Non-small cell lung cancer
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Authority to supply gefitinib (Iressa®) for the treatment of locally advanced or metastatic non-small cell lung cancer through the Pharmaceutical Benefits Scheme under the Section 85 arrangements of the National Health Act 1953.
Restriction details
The Schedule of Pharmaceutical Benefits outlines restrictions for prescribing gefitinib.
Initial treatment
Initial PBS subsidised treatment, as monotherapy of locally advanced or metastatic non-small cell lung cancer in patients with a World Health Organisation (WHO) performance status of two or less, where:
- disease progression has occurred following treatment with at least one chemotherapy agent; and
- there is evidence that the patient has an activating mutation(s) of the Epidermal Growth Factor Receptor (EGFR) gene in tumour material as demonstrated by analysis of the DNA sequence of the EGFR gene.
Continuing treatment
Continuing PBS subsidised treatment, as monotherapy of locally advanced or metastatic non-small cell lung cancer in patients with a WHO performance status of two or less, where the patient has previously been issued with an authority prescription for gefitinib.
Item details
Dose
The maximum dose that can be prescribed is 250 mg per day.
Gefitinib is available as a 250 mg tablet in a pack size of 30.
A maximum of two months supply may be requested and no applications for increased quantities and/or repeats will be authorised.
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
Pathology report
A copy of the pathology report supporting the evidence of activating mutation(s) of the EGFR gene in tumour material must be provided, and must be from an approved Australian Pathology Authority. The mutation(s) must be demonstrated by analysis of the DNA sequence of the EGFR gene.
Lodgement
All initial applications must be in writing.
Applications for continuing treatment may be made in writing or by calling Medicare Australia on 1800 700 270** and selecting option 3 (8 am to 5 pm EST Monday to Friday).
Please ensure that all written applications for initial PBS authorisation include a:
- completed authority prescription form
- completed gefitinib supporting information form
- pathology report confirming eligibility for treatment.
Please send all written applications to:
Medicare Australia
Prior written approval of specialised drugs
Reply paid 9826
GPO Box 9826
Hobart Tasmania 7001
(No stamp required if posted in Australia)
For more information please call 1800 700 270** and select option 3 (8 am to 5 pm EST Monday to Friday).
** Call charges apply from mobile and pay phones only.
Application form
- Initial treatment [PDF, 185Kb]
- PBS authority application supporting information form [PDF, 185Kb]
Lodge this form for a patient starting initial PBS subsidised treatment for locally advanced or metastatic non-small cell lung cancer.
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Last updated: 15 September, 2008