Does Pharma Own the FDA or Something? — AFAIK #2

>>Update 1 — Look what’s in the NY Times — https://www.nytimes.com/2021/12/31/health/aduhelm-alzheimers-medicare.html?searchResultPosition=2 — Medicare may or may not cover, been looking at it for six months — Biogen cut the price in half(!) Hmm.
>>Update 2 — Keeps getting better :(
— https://www.nytimes.com/2022/01/11/health/aduhelm-medicare-alzheimers.html

In an article I published in July, I asked the question, Neuromodulation for Treating Alzheimer’s — Why Not Now? I lamented the lack of progress, or indeed the absence of any treatments for Alzheimer’s Disease in the 30 years since my mother was first diagnosed. My purpose was to call attention to neglected potential neuromodulation treatments. But I also had mentioned the lack of effective drug treatments for AD, including the drug aducanumab, first abandoned then re-submitted for FDA approval. It turns out that the FDA did approve the drug amidst controversy back in June.

This update article was spurred when Medicare patients got a pleasant surprise that the cost of their Part B supplemental insurance premium will go up 13% for 2022. One might expect a cost of living bump, but this was different. According to the notice sent during the current annual reenrollment period, “The increases in the 2022 Medicare Part B premium and deductible are due to:

• Rising prices and utilization across the health care system that drive higher premiums year-over-year alongside anticipated increases in the intensity of care provided.
• Congressional action to significantly lower the increase in the 2021 Medicare Part B premium, which resulted in the $3.00 per beneficiary per month increase in the Medicare Part B premium (that would have ended in 2021) being continued through 2025.
• Additional contingency reserves due to the uncertainty regarding the potential use of the Alzheimer’s drug, Aduhelm™, by people with Medicare. In July 2021, CMS began a National Coverage Determination analysis process to determine whether and how Medicare will cover Aduhelm™ and similar drugs used to treat Alzheimer’s disease. As that process is still underway, there is uncertainty regarding the coverage and use of such drugs by Medicare beneficiaries in 2022. While the outcome of the coverage determination is unknown, our projection in no way implies what the coverage determination will be, however, we must plan for the possibility of coverage for this high cost Alzheimer’s drug which could, if covered, result in significantly higher expenditures for the Medicare program.

Aduhelm™ is the brand name for the drug Aducanumab, a monoclonal antibody that targets the amyloid beta plaque that is found in the brains of people with Alzheimer’s Disease (AD). Looking back, I found that just as I was finishing my article in June, the FDA approved the drug for AD treatment, but not without controversy. As I had noted in the earlier article, one clinical trial showed effectiveness and one did not. This led an FDA panel of outside experts to conclude there was no strong evidence that the drug worked. (10 of 11 on the panel voted against approval, one undecided.) Aduhelm™ is a product of pharmaceutical company Biogen.

Despite that, In June 2021 the FDA approved the drug anyway in an “accelerated approval pathway”, used for drugs that “fill an unmet need.” Several of the experts promptly resigned from the FDA panel in protest. (Also subsequently, according to Wikipedia, Aducanumab has since been approved by the Ministry of Health and Prevention in the United Arab Emirates as of October 3, 2021, making it the second country in the world to approve the treatment.)

And so, the rather odd Medicare announcement just came through during the recent annual Medicare re-enrollment period. Having rates go up on the occasion of a single new drug coming on the market is highly unusual. It turns out the cost of Aduhelm™ is estimated at around $56,000 per year (not counting MRI scans needed to monitor for possible side effects of bleeding in the brain.) The Kaiser Family Foundation estimated that the cost to Medicare could be $USD29 billion annually. This is based on an estimate of 500,000 Medicare patients receiving Aduhelm (there are an estimated 6 million AD sufferers in the U.S.) For comparison, total Medicare spending for all doctor-administered drugs is close to $40 billion annually.

I suspect my lament of the lack of AD treatments is probably shared by millions of other families, which likely has put pressure on the FDA to do something, or anything, for AD sufferers. This action does reveal that large pharmaceutical companies are moving in this direction (and are contemplating huge revenue streams), while large medical technology companies, like Medtronic, still seem to avoid moving in the direction of applying their neuromodulation expertise toward AD treatment.

I will post an update on the state of the art of neuromodulation after a visit to the Consumer Electronics Show and the upcoming annual meeting of the North American Neuromodulation Society in January. This story hopefully is not over yet.