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.

RI Senate Tackles High Cost of Prescription Drugs – Herb Weiss

Published in RINewsToday.com on March 15, 2021

In the shadow of the COVID-19 pandemic, as Governor Dan McKee and the Rhode Island General Assembly move to hammer out their Fiscal Year 2022 budget, Senate lawmakers push a package of eight legislative proposals to put the brakes on skyrocketing cost of prescription drugs.

The Senate resolution (2021-S 0560) sponsored by Senate Majority Whip Maryellen Goodwin (D-District 1, Providence), has already been passed and complements the prescription drug affordability package that will be considered next week that would require health insurers to provide coverage, without cost sharing, for colorectal screenings and follow-up colonoscopies when necessary.

The package of legislation aims to protect Rhode Islanders by limiting copays for insulin, capping out-of-pocket expenses for high deductible plans, requiring health insurers to cover preventive colorectal cancer screening, eliminating clauses hidden in pharmacy contracts that prevent a pharmacist from talking about more affordable options, requiring transparent pricing information, importing wholesale prescription drugs from Canada, and creating a board responsible for evaluating and ensuring drug prices are affordable. 

According to Greg Paré, the state Senate director of communications, this package of legislative proposals was developed in conjunction with AARP during the off session before the 2020 Senate session and first submitted last year, but legislation considered last session was limited due to the pandemic and so it did not pass. The legislation has been resubmitted this year with some small modifications and remains a Senate priority.

Last year, AARP along with 14 groups including, the Alzheimer’s Association, the American Cancer Society Action Network, and Aging in Community, urged lawmakers to pass the package of legislative proposals.  Expect to see some of these groups again call for passage of either the total package or specific bills at a Senate Health and Human Services Committee’s virtual hearing, chaired by Sen. Joshua Miller, on Thursday, at 5:00 p.m. For the hearing’s agenda, go to: For hearing details go to: https://bit.ly/3ezofmJ.

Passage of this legislative package would require action by both the Senate and House. At press time, not all of the Senate bills have companion measures in the House.   

Controlling the Skyrocketing Increase of Prescription Drugs

Here are specifics about the Senate’s prescription drug affordability legislative package that will be considered next week by the Rhode Island’s Senate Health and Human Services Committee:  

Legislation (2021-S-0170 sponsored by Sen. Melissa A. Murray (D–Dist. 24, Woonsocket, North Smithfield), would limit the copay for prescription insulin to $50 for a 30-day supply for health plans that provide coverage for insulin. Additionally, the bill mandates that coverage for prescription insulin would not be subject to a deductible.  

Legislation (2021-S 0381)sponsored by Senate Majority Leader Michael J. McCaffrey (D–Dist. 29, Warwick), would cap out-of-pocket expenses for prescription drugs at the federal minimum dollar amount for high-deductible health plans, currently $1,400 for individual plans and $2,800 for family plans.    

The bill (2021-S-0383), sponsored by Senator Goodwin (D–Dist. 1, Providence), would save lives by requiring health insurers cover preventive colorectal cancer screening in accordance with American Cancer Society (ACA) guidelines. This coverage must be provided without cost-sharing and includes an initial screening and follow-up colonoscopy if screening results are abnormal. The ACA recommends people at average risk of colorectal cancer start regular screening at age 45.  

A bill (2021-S -497) sponsored by Sen. Walter S. Felag Jr. (D–Dist. 10, Warren, Bristol, Tiverton) would allow consumers to pay less for their prescription drugs by banning gag clauses sometimes found in pharmacy contracts that prevent a pharmacist from talking to a customer about more affordable options.   

This bill (2021-S-0494) would require pharmaceutical drug manufacturers, pharmacy benefit managers, health insurers, and hospitals to disclose certain drug pricing information. Such transparency would help payers determine whether high prescription costs are justified. This bill is sponsored by Senate President Dominick J. Ruggerio (D – Dist. 4, North Providence, Providence).  

This bill (2021-S-0499), sponsored by Sen. Louis P. DiPalma (D–Dist. 12, Middletown, Little Compton, Newport, Tiverton), would create a state-administered program to import wholesale prescription drugs from Canada, which has drug safety regulations similar to those of the United States. Such programs are allowed under federal rules, with approval from the U.S. Department of Health and Human Services. 

This legislation (2021-S0498) would create a prescription drug affordability board tasked with investigating and comprehensively evaluating drug prices for Rhode Islanders and possible ways to reduce them to make them more affordable. The bill is sponsored by Sen. Cynthia A. Coyne (D–Dist. 32, Barrington, Bristol, East Providence). 

The bill (2021-S 0496) introduced by Sen. Felag (D-District 12, Bristol, Tiverton, Warren) aims to protect consumers from unexpected changes in their health plan’s formularies (list of covered drugs). Under the legislation, formulary changes can only be made at the time of health plan renewal, if the formulary change is made uniformly across all identical or substantially identical health plans, and if written notice is provided 60 days or more before the change. 

Seniors Hit Hard by High Price of Prescriptions

“The high price of prescriptions is having a severe impact on Rhode Islanders, particularly older residents,” said Ruggerio, noting the state’s population is one of the oldest in the nation.  “Many older Rhode Islanders have limited means, and the high cost of prescriptions means people are 

Ruggerio warns that the pharmaceutical industry is not going to address this on its own, so it’s up to the state and federal governments to take action.”

Maureen Maigret, Co-Chair, Long Term Care Coordinating Council, observes that with Medicare paying the tab for costly pharmaceuticals, controlling rising drug costs is a federal issue.  “But this is a big issue to address for those with low and moderate incomes under-insured for prescription drugs,” she says. “I applaud the Senate legislative package aimed at controlling the cost of prescription drugs for Rhode Islanders, says Maigret, who cites the findings of a Kaiser Family Foundation survey that shows one out of four persons take four or more prescription drugs and more than one-third say that have difficulty taking their medication properly due to cost.  “Seniors may fail to get prescriptions filled, resort to pill splitting or skipping doses. Some may end up with costly hospital Emergency Rooms or inpatient visits as health conditions worsen due to the inability to afford their medications, notes Maigret, calling for lawmakers to make necessary prescription drugs affordable for all who need them. Maigret says, “It is time to make necessary prescription drugs available for all who need them.”

“AARP Rhode Island is eager to work with both the Senate and the House of Representatives to pass this important legislation designed to lower prescription drug costs,” said AARP State Director Kathleen Connell. “The high cost of drugs leads families – and particularly older Rhode Islanders on fixed and limited incomes — to often make impossible decisions. No one should have to choose between paying rent, providing food for themselves or their family and vital prescription medications that keep them healthy,” she says.

We look forward to working with legislators from across the state to help improve the health and financial stability of everyone by lowering the cost of prescription drugs. We thank Senate President Ruggerio for once again bringing forth this very important legislation,” adds Connell.

It’s mid-March. Lawmakers turn their attention now to passing the state budget.  Even if the Senate passes every bill in the prescription drug affordability package, the lower chamber must pass companion measures for these bills.  When passed, Governor Dan McKee must sign the legislation to become law.  Right now, it’s an uphill battle and Rhode Islanders must call on their state lawmakers to get on board to support bills to reduce the high cost of pharmaceuticals.  It’s the right thing to do. 

Things that You Should Know 

This meeting will be streamed live online through Capitol TV:

http://www.rilegislature.gov/CapTV/Pages/default.aspx

Written testimony is encouraged and can be submitted prior to 2:00 PM on Thursday, March 18, 2021, in order for it to be provided to the members of the committee at the hearing and to be included in the meeting records. Finally, if you are interested in providing verbal testimony to the committee at this hearing, please go to the following link and make your request by 4:00 p.m., on Wednesday, March 17, 2021:  https://bit.ly/3bIJAs2

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