WASHINGTON — Medicaid must cover drugs that the Food and Drug Administration has approved with a lower standard of evidence through its “accelerated approval” program, the Centers for Medicare and Medicaid Services said Wednesday in a letter to states.
This announcement comes at a time when state Medicaid agencies and private insurers are trying to figure out what to do about high-priced drugs with unclear benefits. One example is Exondys 51, Sarepta’s treatment for Duchenne muscular dystrophy, which can cost $300,000 a year. Some patients have struggled to get this drug covered by Medicaid, even though Medicaid is supposed to cover all FDA approved outpatient drugs after the state program signs a pricing agreement with the company.
Medicaid is required to pay for FDA-approved drugs. But not all FDA-approved drugs are equal, putting insurance programs in a bind, health policy researchers have argued.
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