National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 2) (No. PB 20 of 2012)

Link to law: https://www.comlaw.gov.au/Details/F2012L00716

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PB 20 of 2012
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 2)
 
National Health Act 1953
___________________________________________________________________________
 
 
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, 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 2012
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
 
___________________________________________________________________________
 
 
 
 
1              Name of Instrument
 
(1)                This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No.2).
 
(2)                This Instrument may also be cited as PB 20 of 2012.
 
2             Commencement
This Instrument commences on 1 April 2012.
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]     Section 4, definition of CAR drug
omit:
(o) tocilizumab
substitute:
(o) tadalafil
(p) tocilizumab
[2]     Section 4, definition of medication for the treatment of HIV or AIDS
omit:
(z) ritonavir;
(za) saquinavir;
(zb) stavudine;
(zc) tenofovir;
(zd) tenofovir with emtricitabine;
(ze) tenofovir with emtricitabine and efavirenz;
(zf) valaciclovir;
(zg) valganciclovir;
(zh) zidovudine.
substitute:
(z) rilpivirine
(za) ritonavir;
(zb) saquinavir;
(zc) stavudine;
(zd) tenofovir;
(ze) tenofovir with emtricitabine;
(zf) tenofovir with emtricitabine and efavirenz;
(zg) valaciclovir;
(zh) valganciclovir;
(zi) zidovudine.
 
 
[3]    Section 4, Definitions, after streamlined authority code
Insert:
 
under co-payment data means information relating to a supply of a HSD pharmaceutical benefit by an approved pharmacist or approved hospital authority for a hospital where a claim is not payable as the dispensed price for the supply of the HSD pharmaceutical benefit does not exceed the amount that the supplier was entitled to charge under subsection 46(2) or subsection 47(2) of this Special Arrangement.
Note: A State or Territory may make an off-line claim under section 28 of this Special Arrangement for supply of a HSD pharmaceutical benefit by a non-approved hospital authority for a public hospital. The definition of under co-payment data does not apply to a non-approved hospital authority.
  
[4]    paragraph 24(2)(a)
substitute:
(a)      for HSD pharmaceutical benefits that have the drug ambrisentan, bosentan, epoprostenol, etanercept, iloprost, sildenafil or tadalafil – a quantity of units sufficient for up to 1 month of treatment with the drug;
[5]    paragraph 25(2)(l)
substitute:
(l)        for epoprostenol, iloprost, sildenafil, or tadalafil — up to 5 repeat supplies;
[6]    after paragraph 51(e)
insert:
(f)       the rules made under subsection 98AC(4) of the Act apply to a supply of a HSD pharmaceutical benefit by an approved pharmacist or approved hospital authority for a hospital under this Special Arrangement as if the definition of under co-payment data appearing in those rules was replaced with the definition of under co-payment data in section 4 of this Special Arrangement.
 
[7]     Schedule 1, entry for Ambrisentan
omit from the column headed “Circumstances”(all instances):
C3211  C3212
insert after C3215 (all instances):
C4019  C4020
[8]    Schedule 1, entry for Bosentan
omit from the column headed “Circumstances”(all instances):
C3013  C3155  C3156  C3157  C3158  C3159  C3160  C3161
insert after C3162 (all instances):
C4009  C4010  C4011  C4012
[9]    Schedule 1, entry for Epoprostenol
substitute:

Epoprostenol
Powder for I.V. infusion, 500 micrograms (as sodium) infusion administration set
Injection
Flolan Kit
GK
EMP
C3167 C4013 C4014
 
See Note 1
See Note 2
D

 
Powder for I.V. infusion, 1.5 mg (as sodium) infusion administration set
Injection
Flolan Kit
GK
EMP
C3167 C4013 C4014
 
See Note 1
See Note 2
D

 
[10]  Schedule 1, entry for Iloprost
omit from the column headed “Circumstances”:
C3168  C3169
insert after C3171:
C4015  C4016
[11]  Schedule 1, entry for Mycophenolic Acid
substitute:

Mycophenolic Acid
Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid
Oral
Myfortic
NV
EMP
C1650 C3355
 
240
5
D

 
Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid
Oral
Myfortic
NV
EMP
C1650 C3355
 
240
5
D

 
Capsule containing mycophenolate mofetil 250 mg
Oral
APO-Mycophenolate
TX
EMP
C1650 C1651 C3355 C3356
 
600
5
D

 
 
 
CellCept
RO
EMP
C1650 C1651 C3355 C3356
 
600
5
D

 
 
 
Ceptolate
AF
EMP
C1650 C1651 C3355 C3356
 
600
5
D

 
 
 
Imulate
QA
EMP
C1650 C1651 C3355 C3356
 
600
5
D

 
 
 
Mycophenolate Sandoz
SZ
EMP
C1650 C1651 C3355 C3356
 
600
5
D

 
Tablet containing mycophenolate mofetil 500 mg
Oral
APO-Mycophenolate
TX
EMP
C1650 C1651 C3355 C3356
 
300
5
D

 
 
 
CellCept
RO
EMP
C1650 C1651 C3355 C3356
 
300
5
D

 
 
 
Ceptolate
AF
EMP
C1650 C1651 C3355 C3356
 
300
5
D

 
 
 
Imulate
QA
EMP
C1650 C1651 C3355 C3356
 
300
5
D

 
 
 
Mycophenolate Sandoz
SZ
EMP
C1650 C1651 C3355 C3356
 
300
5
D

 
Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL
Oral
CellCept
RO
EMP
C1650 C1651 C3355 C3356
 
2
5
D

 
[12]  Schedule 1, after entry for Nevirapine in the form Tablet 200 mg
insert:
 
Tablet 400 mg (extended release)
Oral
Viramune XR
BY
EMP
C3587 C3589 C3994 C3995
 
60
5
D
[13]  Schedule 1, after entry for Rifabutin
insert:
Rilpivirine
Tablet 25 mg (as hydrochloride)
Oral
Edurant
JC
EMP
C3586 C3587 C3588 C3589
 
60
5
D
[14]  Schedule 1, entry for Sildenafil
omit from the column headed “Circumstances”:
C3172  C3173
insert after C3175:
C4017  C4018
[15]  Schedule 1, after entry for Tacrolimus
insert:
Tadalafil
Tablet 20 mg
Oral
Adcirca
LY
EMP
C4021 C4022 C4023 C4024
 
See Note 1
See Note 2
D
 
[16]  Schedule 1, entry for Tocilizumab
omit from the column headed “Circumstances” (all instances):
C3480
[17]  Schedule 2, after entry for AB
insert:
 
AF
Alphapharm Pty Ltd
 93 002 359 739
 
[18]  Schedule 2, after entry for JC
insert:
 
LY
Eli Lilly Australia Pty Ltd
 39 000 233 992
 
[19]  Schedule 2, after entry for PF
insert:
 
QA
Aspen Pharma Pty Ltd
 88 004 118 594
 
[20]  Schedule 2, after entry for SZ
insert:
 
TX
Apotex Pty Ltd
 52 096 916 148
 
[21]  Schedule 3, entry for Ambrisentan
substitute:

Ambrisentan
 
 
Definitions
For the purpose of PBS-subsidised supply of ambrisentan for C3214, C3215, C4019 and C4020:
 
“PAH agent” means ambrisentan, bosentan, epoprostenol, iloprost, sildenafil or sitaxentan
 
“Primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease” means:
 
(i) pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or
(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or
(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function
 

 
C3214
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment
(change or re-commencement for all patients)
Initial treatment with ambrisentan of patients:
(a) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, who wish to re-commence PBS-subsidised ambrisentan after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with ambrisentan; or
(b) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with an alternate PAH agent other than ambrisentan; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes the test results based on which approval for the first application for PBS-subsidised PAH agent was granted; and 
(2) the date off the first application for PBS-subsidised treatment with a PAH agent; and
(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent; and
(4) where fewer than 3 tests (see requirement 1 above) are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C3215
 
Where the patient is receiving treatment at/from a private or public hospital
Continuing treatment
(all patients)
Continuing PBS-subsidised treatment with ambrisentan of patients who have received approval for initial PBS-subsidised treatment with ambrisentan and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of ambrisentan treatment; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that the test results included in the application are from the same tests as were conducted at baseline, except for patients who were able to undergo all 3 tests at baseline and whose subsequent ECHO composite assessment and 6MWT results demonstrate disease stability or improvement, in which case RHC composite assessment can be omitted:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) ECHO composite assessment plus 6MWT; or
(iv) RHC composite assessment alone; or
(v) ECHO composite assessment alone; and
(2) where the same test or tests conducted at baseline cannot be performed on clinical grounds for assessment of response, a patient specific reason why the test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4019
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment 1
(new patients)
Initial PBS-subsidised treatment with ambrisentan of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure of 8 mmHg or less, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure of 8 mmHg or less, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; and
where the patient has failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form; and
(3) details of prior vasodilator treatment, including the dose and duration of treatment; and
(4) where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and
(5) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4020
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment 2
(new patients)
Initial PBS-subsidised treatment with ambrisentan of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; or
(c) WHO Functional Class IV primary pulmonary hypertension; or
(d) WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form; and
(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
[22]  Schedule 3, entry for Bosentan
substitute:

Bosentan
 
 
Definitions
For the purpose of PBS-subsidised supply of bosentan for C3162, C4009, C4010, C4011 and C4012:
 
“PAH agent” means ambrisentan, bosentan, epoprostenol, iloprost, sildenafil or sitaxentan
 
“Primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease” means:
 
(i) pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or
(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or
(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function
 

 
C3162
 
Where the patient is receiving treatment at/from a private or public hospital
Continuing treatment
(all patients)
Continuing PBS-subsidised treatment with bosentan monohydrate of patients who have received approval for initial PBS-subsidised treatment with bosentan monohydrate and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of bosentan monohydrate treatment; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that the test results included in the application are from the same tests as were conducted at baseline, except for patients who were able to undergo all 3 tests at baseline and whose subsequent ECHO composite assessment and 6MWT results demonstrate disease stability or improvement, in which case RHC composite assessment can be omitted:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) ECHO composite assessment plus 6MWT; or
(iv) RHC composite assessment alone; or
(v) ECHO composite assessment alone; and
(2) where the same test or tests conducted at baseline cannot be performed on clinical grounds for assessment of response, a patient specific reason why the test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4009
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment 1
(new patient)
Initial PBS-subsidised treatment with bosentan monohydrate of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure of 8 mmHg or less, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure of 8 mmHg or less, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; and
where the patient has failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form; and
(3) details of prior vasodilator treatment, including the dose and duration of treatment; and
(4) where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and
(5) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
the first supply authorised for the written application under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;
the second supply authorised for the written application under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;
if less than 5 months of treatment is authorised for the second supply under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 5 months of treatment may be submitted by telephone;
determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4010
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment 2
(new patient)
Initial PBS-subsidised treatment with bosentan monohydrate of adult patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; or
(c) WHO Functional Class IV primary pulmonary hypertension; or
(d) WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; or
(e) WHO Functional Class III or IV pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology); and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form; and
(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
the first supply authorised for the written application under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;
the second supply authorised for the written application under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;
if less than 5 months of treatment is authorised for the second supply under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 5 months of treatment may be submitted by telephone;
determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4011
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment
(change or re-commencement for all patients)
Initial treatment with bosentan monohydrate of patients:
(a) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology), who wish to re-commence PBS-subsidised bosentan monohydrate after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with bosentan monohydrate; or
(b) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with an alternate PAH agent other than bosentan monohydrate; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes the test results based on which approval for the first application for PBS-subsidised PAH agent was granted; and
(2) the date of the first application for PBS-subsidised treatment with a PAH agent; and
(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent; and
(4) where fewer than 3 tests (see requirement 1 above) are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
the first supply authorised for the written application under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient for 1 month of treatment;
the second supply authorised for the written application under this criterion provides for up to a maximum of 5 months of treatment with the 62.5 mg or the 125 mg strength tablet;
if less than 5 months of treatment is authorised for the second supply under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 5 months of treatment may be submitted by telephone;
determination of a quantity of the 62.5 mg or the 125 mg strength tablet sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4012
 
Where the patient is receiving treatment at/from a private or public hospital
Cessation of treatment
(all patients)
Final PBS-subsidised supply to allow for gradual cessation of treatment for patients with World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, or WHO Functional Class III or IV pulmonary arterial hypertension secondary to connective tissue disease, or WHO Functional Class III or IV pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology), who have not responded to bosentan monohydrate therapy; and
where the following conditions apply:
the authority application may be submitted by telephone;
the supply authorised under this criterion is limited to the provision of a quantity of the 62.5 mg strength tablet sufficient to allow gradual dose reduction over a period of 1 month
Compliance with modified Authority Required procedures

 
[23]  Schedule 3. entry for Epoprostenol
substitute:

Epoprostenol
 
 
Definitions
For the purpose of PBS-subsidised supply of epopostenol for C3167, C4013 and C4014:
 
“PAH agent” means ambrisentan, bosentan, epoprostenol, iloprost, sildenafil or sitaxentan
 
“Primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease” means:
 
(i) pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or
(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or
(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function
 

 
C3167
 
Where the patient is receiving treatment at/from a private or public hospital
Continuing treatment
(all patients)
Continuing PBS-subsidised treatment with epoprostenol sodium of patients who have received approval for initial PBS-subsidised treatment with epoprostenol sodium and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of epoprostenol sodium treatment; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that the test results included in the application are from the same tests as were conducted at baseline, except for patients who were able to undergo all 3 tests at baseline and whose subsequent ECHO composite assessment and 6MWT results demonstrate disease stability or improvement, in which case RHC composite assessment can be omitted:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) ECHO composite assessment plus 6MWT; or
(iv) RHC composite assessment alone; or
(v) ECHO composite assessment alone; and
(2) where the same test or tests conducted at baseline cannot be performed on clinical grounds for assessment of response, a patient specific reason why the test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4013
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment
(new patients)
Initial PBS-subsidised treatment with epoprostenol sodium of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class IV primary pulmonary hypertension; or
(b) World Health Organisation (WHO) Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form; and
(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4014
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment
(change or re-commencement for all patients)
Initial PBS-subsidised treatment with epoprostenol sodium of patients:
(a) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, and who wish to re-commence PBS-subsidised epoprostenol sodium after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with epoprostenol sodium; or
(b) who have World Health Organisation (WHO) Functional Class IV primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease and who have received prior treatment with a PBS-subsidised PAH agent other than epoprostenol sodium; or
(c) who have WHO Functional Class III primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease and who have failed to respond to a prior PBS-subsidised PAH agent; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes the test results based on which approval for the first application for PBS-subsidised PAH agent was granted; and
(2) the date of the first application for PBS-subsidised treatment with a PAH agent; and
(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent; and
(4) for WHO Functional Class III patients, where this is the first application for epoprostenol sodium, assessment details of the PBS-subsidised PAH agent they have failed to respond to; and
(5) where fewer than 3 tests (see requirement 1 above) are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
[24]  Schedule 3, entry for Iloprost
substitute:

Iloprost
 
 
Definitions
For the purpose of PBS-subsidised supply of iloprost for C3170, C3171, C4015 and C4016:
 
“PAH agent” means ambrisentan, bosentan, epoprostenol, iloprost, sildenafil or sitaxentan
 
“Primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease” means:
 
(i) pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or
(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or
(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function
 

 
C3170
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment
(change or re-commencement for all patients)
Initial PBS-subsidised treatment with iloprost trometamol of patients:
(a) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, who wish to re-commence PBS-subsidised iloprost trometamol after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with iloprost trometamol; or
(b) who have World Health Organisation (WHO) Functional Class IV primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease and who have received prior treatment with a PBS-subsidised PAH agent other than iloprost trometamol; or
(c) who have WHO Functional Class III primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease and who have failed to respond to a prior PBS-subsidised PAH agent; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes the test results based on which approval for the first application for PBS-subsidised PAH agent was granted; and
(2) the date of the first application for PBS-subsidised treatment with a PAH agent; and
(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent; and
(4) for WHO Functional Class III patients, where this is the first application for iloprost trometamol, assessment details of the PBS-subsidised PAH agent they have failed to respond to; and
(5) where fewer than 3 tests (see requirement 1 above) are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C3171
 
Where the patient is receiving treatment at/from a private or public hospital
Continuing treatment
(all patients)
Continuing PBS-subsidised treatment with iloprost trometamol of patients who have received approval for initial PBS-subsidised treatment with iloprost trometamol and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of iloprost trometamol treatment; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that the test results included in the application are from the same tests as were conducted at baseline, except for patients who were able to undergo all 3 tests at baseline and whose subsequent ECHO composite assessment and 6MWT results demonstrate disease stability or improvement, in which case RHC composite assessment can be omitted:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) ECHO composite assessment plus 6MWT; or
(iv) RHC composite assessment alone; or
(v) ECHO composite assessment alone; and
(2) where the same test or tests conducted at baseline cannot be performed on clinical grounds for assessment of response, a patient specific reason why the test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4015
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment 1
(new patients)
Initial PBS-subsidised treatment with iloprost trometamol of patients who have not received prior PBS-subsidised treatment with iloprost, who have been assessed by a physician from a designated hospital to have World Health Organisation (WHO) Functional Class III drug-induced pulmonary arterial hypertension and a mean right atrial pressure of 8 mmHg or less, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO), and who have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form; and
(3) details of prior vasodilator treatment, including the dose and duration of treatment; and
(4) where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and
(5) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4016
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment 2
(new patients)
Initial PBS-subsidised treatment with iloprost trometamol of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III drug-induced pulmonary arterial hypertension and a mean right atrial pressure greater than 8 mmHg, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds; right ventricular function as assessed by echocardiography (ECHO); or
(b) WHO Functional Class IV primary pulmonary hypertension; or
(c) WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; or
(d) WHO Functional Class IV drug-induced pulmonary arterial hypertension; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form; and
(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
[25]  Schedule 3, entry for Nevirapine
insert in numerical order following the last circumstance:

 
C3994
 
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 who has been stabilised on nevirapine immediate release with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures

 
C3995
 
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 who has been stabilised on nevirapine immediate release 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 3995

 
[26]  Schedule 3, after entry for Rifabutin
insert:

Rilpivirine
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

 
[27]  Schedule 3, entry for Sildenafil
substitute:

Sildenafil
 
 
Definitions
For the purpose of PBS-subsidised supply of sildenafil for C3174, C3175, C4017 and C4018:
 
“PAH agent” means ambrisentan, bosentan, epoprostenol, iloprost, sildenafil or sitaxentan
 
“Primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease” means:
 
(i) pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or
(ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or
(iii) where right heart catheterisation cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function
 
 

 
C3174
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment
(change or re-commencement for all patients)
Initial PBS-subsidised treatment with sildenafil citrate of patients:
(a) who have World Health Organisation (WHO) Functional Class III primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, who wish to re-commence PBS-subsidised sildenafil citrate after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with sildenafil citrate; or
(b) who have WHO Functional Class III primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with a PAH agent other than sildenafil citrate; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes the test results based on which approval for the first application for PBS-subsidised PAH agent was granted; and
(2) the date of the first application for PBS-subsidised treatment with a PAH agent; and
(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent; and
(4) where fewer than 3 tests (see requirement 1 above) are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C3175
 
Where the patient is receiving treatment at/from a private or public hospital
Continuing treatment
(all patients)
Continuing PBS-subsidised treatment with sildenafil citrate of patients who have received approval for initial PBS-subsidised treatment with sildenafil citrate and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of sildenafil citrate treatment; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that the test results included in the application are from the same tests as were conducted at baseline, except for patients who were able to undergo all 3 tests at baseline and whose subsequent ECHO composite assessment and 6MWT results demonstrate disease stability or improvement, in which case RHC composite assessment can be omitted:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) ECHO composite assessment plus 6MWT; or
(iv) RHC composite assessment alone; or
(v) ECHO composite assessment alone; and
(2) where the same test or tests conducted at baseline cannot be performed on clinical grounds for assessment of response, a patient specific reason why the test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4017
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment 1
(new patients)
Initial PBS-subsidised treatment with sildenafil citrate of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure of 8 mmHg or less, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure of 8 mmHg or less, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; and
where the patient has failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form; and
(3) details of prior vasodilator treatment, including the dose and duration of treatment; and
(4) where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and
(5) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4018
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment 2
(new patients)
Initial PBS-subsidised treatment with sildenafil citrate of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form; and
(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
 
 
[28]  Schedule 3, after entry for Tacrolimus
insert:

Tadalafil
C4021
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment 1
(new patients)
Initial PBS-subsidised treatment with tadalafil of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure of 8 mmHg or less, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure of 8 mmHg or less, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; and
where the patient has failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form; and
(3) details of prior vasodilator treatment, including the dose and duration of treatment; and
(4) where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information, details on the nature of the adverse event or contraindication; and
(5) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4022
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment 2
(new patients)
Initial PBS-subsidised treatment with tadalafil of patients who have not received prior PBS-subsidised treatment with a PAH agent and who have been assessed by a physician from a designated hospital to have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg, as measured by right heart catheterisation (RHC), or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by echocardiography (ECHO); or
(b) WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC, or, where RHC cannot be performed on clinical grounds, right ventricular function as assessed by ECHO; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a RHC composite assessment plus ECHO composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that 1 of the test results submitted is a RHC composite assessment, unless RHC cannot be performed on clinical grounds:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) RHC composite assessment alone; or
(iv) ECHO composite assessment plus 6MWT; or
(v) ECHO composite assessment alone; and
(2) a signed patient acknowledgment form; and
(3) where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4023
 
Where the patient is receiving treatment at/from a private or public hospital
Initial treatment
(change or re-commencement for all patients)
Initial treatment with tadalafil of patients who have:
(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, who wish to re-commence PBS-subsidised tadalafil after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with tadalafil; or
(b) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with a PAH agent other than tadalafil; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes the test results based on which approval for the first application for PBS-subsidised PAH agent was granted; and
(2) the date of the first application for PBS-subsidised treatment with a PAH agent; and
(3) the results of the patient's response to treatment with their last course of PBS-subsidised PAH agent; and
(4) where fewer than 3 tests (see requirement 1 above) are able to be performed on clinical grounds, a patient specific reason outlining why the particular test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
C4024
 
Where the patient is receiving treatment at/from a private or public hospital
Continuing treatment
(all patients)
Continuing PBS-subsidised treatment with tadalafil of patients who have received approval for initial PBS-subsidised treatment with tadalafil and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of tadalafil treatment; and
where the following conditions apply:
the authority application is made in writing and includes:
(1) a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where it is not possible on clinical grounds to perform all 3 of the tests, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that the test results included in the application are from the same tests as were conducted at baseline, except for patients who were able to undergo all 3 tests at baseline and whose subsequent ECHO composite assessment and 6MWT results demonstrate disease stability or improvement, in which case RHC composite assessment can be omitted:
(i) RHC composite assessment plus ECHO composite assessment; or
(ii) RHC composite assessment plus 6MWT; or
(iii) ECHO composite assessment plus 6MWT; or
(iv) RHC composite assessment alone; or
(v) ECHO composite assessment alone; and
(2) where the same test or tests conducted at baseline cannot be performed on clinical grounds for assessment of response, a patient specific reason why the test or tests could not be conducted;
a maximum of 6 months of treatment will be authorised under this criterion;
if less than 6 months of treatment is authorised for the written application under this criterion, subsequent authority applications under this criterion for supplies sufficient to enable the patient to complete 6 months of treatment may be submitted by telephone;
determination of a quantity of the drug sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information
Compliance with modified Authority Required procedures

 
 
[29]  Schedule 3, entry for Tocilizumab
substitute:

Tocilizumab
C3716
 
Where the patient is receiving treatment at/from a private or public hospital
Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with tocilizumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) 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:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) 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 — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes 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, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) 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
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is 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 are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are 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 authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with tocilizumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone
Compliance with modified Authority Required procedures

 
C3825
 
Where the patient is receiving treatment at/from a private or public hospital
Rheumatoid arthritis — continuing treatment
Continuing PBS-subsidised treatment with tocilizumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with tocilizumab; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with tocilizumab; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) 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
(b) either of the following:
(i) 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
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/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 an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and 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 tocilizumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of tocilizumab therapy is 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;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment;
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone
Compliance with modified Authority Required procedures

 
C3826
 
Where the patient is receiving treatment at/from a private or public hospital
Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with tocilizumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with tocilizumab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with tocilizumab are not eligible to commence treatment with tocilizumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with tocilizumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised tocilizumab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised tocilizumab treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone
Compliance with modified Authority Required procedures

 
Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.  See http://www.frli.gov.au.