National Health Act 1953 Amendment special arrangements under subsection 100(1) Highly Specialised Drugs Program (No. PB 36 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 36 of 2008

Amendment special arrangements under subsection 100(1) of the National Health Act 1953

I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.

Dated 3^rdMarch 2008

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment Special Arrangements — Highly Specialised Drugs Program

1 Commencement

This instrument commences on 1 April 2008.

2 Amendment of PB 92 of 2007

Schedule 1 amends PB 92 of 2007.

Schedule 1 Amendments

[1] Subparagraph 11AA(a)

omit:

and “sildenafil”

and substitute:

, “sildenafil” and “sitaxentan”

[2] Subparagraph 14A(a)

omit:

and “sildenafil”

and substitute:

, “sildenafil” and “sitaxentan”

[3] Subparagraph 14B(b)

(a) omit:

“sildenafil”

and substitute:

“sitaxentan”

(b) omit:

sildenafil

and substitute:

sitaxentan

(c) omit:

March 2007

and substitute:

April 2008

[4] Schedule 1, item dealing with Bosentan

omit all text from the column headed “Circumstances” and substitute:

Initial treatment, for up to six months, of adult patients who have not received prior treatment with iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) and:

(a) who have been assessed by a physician from a designated hospital to have 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) unless RHC is contraindicated on clinical grounds, and who have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; or

(b) who have been assessed by a physician from a designated hospital to have WHO Functional Class III pulmonary arterial hypertension secondary to scleroderma, and a mean right atrial pressure of 8 mmHg or less as measured by RHC unless RHC is contraindicated on clinical grounds, 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 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 is contraindicated 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 indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; 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 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the first supply authorised 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 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, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 5 months of uninterrupted therapy 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

Initial treatment, for up to 6 months, of adult patients who have not received prior treatment with iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) 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) unless RHC is contraindicated on clinical grounds; or

(b) WHO Functional Class III pulmonary arterial hypertension secondary to scleroderma and a mean right atrial pressure greater than 8 mmHg as measured by RHC unless RHC is contraindicated on clinical grounds; or

(d) WHO Functional Class IV pulmonary arterial hypertension secondary to scleroderma; and

where the following conditions apply:

the authority application is made in writing and includes:

(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

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the first supply authorised 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 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;

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

Initial treatment, for up to 6 months, of patients aged less than 18 years who have not received prior treatment with epoprostenol sodium or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS), who have been assessed by a physician from a designated hospital to have World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and either 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, normal right ventricular function as assessed by echocardiography (ECHO), and who have failed to respond to 6 or more weeks of appropriate prior 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:

(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 patient acknowledgment, signed by the parent or authorised guardian, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) details of prior vasodilator treatment, including the dose and duration of treatment; and

(5) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the first supply authorised 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 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;

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

(a) World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and either 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 dysfunction as assessed by echocardiography (ECHO); or

(b) WHO Functional Class IV primary pulmonary hypertension; and

where the following conditions apply:

the authority application is made in writing and includes:

(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

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the first supply authorised 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 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;

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

Initial treatment, for up to 6 months, of adult patients:

(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma, who wish to re-commence bosentan monohydrate treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with bosentan monohydrate; or

(b) who have WHO Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma and whose most recent course of PBS-subsidised treatment was with iloprost trometamol, sildenafil citrate or sitaxentan sodium; or

(c) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with epoprostenol sodium; 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 the first authorisation for PBS-subsidised treatment with bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever was initiated first, was granted; and

(2) the date of the first application which resulted in approval for PBS-subsidised treatment with bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever was initiated first; and

(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium;

the first supply authorised 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 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;

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

Initial treatment, for up to 6 months, of patients aged less than 18 years:

(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, who wish to re-commence bosentan monohydrate treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with bosentan monohydrate; or

(b) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with epoprostenol sodium or 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 the first authorisation for PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate, whichever was initiated first, was granted; and

(2) the date of the first application which resulted in approval for PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium or sildenafil citrate, whichever was initiated first; and

(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised bosentan monohydrate, epoprostenol sodium or sildenafil citrate;

the first supply authorised 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 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;

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

Continuing PBS-subsidised treatment with bosentan monohydrate, for up to 6 months, 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), unless results from all 3 of the tests were included in the application for initial treatment and subsequent ECHO composite assessment and 6MWT results demonstrate stability or improvement of disease in which case RHC composite assessment can be omitted, or, where results from all 3 of the tests specified above were not able to be included in the application for initial treatment, from 1 of the following combinations of tests which are listed in order of decreasing acceptability, provided that, unless contraindicated on clinical grounds, the test results submitted include results from the same tests as were included in the application for initial treatment:

(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 1 or more of the 3 tests above cannot be performed on clinical grounds to enable assessment of response, the reason why the test or tests cannot be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

if less than 6 months of treatment is authorised for the written application under this criterion, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete 6 months of uninterrupted therapy 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

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 scleroderma, who have not responded to bosentan monohydrate therapy; and

where the following conditions apply:

the authority application is 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 and no longer

For the purpose of PBS-subsidised supply of bosentan monohydrate for the circumstances specified above:

Primary pulmonary hypertension and pulmonary arterial hypertension secondary to scleroderma are defined as:

(i) mean 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

Response to bosentan monohydrate or prior vasodilator treatment is defined:

(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(ii) for adult patients with an RHC composite assessment alone at baseline – as an RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(iii) for adult patients with an ECHO composite assessment alone at baseline – as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(iv) for patients aged less than 18 years – as at least 1 of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital

[5] Schedule 1, item dealing with Epoprostenol

omit all text from the column headed “Circumstances” and substitute:

Initial treatment, for up to six months, of adult patients who have not received prior treatment with bosentan monohydrate, iloprost trometamol, sildenafil citrate or sitaxentan sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have 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) unless RHC is contraindicated on clinical grounds, 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:

(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 indicating that the patient understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium for primary pulmonary hypertension, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) details of prior vasodilator treatment, including the dose and duration of treatment; and

(5) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment, for up to 6 months, of adult patients who have not received prior treatment with bosentan monohydrate, iloprost trometamol, sildenafil citrate or sitaxentan sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have:

(b) WHO Functional Class IV primary pulmonary hypertension; and

where the following conditions apply:

the authority application is made in writing and includes:

(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

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment, for up to 6 months, of patients aged less than 18 years who have not received prior treatment with bosentan monohydrate or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have World Health Organisation (WHO) Functional Class III primary pulmonary hypertension and either 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, normal right ventricular function as assessed by echocardiography (ECHO), and who have failed to respond to 6 or more weeks of appropriate prior 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:

(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 patient acknowledgment signed by the parent or authorised guardian, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium, bosentan monohydrate or sildenafil citrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) details of prior vasodilator treatment, including the dose and duration of treatment; and

(5) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

(b) WHO Functional Class IV primary pulmonary hypertension; and

where the following conditions apply:

the authority application is made in writing and includes:

(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 patient acknowledgment, signed by the parent or authorised guardian, indicating that the parent or authorised guardian understands and acknowledges that PBS-subsidised treatment with epoprostenol sodium, bosentan monohydrate or sildenafil citrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment, for up to 6 months, of adult patients:

(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, who wish to re-commence epoprostenol sodium treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with epoprostenol sodium; or

(b) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with bosentan monohydrate, iloprost trometamol, sildenafil citrate or sitaxentan sodium; 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 the first authorisation for PBS-subsidised treatment with epoprostenol sodium, iloprost trometamol, bosentan monohydrate, sildenafil citrate or sitaxentan sodium, whichever was initiated first, was granted; and

(2) the date of the first application which resulted in approval for PBS-subsidised treatment with epoprostenol sodium, iloprost trometamol, bosentan monohydrate, sildenafil citrate or sitaxentan sodium, whichever was initiated first; and

(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised epoprostenol sodium, iloprost trometamol, bosentan monohydrate, sildenafil citrate or sitaxentan sodium;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment, for up to 6 months, of patients aged less than 18 years:

(b) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with bosentan monohydrate or 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 the first authorisation for PBS-subsidised treatment with epoprostenol sodium, bosentan monohydrate or sildenafil citrate, whichever was initiated first, was granted; and

(2) the date of the first application which resulted in approval for PBS-subsidised treatment with epoprostenol sodium, bosentan monohydrate or sildenafil citrate, whichever was initiated first; and

(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised epoprostenol sodium, bosentan monohydrate or sildenafil citrate;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Continuing PBS-subsidised treatment with epoprostenol sodium, for up to 6 months, 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:

(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 1 or more of the 3 tests above cannot be performed on clinical grounds to enable assessment of response, the reason why the test or tests cannot be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

For the purpose of PBS-subsidised supply of epoprostenol sodium for the circumstances specified above:

Primary pulmonary hypertension is defined as:

(i) mean 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

Response to epoprostenol sodium or prior vasodilator treatment is defined:

(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(iv) for patients aged less than 18 years – as at least 1 of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital

[6] Schedule 1, item dealing with Iloprost

omit all text from the column headed “Circumstances” and substitute:

Initial treatment, for up to 6 months, of adult patients who have not received prior treatment with bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) and:

(b) who have been assessed by a physician from a designated hospital to have 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 unless RHC is contraindicated on clinical grounds, and who have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; or

(c) who have been assessed by a physician from a designated hospital to have WHO Functional Class III drug-induced pulmonary arterial hypertension, and a mean right atrial pressure of 8 mmHg or less as measured by RHC unless RHC is contraindicated on clinical grounds, 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:

(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 indicating that the patient understands and acknowledges that PBS-subsidised treatment with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with epoprostenol sodium for primary pulmonary hypertension, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) details of prior vasodilator treatment, including the dose and duration of treatment; and

(5) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

(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 unless RHC is contraindicated on clinical grounds; or

(c) WHO Functional Class III drug-induced pulmonary arterial hypertension and a mean right atrial pressure greater than 8 mmHg as measured by RHC unless RHC is contraindicated on clinical grounds; or

(d) WHO Functional Class IV primary pulmonary hypertension; or

(e) WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; or

(f) WHO Functional Class IV drug-induced pulmonary arterial hypertension; and

where the following conditions apply:

the authority application is made in writing and includes:

(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

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment, for up to 6 months, of adult patients:

(a) who have World Health Organisation (WHO) Functional Class III or IV primary pulmonary hypertension, WHO Functional Class III or IV drug-induced pulmonary arterial hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to connective tissue disease, who wish to re-commence iloprost trometamol treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with iloprost trometamol; or

(c) who have WHO Functional Class III or IV primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with epoprostenol sodium; or

(d) who have WHO Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with sildenafil citrate; or

(e) who have WHO Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with sitaxentan sodium; 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 the first authorisation for PBS-subsidised treatment with iloprost trometamol, bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever was initiated first, was granted; and

(2) the date of the first application which resulted in approval for PBS-subsidised treatment with iloprost trometamol, bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever was initiated first; and

(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised iloprost trometamol, bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium;

the supply authorised under this criterion provides for up to a maximum of 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Continuing PBS-subsidised treatment with iloprost trometamol, for up to 6 months, of adult 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:

(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 1 or more of the 3 tests above cannot be performed on clinical grounds to enable assessment of response, the reason why the test or tests cannot be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

For the purpose of PBS-subsidised supply of iloprost trometamol for the circumstances specified above:

Primary pulmonary hypertension, drug-induced pulmonary arterial hypertension and pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma are defined as:

(i) mean 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

Response to iloprost trometamol or prior vasodilator treatment is defined:

(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

[7] Schedule 1, item dealing with Sildenafil

omit all text from the column headed “Circumstances” and substitute:

Initial treatment, for up to 6 months, of patients who have not received prior treatment with bosentan monohydrate, iloprost trometamol, epoprostenol sodium or sitaxentan sodium subsidised under the Pharmaceutical Benefits Scheme (PBS) and:

where the following conditions apply:

the authority application is made in writing and includes:

(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 indicating that the patient understands and acknowledges that PBS-subsidised treatment with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, or with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) details of prior vasodilator treatment, including the dose and duration of treatment; and

(5) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

where the following conditions apply:

the authority application is made in writing and includes:

(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

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment, for up to 6 months, of patients:

(a) who have World Health Organisation (WHO) Functional Class III primary pulmonary hypertension or WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease, who wish to re-commence sildenafil citrate treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to 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 WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with iloprost trometamol; or

(c) who have WHO Functional Class III primary pulmonary hypertension or WHO Functional Class III pulmonary arterial hypertension secondary to scleroderma and whose most recent course of PBS-subsidised treatment was with bosentan monohydrate; or

(d) who have WHO Functional Class III primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with epoprostenol sodium; or

(e) who have WHO Functional Class III primary pulmonary hypertension or WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and whose most recent course of PBS-subsidised treatment was with sitaxentan sodium; 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 the first authorisation for PBS-subsidised treatment with sildenafil citrate, epoprostenol sodium, iloprost trometamol, bosentan monohydrate or sitaxentan sodium, whichever was initiated first, was granted; and

(2) the date of the first application which resulted in approval for PBS-subsidised treatment with sildenafil citrate, epoprostenol sodium, iloprost trometamol, bosentan monohydrate or sitaxentan sodium, whichever was initiated first; and

(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised sildenafil citrate, epoprostenol sodium, iloprost trometamol, bosentan monohydrate or sitaxentan sodium;

the supply authorised under this criterion provides for up to a maximum of 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Continuing PBS-subsidised treatment with sildenafil citrate, for up to 6 months, 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:

(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 1 or more of the 3 tests above cannot be performed on clinical grounds to enable assessment of response, the reason why the test or tests cannot be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

For the purpose of PBS-subsidised supply of sildenafil citrate for the circumstances specified above:

Primary pulmonary hypertension and pulmonary arterial hypertension secondary to connective tissue disease, are defined as:

(i) mean 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

Response to sildenafil citrate or prior vasodilator treatment is defined:

(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(iv) for patients aged less than 18 years – as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital

[9] Schedule 1, after item dealing with Sirolimus

insert in the columns in the order indicated:

Sitaxentan	Initial treatment, for up to 6 months, of patients who have not received prior treatment with bosentan monohydrate, iloprost trometamol, epoprostenol sodium or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and:
(a) who have been assessed by a physician from a designated hospital to have 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) unless RHC is contraindicated on clinical grounds, and who have failed to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; or
(b) who have been assessed by a physician from a designated hospital to have 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 unless RHC is contraindicated on clinical grounds, 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 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 is contraindicated 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 indicating that the patient understands and acknowledges that PBS-subsidised treatment with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) details of prior vasodilator treatment, including the dose and duration of treatment; and

(5) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment, for up to 6 months, of patients who have not received prior treatment with bosentan monohydrate, iloprost trometamol, epoprostenol sodium or sildenafil citrate subsidised under the Pharmaceutical Benefits Scheme (PBS) and who have been assessed by a physician from a designated hospital to have:

where the following conditions apply:

the authority application is made in writing and includes:

(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 indicating that the patient understands and acknowledges that PBS-subsidised treatment with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(3) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial PBS-subsidised supply for continuing treatment, for up to 6 months, of patients who were receiving treatment with sitaxentan sodium prior to 1 April 2008, who have not received prior PBS-subsidised treatment with bosentan monohydrate, iloprost trometamol, epoprostenol sodium or sildenafil citrate 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; or

(b) WHO Functional Class III 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) for patients who have received less than 6 months of sitaxentan sodium treatment at the time of application - a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results, as measured at the time that the patient commenced treatment with sitaxentan sodium, from a right heart catheterisation (RHC) composite assessment plus echocardiography (ECHO) composite assessment plus 6 minute walk test (6MWT), or, where results from all 3 of the tests are not available or it was 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:

(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; or

(b) for patients who have received 6 or more months of sitaxentan sodium treatment at the time of application - a completed copy of the appropriate Pulmonary Arterial Hypertension PBS Authority Application – Supporting Information form which includes results, as measured both at the time that the patient commenced treatment with sitaxentan sodium and at the time of application, from a RHC composite assessment plus ECHO composite assessment plus 6MWT, or, where results as at commencement of treatment are not available for all 3 of the tests or where it is, or was at commencement of treatment, 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:

(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) the date of commencement of sitaxentan sodium treatment; and

(3) a signed patient acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with sitaxentan sodium for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with sildenafil citrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with epoprostenol sodium for primary pulmonary hypertension, or with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, or with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, will cease if the treating physician determines that the patient has not achieved a response to treatment; and

(4) where 1 or more of the 3 tests listed above are not able to be performed on clinical grounds, a reason outlining why the particular test or tests could not be conducted;

for patients who have received less than 6 months of sitaxentan sodium treatment at the time of application – the supply authorised under this criterion provides sufficient to allow the patient to complete a total of 6 months of combined PBS-subsidised and non-PBS-subsidised therapy;

for patients who have received 6 or more months of sitaxentan sodium treatment at the time of application – the supply authorised under this criterion provides for up to 6 months of therapy;

if the supply initially authorised under this criterion is less than that to which the patient is entitled, a subsequent authority application under this criterion for a supply sufficient to enable the patient to complete the maximum allowable duration of treatment may be submitted by telephone;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Initial treatment, for up to 6 months, of patients:

(a) who have World Health Organisation (WHO) Functional Class III primary pulmonary hypertension or WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease, who wish to re-commence sitaxentan sodium treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) after a break in therapy and who have been assessed by a physician from a designated hospital to have demonstrated a response to their most recent course of PBS-subsidised treatment with sitaxentan sodium; or

(d) who have WHO Functional Class III primary pulmonary hypertension and whose most recent course of PBS-subsidised treatment was with epoprostenol sodium; or

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 the first authorisation for PBS-subsidised treatment with sitaxentan sodium, sildenafil citrate, epoprostenol sodium, iloprost trometamol or bosentan monohydrate, whichever was initiated first, was granted; and

(2) the date of the first application which resulted in approval for PBS-subsidised treatment with sitaxentan sodium, sildenafil citrate, epoprostenol sodium, iloprost trometamol or bosentan monohydrate, whichever was initiated first; and

(3) the results of the patient’s response to treatment with their most recent course of PBS-subsidised sitaxentan sodium, sildenafil citrate, epoprostenol sodium, iloprost trometamol or bosentan monohydrate;

the supply authorised under this criterion provides for up to a maximum of 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

Continuing PBS-subsidised treatment with sitaxentan sodium, for up to 6 months, of patients who have received approval for initial PBS-subsidised treatment with sitaxentan sodium and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of sitaxentan sodium treatment; and

where the following conditions apply:

the authority application is made in writing and includes:

(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 1 or more of the 3 tests above cannot be performed on clinical grounds to enable assessment of response, the reason why the test or tests cannot be conducted;

the supply authorised under this criterion provides for up to 6 months of treatment;

determination of a quantity sufficient to provide 1 month of therapy is based on the dosage recommendations in the TGA-approved Product Information

For the purpose of PBS-subsidised supply of sitaxentan sodium for the circumstances specified above:

Primary pulmonary hypertension and pulmonary arterial hypertension secondary to connective tissue disease, are defined as:

(i) mean 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

Response to sitaxentan sodium or prior vasodilator treatment is defined:

(i) for adult patients with 2 or more baseline tests – as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital;

(iv) for patients aged less than 18 years – as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital

[10] Schedule 1, item dealing with Tacrolimus

(a) insert in the column headed “Circumstances” after the last word in paragraph (b):

; or

(b) insert in the column headed “Circumstances” after paragraph (b):

(c) prophylaxis and treatment of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as required

[11] Schedule 2, after items dealing with Sirolimus

insert in the columns in the order indicated:

Sitaxentan

Tablet containing sitaxentan sodium 100 mg

Oral

Thelin