References
- National Cancer Institute. Cancer stat facts: colorectal cancer; 29 July 2021. Available from: https://seer.cancer.gov/statfacts/html/colorect.html.
- Le DT, Durham JN, Smith KN, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017;357(6349):409–413.
- Venderbosch S, Nagtegaal ID, Maughan TS, et al. Mismatch repair status and BRAF mutation status in metastatic colorectal cancer patients: a pooled analysis of the CAIRO, CAIRO2, COIN, and FOCUS studies. Clin Cancer Res. 2014;20(20):5322–5330.
- National Comprehensive Cancer Network. Clinical practice guidelines in oncology (NCCN Guidelines) – rectal cancer; version 1.2021; 2021 [accessed 2021 July 6]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/rectal.pdf.
- National Comprehensive Cancer Network. Clinical practice guidelines in oncology (NCCN Guidelines) – colon cancer; version 2.2021; 2021 [accessed 2021 Jul 6]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf.
- Agency for Healthcare Research and Quality. Healthcare cost and utilization project; 2017 [accessed May 2021]. Available from: https://hcupnet.ahrq.gov/#setup.
- Gelsomino F, Barbolini M, Spallanzani A, et al. The evolving role of microsatellite instability in colorectal cancer: a review. Cancer Treat Rev. 2016;51:19–26.
- Battaglin F, Naseem M, Lenz HJ, et al. Microsatellite instability in colorectal cancer: overview of its clinical significance and novel perspectives. Clin Adv Hematol Oncol. 2018;16(11):735–745.
- Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA. KEYTRUDA (pembrolizumab); 2021 [updated May 2021; accessed 2021 June 17]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s097lbl.pdf.
- Food and Drug Administration. FDA approves pembrolizumab for first-line treatment of MSI-H/dMMR colorectal cancer; 2021 [updated March 2021; accessed 2021 Aug 27]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s096lbl.pdf.
- European Medicines Agency. Keytruda: assessment report; 2020 [updated 2020 Dec 10; accessed 2021 Jun 17]. Available from: https://www.ema.europa.eu/en/documents/variation-report/keytruda-h-c-3820-ii-0091-epar-assessment-report-variation_en.pdf.
- Pharmaceutical Benefits Advisory Committee. Pharmaceutical Benefits Advisory Committee (PBAC) meeting outcomes: March 2021 PBAC Meeting; 2021 [updated Mar 2021; accessed 2021 Jun 17]. Available from: https://www.pbs.gov.au/pbs/industry/listing/elements/pbac-meetings/pbac-outcomes/recommendations-made-by-the-pbac-march-2021.
- National Institute for Health and Care Excellence. TA709: Pembrolizumab for untreated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency; 2021 [updated 2021 Jun 23; accessed 2021 Jul 16]. Available from: https://www.nice.org.uk/guidance/ta709.
- Canadian Agency for Drugs and Technologies in Health. CADTH reimbursement recommendation (draft): Pembrolizumab (Keytruda); 2021 [updated 2021 Jun 10; accessed 2021 Jul 29]. Available from: https://cadth.ca/sites/default/files/pcodr/Reviews2021/PC0235%20Keytruda%20-%20Draft%20CADTH%20Recommendation_For%20posting%20June%2010,%202021.pdf.
- Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA. A phase III study of pembrolizumab (MK-3475) vs. chemotherapy in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) stage IV colorectal carcinoma (KEYNOTE-177): protocol, version 4, 2018.
- André T, Shiu K-K, Kim TW, KEYNOTE-177 Investigators, et al. Pembrolizumab in microsatellite-instability-high advanced colorectal cancer. N Engl J Med. 2020;383(23):2207–2218.
- Chen CT, Li L, Brooks G, et al. Medicare spending for breast, prostate, lung, and colorectal cancer patients in the year of diagnosis and year of death. Health Serv Res. 2018;53(4):2118–2132.
- Andre T, Shiu K-K, Kim TW, et al. Final overall survival for the phase III KN177 study: Pembrolizumab versus chemotherapy in microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC). J Clin Oncol. 2021;39(15_suppl):3500–3500.
- Institute for Clinical and Economic Review. 2020–2023 value assessment framework; 2020. [updated 2020 Jan 31; accessed May 2021]. Available from: https://icer.org/wp-content/uploads/2020/10/ICER_2020_2023_VAF_013120-4-1.pdf.
- Institute for Clinical and Economic Review. ICER’s reference case for economic evaluations: principles and rationale; 2020 [updated 2020 Jan 31; accessed 2021 Jun 17]. Available from: https://icer.org/wp-content/uploads/2020/10/ICER_Reference_Case_013120.pdf.
- Sanders GD, Neumann PJ, Basu A, et al. Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine. JAMA. 2016;316(10):1093–1103.
- Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA. Estimated usage of dosing options by tumor type – Keytruda Q4 2020. Data on file. 2020.
- Kantar. CancerMPact treatment architecture: colorectal cancer, United States v1.1. Data on file. 2019.
- Jin H, Amonkar M, Aguiar-Ibáñez R, et al. Systematic literature review and network meta-analysis of pembrolizumab versus other interventions for previously untreated, unresectable or metastatic, microsatellite instability-high or mismatch repair-deficient colorectal cancer. Future Oncol. 2022. DOI:10.2217/fon-2021-1633
- Latimer N. NICE DSU technical support document 14: survival analysis for economic evaluations alongside clinical trials – extrapolation with patient-level data 2011 [updated March 2013; accessed 2020 Jul 2]. Available from: http://nicedsu.org.uk/wp-content/uploads/2016/03/NICE-DSU-TSD-Survival-analysis.updated-March-2013.v2.pdf.
- Latimer N. Survival analysis for economic evaluations alongside clinical trials-extrapolation with patient-level data: inconsistencies, limitations, and a practical guide. Med Decis Making. 2013;33(6):743–754.
- Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care. 2005;43(3):203–220.
- IBM Corp. IBM Micromedex REDBOOK; 2020 [accessed May 2021]. Available from: https://www.micromedexsolutions.com/micromedex2/librarian/ssl/true.
- Centers for Medicare & Medicaid Services. Physician fee schedule search; 2020 [updated 2021 Jan 20; accessed May 2021]. Available from: https://www.cms.gov/apps/physician-fee-schedule/search/search-criteria.aspx.
- IQVIA. MSI/MMR Treatment. 2020. Data on file.
- Chastek B, Harley C, Kallich J, et al. Health care costs for patients with cancer at the end of life. J Oncol Pract. 2012;8(6):75s–80s.
- Färkkilä N, Torvinen S, Sintonen H, et al. Costs of colorectal cancer in different states of the disease. Acta Oncol. 2015;54(4):454–462.
- U.S. Bureau of Labor Statistics. Employer costs for employee compensation – March 2021; 2021 [accessed 2021 Aug 13]. Available from: https://www.bls.gov/news.release/pdf/ecec.pdf.
- Ara R, Brazier JE. Populating an economic model with health state utility values: moving toward better practice. Value Health. 2010;13(5):509–518.
- Mennini FS, Marcellusi A, Fabiano G, et al. Budget impact of bimonthly use of cetuximab in patients diagnosed with metastatic colorectal cancer. Future Oncol. 2019;15(18):2107–2112.
- Goldstein DA, Zeichner SB, Bartnik CM, et al. Metastatic colorectal cancer: a systematic review of the value of current therapies. Clin Colorectal Cancer. 2016;15(1):1–6.
- Degeling K, Vu M, Koffijberg H, et al. Health economic models for metastatic colorectal cancer: a methodological review. Pharmacoeconomics. 2020;38(7):683–713.