Tweaks To CBO Model May Add Another Hurdle To Congressional Drug Pricing Reform Effort
New model suggests extra hit for accelerated approval drugs. But despite Congress and President Biden looking toward a scaled-backed version of the Build Back Better reconciliation package, many health care politics experts believe drug price negotiation will make it into law this year.
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Mark McClellan discusses whether CMS’s pending final version of the Medicare national coverage determination on Alzheimer’s drugs might change from the draft and whether the decision should be viewed as a precedent for drugs granted accelerated approvals.
Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims
US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.
Biopharma analysts discuss the likely impact of the drug pricing reform provisions in the Build Back Better legislation, which has hit a roadblock created by Democratic Senator Joe Manchin of West Virginia.