Radar on Drug Benefits
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New Law Could Make Accelerated Approval Stricter, If FDA Enforces It
The FDA’s accelerated approval pathway will see major changes following December’s passage of the Consolidated Appropriations Act, 2023 (2023 CAA), the latest version of the annual legislation that funds the federal government. Experts say that the changes should force drugmakers to be more diligent about proving the clinical value of their early-stage pharmaceuticals — as long as the FDA uses its enforcement powers.
Stakeholders across the health care system have criticized the FDA’s approach to accelerated approval in recent years. The agency’s critics say that it has taken a lax approach, granting accelerated approval to drugs of dubious clinical value, which ultimately costs the health care system billions. In particular, the FDA’s move to grant accelerated approval to Biogen Inc.’s Alzheimer’s drug Aduhelm (aducanumab) faced criticism from researchers, medical practitioners, health systems and insurers. In addition, a recent congressional report documented ethical lapses by agency employees during the accelerated approval process for Aduhelm, and the HHS Office of Inspector General is currently investigating the agency’s decision.
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Amazon Offers Subscription Scripts; Optum Rx to Roll Up Coupons for Members
UnitedHealth Group’s Optum Rx PBM is rolling out a new price shopping tool, while Amazon.com Inc.’s pharmacy division is offering a flat-rate monthly prescription service to Prime members. Experts tell AIS Health, a division of MMIT, that the new offerings are signs that disruptors like Amazon, Mark Cuban Cost Plus Drug Co. and GoodRx Inc. are mounting an effective challenge to traditional generics coverage inside the pharmacy benefit.
Amazon’s new offering, RxPass, will allow members to pay a flat fee of $5 per month to fill any combination of 52 eligible generics, plus free delivery, per a Jan. 24 press release. RxPass will be available in 42 states.
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ICER Report Aims to Nudge Payers Toward Fairer Drug Coverage Policies
In a new analysis that assesses whether major formularies provide “fair access” to select prescription drugs, payers achieved high scores in most categories. But industry observers as well as the organization behind the report, the Institute for Clinical and Economic Review (ICER), say that conclusion may not be the most important takeaway.
ICER — which is best known for its assessments of prescription drugs’ cost-effectiveness — says in a press release that “one of the most notable results of this effort is the change in coverage policies made by five payers for 11 drugs following receipt of draft results of the assessment.”
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Medicare Enrollees May Still Face Affordability Issues After Part D Benefit Redesign
About 800,000 Medicare beneficiaries in 2024 and 200,000 in 2025 could see their out-of-pocket (OOP) medication costs exceed 10% of their annual income, even with the Part D drug benefit reforms passed via the Inflation Reduction Act (IRA), according to an Avalere analysis.
The IRA will establish a beneficiary OOP cap at the catastrophic threshold, which is estimated to be $3,233 in 2024. Avalere estimated that 1.5 million Part D enrollees without low-income subsidies (LIS) are projected to reach OOP drug spending levels above the catastrophic threshold in 2024. Among them, about 18% of beneficiaries will reach the catastrophic phase in the first three months. Greater shares of beneficiaries who are younger than 65 years old or who are Hispanic will face affordability challenges compared to the average non-LIS enrollees. The analysis also suggested that non-LIS enrollees taking asthma drugs, blood thinners, immunology therapies, cancer treatments and HIV drugs are more likely to reach the OOP cap in 2024.
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News Briefs: Lilly Alzheimer’s Drug Fails to Win Accelerated Approval
The FDA declined to grant accelerated approval for Alzheimer’s disease treatment donanemab and requested additional data from its manufacturer, Eli Lilly & Co. said on Jan. 19. The move comes on the heels of the FDA’s decision to bestow accelerated approval on another Alzheimer’s treatment called Leqembi (lecanemab) from Biogen and Eisai — although a National Coverage Determination issued for Biogen’s Aduhelm (aducanumab) significantly limits who can access any drug in that class that receives accelerated approval. In its response letter to Lilly, the FDA cited “the limited number of patients with at least 12 months of drug exposure data provided in the submission” for accelerated approval as its justification for denying the application, and the agency asked Lilly to provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. Lilly said it expects to unveil results from its Phase III confirmatory trial in the second quarter of this year, and that “will form the basis of donanemab's application for traditional approval shortly thereafter.”
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