Controversial move by CMS limits coverage for new Alzheimer’s drug, Aduhelm 

Published in RINewsToday on April 25, 2022

Earlier this month, amid the pleas of the Alzheimer’s Association, the National Committee to Protect Social Security and Medicare, and other aging advocacy groups, the Centers for Medicare & Medicaid Services (CMS) made its final decision to limit their Medicare coverage of the controversial Alzheimer’s drug, ADUHELM® , for only those Medicare recipients participating in clinical studies overseen by the National Institutes of Health (NIH) or in other approved clinical trials.

When releasing its decision on April 7, CMS noted from the onset, the federal agency “ran a transparent, evidence-based process that incorporated more than 10,000 stakeholder comments and more than 250 peer-reviewed documents into the determination” to make its decision.

Calls for More Rigorous Studies

According to CMS, over 6 million older Americans are believed to have Alzheimer’s, and this prevalence is expected to rise to 14 million by 2060, barring effective interventions. CMS stated that effective treatments are needed, and because of the early, but promising, evidence and the immense burden of this devastating disease on the Medicare population, the agency is finalizing Medicare coverage, calling for rigorous studies approved by the U.S. Federal Drug Administration (FDA) and NIH to help answer whether this class of drugs improves health outcomes for patients.

“Science, evidence, and stakeholder input led our team of career civil servants and clinicians through this national coverage determination process. There is potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improving health outcomes to say that it is reasonable and necessary for people with Medicare, which is key consideration for CMS when making national coverage determination, said Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality, in a statement announcing CMS’s regulatory payment decision.

“In arriving at this final decision, we looked at the unique circumstances around this class of treatments and made a decision that weighed the potential for patient benefit against the significance of serious unknown factors that could lead to harm,” added Fleisher. “If a drug in this class shows evidence of clinical benefit through the traditional FDA approval process, then CMS will provide broad access and ensure the results from the rigorous trials are generalizable for people with Medicare participating in a CMS-approved study, such as a registry,” she said, noting that this decision was made to provide CMS flexibility to respond quickly to providing coverage for any new drugs in this class showing a clinical benefit. 

Biogen, a biotechnology company that manufacturers ADUHELM®m , was quick to give its opinion about CMS’s final decision about coverage of this drug. The Cambridge, Massachusetts based company charged that “this unprecedented decision effectively denies all Medicare beneficiaries access to ADUHELM®m , the first and only FDA approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas.”

When additional data from this new class of treatments become available, Biogen urged CMS to reconsider its final decision for all FDA-approved amyloid-beta targeting therapies. The company says that it is carefully considering its options and will provide updates as the company further evaluates the business impact of this decision.

Creating Unnecessary Barriers to Care 

Calling the CMS decision wrong, the Chicago-based Alzheimer’s Association expressed deep disappointment, charging that it has essentially ignored the needs of people living with Alzheimer’s disease. “CMS has created unnecessary barriers for individuals with Alzheimer’s disease. Patients with Alzheimer’s, a fatal disease, should have FDA approved treatments covered by Medicare just as those facing other diseases do,” said Harry Johns, Alzheimer’s Association chief executive officer. 

Notably, CMS has said in its decision the only way for patients to access the first approved FDA treatment targeting amyloid in those living with Alzheimer’s is to enroll in a clinical trial. While we note CMS has expanded where those clinical trials may take place, in reality this remains an unnecessary and never before imposed barrier to access an FDA-approved treatment, says Johns.

“People living with MCI, Alzheimer’s disease and other dementia deserve the same access to therapies given to those living with other conditions like cancer, heart disease and HIV/AIDS. They deserve the opportunity to assess if an FDA-approved treatment is right for them,” said Joanne Pike, Dr.P.H., Alzheimer’s Association president. “Drugs that treat people in the early stages of Alzheimer’s could mean more time for individuals to actively participate in daily life, have sustained independence and hold on to memories longer,” she said.

According to the Alzheimer’s Association, CMS has incorporated one of its recommendations into the final rule. “Importantly, CMS has decided to utilize a registry for future treatments granted full FDA approval. The Alzheimer’s Association registry will play an important role in collecting and analyzing real-world data. This registry will monitor and report clinical and safety endpoints for patients treated with FDA-approved AD therapies, including accompanying diagnostics, to track the long-term outcomes associated with these therapies in real-world settings. Similar successful registries in heart disease and cancer have enabled researchers, clinicians, health systems and payers to track the long-term performance of therapies using a large, real-world evidence dataset,” the advocacy group says. 

The Alzheimer’s Association also expressed strong concern about the immediate impact CMS’s decision will have on Alzheimer’s and dementia research and innovation. “The agency’s decision to essentially reject the Accelerated Approval Pathway for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease is broad overreach. Accelerated approval is a pathway created by Congress and utilized by FDA to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need. Alzheimer’s is a deadly disease with no survivors,” stated the advocacy group.

“The decision by CMS is a step backward for families facing Alzheimer’s disease,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer. “Years of increased research funding has led to more progress and innovation than ever before, but today’s decision may halt this progress as developers question if there is a pathway forward to coverage,” she said.

Calls for Reducing Cost of Medicare Part B Premiums

Max Richtman, President and CEO of the National Committee to Preserve Social Security and Medicare, calls on CMS to “swiftly reduce the hefty 2022 Medicare Part B premium increase ($21.60 per month), now that the agency has made its final decision to limit coverage of the controversial Alzheimer’s drug, ADUHELM®m, to patients in clinical trials.” 

“The spike in Medicare Part B premiums was partly based on the drug’s exorbitant cost (originally priced at $56,000 per year) and the potential expense of wider coverage,” says Richtman, noting that the agency is still “reviewing” Part B premiums, under previous direction from HHS Secretary Xavier Becerra. “Medicare beneficiaries struggling to pay their bills need relief from this year’s premium increase as soon as possible, warns Richtman. .

“The Aduhelm controversy highlights the urgent need for Medicare to be able to negotiate drug prices with Big Pharma. If the price of Aduhelm had been negotiated, it is unlikely that it would have impacted Medicare premiums so dramatically in the first place,”  adds Richtman, 

For a fact sheet on Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, visit https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment-alzheimers-disease.

To read the final NCD CED decision memorandum, visit https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305.

AAIC 2019 Concludes, Researchers Share Findings to Combat Alzheimer’s disease

Published in the Woonsocket Call on July 20, 2019

Thousands of the world’s leading professionals, involved in dementia care and neuroscience research, came at the Los Angeles Convention Center from July 13 to July 18, 2019, to attend the Alzheimer’s Association International Conference® to learn about the findings of the latest Alzheimer’s disease clinical trial and a government-driven public/private initiative to speed them up.

AAIC® is considered to be the largest and most influential international meeting with a mission to advancing dementia research. Every year, AAIC® brings together the world’s leading basic science and clinical researchers, next-generation investigators, clinicians and the care research community, to share research findings that’ll lead to methods of preventing, treating, and improving the diagnosis of Alzheimer’s disease.

“It is clear, and has been for some years that the (Alzheimer’s) field needs to explore other options, and diversify the portfolio of targets. A renewed energy has been brought about by a fivefold increase in Alzheimer’s research funding at the federal level. These gains will propel already-established efforts by the National Institute on Aging, Alzheimer’s Association and others to diversify (therapeutic) targets,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer, in a July 17 statement publicizing research findings from the international conference.

Hundreds of Findings of Clinical Trials Shared

According to the Chicago-based Alzheimer’s Association, “a record number of scientific abstracts – more than 3,400 – were submitted to AAIC this year, including 229 abstracts with results from or descriptions of Alzheimer’s clinical trials. AAIC 2019 also spotlighted three clinical trials using innovative methods and targets.”

At AAIC 2019, attendees were updated about the activities of the Accelerating Medicine Partnership-Alzheimer’s Disease (AMP-AD), a partnership among government, industry, and nonprofit organizations (including the Alzheimer’s Association) that focuses on discovering, validating and accelerating new drug targets. The Alzheimer’s Association says that this $225 million research initiative is made possible through the highest-ever levels of U.S. federal funding for research on Alzheimer’s and other dementias, approved and allocated in the last five years.

“This is an example of how the government and private entities and researchers can work together [via AMP-AD funded studies] on providing the resources necessary to expand our abilities to test new drugs and find a treatment for Alzheimer’s disease, and, hopefully find a cure,” said Donna M. McGowan, Executive Director of the Alzheimer’s Association, Rhode Island Chapter. “Rhode Island has tremendous researchers, and they are at the forefront of this initiative. they need the tools to increase their scope of work.”

Adds Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer, “It is clear, and has been for some years that the field needs to explore other options, other avenues, and diversify the portfolio of targets. A renewed energy has been brought about by a fivefold increase in Alzheimer’s research funding at the federal level, achieved largely due to efforts by the Alzheimer’s Association, the Alzheimer’s Impact Movement, and our ferocious advocates. These gains will propel already-established efforts by the National Institute on Aging, Alzheimer’s Association and others to diversify the portfolio of drug targets for the scientific community.”

The achievements of the AMP-AD Target Discovery Project were highlighted in a series of presentations by the leading AMP-AD investigators at AAIC 2019.

One study noted for the first time, 18-month results from an open-label extension of inhaled insulin in Mild Cognitive Impairment and Alzheimer’s including significant benefits for memory ad thinking, day to day functioning, and biological markers of Alzheimer’s.

Another described a newly-initiated 48-week Phase 2/3 clinical trial of a drug targeting toxic proteins released in the brain by the bacterium, P. gingivalis, generally associated with degenerative gum disease. Previous research findings identified the bacterium in brains of more than 90 percent of people with Alzheimer’s across multiple studies and demonstrated that infection may trigger Alzheimer’s pathology in the brain.

Can lifestyle Interventions Promote Brain Health?

There was also an update on the Alzheimer’s Association U.S. Study to Protect Brain health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) study, now up and running in multiple locations. The U.S. POINTER is a two-year clinical trial to evaluate whether intensive lifestyle interventions that target many risk factors for cognitive decline and dementia can protect cognitive function in older adults at increased risk for cognitive impairment and dementia. Researchers will compare the effects of two lifestyle interventions on brain health in older adults at risk for memory loss in the future. The U.S. POINTER is the first such study to be conducted in a large group of Americans across the United States.

The researchers say people age 60 to 79 will be randomly assigned to one of two lifestyle interventions. Both groups will be encouraged to include more physical and cognitive activity and a healthier diet into their lives and will receive regular monitoring of blood pressure and other health measurements. Participants in one intervention group will design a lifestyle program that best fits their own needs and schedules. Participants in the other intervention group will follow a specific program that includes weekly healthy lifestyle activities.

Laura Baker, Ph.D., associate professor of gerontology and geriatric medicine at Wake Forest School of Medicine, and one of the principal investigators of the U.S. POINTER study, said, “Lifestyle interventions focused on combining healthy diet, physical activity and social and intellectual challenges represent a promising therapeutic strategy to protect brain health.”

“U.S. POINTER provides an unprecedented opportunity to test whether intensive lifestyle modification can protect cognitive function in older Americans who are at increased risk of cognitive decline and dementia,” Baker added.

“We envision a future where we can treat and even prevent Alzheimer’s through a combination of brain-healthy lifestyle and targeted medicines, as we do now with heart disease,” Carrillo said. “We hope to prevent millions from dying with Alzheimer’s and reduce the terrible impact this disease has on families.”

For more details about research findings presented at AAIC 2019, http://www.alz.org/aaic