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Q&A on the latest guidelines for statistical analysis in EU Health Technology Assessment

By Michael Hennig, PhD

Q&A with Dr. Michael Hennig

Senior Director, Expertise Line Head HTA Statistics, at Cencora PharmaLex

The European health technology assessment (HTA) landscape is evolving, with new guidelines on statistical analysis set to impact biopharmaceutical companies starting in January 2025. These guidelines focus on evidence synthesis and the methods for combining existing data on study drugs. In this Q&A session, we interview Dr. Michael Hennig, Senior Director, Expertise Line Head HTA Statistics, at Cencora PharmaLex, and delve into the details of these guidelines, their evolution, stakeholder involvement, challenges in implementation, promising approaches, adaptability to emerging trends, and their potential influence on decision-making processes within healthcare systems across Europe. 

Q. 1: Can you provide an overview of the latest guidelines on statistical analysis for EU health technology assessment? 

Dr. Michael Hennig: The latest guidelines for EU HTA revolve around evidence synthesis, specifically focusing on how existing evidence from study drugs should be combined statistically. This involves determining how to merge evidence from direct comparisons between drugs as well as indirect comparisons when direct data is lacking1,2

Q 2: How does the process of approving or adjusting these guidelines typically unfold, and what stakeholders are involved in this process? 

Dr. Michael Hennig: The recent adoption of these guidelines was solely conducted by the European Union without direct stakeholder involvement. However, previous iterations under EUnetHTA involved stakeholders such as pharmaceutical companies and methodological experts who provided feedback during a consultation period. The consolidated version published by the European Coordinating Group reflects slight modifications based on stakeholder input from earlier stages. 

Q 3: In what ways have these new guidelines evolved since the era of EUnetHTA, and what significant changes or improvements do they bring to the field of HTA? 

Dr. Michael Hennig: While minor adjustments have been made to enhance clarity and readability since the original version in 2022, substantial changes have not been prevalent in the recent update. These refinements aim to improve understanding and align with any emerging trends without fundamentally altering the core content of the guidelines. 

Q 4: When it comes to regulatory aspects versus allowing flexibility for unique circumstances within the current guidelines concerning key elements of statistical analysis, how is this balance achieved? 

Dr. Michael Hennig: The current guidelines provide a framework rather than prescriptive rules for statistical analysis in HTAs. They outline principles while leaving room for interpretational flexibility based on specific circumstances or preferences of assessors. This approach allows for adaptability but may lead to variations in application among users. 

Q 5: What would you identify as primary challenges that researchers and organizations may encounter when implementing these new statistical analysis guidelines? 

Dr. Michael Hennig: One primary challenge lies in uncertainty regarding how these broad guidelines will be practically applied by assessors. The lack of established norms or precedents may lead to varied interpretations or applications by different parties involved in HTAs. 

Q 6: Could you elaborate on any specific approach that shows promising results in improving accuracy and reliability of HTAs? 

Dr. Michael Hennig: Harmonizing methodological choices between drug developers and assessors presents a promising avenue towards enhancing accuracy and reliability in HTAs. Establishing clear communication channels early on can help align perspectives and methodologies between parties involved. 

Q 7: How do the guidelines account for emerging trends and innovations that may impact statistical analysis methods in HTAs? 

Dr. Michael Hennig: While intended as living documents that can evolve with scientific advancements, there might be ambiguity regarding how frequently updates will occur or how stakeholders can contribute to revisions effectively. Ensuring transparency and engagement with scientific communities could enhance guideline responsiveness to emerging trends. 

Q 8: How do you foresee these new guidelines shaping the future landscape of HTA across Europe? 

Dr. Michael Hennig: These new guidelines present an opportunity to harmonize HTA practices across diverse European healthcare systems by providing a common standard framework for evaluations. This harmonization could streamline decision-making processes and promote consistency across Member States while accommodating regional differences. 

This article is intended to communicate Cencora PharmaLex's capabilities which are backed by the author’s expertise. However, Cencora PharmaLex and its parent, Cencora, strongly encourage readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto as the article may contain certain marketing statements and does not constitute legal advice.  

1 European Commission. Methodological Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons. Accessed May 17, 2024. 
2 European Commission. Practical Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons. Accessed May 17, 2024. 


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About The Author

Michael Hennig, PhD
Senior Director, Expertise Line Head HTA Statistics
PharmaLex, part of Cencora
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