PONE-D-23-06711Etonogestrel-releasing subdermal contraceptive implant: Budget impact analysis based on the Brazilian private healthcare systemPLOS ONE

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Additional Editor Comments:

Please respond to all reviewers comments

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Thank you for asking me to review the manuscript titled “ETONOGESTREL-RELEASING SUBDERMAL CONTRACEPTIVE IMPLANT: BUDGET IMPACT ANALYSIS BASED ON THE BRAZILIAN PRIVATE HEALTHCARE SYSTEM”. (PONE-D-23-06711)

I have gone through the manuscript and the following are my observations and comments:

1. It is not clear what the study set out to address as the reference to “cost avoidance” did not state who the cost avoidance relates to.

2. Cost alone, as the Authors also pointed out, is not the only consideration for contraceptive choice.

3. No human subjects were used to test the validity of all the positive and negative impacts the Authors attributed to the contraceptive (IMP-ETN) and references to published articles were limited.

4. The article appears more like a “marketing strategy” presentation with obvious bias towards the product IMP-ETN and therefore does not qualify for publication in PLOS ONE. This is not surprising judging from the fact that some of the Authors have conflicting interests being employees of the sponsoring organisation (ORGANON).

Reviewer #2: This article is an economic analysis that assesses the cost-effectiveness of adopting IMP-ETN over a period of five year compared to LNG-IUS. The author has the strength of presenting evidence in a setting that previous evidence is scarce – few economic analysis has been performed on this topic in the Brazilian setting, and therefore this article would be interesting to readers working in the country and neighbouring region, or even countries that are socio-economically similar. However revisions are needed as charted below.

As this study derives the outcome figures based on available data, the conclusion is only as good as the data. Therefore more justification on the validity of the data sets, the references, and the figures selected should be added in the methodology section. For example in line 131, it would be easier for readers to understand the methodology by explaining what specific data are retrieved from the ANS, and how comprehensive and accurate are the data on ANS (e.g. any data checks by ANS, any previous study validating data of ANS). It would also be good to explain if the costs defined by CBHPM (line 150-151) and CMED (line 154-155) correlate to the cost actually imposed by the fee-for-service private healthcare sector – as many readers are unfamiliar with the Brazilian medical system, one wonders if the costs in these lists are legally binding or whether private sectors can inflate the price as they wish. On the other hand, why is ANS data on the actual cost for procedures not used, is it because such data is not available in ANS?

I am also a bit confused by line 147, which mentions an assumed annual growth of 7% - does this refer to the growth in target population, or growth of IMP-ETN market share? Better clarify that. Also for line 165, is there any justification for the assumed constant growth of 5% per year? I understand it may be difficult to accurately make estimations, and the authors have also acknowledged this issue in the discussion.

Another suggestion I have is to move the literature review (line 186-259) to the introduction or discussion, as the main outcome should be the on the cost-effectiveness analysis.

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Reviewer #1: Yes: Dr Francis E. Alu

Consultant Obstetrician & Gynaecologist

Abuja Nigeria

Reviewer #2: Yes: Liu Qinyang

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Attachments

Attachment

Submitted filename: Reviewer Comment and Recommendation.docx

Etonogestrel-releasing subdermal contraceptive implant: budget impact analysis based on the Brazilian private healthcare system

PONE-D-23-06711R1

Dear Dr. Lino,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Ahmed Mohamed Maged, MD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

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4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The Authors have substantially addressed the issues i raised. The explanation as to what the cost implication is referring to has been addressed as has other comments relating to comparison with other forms of LARCs. The economic analysis of the study and the cost-effectiveness of IMP-ETN in the country of study have been elucidated. i recommend its acceptance for publication as amended.

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

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