1.1 Avelumab is recommended as an option for treating metastatic Merkel cell carcinoma in adults, only if they have had 1 or more lines of chemotherapy for metastatic disease.
1.2 Avelumab is recommended for use within the Cancer Drugs Fund as an option for treating metastatic Merkel cell carcinoma in adults, only if:
they have not had chemotherapy for metastatic disease and
the conditions in the managed access agreement for avelumab are followed.
1.3 This recommendation is not intended to affect treatment with avelumab 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 clinician consider it appropriate to stop.
Why the committee made these recommendations
Treatment options for metastatic Merkel cell carcinoma are limited. People are usually offered chemotherapy or best supportive care. Avelumab could potentially be used as a first-line treatment or after chemotherapy.
Clinical trial evidence suggests that avelumab may improve overall survival compared with chemotherapy. But chemotherapy has not been compared directly with avelumab so the results are highly uncertain. The evidence on avelumab is promising, but the trial included only a small number of people and data are still being collected.
Avelumab as a first-line or second-line treatment meets NICE's criteria to be considered a life-extending end-of-life treatment.
Avelumab is recommended as a second-line treatment after chemotherapy because it is within the range NICE normally considers acceptable for end-of-life treatments. Avelumab has the potential to be cost effective as a first-line treatment, at the price agreed in the managed access agreement with NHS England. But more evidence is needed to address the clinical uncertainties. It is therefore recommended for use within the Cancer Drugs Fund as a first-line treatment while further data are collected.