{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T14:51:44Z","timestamp":1788274304682,"version":"build-2803163510"},"reference-count":21,"publisher":"Becaris Publishing Limited","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Comp. Eff. Res."],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:p>\n            <jats:bold>Aim:<\/jats:bold>\n            To understand the impact of the niraparib individualized starting dose (ISD), compared with fixed starting dose (FSD), on the cost of hematologic adverse event (AE) management from a US payer perspective.\n            <jats:bold>Methods:<\/jats:bold>\n            The frequencies of grade \u22653 hematologic AEs that occurred in &gt;1% of patients treated with niraparib were obtained from the primary analysis results of the phase III PRIMA\/ENGOT-OV26\/GOG-3012 trial. US unit costs for each grade \u22653 AE in the base case were obtained from the 2017 Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project database; unit costs were adjusted to 2020 US dollars. AE management costs per patient were calculated by multiplying AE unit cost by the frequency of each AE by niraparib starting dose. Because AEs were assumed to occur independently of one another, costs were added to derive the total cost.\n            <jats:bold>Results:<\/jats:bold>\n            For niraparib, the estimated AE management cost per patient was lower for the ISD than the FSD for all hematologic AEs (FSD vs ISD: thrombocytopenia, $4701.87 vs $1921.89; anemia, $2784.00 vs $1760.59; platelet count decreased, $2103.47 vs $922.51; neutropenia, $2112.50 vs $1369.56; neutrophil count decreased, $1285.87 vs $770.38). The total mean calculated AE management cost per patient was $12,987.71 with the FSD and $6744.93 with the ISD.\n            <jats:bold>Conclusion:<\/jats:bold>\n            For niraparib, the cost of managing hematologic AEs in the US was reduced by almost half with the ISD compared with the FSD. The cost reduction and improvements in safety associated with the niraparib ISD support its use in clinical practice.\n          <\/jats:p>","DOI":"10.57264\/cer-2024-0133","type":"journal-article","created":{"date-parts":[[2024,12,13]],"date-time":"2024-12-13T10:35:27Z","timestamp":1734086127000},"source":"Crossref","is-referenced-by-count":1,"title":["Use of individualized starting dose and niraparib hematologic adverse event management costs in ovarian cancer"],"prefix":"10.57264","volume":"14","author":[{"given":"Whitney S","family":"Graybill","sequence":"first","affiliation":[{"name":"Division of Gynecologic Oncology, Medical University of South Carolina, Charleston, SC\u00a029425, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ignace","family":"Vergote","sequence":"additional","affiliation":[{"name":"University Hospitals Leuven, Leuven Cancer Institute, and Belgium &amp; Luxembourg Gynaecological Oncology Group (BGOG), Leuven, B912 3000, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bhavana","family":"Pothuri","sequence":"additional","affiliation":[{"name":"GOG Foundation and Laura &amp; Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY\u00a010016, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maarit","family":"Anttila","sequence":"additional","affiliation":[{"name":"Kuopio University Hospital, Kuopio, Finland, and NSGO, Copenhagen, 9 70200, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David M","family":"O'Malley","sequence":"additional","affiliation":[{"name":"The Ohio State University andthe James Comprehensive Cancer Center, Columbus, OH\u00a043210, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domenica","family":"Lorusso","sequence":"additional","affiliation":[{"name":"Humanitas San Pio X, Milan, Humanitas University, Rozzano,\u00a020089, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley F","family":"Haggerty","sequence":"additional","affiliation":[{"name":"Hackensack Meridian Health, Hackensack, NJ\u00a007601, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michel","family":"Fabbro","sequence":"additional","affiliation":[{"name":"Institut R\u00e9gional du Cancer de Montpellier, Montpellier, and GINECO, Paris,\u00a034298, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John K","family":"Chan","sequence":"additional","affiliation":[{"name":"California Pacific Medical Center Palo Alto Medical Foundation, Sutter Cancer Research Consortium, San Francisco, CA\u00a094301, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"Heitz","sequence":"additional","affiliation":[{"name":"AGO Study Group and Kliniken Essen-Mitte, Essen, and Charit\u00e9 - Universit\u00e4tsmedizin Berlin, Humboldt-Universit\u00e4t zu Berlin, Berlin Institute of Health, Department of Gynaecology, Berlin,\u00a012203, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lyndsay J","family":"Willmott","sequence":"additional","affiliation":[{"name":"Arizona Center for Cancer Care, Phoenix, AZ\u00a085027, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilan","family":"Bruchim","sequence":"additional","affiliation":[{"name":"Hillel Yaffe Medical Center, Hadera, Technion Institute of Technology, Haifa,\u00a038100, Israel, &amp; ISGO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Zhuo","sequence":"additional","affiliation":[{"name":"Kadlec Hematology and Oncology Clinic, Richland, WA\u00a099336, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Purificaci\u00f3n","family":"Est\u00e9vez-Garc\u00eda","sequence":"additional","affiliation":[{"name":"Hospital Universitario Virgen del Roc\u00edo, Sevilla, and GEICO, Madrid,\u00a041013, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley J","family":"Monk","sequence":"additional","affiliation":[{"name":"GOG Foundation; Florida Cancer Specialists and Research Institute, West Palm Beach, FL\u00a033401, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannelore","family":"Denys","sequence":"additional","affiliation":[{"name":"Ghent University Hospital, Ghent,\u00a09000, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anja","family":"Knudsen","sequence":"additional","affiliation":[{"name":"Odense University Hospital, Odense,\u00a05000, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna V","family":"Tinker","sequence":"additional","affiliation":[{"name":"BC Cancer Vancouver, and Department of Medicine, University of British Columbia, Vancouver, BC, V6T1Z1, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis Manso","family":"S\u00e1nchez","sequence":"additional","affiliation":[{"name":"Hospital Universitario 12 de Octubre &amp; GEICO, Madrid,\u00a028041, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane","family":"Provencher","sequence":"additional","affiliation":[{"name":"Centre Hospitalier de l'Universit\u00e9 de Montr\u00e9al, Universit\u00e9 de Montr\u00e9al and Institut du Cancer de Montr\u00e9al, Montreal, QC, H3T1J4, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Pilar","family":"Barretina-Ginesta","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Institut Catal\u00e0 d'Oncologia; Girona Biomedical Research Institute (IDIBGI-CERCA), Girona University, Girona, Spain, and GEICO, 08908, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Hartman","sequence":"additional","affiliation":[{"name":"GSK, Philadelphia, PA\u00a019112, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donna V","family":"Booth","sequence":"additional","affiliation":[{"name":"GSK, Durham, NC\u00a027709, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Gonz\u00e1lez-Mart\u00edn","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Program in Solid Tumours, CIMA, Cancer Center Cl\u00ednica Universidad de Navarra, Madrid, and Grupo Espa\u00f1ol de Investigaci\u00f3n en Cancer ginecol\u00f3gicO (GEICO), Madrid,\u00a028027, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"36897","reference":[{"issue":"3","key":"e_1_3_8_3_2","doi-asserted-by":"crossref","first-page":"209","DOI":"10.3322\/caac.21660","article-title":"Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries","volume":"71","author":"Sung H","year":"2021","unstructured":"Sung H, Ferlay J, Siegel RL Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 71(3), 209\u2013249 (2021).","journal-title":"CA Cancer J. Clin."},{"issue":"1","key":"e_1_3_8_4_2","doi-asserted-by":"crossref","first-page":"12","DOI":"10.3322\/caac.21820","article-title":"Cancer statistics, 2024","volume":"74","author":"Siegel RL","year":"2024","unstructured":"Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J. Clin. 74(1), 12\u201349 (2024).","journal-title":"CA Cancer J. Clin."},{"issue":"33","key":"e_1_3_8_5_2","doi-asserted-by":"crossref","first-page":"3878","DOI":"10.1200\/JCO.22.01934","article-title":"Poly(ADP-ribose) polymerase inhibitors in the management of ovarian cancer: ASCO Guideline Rapid Recommendation Update","volume":"40","author":"Tew WP","year":"2022","unstructured":"Tew WP, Lacchetti C, Kohn EC. PARP Inhibitors in the Management of Ovarian Cancer Guideline Expert Panel. Poly(ADP-ribose) polymerase inhibitors in the management of ovarian cancer: ASCO Guideline Rapid Recommendation Update. J. Clin. Oncol. 40(33), 3878\u20133881 (2022).","journal-title":"J. Clin. Oncol."},{"issue":"10","key":"e_1_3_8_6_2","doi-asserted-by":"crossref","first-page":"833","DOI":"10.1016\/j.annonc.2023.07.011","article-title":"Newly diagnosed and relapsed epithelial ovarian cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up","volume":"34","author":"Gonz\u00e1lez-Mart\u00edn A","year":"2023","unstructured":"Gonz\u00e1lez-Mart\u00edn A, Harter P, Leary A Newly diagnosed and relapsed epithelial ovarian cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann. Oncol. 34(10), 833\u2013848 (2023).","journal-title":"Ann. Oncol."},{"issue":"25","key":"e_1_3_8_7_2","doi-asserted-by":"crossref","first-page":"2391","DOI":"10.1056\/NEJMoa1910962","article-title":"Niraparib in patients with newly diagnosed advanced ovarian cancer","volume":"381","author":"Gonz\u00e1lez-Mart\u00edn A","year":"2019","unstructured":"Gonz\u00e1lez-Mart\u00edn A, Pothuri B, Vergote I Niraparib in patients with newly diagnosed advanced ovarian cancer. N. Engl. J. Med. 381(25), 2391\u20132402 (2019).","journal-title":"N. Engl. J. Med."},{"key":"e_1_3_8_8_2","doi-asserted-by":"crossref","first-page":"112908","DOI":"10.1016\/j.ejca.2023.04.024","article-title":"Progression-free survival and safety at 3.5 years of follow-up: results from the randomised phase 3 PRIMA\/ENGOT-OV26\/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer","volume":"189","author":"Gonz\u00e1lez-Mart\u00edn A","year":"2023","unstructured":"Gonz\u00e1lez-Mart\u00edn A, Pothuri B, Vergote I Progression-free survival and safety at 3.5 years of follow-up: results from the randomised phase 3 PRIMA\/ENGOT-OV26\/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer. Eur. J. Cancer 189, 112908 (2023).","journal-title":"Eur. J. Cancer"},{"issue":"9","key":"e_1_3_8_9_2","doi-asserted-by":"crossref","first-page":"1230","DOI":"10.1001\/jamaoncol.2023.2283","article-title":"Treatment with niraparib maintenance therapy in patients with newly diagnosed advanced ovarian cancer: a phase 3 randomized clinical trial","volume":"9","author":"Li N","year":"2023","unstructured":"Li N, Zhu J, Yin R Treatment with niraparib maintenance therapy in patients with newly diagnosed advanced ovarian cancer: a phase 3 randomized clinical trial. JAMA Oncol. 9(9), 1230\u20131237 (2023).","journal-title":"JAMA Oncol."},{"issue":"1","key":"e_1_3_8_10_2","doi-asserted-by":"crossref","first-page":"321","DOI":"10.3390\/curroncol29010029","article-title":"Safety profile of niraparib as maintenance therapy for ovarian cancer: a systematic review and meta-analysis","volume":"29","author":"Pagkali A","year":"2022","unstructured":"Pagkali A, Mamais I, Michalinos A, Agouridis AP. Safety profile of niraparib as maintenance therapy for ovarian cancer: a systematic review and meta-analysis. Curr. Oncol. 29(1), 321\u2013336 (2022).","journal-title":"Curr. Oncol."},{"issue":"2","key":"e_1_3_8_11_2","doi-asserted-by":"crossref","first-page":"285","DOI":"10.1007\/s00404-021-06070-2","article-title":"Poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors as maintenance therapy in women with newly diagnosed ovarian cancer: a systematic review and meta-analysis","volume":"304","author":"Cheng H","year":"2021","unstructured":"Cheng H, Yang J, Liu H, Xiang Y. Poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors as maintenance therapy in women with newly diagnosed ovarian cancer: a systematic review and meta-analysis. Arch. Gynecol. Obstet. 304(2), 285\u2013296 (2021).","journal-title":"Arch. Gynecol. Obstet."},{"issue":"6","key":"e_1_3_8_12_2","doi-asserted-by":"crossref","first-page":"971","DOI":"10.1136\/ijgc-2022-004079","article-title":"Safety and management of niraparib monotherapy in ovarian cancer clinical trials","volume":"33","author":"Monk BJ","year":"2023","unstructured":"Monk BJ, Gonz\u00e1lez-Mart\u00edn A, Buckley L Safety and management of niraparib monotherapy in ovarian cancer clinical trials. Int. J. Gynecol. Cancer. 33(6), 971\u2013981 (2023).","journal-title":"Int. J. Gynecol. Cancer."},{"issue":"22","key":"e_1_3_8_13_2","doi-asserted-by":"crossref","first-page":"2154","DOI":"10.1056\/NEJMoa1611310","article-title":"Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer","volume":"375","author":"Mirza MR","year":"2016","unstructured":"Mirza MR, Monk BJ, Herrstedt J Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N. Engl. J. Med. 375(22), 2154\u20132164 (2016).","journal-title":"N. Engl. J. Med."},{"issue":"8","key":"e_1_3_8_14_2","doi-asserted-by":"crossref","first-page":"1784","DOI":"10.1093\/annonc\/mdy181","article-title":"Safety and dose modification for patients receiving niraparib","volume":"29","author":"Berek JS","year":"2018","unstructured":"Berek JS, Matulonis UA, Peen U Safety and dose modification for patients receiving niraparib. Ann. Oncol. 29(8),1784\u20131792 (2018).","journal-title":"Ann. Oncol."},{"issue":"12","key":"e_1_3_8_15_2","doi-asserted-by":"crossref","first-page":"1846","DOI":"10.1002\/cncr.34706","article-title":"Prospective evaluation of the tolerability and efficacy of niraparib dosing based on baseline body weight and platelet count: results from the PRIMA\/ENGOT-OV26\/GOG-3012 trial","volume":"129","author":"Mirza MR","year":"2023","unstructured":"Mirza MR, Gonz\u00e1lez-Mart\u00edn A, Graybill WS Prospective evaluation of the tolerability and efficacy of niraparib dosing based on baseline body weight and platelet count: results from the PRIMA\/ENGOT-OV26\/GOG-3012 trial. Cancer 129(12),1846\u20131855 (2023).","journal-title":"Cancer"},{"key":"e_1_3_8_16_2","unstructured":"Zejula [prescribing information]. GSK (2023) (Accessed 10 May 2024). https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/214876s000lbl.pdf"},{"key":"e_1_3_8_17_2","unstructured":"Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project (HCUPnet). (Accessed 25 July 2023). https:\/\/datatools.ahrq.gov\/hcupnet\/"},{"key":"e_1_3_8_18_2","unstructured":"Healthcare Cost and Utilization Project. HCUP Fact Sheet 2022. (2022). https:\/\/hcup-us.ahrq.gov\/news\/exhibit_booth\/HCUPFactSheet.pdf"},{"key":"e_1_3_8_19_2","unstructured":"Agency for Healthcare Research and Quality. HCUP Overview. Healthcare Cost and Utilization Project (HCUP). (2022) (Accessed 7 May 2024). https:\/\/hcup-us.ahrq.gov\/overview.jsp"},{"key":"e_1_3_8_20_2","doi-asserted-by":"crossref","first-page":"e390876","DOI":"10.1200\/EDBK_390876","article-title":"Managing adverse effects associated with poly(ADP-ribose) polymerase inhibitors in ovarian cancer: a synthesis of clinical trial and real-world data","volume":"43","author":"Friedlander M","year":"2023","unstructured":"Friedlander M, Lee C, Tew W. Managing adverse effects associated with poly(ADP-ribose) polymerase inhibitors in ovarian cancer: a synthesis of clinical trial and real-world data. Am. Soc. Clin. Oncol. Educ. Book. 43, e390876 (2023).","journal-title":"Am. Soc. Clin. Oncol. Educ. Book."},{"key":"e_1_3_8_21_2","doi-asserted-by":"crossref","first-page":"114157","DOI":"10.1016\/j.ejca.2024.114157","article-title":"Tolerability of the niraparib individualized starting dose in the PRIMA\/ENGOT-OV26\/GOG-3012 trial of niraparib first-line maintenance therapy","volume":"208","author":"Vulsteke C","year":"2024","unstructured":"Vulsteke C, Chambers SK, Jes\u00fas Rubio P\u00e9rez M Tolerability of the niraparib individualized starting dose in the PRIMA\/ENGOT-OV26\/GOG-3012 trial of niraparib first-line maintenance therapy. Eur. J. Cancer 208, 114157 (2024).","journal-title":"Eur. J. Cancer"},{"key":"e_1_3_8_22_2","unstructured":"National Institute for Health and Care Excellence. Niraparib for maintenance treatment of advanced ovarian fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy. (2021) (Accessed 10 May 2024). https:\/\/www.nice.org.uk\/guidance\/ta673\/documents\/final-appraisal-determination-document"},{"key":"e_1_3_8_23_2","unstructured":"Zejula [summary of product characteristics]. (2023) (Accessed 11February 2024). https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/zejula-epar-product-information_en.pdf"}],"container-title":["Journal of Comparative Effectiveness Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/becarispublishing.com\/doi\/pdf\/10.57264\/cer-2024-0133","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,12,13]],"date-time":"2024-12-13T10:35:36Z","timestamp":1734086136000},"score":1,"resource":{"primary":{"URL":"https:\/\/becarispublishing.com\/doi\/10.57264\/cer-2024-0133"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1]]},"references-count":21,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,1]]}},"alternative-id":["10.57264\/cer-2024-0133"],"URL":"https:\/\/doi.org\/10.57264\/cer-2024-0133","relation":{},"ISSN":["2042-6305","2042-6313"],"issn-type":[{"value":"2042-6305","type":"print"},{"value":"2042-6313","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1]]},"article-number":"e240133"}}