Controversial U.S. cost watchdog plans to expose 'unsupported' price hikes on old drugs

U.S. drug cost effectiveness organization Institute for Clinical and Economic Review routinely clashes with pharma by arguing that new drug prices are too high. Now, the group plans to spotlight price hikes on old drugs that aren't supported by new clinical evidence. 

ICER plans to convene a group of experts for annual reports on drug price hikes without new data to justify them. Among the experts are representatives from Merck & Co., Regeneron, the Memorial Sloan Kettering Cancer Center and Patients for Affordable Drugs. The first report is expected early next year.

Pharma's routine price hikes have made countless headlines in recent years, beginning in 2015 with enormous increases from Valeant Pharmaceuticals and Turing, the pharma then led by Martin Shkreli. The controversy's latest iteration came last month with the Trump Administration's drug pricing plan. 

The administration says it aims to boost pricing negotiations and competition, provide incentives for lower list prices and help lower patients' out-of-pocket costs. Already, the FDA is highlighting complaints about regulatory abuses that stifle generic competition. 

ICER, for its part, wants to expose the rising prices on older meds that drive up U.S. drug spending. Early this year, for instance, Wells Fargo analyst David Maris spotlighted dozens of price hikes from Pfizer, Novartis, AstraZeneca, Eli Lilly, Sanofi and other companies. He predicted one increase—AbbVie's 9.7% price hike on megablockbuster Humira—would cost the U.S. health system $1.2 billion this year alone. 

In recent years, ICER and pharma companies have clashed over prices set on new drugs. The group has said prices for cancer meds, PCSK9 cholesterol drugs and more are too high, while companies hit back by questioning the ICER's motives and review processes.

But the organization has also endorsed some. It recently found that Amgen and Novartis' new migraine launch Aimovig, priced at $6,900 per year, is cost effective after "existing preventive treatments, which are far less expensive." The companies agreed with the assessment but said ICER's analysis might underestimate Aimovig's cost-effectiveness.  

"Patients have been waiting a long time for an option developed specifically for migraine prevention, and decisions as to who should try Aimovig should be left to the discretion of the physician based on patient need," an Amgen spokesperson told FiercePharma.  

ICER also found that new CAR-T cancer drugs from Gilead Sciences and Novartis—which cost $373,000 and $475,000 per year, respectively—"seem to be priced in alignment with clinical benefits over a lifetime time horizon." ICER also recently signed off on the price of Roche's new hemophilia med Hemlibra.  

However, ICER has hit back at the stickers for meds to treat osteoporosis, multiple sclerosis and more. Most recently, the group said Vertex's cystic fibrosis drugs Kalydeco, Orkambi and newly approved Symdeko would need discounts of 77% to be considered cost-effective. Vertex responded in a strongly worded letter that the analysis is flawed.