Peer Review History
Original SubmissionSeptember 17, 2023 |
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PONE-D-23-29905Cost-effectiveness analysis of olaparib maintenance therapy for BRCA mutation ovarian cancer in the public sector in MalaysiaPLOS ONE Dear Dr. Lee, 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 submit your revised manuscript by Dec 28 2023 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. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript:
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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 ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know ********** 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 ********** 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: No ********** 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: Introduction - The authors indicate that a number of PARPi's are available as first-line maintenance therapies. Why focus here on only olaparib? - First sentence of para 4 is unclearly written. The relevance of data for olaparib in PSROC, a setting later than the one considered in this paper is unclear. - Sentence 2 of para 5 requires a supporting reference. Suggested where? Methods - The rationale for this model structure is unclear. In this evaluation of olaparib, the authors cite structures from HTA evaluations of niraparib. This seems potentially disingenuous if HTA evaluations of olaparib, the subject of this paper, used a different structure. Certainly, Muston et al used 3 states, not 4 states as here [32]. Why use 4 states if others have used 3? - Paragraph 3 explaining health state membership is rather unclear, compounded by Suppl Table 1. We are told this is a 4 state partitioned survival model with states of PF, PD1, PD2 and death. This structure requires survival modeling of PFS1, PFS2 and OS. The supplementary table provides other information that does not correspond with this. The parameter values should be reported. The textual description in the manuscript is rather unclear. - 28 seems a curious number to pick for the time horizon (years). Why not 20, 25, 30 or 40? The time horizon may be missing from the OWSA. - Health state utilities. Please confirm the references - some are included in Table 1, but not the text. What value sets / country do these relate to? Two sources are used, contrary to ISPOR guidelines because they may not be consistent. Why were niraparib utilities used? - Table 1. What kind of drug cost is quoted in Table 1 for olaparib. 'IMS' is indicated as a reference, but no full reference is actually provided. Is this derived from a public list price? Or does this value already reflect discounts/rebates that may be available and be a net price? This is important to know in understanding the conclusion from this paper. - Resource utilization information is missing from the section on resource utilization. The section describes what resources are assumed, but not how much of each. For example, what subsequent treatments were recommended in the clinician survey? How frequently are physician visits required? - Sensitivity analyses. Why were only 'key' parameters varied? How was it pre-determined which parameters were 'key'? What is the difference between a PFS model and probability in this context? Was OS not varied? What statistical distributions were used for the PSA? Results - Sentence 2 is unclear as it contains two instances of 'which'. - Sensitivity analyses, paragraph 2. Articles 'a' and 'the' are occasionally missing. - What is the relevance of a WTP threshold of RM53,043? Is this a local standard? Please explain. Otherwise it is little surprise that about half of PSA simulations were above/below a value so close to the mean ICER. - Total LYs and total QALYs should be added to Table 2. Discussion - What is a 'quality of life year' (line 6)? Is it related to QALY? - Life years appear to increase by either 3.05 years (line 6) or 2.87 years (line 8). Which? - Para 2 cites a slightly confusing mix of studies. The most relevant study here by treatment setting appears to be Muston [32], since this also evaluates olaparib in this same treatment setting (but in the US). It is questionable whether the others mentioned are truly 'similar studies' as claimed [10, 29-31] because they mostly appear in later PROC settings. One cannot easily compare CE of an agent between two different treatment settings - or the substantial difficulties with this should be acknowledged. - The assumption of ToT=PFS (but capped at 2 years) may also be key to the results and should ideally be explored. What if ToT was longer/shorter than PFS? Conclusion - Not well worded. This suggests patients ('those') have a 53,043 (no units) /QALY threshold. 'The need' in sentence 2 is unclear. Supplementary information - Table 1 is poorly designed and unhelpful. See also comment above. The authors should disclose the statistical distributions, parameters, and ideally variance matrix for the three survival curves required in this model - PFS1, PFS2 and OS. Since two piece modeling is used, PFS1, PFS2 and OS survival at the 24 month cutoff (per Methods model input) is also important to disclose. ********** 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 ********** [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. 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Revision 1 |
Cost-effectiveness analysis of olaparib maintenance therapy for BRCA mutation ovarian cancer in the public sector in Malaysia PONE-D-23-29905R1 Dear Dr. Lee, 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 for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, 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, Alvaro Galli 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 ********** 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 ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 #1: 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 #1: 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 #1: I am just writing some words here in order to meet your website's minimum character count. I don't actually have any comments to make. ********** 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 ********** |
Formally Accepted |
PONE-D-23-29905R1 PLOS ONE Dear Dr. Lee, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. 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. If we can help with anything else, please email us at customercare@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Alvaro Galli Academic Editor PLOS ONE |
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