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Why the controversy over the Alzheimer’s drug?



… cost and danger are issues


When a drug has the potential to help people with a devastating disease, it should have widespread approval.


That is not the case with the pharmaceutical Aduhelm, which has been approved by the Food & Drug Administration (FDA) for us by people with symptoms of Alzheimer’s.

The drug was developed by the pharmaceutical giant Biogen, but it received a severe setback yesterday when Medicare said that it would only approve it under stringent conditions.


Part of that is because it will cost $28,000 a year, but other concerns are at the root of the debate.


Concerns


Generally, Medicare approves all FDA-approved pharmaceuticals. However, in this case, some of the preliminary testing has resulted in experts saying that the dangers outweigh the benefits,

Biogen had envisioned Aduhelm as a potential blockbuster drug that could be marketed to people with mild Alzheimer’s-related dementia, a population estimated to be 1.5 million Americans. If the decision stands, only a tiny fraction of them would likely get access to it.


Even before Aduhelm was approved last June, medical experts repeatedly raised concerns about potentially serious side effects experienced by patients who received it in clinical trials. About 40 percent of patients who got the highest dose showed abnormalities on MRI scans, indicating brain swelling or tiny hemorrhages. More than three-quarters of those imaging abnormalities caused no symptoms, but about 6 percent of patients on the highest dose had to stop taking the drug.

The draft decision, if finalized, doesn’t apply just to Aduhelm, but to several other similar experimental Alzheimer’s medicines from multiple companies that are in clinical trials and could come before the FDA soon.


Like Aduhelm, the drugs are monoclonal antibodies that target a sticky protein called amyloid that clumps into plaques in the brains of people with Alzheimer’s. Some doctors believe amyloid buildup causes cognitive impairment, although that’s unproven and strongly contested by some experts.


Jonathan Saltzman, “In preliminary decision, Medicare offers only

limited coverage of Aduhelm,” Boston Globe, January 11, 2022

Decision unusual


The Biogen drug has evoked strong passions on both sides of this situation. That is not unusual because of the issues involved with this,


Medicare said Tuesday that it will cover Biogen’s controversial $28,000-a-year Alzheimer’s drug Aduhelm only for patients who participate in clinical trials, an extraordinary move that will significantly restrict the number of people who can get a costly medicine whose benefits and risks have been fiercely debated.


The preliminary decision by the Centers for Medicare and Medicaid Services represents a highly unusual case of the agency balking at fully covering a drug that had been approved by another government agency, the Food and Drug Administration. It is also another stinging setback for the Cambridge-based biotech.


Medicare has occasionally declined to cover an FDA-approved medical device or technology, but experts couldn’t cite a precedent for doing that with an approved drug.


Dr. Lee A. Fleisher, CMS’s chief medical officer, said in a news conference that the “national coverage determination” followed a rigorous six-month analysis by experts. It determined that “while there may be the potential for promise with this treatment, there is also the potential for harm to patients,” he said.

“We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision,” Fleisher added.


Jonathan Saltzman, Boston Globe, January 11, 2022


The anger


Obviously, the company is upset by the Medicare decision, but so are some advocates of dementia,


Limiting the coverage to people in clinical trials “will exclude almost all patients who may benefit,” it said.


Biogen said that trials to gather the evidence sought by CMS “can take months to years to initiate, and hundreds of Alzheimer’s patients ― the majority of whom are Medicare beneficiaries ― are progressing each day from mild to moderate disease stages, where treatment may no longer be an option.”


John Dwyer, president of the Global Alzheimer’s Platform Foundation, a Washington, D.C.-based nonprofit that seeks to speed the development of treatments for the disease, called CMS’s decision “unprecedented, reckless and stands in direct opposition to the president’s personal commitment to better address the Alzheimer’s public health crisis in the US.”


Jonathan Saltzman, Boston Globe, January 11, 2022


The cost part of this is just another issue of whether or not these treatments are feasible. It costs a great deal to develop them, but the cost of drugs is out of control in the U.S., and until that is addressed, thsse issues will remain.

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