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PB 94 of 2020 Arrangements as made
This instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) to add, delete and make changes to drugs, forms, manners of administration, brands, responsible person codes, authorised prescribers, maximum quantities/amounts and repeats and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 30 Sep 2020
Tabling HistoryDate
Tabled HR06-Oct-2020
Tabled Senate06-Oct-2020

PB 94 of 2020

 

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 8)

 

National Health Act 1953

___________________________________________________________________________

 

I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under subsection 100(2) of the National Health Act 1953.

 

Dated         28 September 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BEN SLADIC

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 


___________________________________________________________________________

1          Name of Instrument

(1)          This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 8).

(2)          This Instrument may also be cited as PB 94 of 2020.

2          Commencement

This Instrument commences on 1 October 2020.

3          Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

 

 


Schedule 1     Amendments

[1]        Schedule 1, Part 1, entry for Brentuximab vedotin

(a)        omit from the column headed “Circumstances”: C6903 C6936

(b)        insert in numerical order in the column headed “Circumstances”: C10811 C10902    

[2]        Schedule 1, Part 1, entry for Carfilzomib in each of the forms: Powder for injection 10 mg; Powder for injection 30 mg; and Powder for injection 60 mg

(a)        omit from the column headed “Circumstances”: C7344

(b)        omit from the column headed “Circumstances”: C7355

(c)        insert in numerical order in the column headed “Circumstances”: C10855   

[3]        Schedule 1, Part 1, entry for Inotuzumab ozogamicin

omit from the column headed “Circumstances”: C9600

[4]        Schedule 1, Part 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL

omit from the column headed “Circumstances”: C8569

[5]        Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

(a)        omit from the column headed “Circumstances”: C8571

(b)        omit from the column headed “Circumstances”: C9253

[6]        Schedule 1, Part 1, entry for Pembrolizumab

(a)        omit from the column headed “Circumstances”: C9897

(b)        omit from the column headed “Circumstances”: C9966 C10675

(c)        omit from the column headed “Circumstances”: C10685

(d)        insert in numerical order in the column headed “Circumstances”: C10809 C10888   

[7]        Schedule 1, Part 2, entry for Brentuximab vedotin [Maximum Amount: 200; Number of Repeats: 3]

(a)        omit from the column headed “Purposes”: P6903 P6936

(b)        insert in numerical order in the column headed “Purposes”: P10811 P10902

[8]        Schedule 1, Part 2, entry for Inotuzumab ozogamicin

omit:

 

P9600

3384

1

 


 

[9]        Schedule 1, Part 2, entry for Ipilimumab

omit:                  

 

P8569

120

2

[10]      Schedule 1, Part 2, entry for Nivolumab

omit:

 

P8571

360

2

[11]      Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 480; Number of Repeats: 11]

omit from the column headed “Purposes”: P9253

[12]      Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 6]

(a)        omit from the column headed “Purposes”: P9897

(b)        omit from the column headed “Purposes”: P9966

[13]      Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 7]

(a)        omit from the column headed “Purposes”: P10685

(b)        insert in numerical order in the column headed “Purposes”: P10888

[14]      Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 400; Number of Repeats: 3]

(a)        omit from the column headed “Purposes”: P10675

(b)        insert in numerical order in the column headed “Purposes”: P10809

[15]      Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Zotren ODT

RF

MP

C5743

 

4

0

C

[16]      Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Zotren ODT

RF

MP

C5743

 

4

0

C

[17]      Schedule 3, after details relevant to Responsible Person code RA

insert:

RF

Arrow Pharma Pty Ltd

35 605 909 920


 

[18]      Schedule 4, entry for Brentuximab vedotin

(a)        omit:

 

C6903

P6903

Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multi‑agent chemotherapy for this condition; AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application; and
(c) a signed patient acknowledgement.

Compliance with Authority Required procedures

 

C6936

P6936

Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must have undergone a primary autologous stem cell transplant (ASCT); AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application; and
(c) a signed patient acknowledgement.

Compliance with Authority Required procedures

(b)        insert in numerical order after existing text:

 

C10811

P10811

Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must have undergone a primary autologous stem cell transplant (ASCT); AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application.

Compliance with Written Authority Required procedures

 

C10902

P10902

Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
Patient must not be suitable for ASCT for this condition; OR
Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND
Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; OR
Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND
Patient must not receive more than 4 cycles of treatment under this restriction.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Hodgkin lymphoma brentuximab PBS Authority Application.

Compliance with Written Authority Required procedures

[19]      Schedule 4, entry for Carfilzomib

(a)        omit:

 

C7344

 

Multiple myeloma
Grandfathering
Patient must have received treatment with this drug for this condition prior to 1 January 2018; AND
Patient must have a documented histological diagnosis; AND
The treatment must be in combination with dexamethasone; AND
Patient must have had documented progressive disease after at least one prior therapy prior to commencing non‑PBS subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
Patient must have undergone or be ineligible for a stem cell transplant; AND
Patient must not be receiving concomitant PBS‑subsidised bortezomib, thalidomide or its analogues; AND
Patient must not receive more than three cycles of treatment under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.
A patient may qualify for PBS‑subsidised treatment under this restriction once only. For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures

(b)        omit:

 

C7355

 

Multiple myeloma
Initial treatment
The condition must be confirmed by a histological diagnosis; AND
The treatment must be in combination with dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a stem cell transplant; AND
Patient must not have previously received this drug for this condition; AND
Patient must not be receiving concomitant PBS‑subsidised bortezomib, thalidomide or its analogues; AND
Patient must not receive more than three cycles of treatment under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Compliance with Authority Required procedures

(c)        insert in numerical order after existing text:

 

C10855

 

Multiple myeloma
Initial treatment
The condition must be confirmed by a histological diagnosis; AND
The treatment must be in combination with dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a stem cell transplant; AND
Patient must not have previously received this drug for this condition; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND
Patient must not receive more than three cycles of treatment under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Compliance with Authority Required procedures

[20]      Schedule 4, entry for Inotuzumab ozogamicin

omit:

 

C9600

P9600

Acute lymphoblastic leukaemia
Grandfather treatment
Patient must have a documented history of relapsed or refractory B‑precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
Patient must have a documented history of receiving intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
Patient must not have received more than 2 lines of salvage therapy; AND
The condition must be Philadelphia chromosome negative; AND
The condition must be CD22‑positive; AND
Patient must have a documented history of more than 5% blasts in bone marrow; AND
Patient must have received treatment with this drug for this condition prior to 1 May 2019; AND
Patient must not receive PBS‑subsidised treatment with this drug if progressive disease develops while on this drug.
This drug is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting.
A patient may qualify for PBS‑subsidised treatment under this restriction once only.
Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.
Patients who have received up to three treatment cycles as induction therapy with this drug for this condition prior to 1 May 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS‑subsidised treatment with this drug.
Patients who have received at least one treatment cycle as consolidation therapy with this drug for this condition prior to 1 May 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS‑subsidised treatment with this drug.
Patients who fail to demonstrate a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) after 3 cycles of PBS‑subsidised treatment with this agent must cease PBS‑subsidised treatment with this agent.
The authority application must be made in writing and must include:
(1) a completed authority prescription form;
(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application ‑ Supporting Information Form; and
(3) evidence that the condition is CD22‑positive; and
(4) date of most recent inotuzumab ozogamicin dose, if this was for induction or consolidation therapy, and how many treatment cycle(s) of PBS‑subsidised inotuzumab ozogamicin will be required for completion of induction or consolidation therapy; and
(5) date of latest chemotherapy prior to receiving non‑PBS subsidised inotuzumab ozogamicin, and if it was the initial chemotherapy regimen or for salvage therapy and what line of salvage; and
(6) a copy of bone marrow biopsy report prior to receiving non‑PBS subsidised inotuzumab ozogamicin.

Compliance with Written Authority Required procedures

[21]      Schedule 4, entry for Ipilimumab

omit:

 

C8569

P8569

Stage IV clear cell variant renal cell carcinoma (RCC)
Induction treatment ‑ Grandfather patients
Patient must have received less than 4 doses of combined therapy with ipilimumab and nivolumab as induction therapy for this condition prior to 1 March 2019; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prior to initiating non‑PBS‑subsidised induction therapy with nivolumab and ipilimumab; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non‑PBS‑subsidised induction therapy with nivolumab and ipilimumab; AND
The condition must not have previously been treated prior to initiating non‑PBS‑subsidised induction therapy with nivolumab and ipilimumab; AND
The treatment must be in combination with PBS‑subsidised‑treatment with nivolumab as induction for this condition; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition.
A patient may qualify for PBS‑subsidised treatment under this restriction once only. For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 8569


 

[22]      Schedule 4, entry for Nivolumab

(a)        omit:

 

C8571

P8571

Stage IV clear cell variant renal cell carcinoma (RCC)
Grandfather patients
Patient must have received less than 4 doses of combined therapy with ipilimumab and nivolumab as induction therapy for this condition prior to 1 March 2019; OR
Patient must have received monotherapy with nivolumab as maintenance for this condition prior to 1 March 2019; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prior to initiating non‑PBS‑subsidised induction therapy with nivolumab and ipilimumab; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non‑PBS‑subsidised induction therapy with nivolumab and ipilimumab; AND
The condition must not have previously been treated prior to initiating non‑PBS‑subsidised induction therapy with nivolumab and ipilimumab; AND
Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition; OR
Patient must not have developed disease progression while being treated with monotherapy with nivolumab as maintenance for this condition; AND
The treatment must be in combination with PBS‑subsidised treatment with ipilimumab as induction for this condition; OR
The treatment must be as monotherapy as maintenance for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
Maintenance treatment with nivolumab must not exceed a maximum dose of 3 mg per kg every 2 weeks.
A patient may qualify for PBS‑subsidised treatment under this restriction once only. For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 8571

(b)        omit:

 

C9253

P9253

Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Grandfather treatment
Patient must have received non‑PBS subsidised treatment with this drug for this condition prior to 1 August 2018; AND
Patient must have had a WHO performance status of 0 or 1; AND
The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy, prior to commencing non‑PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving non‑PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
A patient may qualify for PBS‑subsidised treatment under this restriction once only. For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 9253

[23]      Schedule 4, entry for Pembrolizumab

(a)        omit:

 

C9897

P9897

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Grandfathering treatment
Patient must have received non‑PBS treatment with this drug for this condition prior to 1 March 2019; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy prior to initiating treatment with this drug for this condition; OR
The condition must have progressed on or within 12 months of completion of adjuvant platinum‑containing chemotherapy following cystectomy for localised muscle‑invasive urothelial cancer prior to initiating treatment with this drug for this condition; OR
The condition must have progressed on or within 12 months of completion of neoadjuvant platinum‑containing chemotherapy prior to cystectomy for localised muscle‑invasive urothelial cancer prior to initiating treatment with this drug for this condition; AND
Patient must have a WHO performance status of 2 or less prior to initiating treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 9897

(b)        omit:

 

C9966

P9966

Relapsed or Refractory Hodgkin lymphoma
Initial treatment ‑ Grandfathered patients
Patient must have previously received non‑PBS‑subsidised treatment with a programmed cell death 1 (PD‑1) inhibitor for this condition prior to 1 May 2018; AND
Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT prior to receiving treatment with a PD‑1 inhibitor for this condition; OR
Patient must not have been suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition prior to receiving treatment with a PD‑1 inhibitor for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
The treatment must not exceed a total of 35 cycles in a lifetime.
A patient may qualify for PBS‑subsidised treatment under this restriction once only.
For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed Hodgkin lymphoma pembrolizumab PBS Authority Application for Grandfathered patients.

Compliance with Written Authority Required procedures

 

C10675

P10675

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfather treatment - 6 weekly treatment regimen
Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 May 2020; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures

(c)        omit:

 

C10685

P10685

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfather treatment - 3 weekly treatment regimen
Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 May 2020; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures

(d)        insert in numerical order after existing text:

 

C10809

P10809

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfather treatment - 6 weekly treatment regimen
Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 September 2020; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures

 

C10888

P10888

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Grandfather treatment - 3 weekly treatment regimen
Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 September 2020; AND
Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND
Patient must not have evidence of recurrence; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have received prior PBS-subsidised treatment for this condition; AND
Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND
Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures