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NICE fast-tracks approval of new skin cancer treatment

Patients in England to be first in Europe to access immunotherapy to stall cancer progress

Louise Prime

Friday, 17 June 2016

People in England with advanced skin cancer are to be the first in Europe to benefit from an effective new combination treatment, the National Institute for Health and Care Excellence announced this morning. The approval of the drugs, which can stall cancer progression by many months, follows one of NICE’s fastest ever drug appraisals.

In its final draft guidance published this morning NICE recommends using nivolumab (Opdivo) with ipilimumab (Yervoy) to treat unresectable or metastatic melanoma. The drugs belong to a new class of immunotherapy cancer treatments that disable the natural restrictions that would normally prevent the patient’s immune system from fighting cancer cells. Unusually, NICE decided that it did not need to open a consultation on its draft recommendations – so the decision went straight to final, which only happens when a committee recommends a treatment in line with its licence.

NICE said that compared with standard treatment, nivolumab and ipilimumab can stall progression of advanced melanoma by 8 months on average. It has estimated that about 1,300 people a year in England could be eligible for the combination treatment. But it warned that because of its often significant adverse effects such as diarrhoea and liver damage, doctors will need to ensure that patients are both fit enough and willing to tolerate the side-effects.

Both drugs will be provided to the NHS at an agreed (and confidential) discount through patient access schemes. NICE’s independent appraisal committee concluded that on this basis, on balance, the ‘incremental cost-effectiveness ratio’ for nivolumab plus ipilimumab compared with pembrolizumab is likely to be under £30,000 per extra quality-adjusted life year in the mixed population of BRAF mutation-positive and mutation-negative advanced melanoma – making nivolumab plus ipilimumab a cost-effective use of NHS resources.

Director of NICE’s Health Technology Evaluation Centre Professor Carole Longson 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 committee concluded that the availability of an effective new treatment option such as nivolumab in combination with ipilimumab would be valuable for people with advanced melanoma who are fit enough to tolerate it.”

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