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.

Your eyes, ears, and teeth are connected to your body – Medicare/Medicaid at 56

Published in RINewsToday on August 2, 2021

Over 56 years ago, Congress became actively involved in the health insurance business with President Lyndon Johnson signing the Social Security Amendments establishing Medicare and Medicaid. The bipartisan legislation creating a national health insurance program. It was introduced in March 1965, and was passed by large majorities of Democratic and Republican lawmakers in the House and Senate chambers. 

At the signing ceremony that took place at the Truman Library in Independence, Missouri on July 30, 1965, Johnson handed the first Medicare cards, numbers one and two, to 81-year-old former President Harry S. Truman and his wife, Bess. Johnson proclaimed the former president to be “the real Daddy of Medicare.” Truman, the 33rd President, was considered to be the first president to vigorously call for national health insurance who ultimately saw his proposals stall on Capitol Hill, as the American Medical Association, the American Hospital Association and conservatives tagged it “socialized medicine.” 

Celebrating Medicare and Medicaid 

On July 30th of this year, top federal officials, Congressional Democrats, and aging advocates celebrated the 56th Anniversary of Medicare and Medicaid.

“For decades, Medicare and Medicaid have been a lifeline and a steady foundation for our seniors, children, women, families, people with disabilities, and at every stage in life,” says HHS Secretary Xavier Becerra, noting that about 140 million Americans have health insurance coverage through either Medicare (63 million) or Medicaid (74 million). An additional 4 million adults could benefit if the remaining 12 states expanded Medicaid through the Affordable Care Act.

“For 56 years, Medicare and Medicaid have made health coverage a reality for individuals and families when they have needed it,” adds Administrator Chiquita Brooks-LaSure, of the Centers for Medicare Services (CMS). “When President Lyndon Johnson called on Congress to spare the nation’s seniors of ‘the darkness of sickness without hope,’ nearly half of seniors were uninsured, most hospitals around the country were segregated, and health coverage was out of reach for many,” she noted. 

“Medicare and Medicaid were critical steps forward in the fight for civil rights that brought the peace of mind that health coverage provides to many, made health care access more equitable by requiring the integration of hospitals, and improved health outcomes across the country,” says LaSure.

With the health needs of those CMS programs recipients always evolving, LaSure calls for the expansion and strengthening of Medicare and Medicaid so they remain quality and reliable health programs. “Ensuring these programs also work to advance health equity nationwide is also a top priority for CMS. Access to health coverage is a right and no one should be left out, left behind or left on the sidelines,” she says.

House Speaker Nancy Pelosi also took time from her schedule to celebrate President Johnson’s landmark law creating Medicare and Medicaid. “Fifty-six years ago, our nation made a bedrock promise to our seniors and working families: that they deserve the dignity and security of quality, affordable health care. Today Medicare and Medicaid stand as pillars of health and justice, ensuring that millions of Americans receive the care they need, regardless of age or financial means,” says Pelosi.

“As we celebrate this anniversary, Democrats reaffirm this longstanding and unyielding belief: health care is a right, not a privilege. That is why we remain committed to defending Medicare and Medicaid against Republicans’ constant, callous attacks, as well as advancing legislation to bring down sky-high prescription drug prices, improve Medicare’s benefits for seniors and build on the success of the Affordable Care Act to lower health care costs for American’s families,” Pelosi adds.

As the nation celebrates Medicare and Medicaid’s 56th Anniversary, Max Richtman, president and CEO, of the Washington, DC-based National Committee to Preserve Social Security and Medicare, watches Congress’s continued debates about expanding Medicare benefits. “If you need to see a dentist, if you can’t see properly, if you can’t hear alarms, it’s not a luxury; it’s essential for the safety and health of older people,” he says.

Social Security Works Goes to Washington

On July 30, Social Security Works came to Capitol Hill to celebrate Medicare’s 56th anniversary by delivering more than 125,000 petitions to lawmakers urging them to lower the popular program’s eligibility age from age 65 to 60, allow Medicare to renegotiate lower prescription drug prices for everyone and to upgrade coverage to include vision, hearing and dental services.

“The 56th anniversary is as good as any other occasion to expand Medicare to cover more people, to do work that has not been done for generations,” says Dr.  Sanjeev Sriram, an adviser to the advocacy group Social Security Works, during the Capitol Hill rally. The Maryland primary care provider called these changes long overdue. 

“Now, as a doctor I can tell you: Your eyes, your ears, and your teeth are connected to your body,” said, Sriram during Friday’s rally on Capitol Hill to explain the importance Medicare covering vision, dental and hearing benefits. “I did not have to go to medical school to tell y’all this, but apparently I do have to tell Congress this.”

“We put Democrats in power to make changes, not excuses. It’s time to expand Medicare,” Sriram told senior advocates holding signs with the message, “Medicare for All” and “Medicare Expansion Now.”

Although Senate Democratic leadership agreed to expand Medicare in a recently $3.5 trillion budget reconciliation package, the measure does not lower the program’s eligibility from age 65 to age 60, says Sriram, noting that lowering the Medicare’s age requirement gives more than 23 million people health care coverage.

While critics say that the nation can’t afford to add vision, dental, hearing and vision benefits, a recently released poll says the Americans support this expansion of benefits. In June 2021, survey findings released by Data for Progress and Social Security Works proves just how popular these proposals are. A survey of 1,175 likely voters shows a full 83% of voters support expanding Medicare to cover hearing, vision and dental care, including 86% of those over the age of 45. That popularity even crosses party lines: 89% of Democrats, 82 of Independents, and 76% of Republicans are in favor.

Congress now has an opportunity to listen to constituents. And many think it’s time to expand Medicare’s benefits and lower the program’s eligibility age, for the benefit of America’s seniors.