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

CD30 positive cutaneous T-cell lymphoma

Initial treatment

Patient must have pathologically confirmed CD30 positive cutaneous T-cell lymphoma; AND

Patient must have CD30 positivity of at least 3% of malignant cells; AND

Patient must have a diagnosis of mycosis fungoides; or

Patient must have a diagnosis of Sezary syndrome; or

Patient must have a diagnosis of primary cutaneous anaplastic large cell lymphoma; AND

Patient must have received prior systemic treatment for this condition; AND

The condition must be relapsed or refractory; AND

The treatment must not exceed 4 cycles under this restriction in a lifetime; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.

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 histopathology report from an Approved Pathology Authority demonstrating the patient has a diagnosis of either mycosis fungoides, Sezary syndrome or primary cutaneous anaplastic large cell lymphoma; and

(b) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample or of a flow cytometric analysis of lymphoma cells of the blood showing CD30 positivity of at least 3% of malignant cells; and

(c) Date of commencement and completion of the most recent prior systemic treatment.

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).