Priced around US$7,000 each, the drugmakers called them"breakthrough" treatments designed to prevent migraines when taken year-round, and estimated that millions of patients could benefit. The U.S. Food & Drug Administration said Amgen's Aimovig – the first of the three drugs approved – was an"important addition" to available treatments.But a small group of medical experts who quietly advise U.S.
These relatively unknown expert committees have been involved in drug coverage decisions for decades. Their members' identities are kept secret due to federal regulations aimed at preventing pharmaceutical industry interference. Their decisions have new consequences as the pharmacy benefits companies they advise are more likely to exclude a new treatment from coverage if it is deemed on par with existing therapies. Or they can demand discounts - or rebates - from drugmakers in exchange for the coverage.
U.S. Congress and President Donald Trump have taken up that criticism, and the administration has proposed banning rebates in government health programs unless benefits managers hand over the savings to patients. Migraines affect more than 39 million Americans, mostly women, and Amgen estimated 8 million could be candidates for the preventative therapies, which are delivered by injection every month or few months. Analysts forecast US$4 billion in annual sales by 2026 in major global markets.
"Let's be cautious and see how it all plays out, but we need to look at these studies with a jaundiced eye," one of the members said.
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