The National Institute for Health and Care Excellence (NICE) has approved a combination of two immunotherapy drugs, nivolumab (Opdivo) and ipilimumab (Yervoy), for the treatment of advanced skin cancer (melanoma). This approval comes within a couple of months of the combination getting a licence. Patients with advanced melanoma in England and Wales will be the first in Europe to be treated with the combination of drugs.
NICE have met their new target of reviewing innovative drugs within 90 days of product licence approval on this occasion. The manufacturer, Bristol-Myers Squibb (BMS), agreed to a discount on the price the NHS is charged, which brings it below NICE’s cost-effectiveness threshold of £30,000 per year of quality life gained, making the approval process easier.
About 1,300 people a year diagnosed with advanced skin cancer could potentially benefit from the combination of nivolumab and ipilimumab. People diagnosed with advanced melanoma are usually not expected to survive beyond two years, but some patients who took part in the first clinical trials with these drugs have lived for 10 years or more. It is still not known whether the cancer will return in these patients, because experience with these types of drugs is limited.
Nivolumab and ipilimumab are a type of immunotherapy called checkpoint inhibitors. These drugs release the brakes on the immune system imposed by the cancer to enable it to attack cancer cells; however, in some cases, the immune system can also attack healthy cells causing immune-related side effects leading to liver damage, among other thing.
This approval bodes well for the ongoing NICE appraisal of nivolumab for advanced kidney cancer.