Five oncology therapies win approval for PBS listing


By Michael Woodhead

28 Apr 2021

Medications for breast, prostate, colorectal and urothelial cancer have won positive recommendations for PBS listing from the Pharmaceutical Benefits Advisory Committee (PBAC).

At its March 2021 meeting the PBAC made the following positive recommendations:

  • Abemaciclib  for breast cancer.

The PBAC recommended the listing of abemaciclib (Verzenio)in combination with fulvestrant, for the treatment of non-premenopausal patients with HR+ and HER2- inoperable locally advanced or metastatic breast cancer.

  • Avelumab  for urothelial cancer and renal cell carcinoma

A Section 100 (Efficient Funding of Chemotherapy) Authority Required (Telephone/Online) listing was recommended for avelumab (Bavencio) for the maintenance treatment of Stage III or Stage IV urothelial carcinoma in patients whose disease has not progressed following first-line platinum-based chemotherapy. The PBAC also recommended the listing of avelumab in combination with axitinib (AVE + AXI), for the first-line treatment of Stage IV clear cell variant RCC in patients classified as intermediate or poor according to the IMDC prognostic criteria.

  • Pembrolizumab for colorectal cancer.

The PBAC recommended the Section 100 (Efficient Funding of Chemotherapy – Public and Private Hospital) Authority Required (Telephone) listing of pembrolizumab (Keytruda) for the first line treatment of unresectable and metastatic (Stage IV) mismatch repair deficient (dMMR) colorectal cancer.

  • Nivolumab + ipilimumab for malignant pleural mesothelioma (MPM)

PBS listing of nivolumab in combination with ipilimumab (Opdivo/Yervoy) was recommended for the treatment of MPM. The PBAC considered that there was a high clinical need for effective therapies for MPM and nivolumab + ipilimumab provided a substantial clinical benefit compared to pemetrexed-based chemotherapy. The PBAC considered it would be appropriate for the listing of nivolumab in combination with ipilimumab to allow use in the first-and second-line treatment setting and in the small number of patients with non-pleural mesothelioma.

  • Enzalutamide & abiraterone – extension to allow use before docetaxel in patients with metastatic castrate resistant prostate cancer (mCRPC).

An amendment to the PBS listings of abiraterone and enzalutamide (Xtandi + Zytiga) was recommended to allow their use in patients with mCRPC without prior use of docetaxel. The PBAC considered that removal of the requirement for patients to have either received prior docetaxel or to have a predicted intolerance to docetaxel would better align the restrictions for abiraterone and enzalutamide with how these drugs are being used in clinical practice and with their TGA indications.

In other matters, the PBAC recommended the PBS listing for bevacizumab (Mvasi) for NSCLC to be changed to unrestricted listing, subject to the sponsor agreeing to a price reduction to offset the likely increase in use.

The PBAC deferred a recommendation on listing of encorafenib (Braftovi) for patients with BRAF V600E variant mCRC who have received prior systemic therapy, pending an expected positive decision from the Medicare Services Advisory Committee (MSAC) on the funding of the co-dependent BRAF V600 testing.

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