Aduhelm’s rejection of health systems raises questions of FDA approval

While controversy and increased discussion are rare for drugs approved by the Food and Drug Administration, the claim 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 care based on value.

The medical community’s reaction to Aduhelm has been particularly uncommon with independent review boards saying they had not approved the drug and suppliers who refused to administer it, said Rick Kes, RSM’s healthcare partner.

“The last time there was a lot of controversy surrounding a specific drug and the process that went on – with the exception of the COVID-19 vaccine – you probably thought about the drug to treat HIV and AIDS,” Kes said.

About 50 new FDA-approved drugs will hit the market in 2019 and 2020, up from a peak of 59 new drugs in 2018, according to a Statistical study. Thousands of drugs are in development across the country and some companies are weighing the pros and cons of getting FDA approval for their products.

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

“Unfortunately, our current drug approval process is failing,” Hertler said. “We have a system that rewards marginal improvement, not conducting the studies we need [in order] to see comparative effectiveness, and not really give the results we are looking for. “

Although the Center for Drug Evaluation and Research’s accelerated approval process has been put in place to quickly deliver drugs to patients with life-threatening illnesses, it can boost speed over quality, he said.

Only 6% of drugs that have been approved to treat cancer have considered quality of life as part of their clinical trials, according to Hertler. Clinical trials rarely compare a drug against the standard of care, and many drug approvals for life-threatening conditions have no increase in patients ’survival rates.

As more payers delve into value-based care arrangements that encourage positive drug outcomes, it could lead to questions about whether payments advance health care.

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

Aduhelm is the first new Alzheimer’s treatment approved by the FDA in 18 years, something remarkable for the more than 6 million Americans living with the disease. However, due process is needed to determine its side effects, benefits and whether or not it is an effective treatment, Kes said.

The FDA could accomplish this by requiring manufacturers to complete comparative efficacy studies and better enforce rules already in place. according to Hertler.

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

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

“I’m a little worried about that, regardless of whether [the FDA was] right or wrong, this issue of the approval procedure that is not trusted in general could have a cascading effect. [on] future approvals from the agency as well, ”Ciaccia said.

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

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

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