ALK-positive non-small cell lung cancer

The PBS subsidises crizotinib for patients with anaplastic lymphoma kinase, positive non-squamous type non-small cell lung cancer or not otherwise specified type.

Crizotinib (Xalkori®) is PBS subsidised for patients with anaplastic lymphoma kinase, positive non-squamous type non-small cell lung cancer or not otherwise specified type.

Crizotinib (Xalkori®) can be subsidised through the Pharmaceutical Benefit Scheme (PBS) under section 85 of the National Health Act 1953 for patients with ALK positive non-squamous NSCLC or not otherwise specified NSCLC.

Restriction details

The Schedule of Pharmaceutical Benefits on the PBS website outlines the restrictions for prescribing crizotinib (Xalkori®).

Treatment

Applications for initial treatment must be submitted in writing by the treating medical practitioner.

After an application for initial treatment has been approved, applications for continuing treatment may be made by contacting us on the Complex Drug enquiry line.

Patients are eligible for treatment until there is evidence of disease progression.

Test Requirements

From 1 July 2015, all patients starting initial PBS subsidised treatment with crizotinib (Xalkori®) must provide evidence of anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as ≥ 15% positive cells by fluorescence in situ hybridisation (FISH) testing.

Patients who started treatment with crizotinib (Xalkori®) before 1 July 2015 must supply evidence of ALK gene rearrangement in tumour material by FISH testing.

Schedule item details

Crizotinib (Xalkori®) is available as a 200 mg capsule or 250 mg capsule. Prescriptions should be written for a quantity of 60 and 1 repeat.

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the PBS.

Patients must be registered with the sponsor’s crizotinib (Xalkori®) Managed Entry Scheme and the patient’s unique identifier (in the form of XALKZZZ, where Z is a numerical value) must be supplied with each application.

Lodging an application

All written applications for initial PBS authorisation of crizotinib (Xalkori®) must include a completed:

All applications for continuing approvals may be made by medical practitioners by contacting us on the Complex Drug enquiry line.

Send all written applications to the Complex Drugs address on the contact us page.

Page last updated: 8 November 2016

This information was printed Friday 9 December 2016 from humanservices.gov.au/health-professionals/enablers/alk-positive-non-small-cell-lung-cancer It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.