National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 11) (PB 103 of 2018) (Cth)

PB 103 of 2018

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 11)

National Health Act 1953

___________________________________________________________________________

I, JULIANNE QUAINE, 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 November 2018

JULIANNE QUAINE

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 2018 (No. 11).

(2)This Instrument may also be cited as PB 103 of 2018.

1. Commencement

This Instrument commences on 1 December 2018.

1. 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. Section 3, Definition for HSD hospital authority

(a)      omit:

HSD hospital authority means a public hospital authority approved by the Chief Executive Medicare under section 52 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010.

(b)      substitute:

HSD hospital authority means a public hospital authority approved under section 52 of the National Health (Highly specialised drugs program) Special Arrangement 2010.

1. Schedule 1, Part 1, entry for Ipilimumab in each of the forms: Injection concentrate for I.V. infusion 50 mg in 10 mL; and Injection concentrate for I.V. infusion 200 mg in 40 mL

insert in numerical order in the column headed “Circumstances”: C8142 C8178 C8180 C8206

1. Schedule 1, Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

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

IRINOTECAN ACT JU MP D

1. 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

insert in numerical order in the column headed “Circumstances”: C8141 C8143 C8146 C8182 C8220

1. Schedule 1, Part 1, entry for Obinutuzumab

(a)      omit from the column headed “Circumstances”: C5126

(b)      insert in numerical order in the column headed “Circumstances”: C8184

1. Schedule 1, Part 2, entry for Nivolumab

substitute:

Nivolumab	P8141 P8146 P8182 P8220	120	3
P6070 P6095 P6988 P7567 P7864	360	8
P6111 P6993 P6997 P6999 P7787 P7802 P8143	360	11

1. Schedule 1, Part 2, entry for Obinutuzumab

substitute:

Obinutuzumab	P7935 P7950	1000	5
P7959 P7968 P8184	1000	7
P7936 P7981	1000	9

1. Schedule 3 details relevant to Responsible Person code RA

substitute:

RA Sun Pharma ANZ Pty Ltd 17 110 871 826

1. Schedule 4, entry for Ipilimumab

insert in numerical order after existing text:

C8142	Unresectable Stage III or Stage IV malignant melanoma Induction treatment The condition must be positive for a BRAF V600 mutation; AND The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor); OR Patient must be contraindicated to treatment with a BRAF inhibitor according to the TGA approved Product Information; OR Patient must have developed intolerance to a BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 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 8142
C8178	Unresectable Stage III or Stage IV malignant melanoma Induction treatment - Grandfather patients The condition must be negative for a BRAF V600 mutation; AND Patient must have received combined therapy with ipilimumab and nivolumab as induction for this condition prior to 1 December 2018; AND Patient must not have previously received treatment with ipilimumab or a programmed cell death factor 1 (PD-1) inhibitor prior to initiating combined therapy with ipilimumab and 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; AND Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to initiating treatment with this drug for this condition; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 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 8178
C8180	Unresectable Stage III or Stage IV malignant melanoma Induction treatment - Grandfather patients The condition must be positive for a BRAF V600 mutation; AND The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor); OR Patient must be contraindicated to treatment with a BRAF inhibitor according to the TGA approved Product Information; OR Patient must have developed intolerance to a BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND Patient must have received combined therapy with ipilimumab and nivolumab as induction for this condition prior to 1 December 2018; AND Patient must not have developed disease progression while being treated with combined therapy with ipilimumab and nivolumab as induction for this condition; AND Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to initiating treatment with this drug for this condition; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 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 8180
C8206	Unresectable Stage III or Stage IV malignant melanoma Induction treatment The condition must be negative for a BRAF V600 mutation; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 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 8206

1. Schedule 4, entry for Nivolumab

insert in numerical order after existing text:

C8141	P8141	Unresectable Stage III or Stage IV malignant melanoma Induction treatment The condition must be positive for a BRAF V600 mutation; AND The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor); OR Patient must be contraindicated to treatment with a BRAF inhibitor according to the TGA approved Product Information; OR Patient must have developed intolerance to a BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 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 8141
C8143	P8143	Unresectable Stage III or Stage IV malignant melanoma Maintenance treatment Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND The treatment must be as monotherapy for this condition; AND Patient must not have developed disease progression while receiving PBS subsidised treatment with this drug for this condition. Maintenance treatment with nivolumab must not exceed a maximum dose of 3 mg per kg every 2 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 8143
C8146	P8146	Unresectable Stage III or Stage IV malignant melanoma Induction treatment - Grandfather patients The condition must be negative for a BRAF V600 mutation; AND Patient must have received combined therapy with ipilimumab and nivolumab as induction for this condition prior to 1 December 2018; OR Patient must have received monotherapy with nivolumab as maintenance for this condition prior to 1 December 2018; AND Patient must not have previously received treatment with ipilimumab or a programmed cell death factor 1 (PD-1) inhibitor prior to initiating combined therapy with ipilimumab and 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; OR Patient must not have developed disease progression while being treated with monotherapy with nivolumab as maintenance for this condition; AND Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to initiating treatment with this drug for this condition; AND The condition must not be ocular or uveal melanoma; 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 1 mg per kg every 3 weeks. Induction treatment with ipilimumab 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 8146
C8182	P8182	Unresectable Stage III or Stage IV malignant melanoma Induction treatment The condition must be negative for a BRAF V600 mutation; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for this condition; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 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 8182
C8220	P8220	Unresectable Stage III or Stage IV malignant melanoma Induction treatment - Grandfather patients The condition must be positive for a BRAF V600 mutation; AND The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor); OR Patient must be contraindicated to treatment with a BRAF inhibitor according to the TGA approved Product Information; OR Patient must have developed intolerance to a BRAF inhibitor of a severity necessitating permanent treatment withdrawal; AND Patient must have received combined therapy with ipilimumab and nivolumab as induction for this condition prior to 1 December 2018; OR Patient must have received monotherapy with nivolumab as maintenance for this condition prior to 1 December 2018; AND Patient must not have previously received treatment with ipilimumab or a programmed cell death factor 1 (PD-1) inhibitor prior to initiating combined therapy with ipilimumab and 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; OR Patient must not have developed disease progression while being treated with monotherapy with nivolumab as maintenance for this condition; AND Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to initiating treatment with this drug for this condition; AND The condition must not be ocular or uveal melanoma; 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 1 mg per kg every 3 weeks. Induction treatment with ipilimumab 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 8220

1. Schedule 4, entry for Obinutuzumab

(a)omit:

C5126 P5126 Chronic lymphocytic leukaemia (CLL)
Patient must require treatment for CD20 positive chronic lymphocytic leukaemia (CLL); AND
The condition must be previously untreated; AND
Patient must be inappropriate for fludarabine based chemo‑immunotherapy; AND
The treatment must be in combination with chlorambucil; AND
Patient must have a creatinine clearance 30 mL/min or greater; AND
Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL‑induced illness or organ damage); OR
Patient must have a creatinine clearance less than 70 mL/min.
Treatment must be discontinued in patients who experience disease progression while on treatment.
Applications for authorisation must be in writing and must include:
(a) a completed authority prescription form; AND
(b) a completed CD20 positive Chronic Lymphocytic Leukaemia PBS Authority Application ‑ Supporting Information Form which includes:
i) documentation that the patient has CD20 positive CLL (flow cytometry pathology report from blood or bone marrow, noting that this may be from some time earlier); AND
ii) a statement that the patient is previously untreated, is inappropriate for fludarabine based chemo immunotherapy, that treatment will be in combination with chlorambucil; AND
iii) documentation that the patient has a creatinine clearance 30 mL/min or greater; AND
iv) One of the following, either:
‑ A completed cumulative illness rating scale (CIRS) score form demonstrating that the patient has a score of greater than 6 (excluding CLL‑induced illness or organ damage)
OR
‑Documentation that the patient has a creatinine clearance less than 70 mL/min; Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C8184 P8184 Chronic lymphocytic leukaemia (CLL)
The condition must be CD20 positive; AND
The condition must be previously untreated; AND
Patient must be inappropriate for fludarabine based chemo-immunotherapy; AND
The treatment must be in combination with chlorambucil; AND
Patient must have a creatinine clearance 30 mL/min or greater; AND
Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); OR
Patient must have a creatinine clearance less than 70 mL/min.
Treatment must be discontinued in patients who experience disease progression whilst on this treatment. Compliance with Authority Required procedures - Streamlined Authority Code 8184