FDA's Robert Califf calls on insurers to help providers participate in critical clinical drug trials

WASHINGTON, D.C.—Insurers must do more to help providers participate in clinical trials that can confirm the effectiveness of drugs granted accelerated approval, Food and Drug Administration Commissioner Robert Califf, M.D., told a room full of payer executives Thursday.

Califf spoke about how to improve the accelerated approval process during a session at the AHIP 2023 Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C. The remarks come as the FDA has new powers granted by Congress to get drug companies to finish trials for drugs after they reach the market via accelerated approval. 

“I am not aware of a major effort by insurance plans to help people get studies done,” Califf said. “What I am hearing from clinicians is that it is hard to do research in the current environment. There are negative incentives to do it.”

The accelerated approval pathway was created to hasten the clearance of new drugs that have the potential to address an unmet medical need. Drug companies must complete a confirmatory trial after the product hits the market, but there isn’t much done to get those trials completed, Califf said. 

Congress granted the agency new powers to get such trials done, including giving FDA the authority to require them to get started before an approval decision. FDA also can pull a drug off the market faster if the trial results are negative. 

Califf said the hears from doctors that they have no time to participate because of “intense pressure and many, many barriers from the insurance industry.”

He did not specify what those barriers were, but providers have often complained about administrative burdens levied by insurers such as prior authorization. A recent survey from the American Medical Association showed that a wide majority of physicians are devoting more time to prior authorization requests, a cost containment tool that requires insurer approval for certain items or services. 

There is a major financial benefit to insurers that work to see these trials to fruition, Califf added.

“If you spend more of your time generating evidence, you can stop paying for a lot of things, because it would be clear that they don’t work, and, ultimately, your cost would go down,” he said. 

Confirmatory trials have put the FDA sometimes at odds with the Centers for Medicare & Medicaid Services (CMS).

In 2021, the FDA cleared the controversial Alzheimer’s disease drug Aduhelm via accelerated approval. CMS decided to only cover that class of drugs in Medicare if a beneficiary was in a qualifying clinical trial, which drew swift rebukes from patient groups. 

The Center for Medicare and Medicaid Innovation recently proposed a model that would cut Medicare payments to accelerated approval drugs until a confirmatory trial is complete. The goal is to give drugmakers an incentive to finish the trial. 

Califf said that the model in general seems like a good idea but cautioned he needs to learn more about how it is done. 

“If you do the right follow-up studies and prove the value, there has to be an adjustment in payment based on value,” he said.