Avelumab plus axitinib can be used as an option for untreated advanced renal cell carcinoma (RCC) in adults, only if:
they have a favourable-risk status, as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria, and
the company provides avelumab according to the commercial arrangement.
This recommendation is not intended to affect treatment with avelumab plus axitinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.
What this means in practice
Avelumab plus axitinib must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option.
Avelumab plus axitinib must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that avelumab plus axitinib provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Why the committee made these recommendations
This evaluation reviews the evidence for avelumab plus axitinib for untreated advanced RCC (NICE technology appraisal guidance 645). It also reviews new evidence collected as part of the managed access agreement, which includes evidence from clinical trials and from people having treatment in the NHS in England.
For this evaluation, the company asked for avelumab plus axitinib to be considered only for untreated advanced RCC in people predicted to have good outcomes (that is, with favourable-risk status). This does not include everyone who it is licensed for.
Untreated advanced RCC in people with favourable-risk status is usually treated with sunitinib or tivozanib, and sometimes pazopanib. There are no immunotherapies (such as avelumab) available for routine use in the NHS for this group, so there is an unmet need.
Clinical trial evidence shows that avelumab plus axitinib increases how long people have before their condition gets worse compared with sunitinib. But there is uncertainty about whether avelumab plus axitinib extends how long people live compared with sunitinib. Avelumab plus axitinib has not been directly compared in a clinical trial with tivozanib and pazopanib, but they are thought to work similarly to sunitinib.
The cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, avelumab plus axitinib can be used.