High Cost Of Single Unproven Drug Forces Medicare To Increase Premiums by 13% for All Seniors

The Centers for Medicare and Medicaid should NOT approve Aducanumab (branded Aduhelm), because it is posing as an effective treatment for Alzheimer’s which hasn’t been proven. All of the clinicians who served on the FDA review board for this drug resigned when FDA leadership overruled their recommendation to deny approval. Further the drug is linked to heightened risk for falls and brain bleeds. Finally, the astronomical cost of the drug has forced the Centers for Medicare and Medicaid to increase its’ Part B premium by 13%, the largest rate increase it has ever had, which impacts low-income seniors disproportionately. CMS is a separate agency from the Food and Drug Administration for a reason and it has a long history of stewarding improvements in public health. The non-inclusion of Aducanumab by CMS for Medicare enrollees represents an effective method for it to soundly manage the Medicare budget and reinforce scientific methods for approval of treatments by a government agency. This conflict represents a unique opportunity for the Centers for Medicare and Medicaid to put the needs of the general public ahead of the interests of pharmaceutical companies.

 In September, I posted an article about the Biogen Aducanumab (Aduhelm) FDA approval controversy. https://healthpolicymaven.blogspot.com/2021/09/is-fda-too-politicized-to-make-sound.html The Centers for Medicare and Medicaid’s decision not to approve Aduhelm for payment reimbursement under any of its plans was a landmark rebuke of the FDA. This is the first time CMS has denied payment for a drug approved by the Food and Drug Administration. This decision speaks to the fact the FDA overruled the recommendations of the clinical experts who voted against approval of Aduncanumab for treatment of Alzheimer’s as it has not been proven to work. Currently CMS will only pay for this drug for those participating in further study via clinical trials. The FDA and CMS are separate government agencies for a reason and one should not serve as a rubber stamp for the other, yet this is the first time CMS has denied a drug for payment. This incidence does provide hope that our government agencies which are responsible for public health policies which impact us all are demonstrating leadership. Biogen, the maker of Aducanumab, branded as Aduhelm is furiously working to roll back this decision, because after all, their profits and bonuses are at stake. Yet our public advocacy efforts, led by the Right Care Alliance have been effective.. https://rightcarealliance.org/we-say-no-to-aduhelm-heres-why/ 

Here are the actions Biogen was forced to take when we made our collective voices known: 

1. Slashed the price of the unproven Aduhelm by 50% from $56,000 to $28,200

2. Aduhelm is currently only approved for payment for patients in clinical trials

3. Centers for Medicare and Medicaid have initiated a public comment period on Aduhelm through February 10th

4. Biogen’s stock has nosedived 40% because of the questions regarding the validity of the drug and the united clinical outcry against it

 Advocacy Works

The fact a group of scrappy healthcare reform advocates could incite these actions is evidence that efforts by the public can work to roll back some of the ineffective and costly treatments approved by the Food and Drug Administration. It is important to note the drug companies have been allowed to conduct their own testing to certify whether their drugs work without third party validation since 1992. No conflict of interest there- “Heh guys, I don’t like these results can you rejigger the data so it makes my drug appear more favorable?”

 Next Steps

Make your voice heard by taking these actions today:

1. Go to the Centers for Medicare and Medicaid site and post your comment here

https://www.cms.gov/medicare-coverage-database/view/national-submit-public-comment.aspx?DocID=305&commentDocType=nca&fromPage=tracking&error=Your%20comment%20has%20been%20submitted%20successfully,%20and%20your%20confirmation%20email%20se

2. Contact your senators and tell them you do favor the CMS decision not to approve Aduhelm for payment, because it has not been proven to work. This is no cure for Alzheimer’s.

 The FDA should require pharmaceutical companies to have independent third-party validation of the effectiveness and safety of their drugs before approval is given. The U.S. government needs to spend more money to oversee the drug approval process, not turn it over to profiteering drug companies. The pharmaceutical industry should not be financing 44% of the FDA’s annual budget. In 1906, when the agency was founded, the government paid 100% of its funding. Public safety and public interest for our health and our wallets are at stake.

 And this is the healthpolicymaven signing off encouraging you not to sign blanket releases when you consent to medical procedures, do stipulate that for which you agree and decline.

References

Centers for Medicare and Medicaid. (2021, November 12). CMS Announces 2022 Medicare Part B Premiums. Retrieved from Centers for Medicare and Medicaid: https://www.cms.gov/newsroom/press-releases/cms-announces-2022-medicare-part-b-premiums

Centers for Medicare and Medicaid. (2022, January 11). CMS Proposes Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. Retrieved from Centers for Medicare and Medicaid Press Release: https://www.cms.gov/newsroom/press-releases/cms-proposes-medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment

 Roberta Winter is a freelance healthcare journalist who has been publishing this column since 2007 and accepts no money from any sector of the healthcare industry. She is the author of a guidebook to the US healthcare industry, published by Rowman and Littlefield in 2013. 

https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972