NICE okays funding for Novartis skin cancer combo

The combination of the Novartis drugs dabrafenib and trametinib for patients with stage 3 skin cancer will be funded by the NHS in England and Wales after a recommendation from cost regulators.

The National Institute for Clinical Excellence (NICE) approved in final draft guidance the simultaneous use of the two drugs for patients with stage III BRAF V600 mutation-positive melanoma that has spread to lymph vessels, or lymph glands close to the melanoma and who have had surgery to remove the tumour and associated lymph glands.

NICE said that the drugs, which are taken orally, will be available at a confidential, discounted rate agreed by Novartis and NHS England.

This development is positive news for patients who would previously have had no adjuvant therapy available.

Clinical trial results showed that patients taking both drugs had higher rates of relapse-free survival (88% at one year, 67% at two years, and 58% at three years) compared with patients taking the placebo (56% at one year, 44% at two years, and 39% at three years).

Mirella Marlow, deputy director for the NICE Centre for Health Technology Evaluation, said: “There are currently no adjuvant treatments available for people with stage III BRAF V600 mutation-positive melanoma, a disease which can cause severe and debilitating symptoms.

“We are therefore delighted that we were able to work with the company and NHS England to recommend dabrafenib plus trametinib as a new treatment option, marking an important development in the management of melanoma.”

Earlier this month, Bristol-Myers Squibb’s Opdivo (nivolumab) was dealt a blow when NICE, in first draft guidance, said that clinical effectiveness for overall survival linked with Opdivo as an adjuvant treatment for completely resected melanoma with lymph node involvement or metastatic disease was “very uncertain”.

NICE also found that there had been no trials comparing Opdivo with routine surveillance, which is the standard way that resected stage 3 and 4 melanoma is managed.

The draft guidance on Opdivo for this type of melanoma is out for public consultation until September 28 with the second appraisal meeting due on October 16.