A cost-consequence model of using the 21-gene assay to identify patients with early-stage node-positive breast cancer who benefit from adjuvant chemotherapy in the Netherlands

References

• Kalinsky K, Barlow WE, Gralow JR, et al. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385(25):2336–2347. doi: 10.1056/NEJMoa2108873.
   PubMed Web of Science ®Google Scholar
• Albain KS, Barlow WE, Shak S, et al. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 2010;11(1):55–65. doi: 10.1016/S1470-2045(09)70314-6.
   PubMed Web of Science ®Google Scholar
• Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351(27):2817–2826. doi: 10.1056/NEJMoa041588.
   PubMed Web of Science ®Google Scholar
• Paik S, Tang G, Shak S, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006;24(23):3726–3734. doi: 10.1200/JCO.2005.04.7985.
   PubMed Web of Science ®Google Scholar
• IKNL. NKR-cijfers. Available from: https://iknl.nl/nkr-cijfers
   Google Scholar
• IKNL-NABON. Borstkanker. Landelijke richtlijn. Version 2.0. 2020.
   Google Scholar
• Ragusi MAA, van der Velden BHM, van Maaren MC, et al. Population-based estimates of overtreatment with adjuvant systemic therapy in early breast cancer patients with data from The Netherlands and the USA. Breast Cancer Res Treat. 2022;193(1):161–173. doi: 10.1007/s10549-022-06550-2.
   PubMed Web of Science ®Google Scholar
• Cobleigh MA, Tabesh B, Bitterman P, et al. Tumor gene expression and prognosis in breast cancer patients with 10 or more positive lymph nodes. Clin Cancer Res. 2005;11(24 Pt 1):8623–8631. doi: 10.1158/1078-0432.CCR-05-0735.
   PubMed Web of Science ®Google Scholar
• Piccart M, van’t Veer LJ, Poncet C, et al. 70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age. Lancet Oncol. 2021;22(4):476–488. doi: 10.1016/S1470-2045(21)00007-3.
   PubMed Web of Science ®Google Scholar
• Cardoso F, Van’t Veer LJ, Bogaerts J, et al. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med. 2016;375(8):717–729. doi: 10.1056/NEJMoa1602253.
   PubMed Web of Science ®Google Scholar
• Buyse M, Loi S, Van’t Veer L, et al. Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer. J Natl Cancer Inst. 2006;98(17):1183–1192. doi: 10.1093/jnci/djj329.
   PubMed Web of Science ®Google Scholar
• Knauer M, Mook S, Rutgers EJ, et al. The predictive value of the 70-gene signature for adjuvant chemotherapy in early breast cancer. Breast Cancer Res Treat. 2010;120(3):655–661. doi: 10.1007/s10549-010-0814-2.
   PubMed Web of Science ®Google Scholar
• van 't Veer LJ, Dai H, van de Vijver MJ, et al. Gene expression profiling predicts clinical outcome of breast cancer. Nature. 2002;415(6871):530–536. doi: 10.1038/415530a.
   PubMed Web of Science ®Google Scholar
• Beumer I, Witteveen A, Delahaye L, et al. Equivalence of MammaPrint array types in clinical trials and diagnostics. Breast Cancer Res Treat. 2016;156(2):279–287. doi: 10.1007/s10549-016-3764-5.
   PubMed Web of Science ®Google Scholar
• de Jongh FE, Efe R, Herrmann KH, et al. Cost and clinical benefits associated with Oncotype DX® test in patients with early-stage HR+/HER2- node-negative breast cancer in The Netherlands. Int J Breast Cancer. 2022;2022:5909724. doi: 10.1155/2022/5909724.
   PubMed Web of Science ®Google Scholar
• Machielsen P, de Jongh FE, Drost P, et al. EE50 A cost-consequence model of using the 21-gene breast recurrence score assay to identify patients with early-stage node-positive breast cancer who benefit from adjuvant chemotherapy in The Netherlands. Value Health. 2022;25(12):S63. doi: 10.1016/j.jval.2022.09.303.
   Web of Science ®Google Scholar
• DICA. NBCA jaarverslag. 2020.
   Google Scholar
• Mamounas EP, Russell CA, Lau A, et al. Clinical relevance of the 21-gene Recurrence Score(®) assay in treatment decisions for patients with node-positive breast cancer in the genomic era. NPJ Breast Cancer. 2018;4(1):27. doi: 10.1038/s41523-018-0082-6.
   PubMedGoogle Scholar
• Retèl VP, Byng D, Linn SC, et al. Cost-effectiveness analysis of the 70-gene signature compared with clinical assessment in breast cancer based on a randomised controlled trial. Eur J Cancer. 2020;137:193–203. doi: 10.1016/j.ejca.2020.07.002.
   PubMed Web of Science ®Google Scholar
• Hakkaart-van Roijen L, Van der Linden N, Bouwmans C, et al. Kostenhandleiding: Methodologie van kostenonderzoek en referentieprijzen voor economische evaluaties in de gezondheidszorg (ZIN). 2015. Available from: https://www.zorginstituutnederland.nl/binaries/zinl/documenten/publicatie/2016/02/29/richtlijn-voor-het-uitvoeren-van-economischeevaluaties-in-de-gezondheidszorg/Richtlijn+voor+het+uitvoeren+van+economische+evaluaties+in+de+gezondheidszorg+%28verdiepingsmodules%29.pdf
   Google Scholar
• NZa code 050531. 2022. Available from: https://zorgproducten.nza.nl/ZoekZorgproduct.aspx?psId=15&pId=19058
   Google Scholar
• NZa code 050530. 2022. Available from: https://zorgproducten.nza.nl/ZoekZorgproduct.aspx?psId=15&pId=85958
   Google Scholar
• NZA. DBC-zorgproduct 020107034. 2022. Available from: https://www.opendisdata.nl/msz/zorgproduct/020107034
   Google Scholar
• NZA. Tarieventabel dbc-zorgproducten en overige-zorgproducten per 1 januari 2019. 2019. Available from: https://puc.overheid.nl/nza/doc/PUC_236092_22/1/
   Google Scholar
• Z-Index. G-standaard April 2021. 2021. Available from: https://www.z-index.nl/
   Google Scholar
• Bouwmans C, Janssen J, Huijgens P, et al. Costs of haematological adverse events in chronic myeloid leukaemia patients: a retrospective cost analysis of the treatment of anaemia, neutropenia and thrombocytopenia in patients with chronic myeloid leukaemia. J Med Econ. 2009;12(2):164–169. doi: 10.3111/13696990903149479.
   PubMedGoogle Scholar
• Wehler E, Zhao Z, Pinar Bilir S, et al. Economic burden of toxicities associated with treating metastatic melanoma in eight countries. Eur J Health Econ. 2017;18(1):49–58. doi: 10.1007/s10198-015-0757-y.
   PubMed Web of Science ®Google Scholar
• Nederland Z. ZIN assessment palbociclib. (Ibrance®). 2017.
   Google Scholar
• de Jong LA, Gout-Zwart JJ, van den Bosch M, et al. Rivaroxaban for non-valvular atrial fibrillation and venous thromboembolism in The Netherlands: a real-world data based cost-effectiveness analysis. J Med Econ. 2019;22(4):306–318. doi: 10.1080/13696998.2018.1563404.
   PubMed Web of Science ®Google Scholar
• van den Hurk CJ, van den Akker-van Marle ME, Breed WP, et al. Cost-effectiveness analysis of scalp cooling to reduce chemotherapy-induced alopecia. Acta Oncol. 2014;53(1):80–87. doi: 10.3109/0284186X.2013.794955.
   PubMed Web of Science ®Google Scholar
• Leunis A, Blommestein HM, Huijgens PC, et al. The costs of initial treatment for patients with acute myeloid leukemia in The Netherlands. Leuk Res. 2013;37(3):245–250. doi: 10.1016/j.leukres.2012.09.018.
   PubMed Web of Science ®Google Scholar
• ZIN. Reassessment—Trastuzumab (Herceptin) bij HER2-positieve vroege borstkanker. 2014.
   Google Scholar
• Boekel NB, Jacobse JN, Schaapveld M, et al. Cardiovascular disease incidence after internal mammary chain irradiation and anthracycline-based chemotherapy for breast cancer. Br J Cancer. 2018;119(4):408–418. doi: 10.1038/s41416-018-0159-x.
   PubMed Web of Science ®Google Scholar
• Wolff AC, Blackford AL, Visvanathan K, et al. Risk of marrow neoplasms after adjuvant breast cancer therapy: the national comprehensive cancer network experience. J Clin Oncol. 2015;33(4):340–348. doi: 10.1200/JCO.2013.54.6119.
   PubMed Web of Science ®Google Scholar
• CBS. StatLine: Arbeidsdeelname; kerncijfers. 2022 [cited 2022 Feb 15]. Available from: https://opendata.cbs.nl/statline/?dl=31E80#/CBS/nl/dataset/82309NED/table
   Google Scholar
• CBS. Statline: vacatures; stroomcijfers, seizoengecorrigeerd. 2022.
   Google Scholar
• Lux MP, Nabieva N, Hildebrandt T, et al. Budget impact analysis of gene expression tests to aid therapy decisions for breast cancer patients in Germany. Breast. 2018;37:89–98. doi: 10.1016/j.breast.2017.11.002.
   PubMed Web of Science ®Google Scholar
• Thomas RJ, Williams M, Marshall C, et al. The total hospital and community UK costs of managing patients with relapsed breast cancer. Br J Cancer. 2009;100(4):598–600. doi: 10.1038/sj.bjc.6604911.
   PubMed Web of Science ®Google Scholar
• Rijksinstituut voor Volksgezondheid en Milieu. Werken tijdens de overgang. 2022. p. 12.
   Google Scholar
• Zhang L, Hsieh MC, Petkov V, et al. Trend and survival benefit of Oncotype DX use among female hormone receptor-positive breast cancer patients in 17 SEER registries, 2004-2015. Breast Cancer Res Treat. 2020;180(2):491–501. doi: 10.1007/s10549-020-05557-x.
   PubMed Web of Science ®Google Scholar
• Stemmer SM, Steiner M, Rizel S, et al. Clinical outcomes in ER + HER2 -node-positive breast cancer patients who were treated according to the Recurrence Score results: evidence from a large prospectively designed registry. NPJ Breast Cancer. 2017;3(1):32. doi: 10.1038/s41523-017-0033-7.
   PubMedGoogle Scholar
• Bello DM, Russell C, McCullough D, et al. Lymph node status in breast cancer does not predict tumor biology. Ann Surg Oncol. 2018;25(Suppl 3):992–2889. doi: 10.1245/s10434-018-6598-z.
   PubMedGoogle Scholar
• Dannehl D, Engler T, Volmer LL, et al. Recurrence Score(®) result impacts treatment decisions in hormone receptor-positive, HER2-negative patients with early breast cancer in a real-world setting-results of the IRMA trial. Cancers (Basel). 2022;14(21):5365. doi: 10.3390/cancers14215365.
   PubMed Web of Science ®Google Scholar
• Berdunov V, Millen S, Paramore A, et al. Cost-effectiveness analysis of the Oncotype DX Breast Recurrence Score test in node-positive early breast cancer. J Med Econ. 2022;25(1):591–604. doi: 10.1080/13696998.2022.2066399.
   PubMed Web of Science ®Google Scholar
• Lamond NW, Skedgel C, Rayson D, et al. Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer. Breast Cancer Res Treat. 2012;133(3):1115–1123. doi: 10.1007/s10549-012-1989-5.
   PubMed Web of Science ®Google Scholar
• Blohmer JU, Rezai M, Kümmel S, et al. Using the 21-gene assay to guide adjuvant chemotherapy decision-making in early-stage breast cancer: a cost-effectiveness evaluation in the German setting. J Med Econ. 2013;16(1):30–40. doi: 10.3111/13696998.2012.722572.
   PubMedGoogle Scholar
• Briggs AH, Weinstein MC, Fenwick EA, et al. Model parameter estimation and uncertainty analysis: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force Working Group-6. Med Decis Making. 2012;32(5):722–732. doi: 10.1177/0272989X12458348.
   PubMed Web of Science ®Google Scholar