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

Chronic Myeloid Leukaemia (CML)

Continuing treatment - first-line therapy

The condition must be in the chronic phase; AND

Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; or

Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with imatinib for this condition; or

Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with nilotinib 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 have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND

The treatment must be the sole PBS-subsidised therapy for this condition; 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 major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records.