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

CD30 positive systemic anaplastic large cell lymphoma

Initial treatment

The treatment must be for curative intent; AND

Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND

Patient must demonstrate relapsed or chemotherapy-refractory disease; AND

Patient must have responded to PBS-subsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral T-cell lymphoma, non-cutaneous type; AND

The treatment must not exceed 4 cycles under this restriction.

Applications for authorisation of initial treatment 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 or provider number) of a histology report showing evidence of the tumour's CD30 positivity; and

(b) The date of initial diagnosis of systemic anaplastic large cell lymphoma; and

(c) Dates of commencement and completion of front-line curative intent chemotherapy; and

(d) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory.

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).