Treatments for NSCLC, renal cell carcinoma, and HER2-low breast cancer are among several anticancer agents that have been recommended for reimbursement by the Pharmaceutical Benefits Advisory Committee.
Positive recommendations also included dabrafenib in combination with trametinib for the treatment of paediatric patients with BRAF V600E mutation positive low grade or high grade glioma.
The endorsement reflected a high clinical need in the relevant population, with the combination offering “high added therapeutic value” for these patients, the PBAC said in an outcome statement following its March meeting (link here).
“The PBAC was satisfied that the therapy provides, for some patients, a significant improvement in efficacy over carboplatin and vincristine in low grade glioma, and over standard chemotherapy in high grade glioma,” it said.
Branded Tafinlar and Mekinist, the agents would also be available in new forms and strengths, per the recommendation.
Cabozantinib gets new indications
The PBAC also backed the listing of cabozantinib for use in combination with nivolumab for the treatment of advanced (Stage IV) clear cell variant renal cell carcinoma RCC in patients who are classified as intermediate or poor risk using the International Metastatic renal cell carcinoma Database Consortium (IMDC) survival risk classification score.
Meanwhile, a move to remove the RCC ‘clear cell variant’ histology requirement to allow treatment in patients with non-clear cell RCC was also supported, in view of the fact there were no alternative therapies currently available on the PBS.
“The PBAC noted that the evidence is limited but considered that the clinical benefit in patients with nccRCC appears to be similar to that in patients with clear cell RCC (ccRCC), particularly in the first line setting,” it said.
“The PBAC considered that on this basis it was reasonable to accept that cabozantinib would be cost-effective for treatment of nccRCC at the same first-line price as accepted for ccRCC.”
And a change to the agent’s listing for differentiated thyroid cancer (DTC) was recommended to support treatment of locally advanced or metastatic disease in patients who have progressed during or after prior vascular endothelial growth factor (VEGF) targeted therapy.
New listings for breast cancer, NSCLC and STS
A new listing for trastuzumab deruxtecan was recommended for the treatment of patients with HER2-low unresectable or metastatic breast cancer.
While the potential very high costs involved were an issue, the PBAC said there was evidence the agent was superior to chemotherapy and there was a moderate clinical need for additional treatments in the therapeutic area.
Larotrectinib was supported for the treatment of adults with locally advanced or metastatic NSCLC or soft tissue sarcoma (STS) harbouring NTRK gene fusions.
Treatment would necessarily require gene panel testing, which was already available to both sets of patients on the MBS, as did those with glioma, glioneuronal tumour and glioblastoma, who could also reasonably benefit from access to larotrectinib, the committee said.
And the committee backed the listing of nivolumab for the adjuvant treatment of high-risk muscle invasive urothelial carcinoma in patients who have received prior neoadjuvant platinum-based chemotherapy.
Interestingly, the PBAC stressed its view that the clinical criterion allowing use in patients who have a contraindication or intolerance to NAC should be removed, citing “important cost and quality use of medicines issues arising from use in this patient population with no proven benefit”.
Other relevant recommendations included support for a biosimilar of bevacizumab, the addition of new doses of cetuximab and a new formulation of atezolizumab across a range of indications.