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

Locally advanced or metastatic non-small cell lung cancer

The condition must have evidence of rearranged during transfection (RET) gene fusion in tumour material - this evidence has been obtained prior to commencing treatment with this drug; AND

Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND

Patient must be initiating treatment with this drug; or

Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.

Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.

Medical practitioners may prescribe selpercatinib 80 mg with a quantity of up to 56 units where the dose does not exceed 120 mg twice daily (i.e., in combination with selpercatinib 40 mg). Selpercatinib 80 mg with a quantity of 112 units must be prescribed only where the dose is 160 mg twice daily to provide 28 days of treatment per dispensing. Prescribers should refer to the TGA PI for dosing and dose adjustments regimens.