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Avelumab for treatment of metastatic urothelial cancer
1 August 2021
NICE draft guidance does not recommend Avelumab for treatment of metastatic urothelial cancer

NICE issued draft guidance for public consultation which does not recommend Avelumab (also called Bavencio and made by Merck Serono) for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy.

The number of people eligible for Avelumab for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy is approximately 750.

Clinical trial evidence shows that for people taking Avelumab it took longer for their cancer to get worse, and they lived longer than if they had the best supportive care. However, the most likely cost-effectiveness estimates are significantly higher than NICE normally considers an acceptable use of NHS resources.

At its list price Avelumab costs £768.00 per 200mg/ 10 ml concentrate for solution for infusion vials. The company has a confidential commercial arrangement which would have made Avelumab available to the NHS with a discount.

Because it was unclear how long people who have not had Avelumab on the NHS would live for, Avelumab does not meet NICE’s criteria to be considered a life-extending treatment at the end of life.

Also, because there are no planned or ongoing studies that could address the key clinical uncertainties identified by the independent appraisal committee, it concluded that Avelumab did not meet the criteria for inclusion in the Cancer Drugs Fund.

Current treatments for people with locally advanced or metastatic urothelial cancer whose disease has progressed after platinum-containing chemotherapy include atezolizumab, docetaxel, paclitaxel or best supportive care.

“We know there are currently few, if any treatments available for people with this form of urothelial cancer, and that Avelumab is a promising drug that has the potential to address this unmet clinical need. We are, therefore, committed to working with the company to help them address the issues identified by the committee that are highlighted in this draft guidance.” 

Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE

Avelumab is taken once every two weeks by intravenous infusion. It is a monoclonal antibody (a type of protein) that attaches to a specific target in the body called PD-L1. PD-L1 is found on the surface of certain tumour cells, and helps protect them from the immune system (the body’s natural defences). Avelumab binds to PD-L1, and blocks this protective effect, allowing the immune system to attack the tumour cells.

The draft guidance was open for consultation until 27 May 2021.

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