VA, in a slap at FDA, will decline to cover newly approved Alzheimer’s drug

aduhelm-150x150The nation’s largest integrated health system has declined to cover a drug approved by the federal Food and Drug Administration for treatment of early Alzheimer’s disease. The action is not only a rebuke by the Department of Veterans Affairs to the FDA, it also offers support of sorts to a plea by President Biden for a way that he says Congress could help slash at soaring prescription drug prices.

The drug that the VA says it will support only in highly select cases — due to safety and effectiveness concerns — for the 9 million patients in its system (military veterans and their loved ones) is made by Biogen and is called Aduhelm.

The FDA approved the prescription medication to the consternation of its own experts and leading specialists in dementia care based on multiple clinical trials which the company itself had deemed unsuccessful.

But agency officials, meeting in private with company officials and offering Biogen a highly unusual cooperative boost, overrode their own independent advisors and gave Aduhelm an accelerated approval to treat not only early stage but all patients with an Alzheimer’s diagnosis.

The FDA later walked back that broad approval — or tried to, working with the company to alter initially approved labeling instructions, and seeking to limit its use to early Alzheimer’s patients only.

That was a distinction without difference, as once the FDA approves a medication and allows it on the market, doctors may prescribe it as they see fit, based on their own medical judgment.

The Aduhelm approval process became even more infuriating to critics, though, when the company ignored an advisory from a respected, independent review organization — which suggested a nominal price for a drug deemed to have limited benefit — and decided its new drug would cost $56,000 annually. The medication, of course, will be even costlier because it is an infusion that must be administered regularly in doctor’s offices, clinics, or hospitals.

Biogen has agreed, too, with regulators that Aduhelm should be prescribed only to those who have undergone extensive workups, including pricey brain scans — not to patients who may be experiencing mild but noticeable Alzheimer’s symptoms, such as occasional memory lapses. The drug maker also found that the drug can have serious side-effects, including brain swelling and bleeding, meaning that patients taking Aduhelm must undergo regular and expensive brain scans.

Experts in the field were quick to blast the FDA approval of the drug, which appeared, the agency said, to clear plaques and tangles in the brain blamed on amyloids, a particular kind of protein. Despite decades of costly research, medical scientists have not proven the long-espoused theoretical link and established that amyloids cause the most common form of dementia, which is Alzheimer’s.

Growing resistance to a costly drug

Besides prominent specialists who have announced they will not prescribe the drug, several respected, major academic medical centers and hospitals have said they will not recommend the medication for their patients. Notable insurers also have turned it away.

The VA decision is a significant rejection by another government health organization of the FDA approval, as the Wall Street Journal reported:

“The VA decided not to add the drug, called Aduhelm, to its formulary list of available medicines because of the drug’s risk of causing serious side effects and a lack of evidence that it improves cognitive function, an agency spokeswoman said. The VA provides medical benefits to more than nine million veterans, and is the largest integrated healthcare system in the U.S. The agency is known for being a shrewd customer of prescription drugs, using its large purchasing power to haggle steep discounts from manufacturers. By law, the VA has greater leeway than other government health programs such as Medicare and Medicaid to deny coverage of medicines it deems to be of poor value. Last month, a research paper by a group of VA doctors and scientists identified more than 150,000 veteran beneficiaries diagnosed with Alzheimer’s and estimated that the drug could cost the VA more than $4 billion annually, plus additional spending on associated care such as screening tests and imaging scans. The paper hasn’t yet been published in a peer-reviewed journal.”

Critics attacked the FDA’s action on Aduhelm, not only due to the limited evidence of its benefit and safety to patients, but also because green lighting the drug all but compels Medicare and Medicaid to pay for the medication, potentially saddling taxpayers with billions of dollars in new costs. The agency that oversees the two safety net programs, the Centers for Medicare and Medicaid Services (CMS) has said it will conduct its own review of the medical-scientific information on Aduhelm.

Allow Medicare to negotiate drug prices?

The VA’s rejection of the drug came even as Biden spoke publicly to urge Congress, as part of a whopping $3.5 trillion Democratic budget plan, to act, too, to deal with prescription drug prices that the president slammed as being ever-more unaffordable.

A key way he, unlike his predecessor, would deal with drugs’ high costs would be for Congress to allow Medicare (CMS) to haggle with Big Pharma over prescription medication prices. The president also said he wants drug companies “to face penalties if they raise prices faster than inflation, and a new cap on how much Medicare recipients have to spend on medications,” the New York Times reported.

Pro-business and anti-regulation Republicans long have blocked Medicare from drug price negotiations and efforts to impose price-controls on Big Pharma and products. President Trump turned on his own party, however, as he provided his last-ditch plans to cut prescription drug prices, including by setting controls on their prices based on international costs. This was heresy to GOP stalwarts.

Still, does the VA action on Aduhelm affirm Biden’s argument that Medicare, too, should better be able to battle Big Pharma on prices? Will FDA approval processes, including with accelerated consideration and approvals based on “surrogate endpoints,” also be subjected to revision due to the Aduhelm case? (The FDA now can approve a drug based on an endpoint, such as whether a prescription medication, say, shrinks a tumor or appears to slow a disease’s progress — without considering what critics say are more meaningful measures, such as if a product improves the quality or duration of patients’ lives).

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by dangerous drugs. As medications proliferate and grow ever more complex, uncertain, and costly, the public, as well as doctors and hospitals, find they must rely a lot of the supposed experience, wisdom, and judgment of federal regulators, especially at the FDA but as well at Veterans Affairs and CMS.

We have much work to do to ensure that the agencies do not cozy up with the very people and enterprises they are supposed to oversee and that dedicated, energetic, smart, and able officials always put patients and the public first.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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