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Speedy NICE appraisal backs BMS' Opdivo/Yervoy combination

But HTA body doesn't find Roche's Cotellic/Zelboraf cost-effective

Bristol-Myers Squibb (BMS)Bristol-Myers Squibb's immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab) has been recommended for NHS use in England and Wales to treat advanced skin cancer.

The National Institute for Health and Care Excellence (NICE) gave the drugs one of its fastest ever appraisals, having decided they should bypass the usual phase of draft guidance.

The move comes just weeks after the European Commission's May approval Opdivo and Yervoy - the first time the regulator had licensed two immuno-oncology drugs.

NICE ruled that the cost per QALY for Opdivo/Yervoy was likely to be less than £30,000 for a mixed patient population of BRAF mutation-positive and mutation‑negative advanced melanoma.

It was helped to this conclusion by the patient access scheme BMS agreed with the Department of Health. The details are confidential, but it provides the NHS with a discount on the list price for Yervoy, which usually comes in at £3,750 per 10‑ml vial or £15,000 per 40‑ml vial (excluding VAT).

NICE also noted that the drugs can stall the progression of advanced (unresectable or metastatic) melanoma by an average of eight months, compared with standard treatment.

It estimated about 1,300 people could be eligible to receive the combination each year, if their doctors decided they are fit enough and willing to tolerate the drugs' often significant side effects, which can include liver damage.

Professor Carole Longson, director of the Health Technology Evaluation Centre at NICE, said: “After one of the fastest drug appraisals NICE has carried out, these promising new immunotherapy treatments for advanced melanoma look set to significantly extend the life of people with the condition.

“The evidence we examined was very promising and I know further trials are ongoing which have also released encouraging data.”

The latest guidance from the cost-effectiveness watchdog adds to NICE's recommendations earlier this year for Opdivo in advanced melanoma and Yervoy as a possible treatment option for adults with advanced melanoma.

The HTA body has also previously given its backing to Merck Sharp & Dohme's Keytruda (pembrolizumab) for advanced melanoma, but has refused BMS' Opdivo in lung cancer.

Draft 'no' for Roche's Cotellic/Zelboraf

However, this week NICE decided not to recommend another advanced skin cancer combination, Roche's Cotellic (cobimetinib) with Zelboraf (vemurafenib), issuing draft guidance saying it was too expensive.

Roche too had offered a patient access scheme - a discount on Zelboraf (which has previously been backed by NICE for advanced skin cancer) - to mitigate the combination's cost to treat advanced BRAF V600 mutation-positive melanoma that has spread and can't be surgically removed.

However, cost-effectiveness estimates from Roche and NICE's evidence review group produced incremental costeffectiveness ratios (ICERs) that were over £100,000 per QALY gained - substantially above the range NICE usually considers to be a cost-effective use of NHS resources.

Article by
Dominic Tyer

17th June 2016

From: Regulatory



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