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New HTA Decisions in England
September 2020
Drug name
BAVENCIO® (avelumab)
Decision date
Therapeutic area
Therapeutic sub area
Recommended (CDF)
Avelumab with axitinib is recommended for use within the Cancer Drugs Fund as an option for untreated advanced renal cell carcinoma in adults.
Decision Detail
It is recommended only if the conditions in the managed access agreement for avelumab with axitinib are followed.
Key evidence was presented from JAVELIN Renal 101, a phase 3 randomised controlled trial of avelumab plus axitinib compared with sunitinib in advanced renal cell carcinoma. The committee concluded that avelumab plus axitinib prolongs progression-free survival compared with sunitinib. However, it added that the company’s immature data meant that uncertainty remained about whether avelumab plus axitinib prolongs overall survival compared with sunitinib and, if so, by how much. There are no head-to-head trials of avelumab plus axitinib compared with tivozanib, pazopanib or cabozantinib, so it is uncertain how it compares with these drugs. The cost-effectiveness results are commercial in confidence and cannot be reported here. The committee concluded that avelumab plus axitinib cannot be recommended for routine use. Avelumab plus axitinib is recommended through the Cancer Drugs Fund while further data are collected, and the economic model is updated. The economic model should reflect the treatment patients in the NHS would have after avelumab plus axitinib.