FDA’s Plan to Speed Drug Reviews Risks Skepticism From Insurers

Drugs approved by the FDA’s expanding program to expedite reviews for products in line with the Trump administration’s agenda may struggle to secure coverage from insurers historically skeptical of fast evaluations.

The Food and Drug Administration last week selected another six drugs for the Commissioner’s National Priority Voucher Program—a new pilot that aims to reduce drug review times from as long as 12 months down to one month. The program now has 15 participants, with some products pursuing approval for the first time and others chasing clearance for a different formulation or target.

While the new voucher seeks to bring meaningful cures to the market faster, it could also shape coverage decisions and pose hurdles for patient access if insurers are skeptical of covering the product, health policy experts say.

“With priority review, it’s introducing another question into the coverage decision,” Zachary Predmore, a health policy researcher at nonprofit research organization RAND, said in an interview. “We can’t necessarily say what the impact is going to be yet, but historically, insurers have been pretty skeptical of faster reviews.”

The basis of the program was recently questioned by George Tidmarsh, the agency’s former drug chief who resigned Nov. 2 after being placed on administrative leave over personal conduct concerns. Tidmarsh raised questions over the legality of a program and indicated it brought politics into the drug review process, according to various reports.

Still, FDA Commissioner Marty Makary reemphasized the agency’s expertise and said it can still spend longer on a decision if needed to ensure safety.

“We’re piloting this program,” Makary said in a video posted on social media discussing the second batch of medicines selected for the program. “It’s really changing the process and the structure of the review.”

Quick Decisions

The FDA says the program uses a collaborative “tumor board” style review process to accelerate approvals for companies aligned with national health priorities.

But some swift FDA decisions haven’t sat right for insurers in the past due to high drug costs or insufficient data related to safety and efficacy.

A prime example was the FDA’s accelerated approval of Eisai Co. and Biogen Inc.’s Leqembi to treat Alzheimer’s disease in 2023. Coverage for the drug currently varies by private insurers, but some have viewed the treatment as experimental and said it won’t cover it due concerns about high cost and side effects.

The Centers for Medicare & Medicaid Services also wasn’t immediately on board when the FDA granted accelerated approval, announcing it was examining available information and may reconsider coverage. The agency later agreed to cover the treatment after it obtained full approval from the FDA, but only for Medicare patients meeting certain criteria.

Another example was in 2017, when insurers were skeptical about the high cost of Regeneron Pharmaceuticals Inc.‘s skin treatment Dupixent. The drug was evaluated under the FDA’s priority review.

“Are payers going to say, ‘hey, you got your product through this pathway, that’s awesome, and we’ll pay for it,” said Michael Werner, co-lead of Holland & Knight’s health-care and life sciences team. “Or are they going to say, ‘that’s great, but we’re not paying for it until there’s more data?’”

Other studies have indicated that for drugs granted conditional approval, payers are concerned about the potential for clearance to be revoked. As a result, some payers may postpone coverage review until the FDA grants full approval after the manufacturer’s confirmatory study is complete, according to a report from Managed Markets Insight & Technology (MMIT).

“Just because a drug enters the market sooner doesn’t mean that it’s going to be more accessible or more affordable,” said Stacey Lee, an associate professor at Johns Hopkins Bloomberg School of Public Health. “Approval doesn’t equal accessible pricing or even guarantee it.”

The program also raises questions about how states will respond, as Medicaid programs have long sought policy reforms to address expensive treatments under accelerated approval.

“All you’ve done is you’ve taken that risk and now transferred it somewhere else,” Lee said.

Eyeing Impact

It’s possible the new voucher might not have a heavy influence on coverage if the science that underpins approvals is there, FDA experts say.

“If the data is adequate and the insurance companies agree with FDA, we’ll see the same coverage for these products as any other product because they have the same approval,” said Rachel Turow, head of the FDA regulatory practice at Skadden Arps Slate Meagher & Flom LLP.

“The question is if you move into a more of an accelerated approval style standard, would there be a coverage question with these products in the same way as we’ve kind of seen in the past,” she said.

Insurers might not be as skeptical, as the FDA has touted the voucher alongside the CMS’s efforts to slash drug costs, others say.

“There seems to be a lot of alignment among different federal agencies,” Predmore said. “If Medicare comes along and says ‘anything approved in this pathway, we’re going to cover,’ then that could lead to more take up by private insurers.”

Still, patient access remains to be seen as the FDA currently reviews participants.

“It looks good on paper but what is happening in terms of patient access,” asked Ryan Conrad, a visiting fellow in the Center on Health Policy at the Brookings Institution.

“My fear would be that a lot of the actions companies take are just PR,” said Conrad, a former senior economist at the FDA. “It’s like we’re going to put all these drugs on TrumpRx and make them cheaper, when in reality, the different price levels can sort of mean nothing depending on who the payer is.”