Anthem Denies Coverage For Eteplirsen, Citing Lack Of Clinical Efficacy
The move to deny coverage for an approved orphan drug is ‘highly unusual,' NORD VP says. 'We certainly hope this isn’t going to set a precedent.'
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Higher Medicaid Rebates For Expedited Approvals Offer Modest Savings But Target Growing Concern
As MACPAC moves toward formal recommendations, a CBO analysis finds that differential Medicaid rebates for drugs approved through the accelerated pathway could save the federal government up to $1bn over five years.
Lower Drug Costs Might End Perception US FDA Approval Standards Are Lower
CDER Director Woodcock says pricing and approval issues are becoming "conflated" but it is hard to change people's minds when they are "determinedly angry about something."
CMS Reminds State Medicaid Agencies: Accelerated Approval Is Still Full Approval
States are eager to try more aggressive methods to rein in prescription drug costs under Medicaid, and CMS is willing to be flexible in permitting innovative contracting. But the agency is also quietly but firmly making clear that all FDA-approved drugs have to be treated the same.