NICE recommends that nivolumab (also called Opdivo, and manufactured by Bristol Myers Squibb) is made available on the NHS as a treatment option for patients with advanced (unresectable or metastatic) melanoma.
The independent Committee decided that a consultation on the draft recommendations 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 licence.
Professor Carole Longson, Health Technology Evaluation Centre Director said: “We are pleased to be able to recommend nivolumab for treating advanced skin cancer in final draft guidance. In 2011, over 13,000 people were diagnosed with melanoma in the UK, and it accounts for more deaths than all other skin cancers combinedi. 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The draft guidance is now with consultees, who have the opportunity to appeal against it.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. 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.
For more information, call the NICE press office on 0845 003 7782 or out of hours on 07775 583 813, or email email@example.com
Notes to Editors
- Cancer Research UK cancer statistics. http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/skin-cancer#heading-Zero
About the guidance
- 1. The draft guidance will be available at https://www.nice.org.uk/guidance/indevelopment/gid-tag515 from 00:01hrs on Friday 22 January 2015. Embargoed copies are available from the press office on request.
- Nivolumab has a marketing authorisation in the UK as monotherapy ‘for treating advanced (unresectable or metastatic) melanoma in adults’.
- The Committee concluded that that the most plausible ICER for nivolumab was likely to be less than £30,000 per QALY gained.
- The acquisition cost of nivolumab is £439 per 4 ml (40 mg) vial and £1,097 per 10 ml (100 mg) vial (excluding VAT; company’s submission). Costs may vary in different settings because of negotiated procurement discounts.
- The Scottish Medicine’s Consortium is due to publish advice on nivolumab for the treatment of patients with advanced unresectable or metastatic melanoma in March 2016. https://www.scottishmedicines.org.uk/SMC_Advice/Forthcoming_Submissions/nivolumab_Opdivo
- In December 2012, NICE published guidance recommending vemurafenib for treating locally advanced or metastatic BRAF V600 mutation-positive malignant melanoma. http://www.nice.org.uk/guidance/ta269
- 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
- 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
- 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
- In October 2015, NICE published guidance recommending pembrolizumab as an option for treating advanced (unresectable or metastatic) melanoma in adults only after the disease has progressed with ipilimumab and, for BRAF V600 mutation‑positive disease, a BRAF or MEK inhibitor and when the company provides pembrolizumab with the discount agreed in the patient access scheme. http://www.nice.org.uk/guidance/ta357
- In November 2015, NICE published guidance recommending pembrolizumab as an option for treating advanced (unresectable or metastatic) melanoma that has not been previously treated with ipilimumab, in adults, only when the company provides pembrolizumab with the discount agreed in the patient access scheme. https://www.nice.org.uk/guidance/ta366
- 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.
- 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.
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