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National Health Act 1953 - Amendment Determinations under sections 85, 85A and 88 - pharmaceutical benefits (No. PB 62 of 2007)

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COMMONWEALTH OF AUSTRALIA
Instrument number PB 62 of 2007
Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953
I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, make this instrument under sections 85, 85A and 88 of the National Health Act 1953.
Dated 14 August 2007
 
STEPHEN DELLAR
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
 
Amendment determination — pharmaceutical benefits
1              Commencement
                This instrument commences on 1 September 2007.
2              Amendment of PB 49 of 2007
                Schedule 1 amends PB 49 of 2007.
Schedule 1        Amendments
(section 2)
 
 
Do not delete : Schedule Part Placeholder
[1]           Part 1 of Schedule 1, after item dealing with Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe
insert in the columns in the order indicated:
 
 
Injection 40 mg in 0.8 mL pre-filled pen
Injection
2
3
Humira
[2]           Part 1 of Schedule 1, item dealing with Ampicillin
omit from the columns in the order indicated:
 

 
Capsule 250 mg (as trihydrate)
Oral
24
1
Alphacin 250

 
Capsule 500 mg (as trihydrate)
Oral
24
..
Alphacin 500

[3]           Part 1 of Schedule 1, after item dealing with Cephazolin
insert in the columns in the order indicated:
 
Cetuximab
Solution for I.V. infusion 100 mg in 50 mL
Injection
6
..
Erbitux
 
 
[4]           Part 1 of Schedule 1, item dealing with Codeine with Paracetamol in the form Tablet containing codeine phosphate 30 mg with paracetamol 500 mg
in the column headed “Brand” insert brand:
Comfarol Forte
after brand: 
Codapane Forte
[5]           Part 1 of Schedule 1, item dealing with Fluconazole in the form Solution for I.V. infusion 100 mg in 50 mL vial
omit from the column headed “Form”:
Solution for I.V. infusion 100 mg in 50 mL vial
and substitute:
Solution for I.V. infusion 100 mg in 50 mL
[6]           Part 1 of Schedule 1, item dealing with Fluconazole in the form Solution for I.V. infusion 200 mg in 100 mL vial
omit from the column headed “Form”:
Solution for I.V. infusion 200 mg in 100 mL vial
and substitute:
Solution for I.V. infusion 200 mg in 100 mL
[7]           Part 1 of Schedule 1, after item dealing with Fluconazole in the form Solution for I.V. infusion 200 mg in 100 mL
insert in the columns in the order indicated:
 
 
Solution for I.V. infusion 400 mg in 200 mL
Injection
1
..
Baxter Healthcare Pty Ltd
 
 
[8]           Part 1 of Schedule 1, item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg
in the column headed “Brand” insert brand:
Hyforil
after brand: 
Fosinopril/HCT Sandoz 10mg/12.5mg
[9]           Part 1 of Schedule 1, item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg, 
in the column headed “Brand” insert brand:
Hyforil
after brand: 
Fosinopril/HCT Sandoz 20mg/12.5mg
[10]         Part 1 of Schedule 1, item dealing with Levonorgestrel in the form Tablets 30 micrograms, 28
omit from the column headed “Brand”: 
Microval 28
[11]         Part 1 of Schedule 1, item dealing with Lumiracoxib in the form Tablet 200 mg
omit from the column headed “Form”:
Tablet 200 mg
and substitute:
Tablet 100 mg
[12]         Part 1 of Schedule 1, items dealing with Meloxicam in the form Tablet 7.5 mg and in the form Tablet 15 mg
in the column headed “Brand” insert brand:
Meloxicam-GA
after brand: 
GenRx Meloxicam
[13]         Part 1 of Schedule 1, item dealing with Omeprazole in the form Tablet 20 mg
in the column headed “Brand” insert brand:
Omeprazole-GA
after brand: 
Meprazol
[14]         Part 1 of Schedule 1, items dealing with Ondansetron in the form I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL and in the form I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
in the column headed “Brand” insert brand:
Onsetron
after brand: 
Ondaz
[15]         Part 1 of Schedule 1, item dealing with “Phenex-1”
omit from the columns in the order indicated:
 
"Phenex-1"
Oral powder 350 g
Oral
8
5
Phenex-1
[16]         Part 1 of Schedule 1, after item dealing with Phenoxybenzamine in the form Capsule containing phenoxybenzamine hydrochloride 10 mg
insert in the columns in the order indicated:
 
 
Capsules containing phenoxybenzamine hydrochloride 10 mg, 30
Oral
3
5
Dibenyline
[17]         Part 1 of Schedule 1, after item dealing with Ramipril in the form Tablet 5 mg
insert in the columns in the order indicated:
 
 
Tablet 10 mg
Oral
30
5
Tritace
[18]         Part 1 of Schedule 1, items dealing with Valproic Acid in the form Tablet (enteric coated) containing sodium valproate 200 mg and in the form Tablet (enteric coated) containing sodium valproate 500 mg
in the column headed “Brand” insert brand:
Sodium Valproate Sandoz
after brand: 
Epilim EC
[19]         Part 2 of Schedule 1, after the last item dealing with Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe
insert in the columns in the order indicated:
 

 
Injection 40 mg in 0.8 mL pre-filled pen
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment with adalimumab within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
Injection
2
5
Humira

 
 
 
 (a) who have a documented history of severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) who have demonstrated an adequate response to treatment with adalimumab; and
 
 
 
 

 
 
 
 (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with adalimumab; and
 
 
 
 

 
 
 
 where bDMARD means adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients who commenced PBS-subsidised bDMARD treatment prior to 1 August 2007 are deemed to have commenced their first bDMARD treatment cycle with that therapy;
 
 
 
 

 
 
 
 an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either 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 a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 the patient has not failed to demonstrate response to a course of PBS-subsidised adalimumab in this Treatment Cycle;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
Injection 40 mg in 0.8 mL pre-filled pen
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
Injection
2
3
Humira

 
 
 
 (1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
 
 
 
 

 
 
 
 (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with either methotrexate or sulfasalazine, at an adequate dose, for a minimum of 3 months; and
 
 
 
 

 
 
 
 (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and
 
 
 
 

 
 
 
 (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by 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 an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;
 
 
 
 

 
 
 
 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
 
 
 
 

 
 
 
 (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and
 
 
 
 

 
 
 
 (3) have not failed treatment with adalimumab during the current Treatment Cycle; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;
 
 
 
 

 
 
 
 patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:
 
 
 
 

 
 
 
 (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and
 
 
 
 

 
 
 
 (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
 
 
 
 

 
 
 
 (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
 
 
 
 

 
 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
Injection 40 mg in 0.8 mL pre-filled pen
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
Injection
2
5
Humira

 
 
 
 (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) were receiving treatment with adalimumab prior to 16 March 2006; and
 
 
 
 

 
 
 
 (3) have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and
 
 
 
 

 
 
 
 (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgment form;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;
 
 
 
 

 
 
 
 patients are eligible for PBS-subsidised treatment under the above criteria once only
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
 
 
 
 

 
 
 
 (1) who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status; and
 
 
 
 

 
 
 
 (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and
 
 
 
 

 
 
 
 (3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 an adequate response to treatment with adalimumab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either 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 a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
Injection 40 mg in 0.8 mL pre-filled pen
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
Injection
2
3
Humira

 
 
 
 (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and
 
 
 
 

 
 
 
 (b) who has at least 2 of the following:
 
 
 
 

 
 
 
 (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
 
 
 
 

 
 
 
 (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
 
 
 
 

 
 
 
 (iii) limitation of chest expansion relative to normal values for age and gender; and
 
 
 
 

 
 
 
 (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
 
 
 
 

 
 
 
 (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response is demonstrated by:
 
 
 
 

 
 
 
 (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
 
 
 
 

 
 
 
 (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;
 
 
 
 

 
 
 
 both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
 
 
 
 

 
 
 
 if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;
 
 
 
 

 
 
 
 if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
 
 
 
 

 
 
 
 an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
 
 
 
 

 
 
 
 if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
 
 
 
 

 
 
 
 the application for authorisation includes:
 
 
 
 

 
 
 
 (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
 
 
 
 

 
 
 
 (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
 
 
 
 

 
 
 
 (ii) a completed BASDAI Assessment Form; and
 
 
 
 

 
 
 
 (iii) a signed patient acknowledgment form; and
 
 
 
 

 
 
 
 (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
 
 
 
 

 
 
 
 a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with adalimumab; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;
 
 
 
 

 
 
 
 the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and
 
 
 
 

 
 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
 
 
 
 

 
 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
 
 
 
 

 
 
 
 if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
Injection 40 mg in 0.8 mL pre-filled pen
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with adalimumab prior to 1 November 2006; and
Injection
2
5
Humira

 
 
 
 (a) who is receiving treatment with adalimumab at the time of application; and
 
 
 
 

 
 
 
 (b) who has not received prior PBS-subsidised treatment with infliximab or etanercept; and
 
 
 
 

 
 
 
 (c) whose current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is either less than or equal to 5 on a 0-10 scale or improved by at least 2 from baseline; and
 
 
 
 

 
 
 
 (d) who has:
 
 
 
 

 
 
 
 (i) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (ii) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
 
 
 
 

 
 
 
 (iii) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; and
 
 
 
 

 
 
 
 (e) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the BASDAI assessment and the ESR and CRP measurements provided are no more than 1 month old at the time of application;
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
 
 
 
 

 
 
 
 (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
 
 
 
 

 
 
 
 (ii) a completed BASDAI Assessment Form; and
 
 
 
 

 
 
 
 (iii) a signed patient acknowledgment form;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;
 
 
 
 

 
 
 
 patients are eligible for PBS-subsidised treatment under the above criteria once only
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 November 2006 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with adalimumab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with adalimumab; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
 
 
 
 

 
 
 
 response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
 
 
 
 

 
 
 
 (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
 
 
 
 

 
 
 
 (c) an ESR or CRP measurement reduced by at least 20% from baseline;
 
 
 
 

 
 
 
 if the patient commenced treatment with adalimumab prior to 1 November 2006, was subsequently commenced on PBS-subsidised treatment and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:
 
 
 
 

 
 
 
 (a) an ESR measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (b) a CRP measurement no greater than 10 mg per L;
 
 
 
 

 
 
 
 all measurements provided are no more than 1 month old at the time of application;
 
 
 
 

 
 
 
 the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;
 
 
 
 

 
 
 
 patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment;
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

[20]         Part 2 of Schedule 1, after item dealing with Ceftriaxone
insert in the columns in the order indicated:
 
Cetuximab
Solution for I.V. infusion 100 mg in 50 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated
Injection
4
6
Erbitux
[21]         Part 2 of Schedule 1, item dealing with Codeine with Paracetamol in the form Tablet containing codeine phosphate 30 mg with paracetamol 500 mg
in the column headed “Brand” insert brand:
Comfarol Forte
after brand: 
Codapane Forte
[22]         Part 2 of Schedule 1, item dealing with Omeprazole in the form Tablet 20 mg
in the column headed “Brand” insert brand:
Omeprazole-GA
after brand: 
Meprazol
[23]         Part 2 of Schedule 1, items dealing with Ondansetron in the form I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL and in the form I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
in the column headed “Brand” insert brand:
Onsetron
after brand: 
Ondaz
[24]         Part 1 of Schedule 3, item dealing with Ampicillin
omit from the columns in the order indicated:
 

 
Capsule 250 mg (as trihydrate)
Oral
24
..
Alphacin 250

 
Capsule 500 mg (as trihydrate)
Oral
24
..
Alphacin 500

[25]         Part 1 of Schedule 3, item dealing with Codeine with Paracetamol in the form Tablet containing codeine phosphate 30 mg with paracetamol 500 mg
in the column headed “Brand” insert brand:
Comfarol Forte
after brand: 
Codapane Forte