NICE green-lights Bristol’s new melanoma drug cocktail

June 17, 2016

The National Institute for Health and Care Excellence (NICE) has given Bristol-Myers Squibb’s Opdivo and Yervoy combination for melanoma immunotherapy treatment a rapid draft approval in record time. The approval comes just weeks after the new drug cocktail was licensed for sale in Europe on May 11.

NICE, the United Kingdom’s healthcare cost agency, decides if therapies are worth using on the state health service. But it is more often known in the news for delaying or refusing access to pricey modern cancer drugs. Just recently, it gave a “no” to a different skin cancer drug combination from Roche.

“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,” NICE health technology evaluation head Carole Longson said.

As with many cancer drugs approved by NICE, the combination will be supplied by the manufacturer to the National Health Service at a discount, which will help mitigate the overall cost. The size of the discount is commercially confidential.

The British list price of the two drugs, based on the median duration of treatment, is approximately £78,500 (US$111,000) per patient, or US$30,000 less than the US price. The high cost of such immune system-boosting cancer drugs is shaping up to be a major challenge for healthcare providers on both sides of the Atlantic, increasing pressure on companies to consider novel ways to ensure patient access.

The new drugs are useful in treating skin, lung, kidney and other cancers, but their relevance in different settings is open to debate. NICE has so far refused to approve Opdivo for people with lung cancer.

NICE said around 1,300 people with advanced melanoma could be eligible to receive the Opdivo-Yervoy combination each year. However, doctors will need to check patients are fit enough, since the medicines can cause significant side effects such as diarrhea and liver damage.

Opdivo and Yervoy are complementary in fighting cancer because they target two different receptors, known as CTLA-4 and PD-1, which are used by tumor cells to evade attack. NICE said they could stall progression of advanced melanoma by an average of eight months compared to standard care.