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.

TV Celeb Valerie Harper Calls for More Funding for Cancer Research

Published in Pawtucket Times, May 12, 2014

With a growing population of aging baby-boomers, the U.S. Special Committee on Aging held a hearing on Wednesday to put the spotlight on how decreased federal funding to support cancer research is derailing the nation’s successful efforts on its fight against cancer and to detail treatment advances. .

In Dirksen Building 562, Chairman Bill Nelson (D-Florida) addressed the packed room on how innovative cancer research has tripled the number of survivors during the last 40 years, while continued federal cuts to balance the nation’s budget are having a severe impact on biomedical research.

But, despite significant advances in medical treatments over the years, cancer still is a major medical condition for the national to confront. About 1.6 million Americans—the majority of them over age 55—will receive a cancer diagnosis this year, and more than 585,000 will die from the disease.

Putting Cancer Research on the Public Agenda

In his opening statement, Nelson stated that “As a result of the sequestered cuts, Francis Collins, director of the National Institutes of Health (NIH), had to stop 700 research grants from going out the door.” Federal funding support has “accelerated the pace of new discoveries and the development of better ways to prevent, detect, diagnose, and treat cancer in all age groups,” he says.

Cancer research has been put on the radar screen of the Senate Aging panel because “little is known about the impact of cancer treatments on the body as it ages,” added Nelson.

Nelson notes that although many cancer survivors are in remission because of ground breaking advances in research, there still remains a large percentage of people with cancer across the nation who are still dependent on their next clinical trial, or even the next NIH research grant to keep them alive just a little bit longer. This is why Congress must be committed in its war against cancer, he adds, noting that the best place to start is to renew the federal government’s role and commitment to innovative research that is taking place at universities, oncology centers and hospitals, where much of the federal funds are being directed by NIH.

Dr. Harold Varmus, director of the National Cancer Institute, said more research is needed to fully understand how cancer is linked to aging. “Because most types of cancer-but not all-are commonly diagnosed in older age groups, the number of people with cancer is rising [with the world’s population rapidly aging], and continue to rise, here and globally.”.

“For people of any age, the first line of defense against cancers and their damaging consequences is prevention,” states Varmus.

Dr. Thomas Sellers, director of the H. Lee Moffitt Cancer Center and Research Institute, made his views quite clear about the federal government’s “irreplaceable role” in funding medical research. “No other public, corporate, or charitable entity is willing or able to provide the broad and sustained funding for the cutting edge research necessary to yield new innovations and technologies for cancer care of the future,” he says.

Sellers warns, “Without increased funding now, the spectacular advancements we have witnessed in the past will not be there in the future.”

Star Power to Make a Point

One of the nation’s most prominent lung cancer survivors, Valerie Harper, who rose to fame on the “The Mary Tyler Moore Show” and “Rhoda,” “Valerie,” and more recently on “Dancing with the Starts, advocated at the May 7 Senate panel for increased funding for cancer research. Harper, detailed her own battle with cancer, reminiscing about her initial diagnosed with lung cancer in 2009, later finding out last year that her cancer had spread to the lining of her brain.

Through the eyes of an entertainer Harper explained her fight with cancer. “Cancer reminds me of a very bad but tenacious performer, who although no one wants to see, insists on doing an encore, having a return engagement, making a comeback and worst of all, going on tour,” she said.

According to Harper, more than two-thirds of all lung cancers occur among former smokers or those who never smoked, the majority being former smokers.  Second hand smoke, air pollution and radon, a colorless, tasteless and odorless gas, can cause lung cancer. But, one’s genes can play a role in developing lung cancer, too, she says.

Seventy four-year old, Harper, a cancer survivor of four years, admitted she never smoked, but was exposed to secondhand smoke for decades. As to family, her mother developed lung cancer and later died from it. The actress believes that her lung cancer might be traced to two risk factors, second-hand smoke and genetics.

In her opening testimony, Harper claimed that 75 percent of all lung cancers are often times discovered too late, in the later stages when the disease has already spread. The vocal cancer advocate called for Congress to put more funding into finding better ways for early detection of the disease.

Harper notes that research can also identify new treatment options for lung cancer when it is detected in stages 3 and 4 and finding promising ways to personalize chemotherapy, by testing genetic markers, making the treatment less toxic and more effective against specific tumors.

Others on the Witness List

In 2012, Chip Kennett, 32, a former Senate staffer, remembers passing his annual physical “with flying colors.” Weeks later, a nagging, blurry spot in his right eye would lead to a PET scan that showed he had cancer “everywhere.”

Looking back, he expressed to the Senate panel the shock of being diagnosed with having cancer. “There are really no words to describe what it feels like to be told you have an incurable disease that will kill you,” he said.

Now 18 months post-diagnosis, Kenett, who is now living with an as-yet incurable form of State IV lung cancer, is now in his fourth targeted treatment, the clinical trials have allowed the young man to lead a relatively normal and productive life. “Research saves lives and I am a living example of that. The drugs that have kept me alive for the past 18 months were not available just seven years ago,” he says.

Other witnesses at the hearing included Mary Dempsey, assistant director and cofounder of the Patrick Dempsey Center for Cancer Hope and Healing in Lewiston, Maine, who shared her experience of taking care of her mother, Amanda with her Brother, nationally renowned actor Patrick Dempsey seen on “Grey’s Anatomy.” Over 17 years since the mother’s initial diagnoses in 1997, she had a total of twelve recurrences and just recently died in March.

“My mom lived this experience, and I shared it with her as her primary caregiver,” notes Dempsey said. “In this role, I experienced first-hand the impact cancer had on every part of my life. For me, it really became a full-time job, navigating resources, understanding the medical world, and coping with the profound changes in our lives.”

A Call for Increased Cancer Funding

Hopefully the Senate Aging Panel’s efforts to put medical research on the short list of the nation’s policy agenda will get the attention of GOP lawmakers who over the years have attempted to balance the nation’s budget by slashing NIH funding.

Cancer touches every family. Everyone knows of a family member, colleague or friend who has died from cancer or is a cancer survivor. Americans must send a strong message to their Congressional lawmakers, “no more cuts to medical research.” If the nation is truly at war with cancer, it is shameful to not give the nation’s medical researchers the adequate funding necessary to defeat it once and for all.

Herb Weiss, LRI ’12, is a Pawtucket based writer who covers aging, health care and medical issues. He can be reached at hweissri@aol.com