Advice

following a full submission considered under the end of life and orphan equivalent process:

cemiplimab (Libtayo®) is accepted for use within NHSScotland on an interim basis subject to ongoing evaluation and future reassessment.

Indication under review: As monotherapy for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

In a phase II study of cemiplimab in patients with metastatic or locally advanced CSCC the objective response rate was 44%.

The base-case economic analysis submitted by the company assumed that patients were treated for a maximum of two years.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Medicine details

Medicine name:
cemiplimab (Libtayo)
SMC ID:
SMC2216
Indication:

As monotherapy for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

Pharmaceutical company
Sanofi
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Interim acceptance
Date advice published
10 February 2020
Additional notes

This medicine has an EMA conditional marketing authorisation and has been accepted by SMC on an interim basis subject to ongoing evaluation and future reassessment.  The company is required to submit an updated SMC submission when the EMA advise that conditional marketing authorisation has been converted to standard marketing authorisation.  Further information on the interim accepted decision option is available here.