Approval close for new skin cancer drug
18th September 2014 – A new medication for the treatment of melanoma should be widely available for NHS use in England, say health officials.
Dabrafenib, which is also known by its brand name Tafinlar, "significantly" improves survival for patients with advanced melanoma, according to the National Institute for Health and Care Excellence (NICE).
Melanoma is a type of skin cancer which can be caused by abnormal changes or mutations in a cell protein called BRAF V600. Dabrafenib is a biological therapy which works by causing cancer cells with the BRAF V600 mutation to die which can slow or stop the growth of the cancer.
Increasingly common cancer
Malignant melanoma is the 5th most common cancer in the UK accounting for 4% of all new cases. In 2011, there were 13,348 new cases of malignant melanoma in the UK.
The rates of people diagnosed with the disease are 5 times higher than in the 1970s. Experts say the popularity of package holidays, sunbeds and 'must have' tans are behind the increase.
NICE says that dabrafenib should be used in the treatment of melanoma which has spread or cannot be completely removed by surgery and tests positive for the BRAF V600 mutation.
The final draft guidance from the health body suggests that the medication should be made available provided it is sold to the NHS at a discount. The list price of Dabrafenib excluding VAT is £1,400 for a pack of 75 mg capsules (28 capsules per pack) and £933.33 for a pack of 50 mg capsules. It is taken orally at a recommended dose of 150 mg twice daily.
Details of the discount from the Patient Access Scheme are not being disclosed because of commercial confidentiality.
Commenting on the draft guidance in a statement, Professor Carole Longson, centre for health technology evaluation director at NICE, says: "For a long time the treatments available for skin cancer which has spread have been very limited. However, in recent years a number of breakthrough treatments that can potentially significantly improve the prognosis for some people with malignant melanoma have become available. NICE has already recommended vemurafenib and ipilimumab and we hope to add dabrafenib to the list of options available.
"The information provided by GlaxoSmithKline, who market the drug, suggested that dabrafenib works just as well as vemurafenib which also targets melanoma with the BRAF V600 mutation. Drugs like dabrafenib are also thought to have very rapid positive effect for patients, even in those who are very unwell or bed-ridden. In some cases, it has enabled people to resume everyday activities."
New generation of drugs
Commenting on the recommendation in a statement, Professor Paul Workman, interim chief executive of The Institute of Cancer Research, says: "It’s great news that NICE has given the green light to use of dabrafenib on the NHS. Its approval underlines the importance of a new generation of cancer drugs targeted at specific molecular features of tumours – drugs which after years of painstaking development are now making their way to patients.