Public Health Decision-Maker Perspective on Joint Clinical Assessments in Central European EU Member States
Round 1
Reviewer 1 Report
Comments and Suggestions for Authors
The manuscript addresses an important topic concerning implementing the Health Technology Assessment Regulation (HTA R) in Central European EU member states. It highlights both opportunities and challenges of the HTA R, particularly from the perspective of public health decision-makers. The paper is well-organized and structured, but more depth and clarity could benefit certain areas.
1. Please explain every abbreviation used.
2. Please specify in more detail when and where JCA will be applied (e.g. what drugs, when).
3. Add a sentence or two contextualizing Central Europe’s specific healthcare landscape.
4. Add an example of a situation where local guidance might conflict with JCA processes.
5. Summarizing the most critical opportunity and challenge could make the conclusion stronger.
Author Response
Dear Reviewer 1,
The authors are grateful for the review of the manuscript and appreciate the time and effort dedicated to providing feedback. Please see below, in bold, for a point-by-point response to your comments and suggestions.
- Please explain every abbreviation used.
Thank you for this observation. The manuscript has been revised to ensure that all abbreviations are resolved. - Please specify in more detail when and where JCA will be applied (e.g. what drugs, when).
Thank you for this comment. We have added details on the medicinal products subject to JCAs in the first paragraph of the Introduction section. - Add a sentence or two contextualizing Central Europe’s specific healthcare landscape.
Thank you for this suggestion. We have amended the second paragraph of the Introduction section to elaborate on the specific healthcare setting in Central Europe (lower funding for healthcare & need for the efficiency of policy interventions in the region). - Add an example of a situation where local guidance might conflict with JCA processes.
Thank you for this observation. To provide an example, we revised the third paragraph of the Challenges section and reflected on choosing the comparator. - Summarizing the most critical opportunity and challenge could make the conclusion stronger.
Thank you for this suggestion. As suggested by the other Reviewer, as well as by the Editor, we decided to add a summary table at the end of the Results section.
Once again, thank you very much for your review. We believe that these observations helped to improve the quality of our manuscript. Should you have more comments, do not hesitate to address them to us.
Yours sincerely,
The authors
Reviewer 2 Report
Comments and Suggestions for Authors
General comment
The manuscript addresses the opportunities and challenges the Health Technology Assessment Regulation (HTA R) presented within Central European EU member states. It highlights how joint clinical assessments (JCAs) under the HTA R can foster cooperation, enhance efficiency, and reduce redundancies while identifying challenges such as scoping timelines, local procedural alignment, and guidance contradictions.
The manuscript's focus on practical implications for public health decision-makers is commendable, as it provides actionable insights for stakeholders navigating this complex regulatory landscape.
Strengths
Relevance and Timeliness: The topic is highly relevant, considering the ongoing implementation of the HTA R and its potential to impact health systems across the EU.
Comprehensive Discussion: The manuscript covers key opportunities, including access to shared data, methodological guidance, and collaborative potential between member states.
Use of Evidence: The authors substantiate their claims with references to regulatory documents and specific studies (e.g., Hungarian reimbursement decisions).
Regional Focus: By narrowing the scope to Central European member states, the paper addresses a niche but critical area of policy implementation.
Practical Recommendations: Suggestions for mitigating challenges, such as stakeholder-friendly templates and revising local guidance, are valuable contributions.
Weaknesses
Abstract Clarity: The abstract could better summarise the challenges discussed in the manuscript. Currently, it focuses primarily on opportunities.
Methodological Depth: While the paper presents qualitative insights, it could benefit from a more structured methodology or framework for analysing the HTA R's impact.
Limited Data and Case Studies: Although the manuscript references Hungarian data, broader regional examples or case studies could strengthen the argument.
Language and Readability: Certain sentences are dense, making the text less accessible to a broader audience. Simplifying the language in sections discussing regulations and procedural details would enhance readability.
Discussion of Stakeholder Perspectives: The manuscript needs to sufficiently explore the perspectives of key stakeholders, such as HTA bodies or patients, beyond public health decision-makers.
Specific Comments
Introduction: The introduction provides a good overview of the HTA R but could benefit from briefly mentioning the specific methodologies or tools that facilitate JCAs.
Opportunities Section: While this section is robust, the authors could elaborate on how regional collaborations (e.g., the Beneluxa Initiative) might serve as models for Central European states.
Challenges Section: The discussion on scoping timelines is relevant but could be supported with quantitative data or examples of missed deadlines. The challenge of aligning local and HTA R guidance is critical but underexplored. The authors could include specific examples of divergences in comparator selection or evidence acceptability.
Conclusion: The conclusion appropriately emphasises the shared responsibility of policymakers and payers but could include a forward-looking perspective on potential metrics for success in HTA R implementation.
Recommendations for improvement
Expand the Scope of Evidence: Include additional regional case studies or data points to more concretely illustrate the challenges and opportunities.
Enhance Abstract: Revise the abstract to provide a balanced overview of both opportunities and challenges discussed in the paper.
Refine Language: Simplify technical jargon and restructure complex sentences for improved readability.
Incorporate Stakeholder Views: Add perspectives from HTA bodies, clinicians, or patient groups to provide a more holistic view of the HTA R's implications.
Visual Elements: Consider including tables or diagrams to summarise key opportunities, challenges, or recommendations for Central European member states.
Final assessment
The manuscript significantly contributes to health policy and HTA R implementation literature. However, addressing the identified weaknesses would enhance its impact and relevance. Once revised, it has strong potential for publication.
Author Response
Dear Reviewer 2,
The authors are grateful for the review of the manuscript and appreciate the time and effort dedicated to providing feedback. Please see below, in bold, for a point-by-point response to your comments and suggestions.
- Expand the Scope of Evidence: Include additional regional case studies or data points to more concretely illustrate the challenges and opportunities.
Thank you for this suggestion. We have amended the manuscript with an example from Slovakia in the third paragraph of the Opportunities section to introduce some diversity in the case studies used for illustration. - Enhance Abstract: Revise the abstract to provide a balanced overview of both opportunities and challenges discussed in the paper.
Thank you for this suggestion. The abstract has been revised to provide a more balanced overview of the paper. - Refine Language: Simplify technical jargon and restructure complex sentences for improved readability.
Thank you for this suggestion. We revised the manuscript text and decided to introduce changes to enhance readability. However, our understanding is that this paper should contribute to a special issue of the journal, therefore some technical jargon is inevitable. We hope our efforts are reflected in the revised text. - Incorporate Stakeholder Views: Add perspectives from HTA bodies, clinicians, or patient groups to provide a more holistic view of the HTA R's implications.
Thank you very much for this suggestion. We decided to limit the perspective we wish to introduce and change the title of the manuscript to fully reflect that. We do not feel competent to fully introduce the position of patients, healthcare providers. - Visual Elements: Consider including tables or diagrams to summarise key opportunities, challenges, or recommendations for Central European member states.
Thank you for this suggestion. As suggested by the other Reviewer, as well as by the Editor, we decided to add a summary table at the end of the Results section.
In other amendments to the text, we attempted to address the weaknesses identified by the Reviewer, namely the methodological depth (see the first paragraph of the Introduction section), or elaborating on specific issues with comparator selection for the JCA and the assessment and appraisal.
Once again, thank you very much for your review. We believe that these observations helped to improve the quality of our manuscript. Should you have more comments, do not hesitate to address them to us.
Yours sincerely,
The authors
Round 2
Reviewer 2 Report
Comments and Suggestions for Authors
The corrections have been made appropriately, and I suggest the acceptance of the paper in its present form.
