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.

Report Outlines Strategy for Combating Senior’s Social Isolation and Loneliness

Published in the Woonsocket Call on March 1, 2020

Nearly one in four older adults residing in the community are socially isolated. Seniors who are experiencing social isolation or loneliness may face a higher risk of mortality, heart disease and depression, says a newly released report from the National Academies of Sciences, Engineering and Medicine (NASEM), a Washington, D.C.-based nonprofit, nongovernmental organization.

For seniors who are homebound, have no family, friends or do not belong to community or faith groups, a medical appointment or home health visit may be one of the few social interactions they have, notes the NASEM report released on Feb. 27, 2020. “Despite the profound health consequences — and the associated costs — the health care system remains an underused partner in preventing, identifying, and intervening for social isolation and loneliness among adults over age 50,” says the report.

“I’m pleased the AARP Foundation sponsored study by NASEM confirms the connection between social isolation or loneliness and death, heart disease and depression for older adults. It also finds that the health care system and community-based organizations have a critical role to play in intervening,” says AARP Foundation President Lisa Marsh Ryerson.

“We also know social isolation, like other social determinants of health, must be addressed to increase economic opportunity and well-being for low-income older adults,” says Ryerson.

Addressing Social Isolation and Loneliness

The 266-page NASEM report, “Social Isolation and Loneliness in Older Adults: Opportunities for the Health Care System,” undertaken by the Committee on the Health and Medical Dimensions of Social Isolation and loneliness in Older Adults, outlines five goals that the nation’s health care system should adopt to address the health impacts of social isolation and loneliness. It also offers 16 recommendations for strengthening health workforce education and training, leveraging digital health and health technology, improving community partnerships, and funding research in understudied areas.

Although social isolation is defined as an objective lack of social relationships, loneliness is a subjective perception, say the NASEM report’s authors. They note that not all older adults are isolated or lonely, but they are more likely to face predisposing factors such as living alone and the loss of loved ones. The issue may be compounded for LGBT, minority and immigrant older adults, who may already face barriers to care, stigma and discrimination, the report says.

Social isolation and loneliness may also directly result from chronic illness, hearing or vision loss, or having mobility issues. In these instances, health care providers might be able to help prevent or reduce social isolation and loneliness by directly addressing the underlying health-related causes.

“Loneliness and social isolation aren’t just social issues — they can also affect a person’s physical and mental health, and the fabric of communities,” said Dan Blazer, J.P. Gibbons professor of Psychiatry Emeritus and professor of community and family medicine at Duke University, and chair of the committee that wrote the report in a statement announcing the its release. “Addressing social isolation and loneliness is often the entry point for meeting seniors’ other social needs — like food, housing and transportation,” he says.

Providing a Road Map…

The 16 recommendations in this report provides a strategy as to how the health care system can identify seniors at risk of social isolation and loneliness, intervene and engage other community partners.

As to improving Clinical Care Delivery, the report calls for conducting assessments to identify at-risk individuals. Using validated tools, health care providers should perform periodic assessments, particularly after life events that may increase one’s risk (such as a geographic move or the loss of a spouse).
The NASEM report also recommends that social isolation be included in electronic health records (EHRs). If a patient is at risk for or already experiencing social isolation, providers should include assessment data in clear locations in the EHR or medical records.

It’s important to connect patients with social care or community programs, too. The NASEM report notes that several state Medicaid programs and private insurers already has programs that target the social determinants of health. These programs can be more intentionally designed to address social isolation and loneliness of the older recipients. Health care organizations could also partner with ride-sharing programs to enable older adults to travel to medical appointments and community events, the report recommends.

The NASEM report also suggests that as more evidence becomes available, roles that health care providers are already performing — such as discharge planning, case management and transitional care planning — can be modified to directly address social isolation and loneliness in older adults. The report also details other interventions that the health care system might consider may include mindfulness training, cognitive behavioral therapy, and referring patients to peer support groups focused on volunteerism, fitness, or common experiences such as bereavement or widowhood.

Strengthening health professional education and training can be another strategy to combating the negative impacts of social isolation and loneliness. The NASEM report calls for schools of health professions and training programs for direct care workers (home health aides, nurse aides and personal care aides) to incorporate social isolation and loneliness in their curricula. Health professionals need to learn core content in areas such as the health impacts of social isolation and loneliness, assessment strategies, and referral options and processes, say the report’s authors.

The NASEM report warns that there are ethical Implications for using Health Technology to reduce social isolation and loneliness. Technologies that are designed to help seniors — including smart home sensors, robots and handheld devices — might intensify loneliness and increase social isolation if they are not easy to use or attempt to substitute for human contact. Moreover, the report found that 67 percent of the current assisitive technologies in dementia care were designed without considering their ethical implications. Developers of technology should properly assess and test new innovations, taking into account privacy, autonomy and the rural-urban digital divide.

The NASEM report says that more research is need because of evidence gaps and calls for more funding of studies to determine the effectiveness of interventions in clinical settings; to develop measures to identify at-risk individuals; and identify trends among younger adults as they age (such as use of technology and economic trends) that may inform how the health care system should target social isolation and loneliness in the future. More research is also needed to identify approaches and interventions that best meet the needs of LGBT and ethnic minority populations.

The National Academies are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln.

For a copy of the NASEM report, go to http://www.nap.edu/catalog/25663/social-isolation-and-loneliness-in-older-adults-opportunities-for-the .