Oncology biologics get nod from PBAC

Major PBS listings for pembrolizumab (Keytruda) in non-small cell lung cancer (NSCLC), urothelial cancer and nivolumab (Opdivo) and ipilimumab (Yervoy) for malignant melanoma have been recommended by the Pharmaceutical Benefits Advisory Committee.

At its July meeting the PBAC made a positive recommendation for an Authority Required (Streamlined) listing of pembrolizumab for the second line treatment of locally advanced or metastatic urothelial cancer.

The Committee said there was a high clinical need for new treatments in urothelial cancer and noted evidence from the clinical trial, KEYNOTE-045, which showed improved overall survival for patients receiving pembrolizumab compared to chemotherapy with paclitaxel, docetaxel, or vinflunine.

The PBAC also recommended an Authority Required (Streamlined) listing for pembrolizumab as first line monotherapy for patients with metastatic (Stage IV) non-small cell lung cancer (NSCLC), who have high expression of programmed cell death ligand 1 (PD-L1), defined as a tumour proportion score (TPS) of ≥50%.

The Committee noted that the Medical Services Advisory Committee (MSAC) had foreshadowed its support for a new MBS item for testing of PD-L1 expression to help determine eligibility for PBS subsidised pembrolizumab

Another major listing recommended at the July meeting was for the concurrent use of nivolumab and ipilimumab (Opdivo and Yervoy) in the treatment of unresectable Stage III or Stage IV malignant melanoma.

The PBAC recommended an Authority Required (Streamlined) listing of concurrent use of nivolumab and ipilimumab (NIVO+IPI) as first-line immunotherapy in patients with BRAF V600 mutation negative melanoma. Listing was also recommended in a second setting of patients with BRAF V600 mutation positive melanoma whose disease has progressed following treatment with a BRAF inhibitor.

Other changes to PBS listings for oncology drugs recommended by the PBAC included:

  • Authority Required (Streamlined) listing of avelumab (Bavencio) for the treatment of metastatic Merkel cell carcinoma (mMCC).
  • Crizotinib (Xalkori) Authority Required listing for the treatment of patients with Stage IIIB (locally advanced) or Stage IV (metastatic) NSCLC with a ROS1 gene rearrangement confirmed by FISH testing, in patients who have failed at least one treatment with platinum based chemotherapy.
  • Lantreotide (Somatuline) Autogel  – extending the listing to include the treatment of non-functional gastroentero-pancreatic neuroendocrine tumours (GEP-NETs) in adults with unresectable locally advanced or metastatic disease.
  • Lenvatinib (Lenvima) for locally advanced or metastatic differentiated thyroid cancer: removing the maximum quantity restriction to allow patients to access one months’ supply via an authority request
  • Trifluridine with tipiracil (Lonsurf) to get an Authority Required (Streamlined) listing for the treatment of patients with metastatic colorectal cancer who have been treated previously or are not considered suitable for current available therapies.

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