NICE recommends Keytruda for advanced skin cancer
pharmafile | September 7, 2015 | News story | Research and Development, Sales and Marketing | Merck, NICE, keytruda, skin cancer
NICE has approved Merck’s Keytruda (pembrolizumab) as a treatment for advanced skin cancer in final draft guidance for the NHS.
The UK healthcare watchdog recommends Keytruda is made available on the NHS as a treatment for some patients with advanced melanoma which is either unresectable (when the full tumour cannot be removed) or metastatic (when the cancer has spread to other parts of the body).
Keytruda has marketing authorisation in the UK as monotherapy “for the treatment of advanced (unresectable or metastatic) melanoma in adults.” However this is a broader remit than has been assessed by NICE, who looked at the cost-effectiveness of Keytruda for people who have already had treatment with Bristol-Myers Squibb’s Yervoy (ipilimumab).
In March Keytruda became the first drug to be fast-tracked to patients with advanced skin cancer and approved through the Medicines and Healthcare Products Regulatory Agency’s Early Access to Medicine Scheme (EAMS). The scheme aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.
NICE recommended Keytruda for the indication covered by Merck’s evidence submission: after the disease has progressed with Yervoy, and in the case of BRAF V600 mutation-positive disease, the BRAF inhibitors Tafinlar (dabrafenib) or Zelboraf (vemurafenib), or the MEK inhibitors Mekinist (tramentinib) or cobimetinib, a drug in development by Exelixis and Roche.
Therefore the independent Committee decided that an appraisal consultation document was not needed for this appraisal, so fast-tracked the recommendation straight to a final appraisal determination. The draft guidance is now with consultees.
In order to gain NICE approval Merck also agreed to provide a discount in a patient access scheme. Mike Nally, the company’s UK managing director, says: “MSD is proud to have helped bring this breakthrough immunotherapy to patients and that the value it can bring has been recognised and enabled patients who could not afford to wait to gain early access.
“This offers a world-leading example of how different stakeholders in a healthcare system can work together to ensure ‘joined up’, accelerated access for patients across agencies involving industry, government, MHRA, NICE and NHS England. From acceptance onto the innovative EAMS scheme, to the speedy NICE reimbursement path taken, it shows how we can work together to benefit patients who are in the most need and have limited options. We are delighted that NICE has been able to expedite its review and has taken the uncommon step of issuing a positive FAD recommendation following the first appraisal committee meeting.”
Professor Carole Longson, director of the NICE Health Technology Evaluation Centre, says: “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.”
Life science minister George Freeman says: “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.”
Lilian Anekwe
Related Content
Merck shares data from phase 3 trial of Keytruda for gastric cancers
Merck, known as MSD outside of the US and Canada, has announced data from the …
NICE recommends migraine treatment for NHS use
The National Institute for Health and Care Excellence (NICE) has shared draft guidance recommending AbbVie’s …
TILT Biotherapeutics shares data on TILT-123 with Keytruda for ovarian cancer treatment
TILT Biotherapeutics has announced promising preliminary safety and efficacy data from its ongoing phase 1 …
