How Could Disease Modifying Therapies for Alzheimer's Reshape our Health Systems? A Health Economics Perspective

On behalf of the GBHI ‘Brain Health Economics’ Special Interest Group, Global Atlantic Fellows Irina Kinchin, Inbal Mayan and Emily Adrion consider what recent medical breakthroughs may mean for health systems across the globe.

Progress in Alzheimer's Therapy

Alzheimer's disease is characterised by the accumulation of beta-amyloid plaques and tau protein tangles in the brain, leading to cognitive decline and memory loss. Available medications such as cholinesterase inhibitors (e.g., donepezil, rivastigmine) and memantine can manage these symptoms but fail to halt or modify the underlying disease process.

However, research and clinical trials focused on developing potential disease-modifying treatments (DMTs) are in progress. These treatments aim to remove abnormal amyloid from the brain and possibly slow disease progression.

In a significant development, the United States Food and Drug Administration (FDA) approved Aduhelm (aducanumab) in 2021, marking the first drug designed to treat Alzheimer's disease to be approved in 20 years. Following this, two more anti-amyloid drugs, Eisai and Biogen's Leqembi (lecanemab) and Lilly's donanemab, are either undergoing or expected to undergo FDA review. Notably, Leqembi is predicted to be the first drug to receive traditional FDA approval on July 6, 2023.

Amid the excitement of these medical breakthroughs, we must also consider their broader economic implications for an equitable and sustainable delivery of these therapies.

Economic Considerations

The introduction of DMTs for Alzheimer's ushers in a new era of hope and promise, yet it also brings significant economic considerations. With these breakthroughs come substantial costs, potentially driving up overall healthcare spending. Even with insurance coverage, these expenses can place a heavy financial burden on patients, causing healthcare systems worldwide to rethink their financial models, explore new reimbursement policies, and consider cost containment measures.

An illustrative case is that of Aduhelm (aducanumab) in the United States. Shortly after its FDA approval in 2021, the Centers for Medicare and Medicaid Services (CMS) announced a 14.5%  increase in the Medicare Part B premium for 2022, half of which was attributed to the cost of covering Aduhelm alone. This premium increase applied to all Medicare enrollees with Part A and B coverage, not merely those prescribed Aduhelm. This decision faced significant pushback, leading CMS to limit access to Aduhelm.

If Eisai and Biogen's Leqembi (lecanemab) receives its expected traditional FDA approval, it will be covered by Medicare. Priced at $26,500 per year, this could trigger a similar or even more significant rise in premium costs than was seen with Aduhelm, leading to potential public backlash. The Kaiser Family Foundation estimated that if only 5% of Medicare enrollees with cognitive impairment are prescribed Leqembi, Medicare spending would surge by $8.9 billion annually.

These costs have profound implications not only for the healthcare system but also for individuals living with Alzheimer's and their families. Beneficiaries would have to spend $5,300 out-of-pocket each year on Leqembi alone.

Cost-Effectiveness 

While Medicare in the United States is unable to consider cost when deciding on coverage, cost-effectiveness is crucial to coverage decisions in other countries. In the UK, the National Institute for Health and Care Excellence (NICE) relies heavily on health technology assessment, including cost-effectiveness analysis. Medications providing good value for money are typically available to patients within three months of approval. Similarly, in Ireland, the Health Service Executive (HSE) decides on drug reimbursement after a health technology assessment by the National Centre for Pharmacoeconomics (NCPE). If approved, the medication enters the reimbursement scheme, with the final price often subject to negotiations. Therefore, the cost of DMTs and their demonstrated effectiveness can significantly influence their inclusion in public coverage. As Alzheimer’s treatment progresses, we must carefully balance potential clinical benefits with healthcare economics and patient willingness to pay affordability.

Service Delivery

From a practical, health services delivery perspective, DMTs will require changes to infrastructure, training and education, monitoring and coordination, and a flexible, transparent approach over time. 

There are important policy considerations in each of these areas:

• Infrastructure: DMTs may have specific storage, handling, and/or administration procedures – including requirements for multiple MRI scans and infusion services – which can pose significant logistical challenges for healthcare systems and carry important additional financial implications. 
• Training and education: DMTs are complex and require informed consideration of the benefits and risks involved. Clinicians, patients and caregivers alike will require clear, comprehensive training and education to ensure appropriate, patient-centered decision-making is supported. New clinical guidelines and clinical decision support structures will be required to ensure these therapies are reaching those most likely to benefit.
• Monitoring and coordination: New DMTs will necessitate long-term monitoring and data collection at the individual patient and wider population level, to manage potential risks and side effects and to assess treatment effectiveness over time. Interoperable electronic medical record systems and open-access data sharing will assist in monitoring safety and effectiveness of these treatments to support optimal patient care.
• Flexibility and transparency: As the pace of new drug development accelerates, it will be crucial for policymakers to be flexible and transparent in making coverage decisions and setting wider health system priorities.

Equity Considerations 

Healthcare is a universal right, and access to DMTs should not be different. Yet, the high cost and complex administration of these therapies can potentially create disparities. It is not difficult to imagine that older adults with limited income and savings could struggle to afford the out-of-pocket expense of these drugs. Moreover, the implications extend beyond individual countries. 

Globally, patients from resource-constrained nations or those in rural or underserved areas may face barriers not only in affording these treatments but also in accessing them. DMTs often require advanced facilities, multiple MRI tests, and specialist physician consultations, which might be challenging to obtain in these regions.

Concluding Remarks

Integrating new DMTs for Alzheimer's into health systems is a journey filled with exciting prospects and considerable challenges. From budget planning to patient education, these new therapies will touch every aspect of healthcare delivery. Policymakers worldwide are at the threshold of making complex decisions to balance the modest clinical benefits and associated health risks of DMTs against the significant economic and equity implications. 

As we negotiate this new landscape in Alzheimer's treatment, we are on the precipice of reshaping our health systems and possibly transforming chronic disease management. With thoughtful planning and coordinated action, we can navigate these challenges, and work to ensure that these groundbreaking therapies are available to all who would benefit.

Special Interest Group ‘Brain Health Economics’

Led by Global Atlantic Fellows for Equity in Brain Health, our group aims to assist research into the economic value of brain health and healthy aging. We are interested in all things efficiency, effectiveness, value and behavior in the production and consumption of health and healthcare for healthy aging and brain health, for people living with neurodegenerative diseases and vascular disorders and their care partners in diverse populations. 

If you are interested in finding out more about our work please contact the group lead Irina Kinchin at irina.kinchin@gbhi.org