NICE has published final draft guidance recommending trametinib (Mekinist, Novartis Pharmaceuticals) in combination with dabrafenib (Tafinlar, Novartis Pharmaceuticals) to treat a type of skin cancer that has spread and can’t be surgically removed.
Patients with BRAF V600 mutation positive melanoma receiving the new treatment in two clinical trials survived an average of 6 months longer than those on other drugs.
Life expectancy for those with advanced melanoma is currently under two years. Melanoma accounted for around 1,750 deaths in 2012 in England1, and 12,200 people were diagnosed in 20132.
Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “This combination treatment is the latest in a line of promising new drugs for advanced melanoma we have recommended that look set to significantly extend the life of people with the condition.
“I know from testimonies presented to the committee that patients and healthcare professionals alike will welcome this positive recommendation.”
The NHS will pay a reduced price for the drugs after a discount was agreed between the company and the Department of Health. The list price of trametinib with dabrafenib per patient per 28 days is £10,080.
In February NICE recommended nivolumab (Opdivo, Bristol Myers Squibb) for advanced melanoma. NICE has also issued two separate recommendations each for ipilimumab (YERVOY, Bristol-Myers Squibb) and pembrolizumab (Keytruda, Merck Sharp & Dohme) for advanced melanoma.
The final draft guidance is now with consultees, who have the opportunity to appeal against it.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. Once NICE recommends a treatment 'as an option', the NHS must make sure it is available within 3 months (unless otherwise specified) of its date of publication.
Notes to Editors
About the guidance
- The committee decided a consultation on draft recommendations was not necessary. This meant the decision went straight to final draft which only happens when a committee recommends a treatment in line with its licence.
- The guidance is available on the NICE website at https://www.nice.org.uk/guidance/indevelopment/GID-TAG365.
- Trametinib and dabrafenib have marketing authorisations in the UK, as monotherapies and in combination with each other, for treating adults with unresectable or metastatic melanoma with a BRAF V600 mutation.
- The acquisition cost of trametinib is £1,120 per pack of 2-mg tablets (7 tablets per pack) (excluding VAT; Monthly index of medical specialties) and the cost of dabrafenib is £1,400 per pack of 75-mg tablets (28 tablets per pack) (excluding VAT; ‘British national formulary’ [BNF] edition 67).
- The Scottish Medicine’s Consortium is due to publish advice on trametinib with dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation in July 2016.
- The independent Appraisal Committee concluded that the institute’s criteria for appraising end-of-life cancer treatments should be applied in this case. This allows the committee more scope to recommend treatments with a higher cost-effectiveness threshold. https://www.scottishmedicines.org.uk/SMC_Advice/Forthcoming_Submissions/trametinib_dabrafenib_Mekinist_Tafinlar
- 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.
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