Cost-Effectiveness Analysis of Adjuvant Olaparib Versus Watch and Wait in the Treatment of Germline BRCA1/2-Mutated, High-Risk, HER2-Negative Early Breast Cancer in Sweden.
Journal
PharmacoEconomics - open
ISSN: 2509-4254
Titre abrégé: Pharmacoecon Open
Pays: Switzerland
ID NLM: 101700780
Informations de publication
Date de publication:
13 Dec 2023
13 Dec 2023
Historique:
accepted:
19
11
2023
medline:
14
12
2023
pubmed:
14
12
2023
entrez:
13
12
2023
Statut:
aheadofprint
Résumé
This study evaluated the cost effectiveness of adjuvant olaparib versus watch and wait (WaW) in patients with germline breast cancer susceptibility gene 1/2 (gBRCA1/2)-mutated, high-risk, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC), previously treated with neoadjuvant or adjuvant chemotherapy, from a Swedish healthcare perspective. A five-state (invasive disease-free survival [IDFS], non-metastatic breast cancer [non-mBC], early-onset mBC, late-onset mBC, death) semi-Markov state transition model with a lifetime horizon was developed. Transition probabilities were informed by data from the Phase III OlympiA trial, supplemented with data from additional studies in BRCA-mutated, HER2-negative mBC. Health state utilities were derived via mapping of OlympiA data and supplemented by literature estimates. Treatment, adverse events and other medical costs were extracted from publicly available Swedish sources. Incremental cost per life-year (LY) and quality-adjusted life-year (QALY) gained were estimated. Costs and outcomes were discounted at 3% annually. One-way deterministic and probabilistic sensitivity analyses (PSA) were conducted. Over a lifetime horizon, adjuvant olaparib was associated with an additional 1.50 LYs and 1.22 QALYs, and incremental cost of 471,156 Swedish krona (SEK) versus WaW (discounted). The resulting ICER was 385,183SEK per QALY gained for olaparib versus WaW. ICERs remained below 1,000,000SEK across a range of scenarios, and were consistent across subgroups (hormone receptor [HR]-positive/HER2-negative and triple-negative breast cancer [TNBC]). In PSA, the probability of olaparib being cost effective at 1,000,000SEK per QALY was 99.8%. At list price, adjuvant olaparib is a cost-effective alternative to WaW in patients with gBRCA1/2-mutated, high-risk, HER2-negative eBC in Sweden.
Identifiants
pubmed: 38093030
doi: 10.1007/s41669-023-00457-4
pii: 10.1007/s41669-023-00457-4
doi:
Types de publication
Journal Article
Langues
eng
Informations de copyright
© 2023. The Author(s).
Références
Socialstyrelsen och Cancerfonden. Cancer i siffror 2018:populärvetenskapliga fakta om cancer. 2018 29/11/2022].
Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, et al. Global Cancer Observatory: Cancer Today. Lyon: International agency for research on cancer; 2020.
Socialstyrelsen. Statistik om cancer: Bilaga—Tabeller—Statistik om nyupptäckta cancerfall 2021. 2021 29/11/2022].
National Quality Registry for Breast Cancer (NKBC). Antal bröstcancerfall Bland alla anmälda fall. Diagnosår: 2022. 2022 29/11/2022].
American Joint Committee on Cancer (AJCC). AJCC cancer staging manual. 8th ed. Cham: Springer; 2017.
National Cancer Institute. National Cancer Institute: surveillance, epidemiology and end results program. Cancer stat facts: female breast cancer subtypes. Delhi: National Cancer Institute; 2022.
Nationellt Kvalitetsregister för Bröstcancer. Årsrapport 2021 från. 2021.
Feng Y, Spezia M, Huang S, Yuan C, Zeng Z, Zhang L, et al. Breast cancer development and progression: risk factors, cancer stem cells, signaling pathways, genomics, and molecular pathogenesis. Genes & Diseases. 2018;5(2):77–106.
doi: 10.1016/j.gendis.2018.05.001
Petrucelli N, Daly MB, Pal T. BRCA1- and BRCA2-associated hereditary breast and ovarian cancer. Gene Reviews. Washington: University of Washington; 1998. (Updated 2022 May 26 ed).
Fu X, Tan W, Song Q, Pei H, Li J. BRCA1 and Breast Cancer: molecular mechanisms and therapeutic strategies. Front Cell Dev Biol. 2022;10: 813457.
pubmed: 35300412
pmcid: 8921524
doi: 10.3389/fcell.2022.813457
Baretta Z, Mocellin S, Goldin E, Olopade OI, Huo D. Effect of BRCA germline mutations on breast cancer prognosis: a systematic review and meta-analysis. Medicine (Baltimore). 2016;95(40): e4975.
pubmed: 27749552
doi: 10.1097/MD.0000000000004975
Tilanus-Linthorst MMA, Lingsma HF, Evans DG, Thompson D, Kaas R, Manders P, et al. Optimal age to start preventive measures in women with BRCA1/2 mutations or high familial breast cancer risk. Int J Cancer. 2013;133(1):156–63.
pubmed: 23292943
doi: 10.1002/ijc.28014
Nilsson MP, Törngren T, Henriksson K, Kristoffersson U, Kvist A, Silfverberg B, et al. BRCAsearch: written pre-test information and BRCA1/2 germline mutation testing in unselected patients with newly diagnosed breast cancer. Breast Cancer Res Treat. 2018;168(1):117–26.
pubmed: 29164420
doi: 10.1007/s10549-017-4584-y
Winter C, Nilsson MP, Olsson E, George AM, Chen Y, Kvist A, et al. Targeted sequencing of BRCA1 and BRCA2 across a large unselected breast cancer cohort suggests that one-third of mutations are somatic. Ann Oncol. 2016;27(8):1532–8.
pubmed: 27194814
pmcid: 4959927
doi: 10.1093/annonc/mdw209
Regionala Cancercentrum i Samverkan. Nationellt vårdprogram bröstcancer, Version 4.3, 2023-03-28, https://kunskapsbanken.cancercentrum.se/diagnoser/brostcancer/vardprogram/ . 2023
Office for National Statistics. Cancer survival in England: adult, stage at diagnosis and childhood—patients followed up to 2018. 2019.
Hess KR, Esteva FJ. Effect of HER2 status on distant recurrence in early stage breast cancer. Breast Cancer Res Treat. 2013;137(2):449–55.
pubmed: 23225147
doi: 10.1007/s10549-012-2366-0
Ragaz J, Irving MA. High-risk breast cancer. 1st ed. Berlin: Springer; 1989.
doi: 10.1007/978-3-642-73718-3
Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, et al. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. N Engl J Med. 2021;384(25):2394–405.
pubmed: 34081848
pmcid: 9126186
doi: 10.1056/NEJMoa2105215
Reddy SM, Barcenas CH, Sinha AK, Hsu L, Moulder SL, Tripathy D, et al. Long-term survival outcomes of triple-receptor negative breast cancer survivors who are disease free at 5 years and relationship with low hormone receptor positivity. Br J Cancer. 2018;118(1):17–23.
pubmed: 29235566
doi: 10.1038/bjc.2017.379
Dent R, Trudeau M, Pritchard KI, Hanna WM, Kahn HK, Sawka CA, et al. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res. 2007;13(15 Pt 1):4429–34.
pubmed: 17671126
doi: 10.1158/1078-0432.CCR-06-3045
Sopik V, Sun P, Narod SA. Predictors of time to death after distant recurrence in breast cancer patients. Breast Cancer Res Treat Vol. 2019;173:465–74.
doi: 10.1007/s10549-018-5002-9
Pan H, Gray R, Braybrooke J, Davies C, Taylor C, McGale P, et al. 20-Year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med. 2017;377(19):1836–46.
pubmed: 29117498
pmcid: 5734609
doi: 10.1056/NEJMoa1701830
European Medicines Agency (EMA). Olaparib (Lynparza®) summary of product characteristics. 2022.
U.S. Food and Drug Administration (FDA). Lynparza® prescribing information. 2022
Geyer CEJ, Garber JE, Gelber RD, Yothers G, Taboada M, Ross L, et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022;33(12):1250–68.
pubmed: 36228963
doi: 10.1016/j.annonc.2022.09.159
European Medicines Agency (EMA). Lynparza-H-C-3726-II-0051-G: EPAR—assessment report—variation. https://www.ema.europa.eu/en/documents/variation-report/lynparza-h-c-3726-ii-0051-g-epar-assessment-report-variation_en.pdf . 2022.
Murphy P, Glynn D, Dias S, Hodgson R, Claxton L, Beresford L, et al. Modelling approaches for histology-independent cancer drugs to inform NICE appraisals: a systematic review and decision-framework. Health Technol Assess. 2021;25(76):1–228.
pubmed: 34990339
pmcid: 8287375
doi: 10.3310/hta25760
National Institute for Health and Care Excellence (NICE). TA632: Trastuzumab emtansine for adjuvant treatment of HER2-positive early breast cancer. 2020.
National Institute for Health and Care Excellence (NICE). TA612: Neratinib for extended adjuvant treatment of hormone receptor-positive, HER2-positive early stage breast cancer after adjuvant trastuzumab. 2019.
National Institute for Health and Care Excellence (NICE). TA569: Pertuzumab for adjuvant treatment of HER2-positive early stage breast cancer. 2019.
National Institute for Health and Care Excellence (NICE). TA501: Intrabeam radiotherapy system for adjuvant treatment of early breast cancer. 2018.
National Institute for Health and Care Excellence (NICE). TA424: Pertuxumab for the neoadjuvant treatment of HER2-positive breast cancer. 2016.
Dawood S, Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival differences among women with de novo stage IV and relapsed breast cancer. Ann Oncol. 2010;21(11):2169–74.
pubmed: 20427349
pmcid: 2962259
doi: 10.1093/annonc/mdq220
Lobbezoo DJ, van Kampen RJ, Voogd AC, Dercksen MW, van den Berkmortel F, Smilde TJ, et al. Prognosis of metastatic breast cancer: are there differences between patients with de novo and recurrent metastatic breast cancer? Br J Cancer. 2015;112(9):1445–51.
pubmed: 25880008
pmcid: 4453676
doi: 10.1038/bjc.2015.127
McKenzie HS, Maishman T, Simmonds P, Durcan L, Group PS, Eccles D, et al. Survival and disease characteristics of de novo versus recurrent metastatic breast cancer in a cohort of young patients. Br J Cancer. 2020;122(11):1618–29.
pubmed: 32231292
pmcid: 7250836
doi: 10.1038/s41416-020-0784-z
Tandvårds- och Läkemedelsförmånsverket (TLV). Ändring i Tandvårds- och läkemedelsförmånsverkets allmänna råd (TLVAR 2003:2) om ekonomiska utvärderingar. 2017.
Liedtke C, Mazouni C, Hess KR, Andre F, Tordai A, Mejia JA, et al. Response to neoadjuvant therapy and long-term survival in patients with triple-negative breast cancer. J Clin Oncol. 2008;26(8):1275–81.
pubmed: 18250347
doi: 10.1200/JCO.2007.14.4147
Statistics Sweden. Population Statistics. 2022.
Mai PL, Chatterjee N, Hartge P, Tucker M, Brody L, Struewing JP, et al. Potential excess mortality in BRCA1/2 mutation carriers beyond breast, ovarian, prostate, and pancreatic cancers, and melanoma. PLoS ONE. 2009;4(3): e4812.
pubmed: 19277124
pmcid: 2652075
doi: 10.1371/journal.pone.0004812
Robson M, Ruddy KJ, Im SA, Senkus E, Xu B, Domchek SM, et al. Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial. Eur J Cancer. 2019;120:20–30.
pubmed: 31446213
pmcid: 6836724
doi: 10.1016/j.ejca.2019.06.023
Robson ME, Tung N, Conte P, Im SA, Senkus E, Xu B, et al. OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician’s choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Ann Oncol. 2019;30(4):558–66.
pubmed: 30689707
pmcid: 6503629
doi: 10.1093/annonc/mdz012
Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, et al. Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer. N Engl J Med. 2018;379(22):2108–21.
pubmed: 30345906
doi: 10.1056/NEJMoa1809615
Collins JM, Nordstrom BL, McLaurin KK, Dalvi TB, McCutcheon SC, Bennett JC, et al. A real-world evidence study of CDK4/6 inhibitor treatment patterns and outcomes in metastatic breast cancer by germline BRCA mutation status. Oncol Therapy. 2021;9(2):575–89.
doi: 10.1007/s40487-021-00162-4
Emens LA, Molinero L, Loi S, Rugo HS, Schneeweiss A, Dieras V, et al. Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer: biomarker evaluation of the IMpassion130 study. J Natl Cancer Inst. 2021;113(8):1005–16.
pubmed: 33523233
pmcid: 8328980
doi: 10.1093/jnci/djab004
Ganz PA, Bandos H, Spanic T, Friedman S, Müller V, Kümmel S, et al. Abstract GS4-09: Quality of life results from OlympiA: a phase III, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)-adjuvant chemotherapy in patients with germline BRCA1/2 mutations and high-risk HER-2 negative early breast cancer. Can Res. 2022;82(4_Supplement): GS4-09-GS4-.
doi: 10.1158/1538-7445.SABCS21-GS4-09
Crott R, Briggs A. Mapping the QLQ-C30 quality of life cancer questionnaire to EQ-5D patient preferences. Eur J Health Econ. 2010;11(4):427–34.
pubmed: 20473703
doi: 10.1007/s10198-010-0233-7
Lidgren M, Wilking N, Jönsson B, Rehnberg C. Health related quality of life in different states of breast cancer. Qual Life Res. 2007;16:1073–81.
pubmed: 17468943
doi: 10.1007/s11136-007-9202-8
Ara R, Brazier JE. Populating an economic model with health state utility values: moving toward better practice. Value Health. 2010;13(5):509–18.
pubmed: 20230546
doi: 10.1111/j.1524-4733.2010.00700.x
Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997;35:1095–108.
pubmed: 9366889
doi: 10.1097/00005650-199711000-00002
Sydöstra sjukvårdsregionen. Priser och ersättningar för Sydöstra sjukvårdsregionen. 2022.
Södra sjukvårdsregionen. Regionala priser och ersättningar för södra sjukvårdsregionen. 2022.
Region Örebro län. Prislista Röntgenkliniken 2021.
Region Skåne. Pris 2022—Region Skåne samt landstingen Blekinge, Södra Halland, Kronoberg—klinisk kemi. 2022.
Tandvårds- och Läkemedelsförmånsverket (TLV). Underlag för beslut i regionerna—Kadcyla (trastuzumab emtansin). 2019.
Statistics Sweden. Konsumentprisindex (1949=100). 2022.
Tandvårds- och Läkemedelsförmånsverket (TLV). Sök i databasen. 2022 March 2022]; https://www.tlv.se/beslut/sok-i-databasen.html .
Apoteket. apoteket.se. 2022. https://www.apoteket.se/ .
Fass. Accofill—dosering. 2022. https://www.fass.se/LIF/product?userType=0&nplId=20140329000214 .
Svensson M, Nilsson FOL, Arnberg K. Reimbursement decisions for pharmaceuticals in Sweden: the impact of disease severity and cost effectiveness. Pharmacoeconomics. 2015;33(11):1229–36.
pubmed: 26093889
doi: 10.1007/s40273-015-0307-6
Viollet J, O’Leary E, Camacho Gonzalez C, Lauppe R, Oldsberg L. HTA228 Willingness to pay for different severity levels in Sweden: an analysis of TLV decisions (2014–2022). Value in Health. 2022;25(12):S341.
doi: 10.1016/j.jval.2022.09.1686
European Medicines Agency (EMA). Summary of product characteristics abemaciclib. 2022.
Tandvårds- och Läkemedelsförmånsverket (TLV). Underlag för beslut om subvention - Omprövning. 2022.
European Medicines Agency (EMA). Summary of product characteristics pembrolizumab. 2022.
European Medicines Agency (EMA). Summary of product characteristics Xeloda. 2023.
Safonov A, Bandlamudi C, de Lara PT, Ferraro E, Derakhshan F, Will M, et al. Abstract GS4-08: comprehensive genomic profiling of patients with breast cancer identifies germline-somatic interactions mediating therapy resistance. Cancer Res. 2022;82(4_Supplement):GS4-08-GS4-.
doi: 10.1158/1538-7445.SABCS21-GS4-08
Kim JY, Oh JM, Park YH, Ahn JS, Im YH. Which clinicopathologic parameters suggest primary resistance to palbociclib in combination with letrozole as the first-line treatment for hormone receptor-positive, HER2-negative advanced breast cancer? Front Oncol. 2021;11: 759150.
pubmed: 34745997
pmcid: 8566811
doi: 10.3389/fonc.2021.759150
Bruno L, Ostinelli A, Waisberg F, Enrico D, Ponce C, Rivero S, et al. Cyclin-dependent kinase 4/6 inhibitor outcomes in patients with advanced breast cancer carrying germline pathogenic variants in DNA repair–related genes. JCO Precis Oncol. 2022;6: e2100140.
pubmed: 35235412
doi: 10.1200/PO.21.00140
National Institute for Health and Care Excellence (NICE). TA886: Olaparib for adjuvant treatment of BRCA mutation-positive HER2-negative high-risk early breast cancer after chemotherapy. 2023.
Taylor AM, Chan DLH, Tio M, Patil SM, Traina TA, Robson ME, et al. PARP (Poly ADP-Ribose Polymerase) inhibitors for locally advanced or metastatic breast cancer. Cochrane Datab Syst Rev. 2021;4(4): CD011395.
Longworth L, Yang Y, Young T, Mulhern B, Hernandez Alava M, Mukuria C, et al. Use of generic and condition-specific measures of health-related quality of life in NICE decision-making: a systematic review, statistical modelling and survey. Health Technol Assess. 2014;18(9):1–224.
pubmed: 24524660
pmcid: 4780954
doi: 10.3310/hta18090
Criscitiello C, Spurden D, Piercy J, Rider A, Williams R, Mitra D, et al. Health-related quality of life among patients with HR+/HER2- early breast cancer. Clin Ther. 2021;43(7):1228-44.e4.
pubmed: 34256965
doi: 10.1016/j.clinthera.2021.04.020
Hsu T, Ennis M, Hood N, Graham M, Goodwin PJ. Quality of life in long-term breast cancer survivors. J Clin Oncol. 2013;31(28):3540–8.
pubmed: 23980087
doi: 10.1200/JCO.2012.48.1903
Sullivan J, Thornton Snider J, van Eijndhoven E, Okoro T, Batt K, DeLeire T. The well-being of long-term cancer survivors. Am J Manag Care. 2018;24(4):188–95.
pubmed: 29668209
Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I, et al. Adjuvant capecitabine for breast cancer after preoperative chemotherapy. N Engl J Med. 2017;376(22):2147–59.
pubmed: 28564564
doi: 10.1056/NEJMoa1612645
Cardoso F, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rubio IT, et al. Early breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30(8):1194–220.
pubmed: 31161190
doi: 10.1093/annonc/mdz173
Zettler C, Silva DD, Blinder VS, Robson ME, Elkin EB. Cost effectiveness of adjuvant olaparib for BRCA-mutated, early-stage breast cancer. J Clin Oncol. 2022;40(16_suppl):6593.
doi: 10.1200/JCO.2022.40.16_suppl.6593
Canadian Agency for Drugs and Technologies in Health (CADTH). CADTH Reimbursement Recommendation: Olaparib (Lynparza). 2023.