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NICE hands Merck & Co’s Keytruda speedy recommendation

Cancer drug backed for NHS use against advanced melanoma
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NICE has given a quick thumbs-up in final draft guidance for Merck & Co's Keytruda as a treatment for advanced skin cancer.

The UK cost-effectiveness body has recommended Keytruda (pembrolizumab) for use on the NHS for patients with advanced melanoma that is either unresectable or metastic.

In March, Keytruda became the first drug to be approved through the MHRA's Early Access to Medicine Scheme (EAMS), which aims to give patients with life-threatening conditions access to medicines that are not yet approved.

Merck's submission focused on data from the Keynote-002 trial that compared Keytruda with chemotherapy in patients with advanced melanoma who had at least two doses of ipilimumab and whose condition had progressed within 24 weeks of their last ipilimumab dose.

Although the drug is yet to prove its full potential in trials, NICE agreed with Merck that Keytruda was a 'step change' in melanoma treatment and the best available evidence suggested a median overall survival gain of 3.5 months.

Therefore, the independent committee decided that an appraisal consultation document was not required; instead saying recommendations could go straight to a final appraisal determination.

Carole Longson, director of NICE Health Technology Evaluation Centre, said: “We are pleased to be able to recommend pembrolizumab, the first EAMS drug, in final draft guidance.

“In 2011, over 13,000 people were diagnosed with skin cancer in the UK, and it accounts for more cancer deaths than all other skin cancers combined. I am sure this will be welcome news to patients and healthcare professionals alike.”

Keytruda is indicated for those where the disease has progressed after treatment with Yervoy (ipilimumab).

It is also indicated for BRAF V600 mutation-positive diseases treated by BRAF or MEK inhibitors Tafinlar (dabrafenib) or Zelboraf (vemurafenib) or MEK inhibitors Mekinist (tramentinib) or cobimetinib - the latter of which is currently in development by Roche and Exelis.

The cost of Keytruda is £1,135 per 50mg vial and Merck has negotiated an undisclosed patient access scheme discount with the UK's Department of Health.

Life science minister George Freeman said: “I am delighted that Merck has decided to use the Early Access to Medicines Scheme to accelerate access for our NHS patients. The accelerated access review will also make practical recommendations to further increase the pace of getting innovative products to patients.”

Article by
Nikhil Patel

8th September 2015

From: Regulatory



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