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New research presented today at ISPOR Europe delves into the challenges and opportunities for evaluating disease-modifying therapies (DMTs) targeting Alzheimer’s disease (AD) across various health technology assessment (HTA) bodies. The findings highlight what is needed to support reimbursed patient access to these innovative treatments. 

The research was conducted using the Lightning Insights platform; an on demand global stakeholder research technology, across a sample of HTA representatives in the UK, Germany, Brazil, Saudi Arabia and Greece. 

Several key considerations were identified as foundational to enhance value demonstration and facilitate patient access: 

• Consensus definition of ‘Disease Modification’: Establishing a clear, standardised definition for what constitutes ‘disease modification’ in AD treatment to align stakeholders and set consistent evaluation criteria 

• Development of feasible managed entry agreements: Designing flexible access agreements to support earlier reimbursed patient access while mitigating the risks associated with uncertain long-term clinical and economic outcomes 

• Commitments for ongoing Real-World Evidence (RWE) generation: Ensuring mechanisms for long-term RWE collection to monitor safety, efficacy, and economic impact, ensuring that HTA bodies have robust data to support sustained reimbursement 

• Consensus on methods and assumptions for Pharmacoeconomic (PE) analysis: Alignment on consistent methodologies and assumptions for use in PE analyses for AD therapies, including transition probabilities, utility values for AD health states and practical implementation of stopping rules, to strengthen the reliability and comparability of assessments across jurisdictions 

Whilst HTA stakeholders acknowledge the significant clinical benefit of slowing disease progression for AD patients through disease modifying therapies, there is agreement across countries that these considerations are essential for advancing HTA processes, supporting the value proposition of AD DMTs, and ultimately enabling broader reimbursed access for patients.  

To discuss how to navigate the challenges associated with the development of disease modifying therapies, contact our expert team.

Article published 19 November 2024.