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

Resected non-small cell lung cancer (NSCLC)

Adjuvant therapy

Patient must be both: (i) initiating treatment, (ii) untreated with an Anaplastic Lymphoma Kinase-Tyrosine Kinase Inhibitor (ALK-TKI) for non-small cell lung cancer; or

Patient must be continuing existing PBS-subsidised treatment with this drug; or

Patient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) untreated with ALK-TKI at the time this drug was initiated; AND

The condition must be/have been at least one of: (i) node positive, (ii) at least 4 cm in size; AND

The treatment must be for the purpose of adjuvant therapy following surgical resection; AND

The treatment must be commenced within 26 weeks of surgery; AND

Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND

Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND

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

Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 24 months of combined non-PBS and PBS-subsidised treatment for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred; 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.