NICE recommends that the drug pembrolizumab (also called Keytruda and manufactured by Merck, Sharp & Dohme) 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 (the cancer has spread to other parts of the body).  Pembrolizumab has a marketing authorisation in the UK as monotherapy ‘for the treatment of advanced (unresectable or metastatic) melanoma in adults’. This is broader than the indication covered by this appraisal which looked at using pembrolizumab in people who had already had ipilimumab. Pembrolizumab is recommended for the indication covered by the company evidence submission, that is:

•        after the disease has progressed with ipilimumab and, for BRAF V600 mutation-positive disease, a BRAF or MEK inhibitor (such as dabrafenib or vemurafenib [BRAF inhibitors] or tramentinib or cobimetinib [MEK inhibitors]), and

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

The independent Committee decided that an 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 in this case, in line with the part of the licensed indication that was included in the scope of the appraisal, .

Pembrolizumab was the first drug to be 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.

Professor Carole Longson, Health Technology Evaluation Centre Director said: “We are pleased to be able to recommend pembrolizumab, the first EAMS drug, in final draft guidance.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 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.”

Life science minister George Freeman said:

“I am delighted that Merck, Sharp & Dohme has decided to use the Early Access to Medicines Scheme to accelerate access for our NHS patients. The Accelerated Access Reviewⁱⁱ will also make practical recommendations to further increase the pace of getting innovative products to patients.”

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.

Ends

For more information call the NICE press office on 0845 003 7782 or out of hours on 07775 583 813, or email pressoffice@nice.org.uk

Notes to Editors

References

1. Cancer Research UK cancer statistics.  http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/skin-cancer#heading-Zero
2. The Accelerated Access Review aims to speed up access to innovative drugs, devices and diagnostics for NHS patients.      https://www.gov.uk/government/organisations/accelerated-access-review

About the guidance

1. The draft guidance will be available at /guidance/indevelopment/gid-tag501      from 00:01hrs on Monday 7 September 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 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. 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
5. The full indication covered by the Early Access to Medicines Scientific Opinion was: “Treatment of unresectable or metastatic melanoma with progressive, persistent, or recurrent disease on or following treatment with  standard of care agents including ipilimumab, and when indicated a V-raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor or mitogen-activated protein kinase (MEK) enzyme inhibitor.” The draft guidance covers the whole population for which pembrolizumab was available through the EAMS.
6. The Scottish Medicine’s Consortium is due to publish advice on pembrolizumab for the treatment of patients with unresectable or metastatic melanoma who  have been previously treated with ipilimumab in November 2015. https://www.scottishmedicines.org.uk/SMC_Advice/Forthcoming_Submissions/pembrolizumab_Keytruda_Treated
7. In October 2014, NICE published guidance recommending dabrafenib as a possible treatment for treating unresectable or metastatic BRAF V600 mutation‑positive melanoma. /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.   /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.   /guidance/ta268
10. NICE is currently  developing guidance on pembrolizumab for treating ipilimumab naive unresectable, metastatic melanoma.  The  anticipated publication date is January 2016.   /guidance/indevelopment/gid-tag505
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.