Immediately after EU nod, England's NHS funds Sanofi skin cancer drug

Patients in England will be among those who are first to benefit from Sanofi and Regeneron’s new cancer immunotherapy Libtayo, after NICE recommended funding for a form of skin cancer immediately after European approval.

In a bid to bring cancer drugs to patients as fast as possible, NICE begins its cost-effectiveness deliberations immediately after the Committee for Medicinal Products for Human Use (CHMP) regulatory committee makes a positive recommendation, which nearly always results in European approval within a few months.

This time the system has worked like clockwork with NICE recommending funding for Libtayo (cemiplimab) in final draft guidance the day after the drug was granted its first marketing authorisation in Europe for advanced cutaneous squamous cell carcinoma (CSCC) patients, who cannot receive surgery or radiation therapy.

The fast review system is in response to criticism from industry that the NHS is slow to fund cancer drugs, and it remains to be seen whether hospitals will follow through and make the drug available to eligible patients in line with NICE's recommendation.

Libtayo is the sixth checkpoint inhibitor to hit the market and is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1). It is the only treatment approved in advanced CSCC in the EU.

Cancer Drugs Fund reimbursement applies only in England, and covers costs of cancer drugs until confirmatory data is available.

Libtayo costs £4,650 per 350 mg vial – enough for a single treatment cycle every three weeks. This equates to £80,877 for a year of therapy, but Sanofi has agreed to a confidential price reduction under the managed access agreement with NICE.

In making its decision NICE noted that although there is significant uncertainty around the evidence for Libtayo, the overall response rates in trials so far are “very promising”.

European approval is based on data from the pivotal, open-label, multi-centre, non-randomised phase 2 trial known as EMPOWER-CSCC-1 (Study 1540) and supported by two advanced CSCC expansion cohorts from a multi-centre, open-label, non-randomised phase 1 trial (Study 1423).

Data from the small EMPOWER-CSCC-1 trial announced at ASCO show a 44% response rate in local advanced CSCC, with 13% of patients showing a complete response, and 31% showing a partial response.

This compared favourably with already marketed checkpoint inhibitors in other diseases, where only around a third of patients typically respond to treatment.

The marketing authorisation is conditional, meaning that it must be renewed every year until confirmatory safety and efficacy data is available.

John Stewart, NHS England’s director of specialised commissioning, said: “NHS England has worked closely with Sanofi and NICE to reach a deal to make this hugely promising innovative drug available, meaning NHS patients in England will be among the first in Europe to benefit.

“Cemiplimab has the potential to make a significant impact for patients when previous treatments have failed, as aggressive surgery is often the only option.”

Usually, squamous cell carcinomas are slow-growing and only spread to other parts of the body if they are left untreated for a long time. But sometimes they can behave more aggressively and spread at a relatively early stage which is known as cutaneous squamous cell carcinoma.