Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Chronic Myeloid Leukaemia (CML)

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; or

Patient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal; AND

Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority; or

Patient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal; or

Patient must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis; AND

Must be treated by a medical practitioner.

Failure of an adequate trial of dasatinib or nilotinib is defined as:

1. Lack of response to dasatinib or nilotinib therapy, defined as either:

(i) failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib or nilotinib; or

(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or

(iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib or nilotinib; OR

2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib or nilotinib therapy; OR

3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib or nilotinib therapy; OR

4. Development of accelerated phase or blast crisis in a patient previously prescribed dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR

5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.

Accelerated phase is defined by the presence of 1 or more of the following:

1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or

2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or

3. Peripheral basophils greater than or equal to 20%; or

4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or

5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).

Blast crisis is defined as either:

1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or

2. Extramedullary involvement other than spleen and liver.

The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:

(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or

(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and

(iii) where there has been a loss of response to dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.

All reports must be documented in the patient's medical records

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Up to a maximum of 18 months of treatment may be authorised under this initial restriction.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Chronic Myeloid Leukaemia (CML)

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; AND

Patient must have failed an adequate trial of imatinib confirmed through a pathology report from an Approved Pathology Authority; or

Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; or

Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority; AND

Must be treated by a medical practitioner.

Failure of an adequate trial of imatinib or dasatinib or nilotinib is defined as:

1. Lack of response to imatinib or dasatinib or nilotinib therapy, defined as either:

(i) failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib or nilotinib; or

(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or

(iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib or nilotinib; OR

2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib or nilotinib therapy; OR

3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib or nilotinib therapy; OR

4. Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR

5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during imatinib or dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.

Accelerated phase is defined by the presence of 1 or more of the following:

1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or

2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or

3. Peripheral basophils greater than or equal to 20%; or

4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or

5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).

Blast crisis is defined as either:

1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or

2. Extramedullary involvement other than spleen and liver.

The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:

(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or

(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and

(iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and

(iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.

All reports must be documented in the patient's medical records.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Up to a maximum of 18 months of treatment may be authorised under this initial restriction.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Chronic Myeloid Leukaemia (CML)

First continuing treatment

Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or

Patient must demonstrated a peripheral blood level of BCR-ABL of less than 1% on the international scale in the preceding 18 months and thereafter at 12 monthly intervals; AND

Must be treated by a medical practitioner; or

Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.

The first continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:

(i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; or

(ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response].

All reports must be documented in the patient's medical records.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Chronic Myeloid Leukaemia (CML)

Subsequent continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have maintained a major cytogenic response of less than 35% Philadelphia positive bone marrow cells at 12 month intervals; or

Patient must have maintained a peripheral blood level of BCR-ABL of less than 1% on the international scale at 12 month intervals; AND

Must be treated by a medical practitioner; or

Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.

A pathology report demonstrating the patient's cytogenetic response or a peripheral blood level of BCR-ABL must be documented in the patient's medical records.