Melanoma is a type of skin cancer which can be caused by abnormal changes or mutations in a cell protein called BRAF V600. Dabrafenib, also known as Tafinlar and marketed by GlaxoSmithKline, 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.

Commenting on the guidance, Professor Carole Longson, centre for health technology evaluation director at NICE, said: “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 and ipilimumab and we are pleased to add dabrafenib to the list of options available for this type of skin cancer.

“NICE was able to publish this final guidance quickly and speed up access – in less than 3 months since the committee first met to discuss the treatment”

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 effects for patients, even in those who are very unwell or bed-ridden. In some cases, it has enabled people to resume everyday activities.

NICE recommends dabrafenib on the basis that GlaxoSmithKline provides it to the NHS with a discount on the list price. The size of the discount is commercial in confidence.

Ends

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

Explanation of terms

1. Dabrafenib is recommended, within its marketing authorisation, as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma only if the company provides dabrafenib with the discount agreed in the patient access scheme.

About the guidance

2. The guidance will be available at http://www.nice.org.uk/guidance/TA321 from 22 October 2014. 
3. Vemurafenib (Zelboraf, Roche) is recommended for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma. The guidance on vemurafenib is available at http://guidance.nice.org.uk/TA269.
4. Ipilimumab (Yervoy, Bristol-Myers Squibb) is recommended for the treatment of advanced malignant melanoma in people who have received prior chemotherapy. The guidance on ipilimumab is available at http://guidance.nice.org.uk/TA268.
5. As dabrafenib was recommended in line with its licensed indication, our process allows us to exclude the consultation stage of the appraisal to speed up access.
6. The Committee concluded that, compared with dacarbazine, dabrafenib significantly improved progression-free survival by 4.2 months and probably improved overall survival, but it was unable to draw firm conclusions about the magnitude of overall survival benefit. In light of the available evidence, the Committee concluded that it was likely that dabrafenib and vemurafenib did not differ in clinical effectiveness and that it would not be unreasonable to assume that they have similar effect.
7. GlaxoSmithKline’s estimated cost per QALY (Quality Adjusted Life Year) was £11,000 gained for dabrafenib compared with vemurafenib, but the committee thought the figure would be much lower than this.
8. The list price of dabrafenib is £1,400 for a pack of 75 mg capsules (28 capsules per pack) and £933.33 for a pack of 50 mg capsules (28 capsules per pack) (excluding VAT). It is taken orally at a recommended dose of 150 mg twice daily. GlaxoSmithKline has agreed a patient access scheme with the Department of Health that makes dabrafenib available with a discount applied at the point of purchase or invoice. The size of the discount is commercial in confidence.