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

Myelodysplastic syndrome

Initial treatment

The treatment must be limited to a maximum duration of 16 weeks; AND

Patient must be classified as Low risk or Intermediate-1 according to the International Prognostic Scoring System (IPSS); AND

Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; AND

Patient must be red blood cell transfusion dependent.

Classification of a patient as Low risk requires a score of 0 on the IPSS, achieved with the following combination: less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias.

Classification of a patient as Intermediate-1 requires a score of 0.5 to 1 on the IPSS, achieved with the following possible combinations:

1. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias; OR

2. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR

3. less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR

4. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 2/3 cytopenias; OR

5. 5%-10% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR

6. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR

7. less than 5% marrow blasts with poor karyotypic status (complex, greater than 3 abnormalities), and 0/1 cytopenias.

Classification of a patient as red blood cell transfusion dependent requires that:

(i) the patient has been transfused within the last 8 weeks; and

(ii) the patient has received at least 8 units of red blood cell in the last 6 months prior to commencing PBS-subsidised therapy with lenalidomide; and would be expected to continue this requirement without lenalidomide treatment.

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:

(a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has myelodysplastic syndrome; and

(b) details (date, unique identifying number/code or provider number) of the full blood examination report; and

(c) details (date, unique identifying number/code or provider number) of the pathology report and details of the cytogenetics demonstrating Low risk or Intermediate-1 disease according to the IPSS (note: using Fluorescence in Situ Hybridization (FISH) to demonstrate MDS -5q is acceptable); and

(d) details of transfusion requirements including: (i) the date of most recent transfusion and the number of red blood cell units transfused; and (ii) the total number of red blood cell units transfused in the 4 and 6 months preceding the date of this application.

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

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

(a) a completed authority prescription form; and

(b) a completed authority 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

Myelodysplastic syndrome

Continuing treatment

Patient must have received PBS-subsidised initial therapy with lenalidomide for myelodysplastic syndrome; AND

Patient must have achieved and maintained transfusion independence; or at least a 50% reduction in red blood cell unit transfusion requirements compared with the four month period prior to commencing initial PBS-subsidised therapy with lenalidomide; AND

Patient must not have progressive disease; AND

The condition must not have progressed to acute myeloid leukaemia.

The first authority application for continuing supply must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. Subsequent authority applications for continuing supply may be made via the Online PBS Authorities System or by telephone.

The following evidence of response must be provided at each application:

(i) a haemoglobin level taken within the last 4 weeks; and

(ii) the date of the last transfusion; and

(iii) a statement of the number of units of red cells transfused in the 4 months immediately preceding this application;

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

For first continuing applications, if the application is submitted through HPOS form upload or mail, it must include:

(a) a completed authority prescription form; and

(b) 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).