Pembrolizumab (Keytruda) will be listed on the PBS from 1 November as a first line treatment of patients with advanced non-small cell lung cancer (NSCLC).
In a statement manufacturer MSD said the drug will be reimbursed for patients with metaststic (stage IV) NSCLC who have high expression of PD-L1 (>50%).
About 1,200 Australians with NSCLC that expresses the PD-L1 protein who have not yet received any treatment are expected to be eligible for reimbursed treatment, the company said.
Announcing the listing on October 28, federal minister for health Greg Hunt said the listing would give patients access to a drug that would otherwise cost over $11,300 per script or $188,000 a year.
Pembrolizumab was assessed by the Pharmaceutical Benefits Advisory Committee (PBAC) in March 2018, at which time the committee noted that the Medical Services Advisory Committee (MSAC) has endorsed use of PD-L1 testing for eligibility to pembrolizumab.
The PBAC noted that other TGA-approved indications for pembrolizumab include:
- advanced NSCLC whose tumours express PD-L1 with a ≥1% TPS (as determined by a validated test) and who have received platinum-containing chemotherapy
- unresectable or metastatic melanoma in adults, as monotherapy
- recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy
- monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin Lymphoma following autologous stem cell transplant or at least two prior therapies
- locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemotherapy or are not eligible for cisplatin-containing therapy.