NICE recommends pembrolizumab (also called Keytruda and manufactured by Merck, Sharp & Dohme) as a treatment for some patients with advanced melanomaⁱ.  Pembrolizumab has a marketing authorisation in the UK as monotherapy ‘for the treatment of advanced (unresectable or metastatic) melanoma in adults’. Pembrolizumab is recommended as an option in adults:

•        for treating advanced melanoma that has not been previously treated with ipilimumab, and

•        when the company provides pembrolizumab with the discount agreed in the patient access scheme.

The independent Appraisal Committee decided that an initial appraisal consultation document (ACD) was not needed for this appraisal, so the recommendations could go straight to a final appraisal determination (FAD). This happens when the Committee recommends a treatment in line with its licensed indication, or as in this case, in line with the part of the licensed indication that was the subject of the appraisal.

Earlier this week, NICE published final guidance recommending pembrolizumab as an option for the treatment of advanced melanoma after the disease has progressed with ipilimumab. 

Professor Gillian Leng, Deputy Chief Executive at NICE said: “The incidence of malignant melanoma has increased fivefold since the mid-1970s in the UK, with around 37 new cases diagnosed every dayⁱⁱ.  We are, therefore, pleased to be able to recommend pembrolizumab as an option for some people with the disease that has not been previously treated with ipilimumab, in final draft guidance. I am sure this will be welcome news to patients and healthcare professionals alike.”

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Final guidance is expected to be published in November 2015. 

Notes to Editors

References

1. Melanoma is classed as ‘advanced‘ when it is either unresectable (when the full tumour cannot be removed) or metastatic (where it has spread to other parts of the body).
2. Cancer Research UK cancer statistics.  http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/skin-cancer#heading-One

About the guidance

1. The draft guidance will be available at: https://www.nice.org.uk/guidance/indevelopment/gid-tag505 from Friday 9 October 2015.
2. The Committee concluded that that the most plausible ICER for pembrolizumab compared with best supportive care was likely to be less than £50,000 per quality-adjusted life year (QALY)  gained.
3. The acquisition cost of pembrolizumab is £1315 per 50 mg vial (excluding VAT; company’s submission). The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple      discount to the list price of pembrolizumab with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence.
4. Pembrolizumab is administered intravenously for 30 minutes at a dose of 2 mg/kg every 3 weeks until disease progression or unacceptable toxicity.
5. In March 2015, Pembrolizumab was the first drug to be approved through the Early Access to Medicine Scheme (EAMS) which fast tracks unlicensed medicines to severely ill patients. Following clinical trials, the Medicines and Health Regulatory Authority (MHRA) approved the drug  designed to treat patients with advanced melanoma. This means that this drug is available to be prescribed to patients before it would normally      have been before the EAMS was established.  https://www.gov.uk/apply-for-the-early-access-to-medicines-scheme-eams
6. In October 2015, NICE published guidance recommending pembrolizumab for treating unresectable, metastatic melanoma after progression with ipilimumab. https://www.nice.org.uk/guidance/ta357
7. In October 2014, NICE published guidance recommending dabrafenib as a possible treatment for treating unresectable or metastatic BRAF V600 mutation‑positive melanoma. https://www.nice.org.uk/guidance/ta321
8. In July 2014, NICE published guidance recommending ipilimumab as a  possible treatment for adults with advanced (unresectable or metastatic) melanoma that has not been treated before. https://www.nice.org.uk/guidance/ta319
9. In December 2012, NICE published guidance recommending ipilimumab as a possible treatment for people with previously treated advanced (unresectable or metastatic) melanoma. https://www.nice.org.uk/guidance/ta268
10. The Scottish Medicine’s Consortium is due to publish advice on pembrolizumab for the treatment of patients with unresectable or metastatic melanoma untreated with ipilimumab in November 2015.  https://www.scottishmedicines.org.uk/SMC_Advice/Forthcoming_Submissions/pembrolizumab_Keytruda_Untreated
11. NICE technology appraisals apply in England.  Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish  Government, and Northern Ireland Executive.
12. In 2011, 13,348 people were diagnosed with malignant melanoma in the UK. http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/skin-cancer.