Melanoma drug gets NHS approval in England
9th October 2015 - Patients in England with advanced skin cancer due to melanoma are set to get more treatment options following two announcements about the medication pembrolizumab from the National Institute for Health and Care Excellence (NICE).
Earlier this week in final guidance, the health rationing body gave the green light for pembrolizumab -which is also known by its marketing name Keytruda - to be offered to NHS patients with advanced melanoma where the immunotherapy drug ipilimumab had not worked.
In the latest development, NICE has issued draft guidance that pembrolizumab should also be made available to patients who have not been previously treated with ipilimumab.
Pembrolizumab has been shown in a trial to work better for some patients than chemotherapy and to cause fewer serious side effects.
Announcing its final guidance on Wednesday, NICE said that the medication will be available in cases when the tumour cannot be removed by surgery or where the cancer has spread to other parts of a patient's body.
Crucially, NICE has been able to approve the drug after its manufacturer, Merck, Sharp and Dohme, agreed to stick to a deal with the NHS over price.
Pembrolizumab was the first drug to be made available under the Government's Early Access to Medicines Scheme (EAMS), which allows pharmaceutical companies to provide and contribute to the cost of promising drugs to be provided on the NHS before they have been formally licensed for sale.
The discount offered by the manufacturer of pembrolizumab is commercially sensitive and is not being disclosed.
'Unmasking' cancer cells
Pembrolizumab is one of a new generation of cancer drugs called checkpoint inhibitors, which work by 'unmasking' cancer cells and allowing the immune system to target them.
In a statement, Professor Carole Longson, health technology evaluation centre director at NICE, says: "We are pleased to be able to recommend pembrolizumab, the first EAMS drug, in final guidance.
"There were over 13,000 people diagnosed with malignant melanoma in the UK in 2011, and melanoma accounts for more deaths than all other skin cancers combined. This will be welcome news to patients and healthcare professionals alike."
Life Sciences Minister George Freeman says in a statement: "This has been a triumph for early access, but this Government wants to go further, which is why we set up the independent Accelerated Access Review which is looking at how we can reduce the time, cost, and risk of drug development, develop a new range of flexible reimbursement models and look at barriers to roll-out of adoption across the NHS."
Today's draft guidance that pembrolizumab should be available for patients who have not previously had ipilimumab is subject to a consultation period, with a final decision expected in November.
Professor Gillian Leng, deputy chief executive at NICE says in a statement: "The incidence of malignant melanoma has increased fivefold since the mid-1970s in the UK, with around 37 new cases diagnosed every day. 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."
NICE's decision applies to England only, but the Welsh government usually follows suit.
The Scottish Medicines Consortium (SMC) is due to publish advice on the availability of pembrolizumab for advanced melanoma patients next month.