Whitney S Graybill, Ignace Vergote, Bhavana Pothuri, Maarit Anttila, David M O'Malley, Domenica Lorusso, Ashley F Haggerty, Michel Fabbro, John K Chan, Florian Heitz, Lyndsay J Willmott, Ilan Bruchim, Ying Zhuo, Purificación Estévez-García, Bradley J Monk, Hannelore Denys, Anja Knudsen, Anna V Tinker, Luis Manso Sánchez, Diane Provencher, Maria Pilar Barretina-Ginesta, John Hartman, Donna V Booth, Antonio González-Martín
{"title":"卵巢癌个体化起始剂量和尼拉帕尼血液学不良事件管理成本的应用。","authors":"Whitney S Graybill, Ignace Vergote, Bhavana Pothuri, Maarit Anttila, David M O'Malley, Domenica Lorusso, Ashley F Haggerty, Michel Fabbro, John K Chan, Florian Heitz, Lyndsay J Willmott, Ilan Bruchim, Ying Zhuo, Purificación Estévez-García, Bradley J Monk, Hannelore Denys, Anja Knudsen, Anna V Tinker, Luis Manso Sánchez, Diane Provencher, Maria Pilar Barretina-Ginesta, John Hartman, Donna V Booth, Antonio González-Martín","doi":"10.57264/cer-2024-0133","DOIUrl":null,"url":null,"abstract":"<p><p><b>Aim:</b> 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. <b>Methods:</b> The frequencies of grade ≥3 hematologic AEs that occurred in >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 ≥3 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. <b>Results:</b> 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. <b>Conclusion:</b> 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.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e240133"},"PeriodicalIF":1.9000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11656343/pdf/","citationCount":"0","resultStr":"{\"title\":\"Use of individualized starting dose and niraparib hematologic adverse event management costs in ovarian cancer.\",\"authors\":\"Whitney S Graybill, Ignace Vergote, Bhavana Pothuri, Maarit Anttila, David M O'Malley, Domenica Lorusso, Ashley F Haggerty, Michel Fabbro, John K Chan, Florian Heitz, Lyndsay J Willmott, Ilan Bruchim, Ying Zhuo, Purificación Estévez-García, Bradley J Monk, Hannelore Denys, Anja Knudsen, Anna V Tinker, Luis Manso Sánchez, Diane Provencher, Maria Pilar Barretina-Ginesta, John Hartman, Donna V Booth, Antonio González-Martín\",\"doi\":\"10.57264/cer-2024-0133\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Aim:</b> 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. <b>Methods:</b> The frequencies of grade ≥3 hematologic AEs that occurred in >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 ≥3 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. <b>Results:</b> 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. <b>Conclusion:</b> 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.</p>\",\"PeriodicalId\":15539,\"journal\":{\"name\":\"Journal of comparative effectiveness research\",\"volume\":\" \",\"pages\":\"e240133\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11656343/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of comparative effectiveness research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.57264/cer-2024-0133\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/12/6 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of comparative effectiveness research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.57264/cer-2024-0133","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/12/6 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
摘要
目的:从美国付款人的角度了解尼拉帕尼个体化起始剂量(ISD)与固定起始剂量(FSD)对血液学不良事件(AE)管理成本的影响。方法:根据III期PRIMA/ENGOT-OV26/GOG-3012试验的初步分析结果,获得尼拉帕尼治疗患者中发生≥3级血液学ae的频率。基准病例中每个≥3级AE的美国单位成本来自2017年美国卫生保健研究和质量机构卫生保健成本和利用项目数据库;单位成本调整为2020美元。每位患者的AE管理费用由AE单位费用乘以每次AE的频率和尼拉帕尼起始剂量计算。由于假定ae是相互独立发生的,因此将成本相加以得出总成本。结果:对于尼拉帕尼,对于所有血液学AE, ISD的每位患者估计AE管理成本低于FSD (FSD vs ISD:血小板减少,4701.87美元vs 1921.89美元;贫血,2784.00美元vs 1760.59美元;血小板计数下降,分别为2103.47美元和922.51美元;中性粒细胞减少症,2112.50美元vs 1369.56美元;中性粒细胞计数下降(1285.87美元vs 770.38美元)。平均计算的每位患者AE管理费用中,FSD组为12,987.71美元,ISD组为6744.93美元。结论:对于尼拉帕尼,在美国,与FSD相比,ISD治疗血液学ae的成本降低了近一半。与尼拉帕尼ISD相关的成本降低和安全性提高支持其在临床实践中的应用。
Use of individualized starting dose and niraparib hematologic adverse event management costs in ovarian cancer.
Aim: 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. Methods: The frequencies of grade ≥3 hematologic AEs that occurred in >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 ≥3 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. Results: 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. Conclusion: 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.
期刊介绍:
Journal of Comparative Effectiveness Research provides a rapid-publication platform for debate, and for the presentation of new findings and research methodologies.
Through rigorous evaluation and comprehensive coverage, the Journal of Comparative Effectiveness Research provides stakeholders (including patients, clinicians, healthcare purchasers, and health policy makers) with the key data and opinions to make informed and specific decisions on clinical practice.