NICE fast-tracks Novartis’ skin cancer combination

NICE has recommended Novartis’ combination of Tafinlar and Mekinist for adults with the most serious form of skin cancer, and has cut short the appraisal process because of the strength of evidence to support cost-effectiveness.

In a rare move, NICE opted to skip publication of an appraisal consultation document (first draft) of its guidance and decided to proceed to the final appraisal determination (final draft).

This removes around seven weeks from the 37-week appraisal process, allowing patients to get faster access to the medicine as it will now almost certainly get backing from NICE.

Previous examples of drugs fast-tracked in this manner include Boehringer Ingelheim’s Giotrif (afatinib) in a lung cancer indication two years ago and The Medicines Company’s Angiox (bivalirudin) heart drug in 2011.

Tafinlar (dabrafenib) + Mekinist (trametinib) is the first targeted oral combination therapy licensed for adults with unresectable or metastatic melanoma with a BRAF V600 mutation, Novartis noted.

Although launched in September last year, NHS patients in England had been unable to access the combination due to the closure of the Cancer Drugs Fund to new medicines last year.

NICE decided to recommend the drug after Novartis offered an undisclosed discount agreed with the Department of Health. The list price per patient for 28 days is £10,080.

NICE ruled that end-of-life criteria applied, allowing it to recommend medicines above the usual cost-effectiveness threshold of £30,000 per Quality Adjusted Life Year.

After a consultation period of 15 working days, NICE will publish final guidance around six weeks later. After this, NHS organisations will have three months to put funding arrangements in place.

Barbara McLaughlan, head of external affairs, Novartis Oncology UK and Ireland, said: “At Novartis, we are delighted with this decision, particularly the unusual step of NICE proceeding straight to final appraisal determination, which should mean significantly faster access for patients.”

In February NICE recommended Bristol-Myers Squibb’s Opdivo (nivolumab) for advanced melanoma. It has also issued two separate recommendations for BMS’ Yervoy (ipilimumab) and Merck, Sharp and Dohme’s Keytruda (pembrolizumab) for advanced melanoma.

Novartis acquired the drugs from GlaxoSmithKline in the $20 billion asset swap deal around a year ago.

They block abnormal signalling in the Mitogen-Activated Protein Kinase pathway, targeting two specific points and potentially stopping or slowing tumour cell growth. The combination therapy has been shown to give patients on average an additional two years of life, six months more than a monotherapy.

Scotland’s SMC is due to make a decision on the combination later this year.

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