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NICE backs CDF funding for Sanofi/Regeneron’s skin cancer drug Libtayo

Acknowledges unmet need


Patients with a form of skin cancer will be able to access Sanofi/Regeneron's new checkpoint inhibitor Libtayo via the NHS in England, after funding for the drug was backed by NICE.

The cost-effectiveness watchdog has published guidance recommending that funding for PD-1 inhibitor Libtayo (cemiplimab) for cutaneous squamous cell carcinoma (CSCC) should be provided by the Cancer Drugs Fund (CDF).

The go-ahead from NICE came just a day after the European Commission gave the drug a conditional approval in adults with CSCC whose cancer cannot be treated effectively with surgery or radiotherapy, making it the sixth PD-1/PD-L1 inhibitor to reach the market.

The access agreement for Libtayo states that treatment can be continued until disease progression or for two years, whichever is sooner, as NICE thinks the data on the drug is “promising but uncertain.”

CSCC accounts for around one in five of all skin cancers overall, and while the disease is rarely fatal if treated before it has spread, NICE acknowledges that living with advanced CSCC is “physically and emotionally challenging, and there is a high unmet need for new treatments.”

The cost-effectiveness modelling for Libtayo also takes it above the recommended threshold for routine NHS funding, says NICE, but that could change once more data is available, and could lead to the drug being restored to routine NHS use.

The list price of Libtayo is £4,650 per 350mg vial – which is enough for one treatment cycle – and for one year that works out at £80,877. However, Sanofi has agreed a managed access deal which makes the drug available to the NHS at a discount.

“Cemiplimab has the potential to make a significant impact for patients when previous treatments have failed, as aggressive surgery is often the only option,” commented John Stewart, NHS England’s director of specialised commissioning.

“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,” he added.

NICE backing bodes well for other reimbursement decisions in Europe, but analysts don’t see the drug making a massive impact despite being on its own in the CSCC category. Around 560 people per year are eligible for treatment with the drug in England.

Evaluate Pharma forecasts the drug reaching revenues of just $600m by 2024, a relative minnow compared to the lead drugs in the checkpoint inhibitor market which are already bringing in multibillion-dollar annual sales.

Article by
Phil Taylor

5th July 2019

From: Regulatory



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