.
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; OR
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form; and
(3) an acknowledgement signed by a parent or authorised guardian.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle. A patient may re-trial etanercept after a minimum of 12 months have elapsed between the date the last PBS-subsidised bDMARD was stopped and the date of the first application under a new treatment cycle.
Compliance with modified Authority Required procedures

 
C4486 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — initial treatment  2 (change or recommencement of treatment after break of less than 12 months)
Patient must have a documented history of severe active juvenile idiopathic arthritis;
Patient must have received prior PBS-subsidised treatment with adalimumab, etanercept or tocilizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with etanercept for this condition in the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.
Applications for a patient who has received PBS-subsidised treatment with etanercept in this treatment cycle and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised etanercept treatment was approved under either of the Initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised etanercept treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept.
If a patient fails to respond to PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Compliance with modified Authority Required procedures

 
C4487 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — initial treatment  1 (new patient or patient recommencing treatment after a break of more than 12 months) or initial treatment  2 (change or recommencement of treatment after break of less than 12 months) – balance of supply
Patient must have received insufficient etanercept therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient etanercept therapy under the Initial 2 (change or recommencement of treatment after break of less than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Compliance with modified Authority Required procedures

 
C4540
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — continuing treatment
Patient must have a documented history of severe active juvenile idiopathic arthritis; AND
Patient must have demonstrated an adequate response to treatment with etanercept; AND
Patient must have received etanercept as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 5 repeats will be authorised.
All applications for continuing treatment with etanercept must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with etanercept, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept.
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle.
 

[45]         Schedule 3, entry for Fosamprenavir
substitute:
Fosamprenavir
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[46]         Schedule 3, entry for Indinavir
substitute:
Indinavir
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[47]         Schedule 3, entry for Infliximab [Circumstances codes: C2996; C2999; C3002; C3004; C3005; C3008; C3259; C3262; C3492; C3513; C3585; C3691; C3693; C3710; C3803; C3804; C3805; C3806; C3807; C3808; C3809; C3810; C3811; C3812; C3813; C3814; C3815; C3816; C3817; C3818; C3819; and C3820]
insert in the column headed “Purposes Code”, corresponding with the equivalent "Circumstances Code” respectively:
P2996  P2999  P3002  P3004  P3005  P3008  P3259  P3262  P3492  P3513  P3585  P3691  P3693  P3710  P3803  P3804  P3805  P3806  P3807  P3808  P3809  P3810  P3811  P3812  P3813  P3814  P3815  P3816  P3817  P3818  P3819  P3820
 
[48]         Schedule 3, entry for Infliximab
insert in numerical order following existing text:
 
C4524
P4524
Where the patient is receiving treatment at/from a public hospital
 
Acute severe ulcerative colitis
Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND
Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; OR
Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND
Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital
Patient must be 6 years of age or older
Must be treated by a gastroenterologist; OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology]
For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:
(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L
(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood
For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours
At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg
Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient's medical records
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4524


 
C4535
P4535
Where the patient is receiving treatment at/from a private hospital
 
Acute severe ulcerative colitis
Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND
Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; OR
Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND
Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital
Patient must be 6 years of age or older
Must be treated by a gastroenterologist; OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology]
For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:
(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L
(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood
For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours
At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg
Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient's medical records
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records
Compliance with Written or Telephone Authority Required procedures

[49]         Schedule 3, entry for Lamivudine
(a)      omit:
 
C3586
 
Where the patient is receiving treatment at/from a private hospital
 
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures

 
C3587
 
Where the patient is receiving treatment at/from a private hospital
 
Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures

 
C3588
 
Where the patient is receiving treatment at/from a public hospital
 
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588

 
C3589
 
Where the patient is receiving treatment at/from a public hospital
 
Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

(b)      insert in numerical order following existing text:
 
C4454
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[50]         Schedule 3, entry for Lamivudine with Zidovudine
substitute:
Lamivudine with Zidovudine
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written and Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written and Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4512

[51]         Schedule 3, entry for Lopinavir with Ritonavir
substitute:
Lopinavir with Ritonavir
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[52]         Schedule 3, entry for Nevirapine
subsitute:
 
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4460
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must have been stabilised on nevirapine immediate release; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures

 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4512


 
C4526
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must have been stabilised on nevirapine immediate release; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4526

[53]         Schedule 3, entry for Raltegravir
(a)      omit:
 
C3586
 
Where the patient is receiving treatment at/from a private hospital
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures

 
C3587
 
Where the patient is receiving treatment at/from a private hospital
Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS‑subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures

 
C3588
 
Where the patient is receiving treatment at/from a public hospital
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3588

 
C3589
 
Where the patient is receiving treatment at/from a public hospital
Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS‑subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3589

(b)      insert in numerical order following existing text:
 
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512


[54]          Schedule 3, entry for Rilpivirine
substitute:
Rilpivirine
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[55]         Schedule 3, entry for Ritonavir
substitute:
Ritonavir
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

 
[56]         Schedule 3, entry for Saquinavir
substitute:
Saquinavir
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454

 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[57]         Schedule 3, entry for Stavudine
substitute:
Stavudine
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[58]         Schedule 3, entry for Tenofovir
substitute:
Tenofovir
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4476 
 
Where the patient is receiving treatment at/from a public hospital
 
Chronic hepatitis B
Patient must have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have detectable HBV DNA; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4476


 
C4489 
 
Where the patient is receiving treatment at/from a public hospital
 
Chronic hepatitis B
Patient must not have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4489


 
C4490 
 
Where the patient is receiving treatment at/from a public hospital
 
Chronic hepatitis B
Patient must not have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4490


 
C4499 
 
Where the patient is receiving treatment at/from a private hospital
 
Chronic hepatitis B
Patient must not have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Compliance with Written or Telephone Authority Required procedures


 
C4509 
 
Where the patient is receiving treatment at/from a private hospital
 
Chronic hepatitis B
Patient must have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have detectable HBV DNA; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures


 
C4510 
 
Where the patient is receiving treatment at/from a public hospital
 
Chronic hepatitis B
Patient must have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4510


 
C4512 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

 
C4544 
 
Where the patient is receiving treatment at/from a private hospital
 
Chronic hepatitis B
Patient must not have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures


 
C4545
 
Where the patient is receiving treatment at/from a private hospital
 
Chronic hepatitis B
Patient must have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have detectable HBV DNA
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures


[59]         Schedule 3, entry for Tenofovir with Emtricitabine
substitute:
Tenofovir with Emtricitabine
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512

[60]         Schedule 3, entry for Tenofovir with emtricitabine and efavirenz
substitute:
Tenofovir with Emtricitabine and Efavirenz
C4470 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4470

 
C4494 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures


 
C4522 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4522

 
C4533
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures


[61]          Schedule 3, entry for Tenofovir with Emtricitabine and Rilpivirine
substitute:
Tenofovir with Emtricitabine and Rilpivirine
C4470 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4470

 
C4494 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures

 
C4522 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4522

 
C4533
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures

 
[62]         Schedule 3, entry for Tociluzumab
insert in numerical order following existing text:
 
C4453 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — continuing treatment – balance of supply
Patient must have received insufficient tocilizumab therapy under the Continuing Treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Compliance with modified Authority Required procedures

 
C4466 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — initial treatment  2 (change or recommencement of treatment after break of less than 12 months)
Patient must have a documented history of severe active juvenile idiopathic arthritis; AND
Patient must have received prior PBS-subsidised treatment with adalimumab, etanercept or tocilizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with tocilizumab for this condition in the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
Applications for a patient who has received PBS-subsidised treatment with tocilizumab in this treatment cycle and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised tocilizumab treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised tocilizumab treatment was approved under either of the Initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised tocilizumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab.
If a patient fails to respond to PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Compliance with modified Authority Required procedures

 
C4493 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — initial treatment 1 (new patient or patient recommencing treatment after a break of more than 12 months)
Patient must have severe active juvenile idiopathic arthritis; AND
Patient must have received no prior PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition; OR
Patient must not have received PBS-subsidised treatment with adalimumab, etanercept or tocilizumab for this condition in the previous 12 months; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or (ii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age and a parent or authorised guardian must have signed a patient acknowledgement.
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; OR
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form; and
(3) an acknowledgement signed by a parent or authorised guardian.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle. A patient may re-trial tocilizumab after a minimum of 12 months have elapsed between the date the last PBS-subsidised bDMARD was stopped and the date of the first application under a new treatment cycle.
Compliance with modified Authority Required procedures

 
C4497 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — continuing treatment – balance of supply
Patient must have received insufficient tocilizumab therapy under the Continuing Treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Compliance with modified Authority Required procedures

 
C4502 
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — initial treatment 1 (new patient or patient recommencing treatment after a break of more than 12 months) or initial treatment 2 (change or recommencement of treatment after break of less than 12 months) – balance of supply.
Patient must have received insufficient tocilizumab therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient tocilizumab therapy under the Initial 2 (change or recommencement of treatment after break of less than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Compliance with modified Authority Required procedures

 
C4508
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — continuing treatment
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years;
AND
Patient must have demonstrated an adequate response to treatment with tocilizumab; AND
Patient must have received tocilizumab as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
All applications for continuing treatment with tocilizumab must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with tocilizumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab.
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle.
Compliance with modified Authority Required procedures

 
C4515
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — initial treatment 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; OR
Patient must have received no PBS-subsidised bDMARD treatment for at least 5 years if they failed or ceased to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) in their last treatment cycle; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle. A patient may re-trial tocilizumab after a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in the last treatment cycle and the date of the first application under a new treatment cycle.
Compliance with modified Authority Required procedures

 
C4521
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — continuing treatment
Patient must have a documented history of severe active juvenile idiopathic arthritis; AND
Patient must have demonstrated an adequate response to treatment with tocilizumab; AND
Patient must have received tocilizumab as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
All applications for continuing treatment with tocilizumab must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with tocilizumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab.
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle.
Compliance with modified Authority Required procedures

 
C4541
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — initial treatment 2 (change or recommencement of treatment after break of less than 24 months)
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years;
AND
Patient must have received prior PBS-subsidised treatment with adalimumab, etanercept or tocilizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with tocilizumab for this condition in the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
Applications for a patient who has received PBS-subsidised treatment with tocilizumab in this treatment cycle and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised tocilizumab treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised tocilizumab treatment was approved under either of the Initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised tocilizumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab.
If a patient fails to respond to PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Compliance with modified Authority Required procedures

 
C4542
 
Where the patient is receiving treatment at/from a private or public hospital
 
Severe active juvenile idiopathic arthritis — initial treatment 1 (new patient or patient recommencing treatment after a break of more than 24 months) or initial treatment 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply
Patient must have received insufficient tocilizumab therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient tocilizumab therapy under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Compliance with modified Authority Required procedures

[63]         Schedule 3, entry for Zidovudine
substitute:
Zidovudine
C4454 
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454


 
C4455 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4469 
 
Where the patient is receiving treatment at/from a private hospital
 
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures


 
C4512
 
Where the patient is receiving treatment at/from a public hospital
 
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512