PBS eases up on some cancer drug restrictions

Medicines

By Mardi Chapman

21 Aug 2018

A number of oncology-related PBS listings will change following requests from the Medical Oncology Group of Australia (MOGA).

At its July 2018 meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended amending the current restriction level of pazopanib for renal cell carcinoma and soft tissue sarcoma from Authority Required to Authority Required (Streamlined).

The amendment applies to all currently listed indications and treatment phases. The PBAC also recommended the change could flow-on to the listings of sunitinib for renal cell carcinoma.

The PBAC has also agreed to a request to amend the listings of pemetrexed to an unrestricted benefit, noting that the price of the drug had dropped substantially in the past several years.

Professor Anna Nowak, from the University of Western Australia and the National Centre for Asbestos Related Diseases, told the limbic the change was a positive step for patients with mesothelioma.

“Whilst the approved indication has previously been in combination with cisplatin, many patients cannot tolerate cisplatin due to pre-existing hearing loss, poor kidney function, or relative frailty. This change will allow pemetrexed to be prescribed in combination with carboplatin, an alternative which is relatively well tolerated by elderly patients and which has an adequate body of literature to support its use in mesothelioma.”

“However, it may also open the gate to less well supported use of pemetrexed as a single agent or as maintenance therapy in mesothelioma. We should continue to use evidence-based prescribing wherever possible.”

The requirement for cardiac function testing every three months with anti-HER2 therapies was also slated to be removed from PBS listings for trastuzumab, pertuzumab and trastuzumab emtansine.

The PBAC advice was that such testing no longer contributed to determining ongoing patient eligibility for PBS-subsidised therapy.

However not all requests were approved by the PBAC including a request to use adjuvant bisphosphonates for post-menopausal women with early breast cancer.

“The PBAC noted the request was to permit use of bisphosphonates for a new population with substantial uncertainties about likely uptake and use, and considered a major submission with full evaluation would be required to progress this request,” the Committee said.

Similarly, a request to remove the requirement for patients with BRAF V600 mutation positive-type melanoma to have progressed following treatment with a BRAF inhibitor prior to trialling a PD-1 inhibitor was not supported.

“The PBAC noted it had established acceptable cost effectiveness of the PD-1 inhibitors in Stage III or Stage IV malignant melanoma on the basis that patients with a BRAF V600 mutation had progressed following treatment with a BRAF inhibitor.”

“The PBAC therefore considered the request would alter the established cost-effectiveness basis on which the PD-1 inhibitors were listed and as such, a major submission with economic model would be required to progress this request.”

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