Stakeholder Insights into Czech Performance-Based Managed Entry Agreements: Potential for Transformative Change in Pharmaceutical Access?

Round 1

Reviewer 1 Report

I have reviewed the paper entitled “Qualitative stakeholder research on performance-based managed entry agreements in the Czech Republic: Could a novel legal framework facilitate deep change?”. The subject of the study falls into the scope of the journal. However, there are some shortcomings in the paper. Therefore, I recommend a major revision.

1) What is the primary objective of the study? Clarify it in the introduction section.

2) Which literature gap will be filled by conducting this study? Uncover it in the introduction section.

3) Present a critical discussion of the former studies.

4) The Conclusion section is poorly written and does not provide concrete policy proposals.

5) The limitations of the study and future directions were slurred over.

6) The material and methods section was poorly written and it needs improvement in clearly presenting used methods and materials.

7) The current similarity level of the study is 16%; however, the similarity level from a single source is 5% which is above reasonable similarity levels. Besides, there is a block quotation problem in the lines between 52-72. Authors should ensure that the revised article has no more than 20% similarity in the total and 1% from a single source. Otherwise, it will require a rejection.

Minor revision required. 

Author Response

Dear Reviewer,

Thank you for your valuable feedback and insightful suggestions on our manuscript. We have made every effort to address each of the points you raised and have incorporated changes throughout the document accordingly. We believe these modifications have significantly strengthened the paper. 

Reviewer 2 Report

Review report for healthcare-2766008 Qualitative stakeholder research on performance-based managed entry agreements in the Czech Republic: Could a novel legal framework facilitate deep change?

Topic

The topic should reflect the field is related to the medical field. Deep change in terms of?

Please provide relevant theories and literature review that develop this study.

Please explain why there is a need to interview these group of people.

• Representatives of the MoH (denoted as MoH cohort)

• Representatives of pharma and their two local associations (Ph),

• Insurance companies (IC),

• Patients and patient organizations (PG)

For the conclusion, please summarizing your thoughts and conveying the larger implications of your study and introducing possible new or expanded ways of thinking about the research problem. Furthermore, please change your topic to reflect the content of the study. Then, please summarise accordingly.

Please avoid using too many abbreviations. It will make it difficult for the readers to read the contents smoothly.

Author Response

Dear Reviewer,

Thank you for your valuable feedback and insightful suggestions on our manuscript. We have made every effort to address each of the points you raised and have incorporated changes throughout the document accordingly. We believe these modifications have significantly strengthened the paper.

Reviewer 3 Report

The paper uses semi-structured interviews to assess stakeholder views on potential changes to a framework for managed entry agreements in the Czech Republic. The paper is clearly presented, and the methods are appropriate for this type of analysis (although of course interviews can never be considered to be at the top of the hierarchy of evidence, and the risk of bias is inevitably high).

It would have bene helpful to see a bit more discussion on the quantitative methods that can be used to inform managed entry agreements (for example, expected value of sample information).

I do not think that the paper's conclusions ("...a more comprehensive transformation is essential to enable PB MEAs to...") truly reflect the evidence (for example, line 276 reads: "...the findings suggest that while there are concerns about incompleteness and insufficient specification in the legislation, there is also a recognition of the benefits of an open and flexible legal framework.").

Finally, a minor point is that it would be helpful to include a guide to acronyms used in each of the figures. It was difficult to have to keep looking back in the text to identify what each acronym stood for.

Author Response

Dear Reviewer,

Thank you for your valuable feedback and insightful suggestions on our manuscript. We have made every effort to address each of the points you raised and have incorporated changes throughout the document accordingly. We believe these modifications have significantly strengthened the paper

Reviewer 4 Report

The paper studies the qualitative stakeholders of performance-based management employment agreement in Czech Republic. It is believed that it contributes to the global discussion of PB MEAs. A more comprehensive and value-based MEA method can reshape future drug reimbursement. However, there are the following problems:

1. The method part is brief, without elaborating the specific process of the interview and the details of the detailed content analysis;

2. The number of charts is insufficient, and the information expression is not enough;

3. The references are relatively old, and the recent related research is insufficient;

4. The discussion part is a little too general, and there is no in-depth analysis of the significance of revealing the truth behind the results;

5. Some arguments in the discussion part also need to be supported by data or literature, not just the author's judgment;

6. The global discourse that contributes to PB MEAs needs to be strengthened.

Author Response

Dear Reviewer,

Thank you for your valuable feedback and insightful suggestions on our manuscript. We have made every effort to address each of the points you raised and have incorporated changes throughout the document accordingly. We believe these modifications have significantly strengthened the paper

Round 2

Reviewer 1 Report

The authors have adressed most of former queries. However, similarity software reports that 7% of the study might be written by using AI tools (the lines between 359-380. Therefore, if authors have benefited AI tools, they must transparently explain details by following MDPI guideline, if not, there is a revision need in regarding section to solve AI-powered similarity.

Author Response

Dear reviewer,

thank you for the valuable feedback, I tried to incorporate everything. Information about the use of AI is in the methods chapter as well as in the acknowledgment section.

Reviewer 2 Report

The authors have made the necessary revisions.

Please use plain and formal English so that all readers can understand the manuscript easier.

Author Response

Dear reviewer,

Thank you for the valuable feedback, I tried to incorporate everything. Information about the use of AI is in the methods chapter as well as in the acknowledgment section.