A recently published article presents the first comprehensive analysis of health technology assessment (HTA) reforms across 14 international agencies. It reveals that HTA reform analysis follows similar processes globally but with varying levels of stakeholder involvement. The research identifies three clusters of agencies based on their proactivity and influence: “catalysts” (like NICE and PBAC) that lead reforms; “traditionalists” that exert influence but remain reactive; and “observers” that follow others’ lead. International collaborations are emerging as crucial accelerators for HTA methodology evolution.

Patterns of HTA Reform, Influence and Collaboration

The study reveals distinct patterns in how HTA agencies influence each other and implement reforms:

1. Agency Clustering: The researchers identified three distinct clusters of HTA agencies:
   • Catalysts: NICE (UK), PBAC (Australia), ZIN (Netherlands), CDA-AMC (Canada), and IQWiG (Germany) are proactive in implementing changes and influencing other agencies.
   • Traditionalists: HAS (France), TLV (Sweden), and KCE (Belgium) exert some influence but are generally reactive to changes.
   • Observers: DMC (Denmark), AIFA (Italy), INFARMED (Portugal), ACE (Singapore), AEMPS (Spain), and CDE (Taiwan) implement changes later and have minimal influence on others.
2. Drivers of Reform: The most influential drivers for HTA reforms were:
   • HTA practices in other countries (18 instances)
   • Healthcare policy, legal, and political context (16 instances)
   • The HTA body itself (15 instances)
3. Reform Processes: The research found similarities in reform processes across agencies. These typically involve reviewing existing methods, drafting proposals, stakeholder consultation, and implementation. However, transparency and stakeholder involvement varied considerably.

A significant finding is the increasing role of international collaborations in accelerating HTA reforms. Recent collaborations include eight agencies across Australia, Canada, and the UK, the Nordic collaboration (JNHB), and EU initiatives like the Joint Clinical Assessment (JCA). These collaborations promote method convergence, resource pooling for literature reviews, and joint piloting of innovative approaches.

Interfacing Regulatory and Patients

The European Medicines Agency (EMA) has been working on closer collaboration with HTA bodies through initiatives like parallel scientific advice. Interestingly, the article found limited evidence that regulatory approval processes drive HTA reforms. This contrasts with the growing emphasis on regulatory-HTA alignment in policy discussions.

The article’s findings on patient involvement as a driver for HTA reforms align with broader trends documented by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). ISPOR’s Patient-Centered Special Interest Group has documented the evolution of patient involvement in HTA globally. It shows progressive integration of patient perspectives in assessment processes.

Implications for Health Economics and Market Access

For Health Economics and Outcomes Research (HEOR)

1. Evidence Generation Planning: Understanding the patterns of HTA reforms and influences between agencies allows for more strategic planning of evidence generation. Companies can anticipate methodological requirements by monitoring changes in “catalyst” agencies and prepare evidence packages accordingly.
2. Methodological Innovation: The identification of drivers for HTA reforms provides a roadmap for researchers. They can focus methodological innovation on areas most likely to influence future HTA requirements, such as patient involvement methodologies and real-world evidence standards.
3. Research Prioritization: As international collaborations grow, HEOR teams should prioritize research that addresses shared methodological challenges across multiple HTA agencies. This is more effective than focusing exclusively on country-specific requirements.

For Market Access and Pricing

1. Submission Strategy Optimization: Understanding the reform processes and stakeholder consultation opportunities allows companies to engage more effectively in shaping HTA requirements. It also helps optimize submission strategies.
2. Geographic Sequencing: The identification of “catalyst” agencies suggests that securing positive recommendations from these influential bodies first may create favorable conditions for subsequent submissions to “observer” agencies.
3. Value Dossier Development: Companies should develop modular value dossiers that can be adapted to different HTA requirements. These should maintain core evidence components that address shared methodological elements across agencies.

Future Outlook

The implementation of the EU HTA Regulation with its JCA represents a significant upcoming change. It will likely accelerate harmonization of methods and processes among European HTA agencies. This may gradually shift the dynamics identified in this study, potentially strengthening the influence of some agencies while requiring adaptation from others. The modular approach to methodology updates being adopted by NICE represents an important evolution. Other agencies may also adopt this, moving away from comprehensive guideline revisions to more agile, topic-specific updates.

For further insights, you can explore the thorough research found in the original article that dives into the nuances of HTA reform analysis.