Sequential interleukin-17 inhibitors for moderate-to-severe plaque psoriasis who have an IL-17 inhibitors failure in a resource limited country: An economic evaluation

Piyameth Dilokthornsakul; Ratree Sawangjit; Nopadon Noppakun; Natta Rajatanavin; Bensachee Pattamadilok; Leena Chularojanamontri; Unchalee Permsuwan

doi:10.1371/journal.pone.0307050

Peer Review History

Original SubmissionDecember 11, 2023
8 Mar 2024 Decision Letter - Robert Jeenchen Chen, Editor PONE-D-23-41330Sequential interleukin-17 inhibitors for moderate-to-severe plague psoriasis who have an inadequate response to systemic conventional treatments in a resource limited country: an economic evaluationPLOS ONE Dear Dr. Dilokthornsakul, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please revise.Please submit your revised manuscript by Apr 22 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. 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Please do not edit.] 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: Partly Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: Yes ****** 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: Yes Reviewer #2: Yes ****** 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 ****** 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: The title of the article need to be improved. -A main concern is that the manuscript was funded Funding statement: This work was supported by Novartis (Thailand) Limited. it maybe possible that the Principal Investigator who has the conflicts of interest could be indirectly helping Novartis medication Secukinumab to be approved in Thailand. The reviewer RESPECTFULLY RECOMMEND TO REQUEST AN OPINION WITH AN STATISTICIAN TO REVIEW THE METHODOLOGY THAT IS SOMEHOW CONFUSING. Reviewer #2: Title Correction in title: plaque and not plague Mhetods Explain the ethical issues of the study in the methods, including approval by a research ethics committee Conclusion I think the conclusions are poor. The results show other things which could be added as conclusions ****** 6. 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 Reviewer #2: Yes: Marilda AparecidaMilanez Morgado de AbreuDear ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0307050.r001
Revision 1
15 Mar 2024 Author Response A rebuttal letter responding to reviewers’ comments point-by-point for a manuscript entitled “Sequential interleukin-17 inhibitors for moderate-to-severe plaque psoriasis who have an inadequate response to systemic conventional treatments in a resource limited country: an economic evaluation” When submitting your revision, we need you to address these additional requirements. Comment 1 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf. Response: We revised the manuscript format according to the guidelines throughout the manuscript. Comment 2 2. Please note that PLOS ONE has specific guidelines on code sharing for submissions in which author-generated code underpins the findings in the manuscript. In these cases, all author-generated code must be made available without restrictions upon publication of the work. Please review our guidelines at https://journals.plos.org/plosone/s/materials-and-software-sharing#loc-sharing-code and ensure that your code is shared in a way that follows best practice and facilitates reproducibility and reuse. Response: We have made our model available in the Harvard Dataverse network at this link. https://doi.org/10.7910/DVN/HN2K7P Comment 3 3. Thank you for stating the following in the Competing Interests section: [Piyameth Dilokthornsakul receives research grants from Novartis (Thailand) Limited, Pfizer (Thailand) Limited. He also receives honorariums from GSK (Thailand) Limited, and Boehringer Ingelheim (Thailand) Limited. Other authors declare no conflict of interest.]. Please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials, by including the following statement: ""This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests). If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. Please include your updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf. Response 3 We confirmed that our conflict of interest does not later our adherence to PLOS ONE policies on sharing data and materials. We added it in the Competing interest statement section as shown below. This does not alter our adherence to PLOS ONE policies on sharing data and materials. Other authors declare no conflict of interest. Comment 4 4. We note that you have indicated that there are restrictions to data sharing for this study. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For more information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Before we proceed with your manuscript, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information, data are owned by a third-party organization, etc.) and who has imposed them (e.g., a Research Ethics Committee or Institutional Review Board, etc.). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. For a list of recommended repositories, please see https://journals.plos.org/plosone/s/recommended-repositories. You also have the option of uploading the data as Supporting Information files, but we would recommend depositing data directly to a data repository if possible. We will update your Data Availability statement on your behalf to reflect the information you provide. Response 4 We have made our model available in the Harvard Dataverse network at this link. https://doi.org/10.7910/DVN/HN2K7P We revised the Data sharing statement as shown below. Data used in this study is available at https://doi.org/10.7910/DVN/HN2K7P Comment 5 5. In the online submission form, you indicated that [Data used in this study will be available by appropriate request to the corresponding author. Only data could be provided for non-commercial purposes.]. All PLOS journals now require all data underlying the findings described in their manuscript to be freely available to other researchers, either 1. In a public repository, 2. Within the manuscript itself, or 3. Uploaded as supplementary information. This policy applies to all data except where public deposition would breach compliance with the protocol approved by your research ethics board. If your data cannot be made publicly available for ethical or legal reasons (e.g., public availability would compromise patient privacy), please explain your reasons on resubmission and your exemption request will be escalated for approval. Response 5 We have made our model available in the Harvard Dataverse network at this link. https://doi.org/10.7910/DVN/HN2K7P We revised the Data sharing statement as shown below. Data used in this study is available at https://doi.org/10.7910/DVN/HN2K7P Comment 6 6. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. [Note: HTML markup is below. Please do not edit.] Response 6 We revised our manuscript and supplement files according to the guideline. Comments to the Author Reviewer #1: Comment 7 The title of the article need to be improved. Response 7 We revised our title to make in more concise as shown below. Original version Sequential interleukin-17 inhibitors for moderate-to-severe plaque psoriasis who have an inadequate response to systemic conventional treatments in a resource limited country: an economic evaluation Revised version Sequential interleukin-17 inhibitors for moderate-to-severe plaque psoriasis who previously have an IL-17 inhibitors failure in a resource limited country: an economic evaluation Comment 8 -A main concern is that the manuscript was funded Funding statement: This work was supported by Novartis (Thailand) Limited. it maybe possible that the Principal Investigator who has the conflicts of interest could be indirectly helping Novartis medication Secukinumab to be approved in Thailand. Response 8 We conducted this study based on the scientific merit not commercial interest. Even though the study was funded by Novartis (Thailand), the funder did not alter our study design, data collection, data analysis, or manuscript writing. The funder only reviewed and approved the submission without any major correction. We originally declared them in the Role of the Funder section. Thus, we don’t think we were attempting to helping secukinumab to be approved in Thailand but providing scientific information on the cost-effectiveness of sequential treatments of anti-IL17 for psoriasis in Thailand for both clinical and policy decisions. Comment 9 The reviewer RESPECTFULLY RECOMMEND TO REQUEST AN OPINION WITH AN STATISTICIAN TO REVIEW THE METHODOLOGY THAT IS SOMEHOW CONFUSING. Response 9 To better explain our statistical analysis, we revised our data analysis section to better explanation as shown below. Original version 2.6.1 Cost-effective analysis Base-case analysis was performed, and the incremental cost-effectiveness ratio (ICER) was calculated. All sequential IL-17 inhibitors were compared to SoC. The fully incremental analysis was also performed to compare quality-adjusted life-years (QALYs) and costs among sequential IL-17 inhibitor treatments. An annual discount rate of 3% was applied.[12, 13] A series of one-way sensitivity analysis was conducted to explore uncertainties among inputs. The 95% credible interval of each ICER and cost-effectiveness acceptability curve were estimated based on the 10,000 iterations of Monte Carlo simulation. The willingness-to-pay (WTP) threshold of 160,000 THB/QALY (5,008 $/QALY) was used.[12, 13] Scenario analyses were also performed including: (1) the changes of information sources of health utility value from previous cost-effectiveness studies to the calculation from pooled baseline PASI in Thai patients, (2 - 3) changes of the definition of treatment response from PASI 75 to PASI 90 and PASI 100, (4-7) changes in a ratio between MTX and ciclosporin from 85:15 to 80:20, 70:30, 0:100, and 100:0 for SoC, (8) changes in MTX from tablet form to injection. All scenario analyses were recommended by experts. 2.6.2 Budget impact analysis A budget impact model was developed to estimate the financial consequences of the adoption of sequential IL-17 inhibitors in lieu of SoC over 5-year time horizon under a payer’s perspective. The dynamic cohort model was used to estimate the number of eligible patients for sequential IL-17 inhibitors. The estimated number of populations aged 40 years or older was approximately 31.6 million.[37] Prevalence,[36] incidence,[38] proportion of patients receiving systemic treatments,[14] and average annual death rate were applied. A 5% uptake rate was assumed. The 91% relapse rate was used for year 4-5 because all patients were assumed to stop their biologic treatments at the end of year 3. All inputs used in budget impact analysis are presented in supplement at S2 Table. Revised version 2.6.1 Cost-effectiveness analysis The incremental cost-effectiveness ratio (ICER) using mean or point estimates of each input was calculated as base-case analysis to compare all sequential IL-17 inhibitors with SoC using the formula. ICER = Total discounted cost of sequential IL-17 inhibitors - Total discounted cost of SoC Total discounted QALY of sequential IL-17 inhibitors - Total discounted QALY of SoC The fully incremental analysis was also performed to calculate the ICER of each comparison between sequential IL-17 inhibitors. All analyses applied an annual discount rate of 3% for both cost and QALY.[12, 13] The willingness-to-pay (WTP) of 160,000 THB/QALY (5,008 $/QALY) was used as the cost-effectiveness threshold.[12, 13] A series of one-way sensitivity analysis was conducted to explore the effect of uncertainties around inputs on ICER. The upper and lower bound of 95% confidence intervals or ± 20% from mean or point estimates of each input were utilized in the one-way sensitivity analyses and presented the findings as tornado plots. Probabilistic sensitivity analysis was also conducted to explore the effect of uncertainties around inputs on ICER using Monte Carlo simulation. The Probabilistic sensitivity analysis randomly selected the value of each input simultaneously and calculated ICER of each iteration for 10,000 iterations and showed the findings as cost-effectiveness analysis plane. The 95% credible interval of ICER from the simulation was also calculated. In addition, the cost-effectiveness acceptability curve by varying WTP was created. Additionally, scenario analyses were also performed including: (1) the changes of information sources of health utility value from previous cost-effectiveness studies to the calculation from pooled baseline PASI in Thai patients, (2 - 3) changes of the definition of treatment response from PASI 75 to PASI 90 and PASI 100, (4-7) changes in a ratio between MTX and ciclosporin from 85:15 to 80:20, 70:30, 0:100, and 100:0 for SoC, (8) changes in MTX from tablet form to injection. All scenario analyses were recommended by experts. 2.6.2 Budget impact analysis A budget impact model was developed to estimate the financial consequences of the adoption of sequential IL-17 inhibitors in lieu of SoC over 5-year time horizon under a payer perspective. The dynamic cohort model was employed to estimate the number of eligible patients for sequential IL-17 inhibitors. The estimated number of populations aged 40 years or older was approximately 31.6 million.[37] Prevalence,[36] incidence,[38] proportion of patients receiving systemic treatments,[14] and average annual death rate were applied. A 5% uptake rate was assumed. The 91% relapse rate was used for year 4-5 because all patients were assumed to stop their biologic treatments at the end of year 3. All inputs used in budget impact analysis are presented in supplement at S2 Table. Reviewer #2: Title Comment 10 Correction in title: plaque and not plague Response 10 We edited it as suggested. Comment 11 Methods Explain the ethical issues of the study in the methods, including approval by a research ethics committee Response 11 Because this study was model-based economic evaluation. All inputs were from existing literature. No human subjects are involved. Thus, EC approval is not required. We add it in our method as shown below. Original version (none) Revised version This study was model-based economic evaluation using all data from existing literature without any additional primary data collection or human subject involvement. Thus, ethical committee approval is not required. Comment 11 Conclusion I think the conclusions are poor. The results show other things which could be added as conclusions. Response 11 We revised our conclusion to better conclude our findings as shown below. Original version At the current willingness-to-pay, no sequential IL17 inhibitor was cost-effective compared to SoC in Thailand. Revised version At the current willingness-to-pay, no sequential IL17 inhibitor was cost-effective compared to SoC in Thailand. The possibility of being cost-effective for all sequential treatments was very low compared to SoC. Secukinumab followed by ixekizumab or brodalumab then guselkumab (Sequence 1) seems to be the better option compared with other sequential treatments. Policy makers might need to create strategies to control IL-17 inhibitors price and improve the accessibility to all IL-17 inhibitors as a sequential treatment for patients with moderate-to-severe plaque psoriasis who previously failed one of IL-17 inhibitors in a real-world setting. Attachments Attachment Submitted filename: A rebuttal letter R1 v2.docx https://doi.org/10.1371/journal.pone.0307050.r002
26 Jun 2024 Decision Letter - Robert Jeenchen Chen, Editor Sequential interleukin-17 inhibitors for moderate-to-severe plaque psoriasis who have an IL-17 inhibitors failure in a resource limited country: an economic evaluation PONE-D-23-41330R1 Dear Dr. Dilokthornsakul, 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. An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org. 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, Robert Jeenchen Chen, MD, MPH 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 #2: All comments have been addressed ******** 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 #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: Yes ****** 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 #2: Yes ****** 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 #2: Yes ****** 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 #2: Dear authors The suggested changes were made. I think the manuscript is now suitable for publication. ****** 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 #2: Yes: Marilda Aparecida Milanez Morgado de Abreu ******** https://doi.org/10.1371/journal.pone.0307050.r003
Formally Accepted
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