The U.S. Institute for Clinical and Economic Review’s (ICER’s) methods could see legal challenges in the near future, a think tank has warned, due to discrimination against disabled individuals. In other news, Novartis’ rare lung cancer drug capmatinib will be fast-track reviewed by the FDA, following its Breakthrough Therapy Status last year; and the UK’s National Institute for Health and Care Excellence (NICE) has rejected Merck’s potent Keytruda-Inlyta lung cancer combo over doubts about long-term efficacy and its price tag. 

NOVARTIS’ CAPMATINIB FOR FAST-TRACK IN RARE LUNG CANCERS – The FDA said it will fast-track the review of Novartis’ capmatinib as a MET inhibitor for first line treatment of a form of non-small cell lung cancer, METex14. There are currently no approved medicines for this disease, which makes up around 3% of new cases. The FDA previously gave the drug Breakthrough Therapy Status last September. Novartis licensed capmatinib from Incyte in 2009. Should the drug reach market, Incyte could receive more than $500 million in milestone payments and royalties.

KEYTRUDA LUNG CANCER COMBO REJECTED BY NICE – The U.K.’s pharma institute NICE has rejected the combination of Merck’s Keytruda and Pfizer’s Inlyta in kidney cancer. The institute said they were uncertain about long-term benefits. The drug’s considerable price range also went beyond their “acceptable” range. It also said there are a number of other current options for untreated patients, including Pfizer’s Sutent and Exelixis’ Cabometyx. Merck now has until 4 March to improve on the list price. 

ICER METHODS COULD BE ILLEGAL IN U.S.A – ICER’s methods for determining dug cost-effectiveness could lead to treatments for non-disabled people being prioritised, a private think tank has claimed. The Pioneer Institute said that ICER’s methods, used by a number of other bodies globally including NICE in the UK, violate the American with Disabilities Act twice, decreasing the availability of effective treatments for people living with a disability, and increasing the risk of institutionalisation of some with mental disabilities. According to the think tank, any adoption of ICER measures by state Medicaid programmes would be met with “almost certain” legal challenges.

In other news: 

Clinical Trials
Gilead close to second U.S. CAR-T approval
Roche’s early Alzheimer’s drug gantenerumab fails in trials

Manufacturing
Abbvie calls Skrizi psoriasis drug launch ‘exceptional’

That’s all for now. See you next week!

Joshua Neil, Editor
Proventa International