Reason for request

Inclusion

-


Clinical Benefit

Substantial

The actual benefit of ERIVEDGE is substantial in the Marketing Authorisation indication.


Clinical Added Value

minor

Taking into account both the demonstration level (efficacy data limited to one non-comparative phase II study) and the absence of a valid alternative in the treatment of metastatic basal cell carcinoma and locally advanced basal cell carcinoma where surgery or radiotherapy is inappropriate, the Committee considers that ERIVEDGE provides a minor improvement in actual benefit (level IV) in the treatment strategy of these cancers.