PBS updates

Tagrisso (Osimertinib)

osimertinib 80 mg tablet, 30 · ORAL · PBS code 11622Q

AUTHORITY_REQUIRED

• • First listed on the PBS: 2019-02-01.
• • Repeats: 5.
• • PBS program: GE.

Eligibility criteria for subsidised access

The following is the government's own wording from the PBS Schedule, shown unchanged.

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

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment as second-line EGFR tyrosine kinase inhibitor therapy

Patient must not have previously received this drug for this condition; AND

The treatment must be as monotherapy; AND

Patient must have a WHO performance status of 2 or less; AND

The condition must have progressed on or after prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy as first line treatment for this condition; AND

Patient must have evidence of EGFR T790M mutation in tumour material at the point of progression on or after first line EGFR TKI treatment; AND

Must be treated by a medical practitioner.

PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).

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

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing treatment of second-line EGFR tyrosine kinase inhibitor therapy

The treatment must be as monotherapy; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND

Patient must be undergoing continuing treatment with this drug as second-line therapy (i.e. there are 2 Continuing treatment listings for this drug - ensure the correct Continuing treatment restriction is being accessed); 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.

PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).

Not medical advice. Voxsanity republishes public PBS data in plain English. PBS listing status and criteria can change; always confirm current subsidised availability with your doctor or pharmacist.

Source: Pharmaceutical Benefits Scheme (PBS), © Commonwealth of Australia. Data used and redistributed under permission; not modified from its original wording where displayed verbatim.