Health systems’ rare rejection of Alzheimer’s drug sparks questions about FDA approvals

While heightened controversy and discussion is rare for Food and Drug Administration-approved drugs, outcry over the Alzheimer’s drug Aduhelm could lead to a broader conversation about the approval process and what patients and providers are looking for with value-based care.

The medical community’s reaction to Aduhelm has been especially uncommon with independent review boards stating that they wouldn’t have approved the drug and providers declining to administer it, said Rick Kes, healthcare partner at RSM.

“The last time that there was a lot of controversy surrounding a specific drug and the process that it went through—with the exception of the COVID-19 vaccine—you’re probably thinking back to drugs to treat HIV and AIDS,” Kes said.

Around 50 new FDA-approved drugs hit the market in 2019 and 2020, down from a peak of 59 novel drugs in 2018, according to a Statista study. Thousands of medications are in development nationwide and some companies are weighing the pros and cons of getting FDA approval for their products.

Ultimately, patients want drugs to be approved that will help them live longer and better, said Andrew Hertler, an oncologist and chief medical officer at New Century Health.

“Unfortunately, our current drug approval process does not accomplish that,” Hertler said. “We’ve got a system that rewards marginal improvement, doesn’t drive the studies we need [in order] to see comparative effectiveness, and really doesn’t deliver the results that we’re looking for.”

Although the Center for Drug Evaluation and Research’s accelerated approval process was put in place to quickly get drugs to patients with life threatening diseases, it can incentivize speed over quality, he said.

Only 6% of drugs that have been approved to treat cancer looked at quality of life as part of their clinical trials, according to Hertler. Clinical trials also rarely compare a drug against the standard of care, and many drug approvals for life-threatening conditions don’t have any increase in patient survival rates.

As more payers delve into value-base care arrangements that incentivize positive drug outcomes, it could lead to questions over whether the payments are advancing healthcare.

It is more common for health systems to not cover medications if there are better alternatives available, said Antonio Ciaccia, CEO of 46brooklyn Research. He said it is unusual that care providers would loudly and publicly reject a drug, in the case of Aduhelm. Particularly a drug that currently has no alternative.

Aduhelm is the first new Alzhiemer’s treatment approved by the FDA in 18 years, something notable for the more than 6 million Americans who live with the disease. Still, due process is necessary to determine its side effects, benefits and whether or not it is an effective treatment, Kes said.

FDA could achieve this by holding manufacturers to completing comparative effectiveness studies and better enforce the rules already in place. according to Hertler.

“You could put some incentive behind that by not allowing companies to charge market price for drugs … until the studies are done,” Hertler said.

But the concerns over Aduhelm have also shaken public trust in FDA’s ability to keep people safe, Ciaccia said.

“I am a little concerned that, regardless of whether [the FDA was] right or wrong, this issue of the approval process not being trusted generally could have a cascading effect [on] future approvals of the agency as well,” Ciaccia said.

In this way, providers have some power and influence by publicly stating that a drug is not good and should not be used if there are other choices available, Hertler said.

“You don’t have to use a drug just because it’s marketed and it’s new and there’s publicity around it,” Hertler said. “[Especially] if the data and the evidence don’t support that this is a significant benefit over what we already have out there.”


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