The National Institute for Health and Care Excellence has issued final guidance recommending GlaxoSmithKline’s Tafinlar (dabrafenib) for the treatment of melanoma which has spread or cannot be completely removed by surgery, and which tests positive for the BRAF V600 mutation.

NICE says it was able to publish this final guidance quickly to speed up access - “in less than three months since the committee first met to discuss the treatment,” according to Professor Carole Longson, director of the centre for health technology evaluation at NICE, commenting on the guidance.

“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 potentially significantly improve the prognosis for some people with malignant melanoma have become available. NICE has already recommended vemurafenib [Roche’s Zelboraf] and iplimumab [Bristol-Myers Squibb’s Yervoy], and we are pleased to add dabrafenib to the list of options available for this type of skin cancer,” Prof Longson added.

GSK’s product 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. 

The information provided to NICE by GSK suggests that Tafinlar works just as well as Zelboraf, which also targets melanoma with the BRAF V600 mutation. Drugs like Tafinlar are also thought to have very rapid positive effects for patients, even in those who are very unwell or bedridden and, in some cases, it has enabled people to resume everyday activities.

In September, NICE said its positive recommendation for Tafinlar had been fast-tracked to the final draft stage in order to accelerate access to the drug, and that the recommendation had been on the basis of GSK providing it to the NHS with a discount on the list price, applied at the point of purchase or invoice through a patient access scheme. 

The list price for Tafinlar is £1,400 for a pack of 28 75mg capsules and £933.33 for a pack of 28 50mg capsules, excluding value-added tax (VAT). The drug is taken orally at a recommended dose of 150mg twice daily.

The size of the discount agreed on the list price is commercial in confidence.