National Health Act 1953 Amendment Special Arrangements under subsection 100(1) Highly specialised drugs program for public hospitals (No. PB 72 of 2009) (Cth)
Case
Special Arrangements – Highly specialised drugs program
(PB 72 of 2009)
Amendment Special Arrangements —Highly specialised drugs program for public hospitals
(PB 72 of 2009)
made under subsection 100(1) of the
National Health Act 1953
I, DECLAN O’CONNOR-COX, Assistant Secretary, Access and Systems 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 23 July 2009
DECLAN O’CONNOR-COX
Assistant Secretary
Access and Systems Branch
Department of Health and Ageing
Amendment Special Arrangements — Highly specialised drugs program for public hospitals
1 Commencement
This instrument commences on 1 August 2009.
2 Amendment of PB 61 of 2009
Schedule 1 amends PB 61 of 2009.
Schedule 1 Amendments
Paragraph 22
(a)omit subparagraph (b)
(b)re-name subsequent subparagraphs as (b) to (k)
Paragraph 23
omit subparagraphs (a), (b), (c) and (d) and substitute:
(a) in the case of a prescription for the balance of a 6 month course of initial treatment for patients who have been issued with an authority prescription for the first month of the 6 month course, up to 4 repeat supplies of the highly specialised drug may be authorised;
(b) in the case of a prescription for continuing treatment of patients who have achieved a response to their most recent course of PBS-subsidised treatment, up to 5 repeat supplies of the highly specialised drug may be authorised.
Schedule 1, item dealing with Bosentan
omit all text from the column headed “Circumstances” and substitute:
| Initial treatment 1 (new adult 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 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 scleroderma 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 and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent 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 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 |
| Initial treatment 2 (new adult 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 scleroderma 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 scleroderma; 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 and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; 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 |
| Initial treatment 1 (new patient under 18 years of age) |
| Initial PBS-subsidised treatment with bosentan monohydrate of patients aged less than 18 years who have not received prior PBS-subsidised treatment with a PAH agent, 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, 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: |
| (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 patient and prescriber acknowledgment, signed by the parent or authorised guardian, indicating that they understand and acknowledge that PBS-subsidised treatment with a PAH agent 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 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 |
| Initial treatment 2 (new patient under 18 years of age) |
| Initial PBS-subsidised treatment with bosentan monohydrate of patients aged less than 18 years 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 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 function 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: |
| (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 patient and prescriber acknowledgment, signed by the parent or authorised guardian, indicating that they understand and acknowledge that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; 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 |
| Initial treatment (new patient) |
| Initial PBS-subsidised treatment with bosentan monohydrate of a patient who has been assessed by a physician from a designated hospital to have World Health Organisation (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 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 and prescriber acknowledgment (and signed by the parent or authorised guardian for patients under 18 years of age) indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate will cease if the treating physician determines that the patient has not achieved a response to treatment; 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 |
| Initial treatment (change or re-commencement for adult patients) |
| Initial treatment with bosentan monohydrate of adult patients: |
| (a) who have primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, 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 scleroderma 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 |
| Initial treatment (change or re-commencement for patients under 18 years of age) |
| Initial treatment with bosentan monohydrate of patients aged less than 18 years: |
| (a) who have primary pulmonary hypertension, 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 and whose most recent course of PBS-subsidised treatment was with a 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 |
| 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 |
| 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 scleroderma, 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 |
| Definitions |
| For the purpose of PBS-subsidised supply of bosentan monohydrate for the circumstances specified above: |
| “PAH agent” means bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium |
| Primary pulmonary hypertension, pulmonary arterial hypertension secondary to scleroderma and pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger’s physiology) 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 |
Schedule 1, item dealing with Epoprostenol
omit all text from the column headed “Circumstances” and substitute:
| Initial treatment (new adult patients) |
| Initial PBS-subsidised treatment with epoprostenol sodium 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 World Health Organisation (WHO) Functional Class IV primary pulmonary 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 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 and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; 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 |
| Initial treatment (new patients under 18 years of age) |
| Initial PBS-subsidised treatment with epoprostenol sodium of patients aged less than 18 years 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 World Health Organisation (WHO) Functional Class IV primary pulmonary 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 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 patient acknowledgment, signed by the parent or authorised guardian and the prescriber, indicating that they understand and acknowledge that PBS-subsidised treatment with PAH agents will cease if the treating physician determines that the patient has not achieved a response to treatment; 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 |
| Initial treatment (change or re-commencement for all adult patients) |
| Initial PBS-subsidised treatment with epoprostenol sodium of adult patients: |
| (a) who have primary pulmonary hypertension, 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 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 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 |
| Initial treatment (change or re-commencement for all patients under 18 years of age) |
| Initial PBS-subsidised treatment with epoprostenol sodium of patients aged less than 18 years: |
| (a) who have primary pulmonary hypertension, 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 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 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 |
| 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 |
| Definitions |
| For the purpose of PBS-subsidised supply of epoprostenol sodium for the circumstances specified above: |
| “PAH agent” means bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium |
| 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 |
| (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 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; |
| (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 |
Schedule 1, item dealing with Iloprost
omit all text from the column headed “Circumstances” and substitute:
| 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 and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent 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 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 |
| 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 and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; 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 |
| 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 |
| 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 |
| Definitions |
| For the purpose of PBS-subsidised supply of iloprost trometamol for the circumstances specified above: |
| “PAH agent” means bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium |
| 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 |
| (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 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; |
| (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 |
Schedule 1, item dealing with Sildenafil
omit all text from the column headed “Circumstances” and substitute:
| 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 and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent 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 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 |
| 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 and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; 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 |
| 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 |
| 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 |
| Definitions |
| For the purpose of PBS-subsidised supply of sildenafil citrate for the circumstances specified above: |
| “PAH agent” means bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium |
| 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 |
| (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 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; |
| (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 one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital |
Schedule 1, item dealing with Sitaxentan
omit all text from the column headed “Circumstances” and substitute:
| Initial treatment 1 (new patients) |
| Initial PBS-subsidised treatment with sitaxentan 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 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 and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent 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 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 |
| Initial treatment 2 (new patients) |
| Initial PBS-subsidised treatment with sitaxentan 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 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 and prescriber acknowledgment indicating that the patient understands and acknowledges that PBS-subsidised treatment with a PAH agent will cease if the treating physician determines that the patient has not achieved a response to treatment; 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 |
| Initial treatment (change or re-commencement for all patients) |
| Initial PBS-subsidised treatment with sitaxentan sodium 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 sitaxentan sodium after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with sitaxentan sodium; 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 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 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 |
| Continuing treatment (all patients) |
| Continuing PBS-subsidised treatment with sitaxentan sodium 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: |
| (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 |
| Definitions |
| For the purpose of PBS-subsidised supply of sitaxentan sodium for the circumstances specified above: |
| “PAH agent” means bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium |
| 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 |
| (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 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; |
| (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 one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital |
Schedule 2, after item dealing with with Apomorphine in the form Injection containing apomorphine hydrochloride 20 mg in 2 mL
insert in the columns in the order indicated:
| Injection containing apomorphine hydrochloride 50 mg in 5 mL | Injection | APO-go |
Schedule 2, after item dealing with Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
insert in the columns in the order indicated:
| Injection 50 mg in 1 mL single use injection pen, 4 | Injection | Enbrel |
Schedule 4, item dealing with Cyclosporin in the form Capsule 25 mg
(a) omit from the column headed “Approved price”: 40.80 and substitute:
39.98 (b) omit from the column headed “Price claimed by manufacturer”: 41.77 and substitute: 40.93
[11] Schedule 4, item dealing with Cyclosporin in the form Capsule 50 mg
(a) omit from the column headed “Approved price”: 84.87 and substitute:
83.17 (b) omit from the column headed “Price claimed by manufacturer”: 85.92 and substitute: 84.20
[12] Schedule 4, item dealing with Cyclosporin in the form Capsule 100 mg
(a) omit from the column headed “Approved price”: 172.92 and substitute:
169.46 (b) omit from the column headed “Price claimed by manufacturer”: 173.98 and substitute: 170.50
[13] Schedule 4, item dealing with Desferrioxamine in the form Powder for injection containing desferrioxamine mesylate 500 mg
(a) omit from the column headed “Approved price”: 97.02 and substitute:
95.08 (b) omit from the column headed “Price claimed by manufacturer”: 105.05 and substitute: 102.95
[14] Schedule 4, item dealing with Desferrioxamine in the form Powder for injection containing desferrioxamine mesylate 2 g
(a) omit from the column headed “Approved price”: 38.81 and substitute:
38.03 (b) omit from the column headed “Price claimed by manufacturer”: 39.20 and substitute: 38.42
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