MSD’s Keytruda receives green light from NICE for NHS use

pharmafile | October 12, 2015 | News story | Sales and Marketing MSD, Merck, NICE, keytruda, melanoma, pembrolizumab, skin cancer 

The UK healthcare watchdog NICE has recommended Keytruda as a treatment for advanced skin cancer – its second endorsement of the drug in a week.

 In final draft guidance, the Institute recommended Keytruda (pembrolizumab) as a first-line treatment for advanced skin cancer in patients who have not already had treatment with Bristol Myers Squibb’s Yervoy (ipilimumab). 

As the treatment is being recommended in line with the part of the licensed indication that was the subject of the appraisal, NICE says its independent appraisal committee decided that an initial appraisal consultation document was not needed for this appraisal, so the recommendations could go straight to a final appraisal determination. 

Shortly before, NICE also recommended Keytruda for treating advanced skin cancer after treatment with Yervoy.  Keytruda is an anti PD-1 inhibitor that works by making the cancer cell ‘visible’ to the immune system so it can be attacked by the body’s natural defence mechanisms. 

MSD estimates that around 1,600 advanced melanoma patients could potentially benefit from Keytruda every year. It is the first of a new class of immunotherapies to be made available to NHS England. 

Life sciences minister George Freeman MP says: “This is welcome news for the thousands of patients diagnosed with malignant melanoma every year, who can now be treated with this life-enhancing medicine. This has been a triumph for early access, but this Government wants to go further, which is why we set up the independent Accelerated Access Review which is looking at how we can reduce the time, cost, and risk of drug development, develop a new range of flexible reimbursement models and look at barriers to roll-out of adoption across the NHS.” 

Dr James Larkin, a consultant medical oncologist at The Royal Marsden, says: “This announcement is further good news for people living with advanced melanoma, as it means pembrolizumab is available to all patients with the disease, whether or not they have had previous treatment with ipilimumab or BRAF targeted therapy.

He adds: “Pembrolizumab is a significant advance on previous treatment options, leading to potentially durable control of melanoma in around a third of patients, with an excellent tolerability profile.” 

The final sign-off, due in November, is still subject to MSD agreeing a discounted patient access scheme.

Yasmita Kumar

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