Cost-effectiveness of pembrolizumab for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma in the United States

References

• National Cancer Institute. Head and neck cancers [cited 2020 Oct 30]. Available from: https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet
   Google Scholar
• Union for International Cancer Control. Locally advanced squamous carcinoma of the head and neck; 2014 [cited 2020 Nov 24]. Available from: https://www.who.int/selection_medicines/committees/expert/20/applications/HeadNeck.pdf
   Google Scholar
• International Agency for Research on Cancer-World Health Organization. Estimated number of new cases in 2020 [cited 2021 May 7]. Available from: https://gco.iarc.fr/today/home
   Google Scholar
• American Cancer Society. Cancer facts & figures; 2021 [cited 2021 Jun 18]. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2021/cancer-facts-and-figures-2021.pdf
   Google Scholar
• National Cancer Institute-Surveillance Research Program. SEER*Stat software version 8.2.1: incidence (relative survival) – total U.S., 1969–2012 counties. Data on file; 2013.
   Google Scholar
• Pfister DG, Spencer S, Adelstein D, et al. Head and neck cancers, version 2.2020. J Natl Compr Canc Netw. 2020;18(7):873–898.
   PubMed Web of Science ®Google Scholar
• Winquist E, Agbassi C, Meyers BM, et al. Systemic therapy in the curative treatment of head and neck squamous cell cancer: a systematic review. J Otolaryngol Head Neck Surg. 2017;46(1):29.
   PubMedGoogle Scholar
• Ang KK, Chen A, Curran WJ, et al. Head and neck carcinoma in the United States: first comprehensive report of the longitudinal oncology registry of head and neck carcinoma (LORHAN). Cancer. 2012;118(23):5783–5792.
   PubMed Web of Science ®Google Scholar
• Cooper JS, Zhang Q, Pajak TF, et al. Long-term follow-up of the RTOG 9501/intergroup phase III trial: postoperative concurrent radiation therapy and chemotherapy in high-risk squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2012;84(5):1198–1205.
   PubMed Web of Science ®Google Scholar
• Bernier J, Domenge C, Ozsahin M, et al. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004;350(19):1945–1952.
   PubMed Web of Science ®Google Scholar
• Pignon JP, Maître A l, Maillard E, et al. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009;92(1):4–14.
   PubMed Web of Science ®Google Scholar
• Forastiere AA, Metch B, Schuller DE, et al. Randomized comparison of cisplatin plus fluorouracil and carboplatin plus fluorouracil versus methotrexate in advanced squamous-cell carcinoma of the head and neck: a southwest oncology group study. J Clin Oncol. 1992;10(8):1245–1251.
   PubMed Web of Science ®Google Scholar
• Jacobs C, Lyman G, Velez-García E, et al. A phase III randomized study comparing cisplatin and fluorouracil as single agents and in combination for advanced squamous cell carcinoma of the head and neck. J Clin Oncol. 1992;10(2):257–263.
   PubMed Web of Science ®Google Scholar
• Gibson MK, Li Y, Murphy B, et al. Randomized phase III evaluation of cisplatin plus fluorouracil versus cisplatin plus paclitaxel in advanced head and neck cancer (E1395): an intergroup trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2005;23(15):3562–3567.
   PubMed Web of Science ®Google Scholar
• Vermorken JB, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008;359(11):1116–1127.
   PubMed Web of Science ®Google Scholar
• Ferris RL, Blumenschein G, Fayette J, et al. Nivolumab for recurrent squamous-cell carcinoma of the head and neck. N Engl J Med. 2016;375(19):1856–1867.
   PubMed Web of Science ®Google Scholar
• Bauml J, Seiwert TY, Pfister DG, et al. Pembrolizumab for platinum- and cetuximab-refractory head and neck cancer: results from a single-arm, phase II study. J Clin Oncol. 2017;35(14):1542–1549.
   PubMed Web of Science ®Google Scholar
• Colevas AD, Bahleda R, Braiteh F, et al. Safety and clinical activity of atezolizumab in head and neck cancer: results from a phase I trial. Ann Oncol. 2018;29(11):2247–2253.
   PubMed Web of Science ®Google Scholar
• Burtness B, Harrington KJ, Greil R, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019;394(10212):1915–1928.
   PubMed Web of Science ®Google Scholar
• Siu LL, Even C, Mesía R, et al. Safety and efficacy of durvalumab with or without tremelimumab in patients with PD-L1-Low/negative recurrent or metastatic HNSCC: the phase 2 CONDOR randomized clinical trial. JAMA Oncol. 2019;5(2):195–203.
   PubMed Web of Science ®Google Scholar
• U.S. Food & Drug Administration. FDA approves pembrolizumab for first-line treatment of head and neck squamous cell carcinoma. FDA; 2019 [cited 2021 Jan 19]. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-head-and-neck-squamous-cell-carcinoma
   Google Scholar
• De Felice F, de Vincentiis M, Valentini V, et al. Follow-up program in head and neck cancer. Crit Rev Oncol Hematol. 2017;113:151–155.
   PubMed Web of Science ®Google Scholar
• Machiels J-P, René Leemans C, Golusinski W, et al. Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS-ESMO-ESTRO clinical practice guidelines for diagnosis, treatment and follow-up. Oral Oncol. 2021;113(11):105042.
   PubMedGoogle Scholar
• BlueCross BlueShield of North Carolina. Medical oncology program and cancer treatment pathways [cited 2022 Jun 22]. Available from: www.medicaloncologyprogram.com
   Google Scholar
• AIM Specialty Health. AIM cancer treatment pathways – anthem cancer care quality program [cited 2022 Jun 22]. Available from: https://aimproviders.com/medoncology-anthem/about-the-program/cancer-treatment-pathways/
   Google Scholar
• Lang Y, Dong D, Wu B. Pembrolizumab vs the EXTREME regimen in recurrent or metastatic head and neck squamous cell carcinoma: a cost-effectiveness analysis. Clin Drug Investig. 2020;40(12):1137–1146.
   PubMed Web of Science ®Google Scholar
• Zhou K, Li Y, Liao W, et al. Pembrolizumab alone or with chemotherapy for squamous cell carcinoma of the head and neck: a cost-effectiveness analysis from Chinese perspective. Oral Oncol. 2020;107:104754.
   PubMed Web of Science ®Google Scholar
• Wurcel V, Chirovsky D, Borse R, et al. Cost-effectiveness of pembrolizumab regimens for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma in Argentina. Adv Ther. 2021;38(5):2613–2630.
   PubMed Web of Science ®Google Scholar
• Keeping (Precision XTRACT) S. Network meta-analysis of pembrolizumab for the first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC); 2019. Data on file.
   Google Scholar
• Ramakrishnan K, Mojebi A, Ayers D, et al. Network meta-analysis (NMA) of pembrolizumab for first-line (1L) treatment of recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). J Clin Oncol. 2021;39(15_suppl):e18012.
   Google Scholar
• U.S. Food & Drug Administration-Center for Drug Evaluation and Research. Highlights of prescribing information – KEYTRUDA® (Pembrolizumab); 2021 [cited 2021 Jun 10]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s096lbl.pdf
   Google Scholar
• Merck Sharp & Dohme Corp. KEYNOTE-048 clinical study report. Data file; 2019.
   Google Scholar
• National Institute for Health and Care Excellence. Cetuximab for treating recurrent or metastatic squamous cell cancer of the head and neck; 2017 [cited 2020 Oct 30]. Available from: https://www.nice.org.uk/guidance/ta473
   Google Scholar
• National Institute for Health and Care Excellence. Nivolumab for treating recurrent or metastatic squamous-cell carcinoma of the [ID971], head and neck after platinum-based chemotherapy; 2017 [cited 2020 Oct 30]. Available from: https://www.nice.org.uk/guidance/ta490/documents/committee-papers
   Google Scholar
• Bagust A, Greenhalgh J, Boland A, et al. Cetuximab for recurrent and/or metastatic squamous cell carcinoma of the head and neck: a NICE single technology appraisal. Pharmacoeconomics. 2010;28(6):439–448.
   PubMed Web of Science ®Google Scholar
• Woods B, Sideris E, Palmer S, et al. NICE DSU technical support document 19: partitioned survival analysis for decision modelling in health care: a critical review report by the decision support unit; 2017 [cited 2021 Apr 30]. Available from: www.nicedsu.org.uk
   Google Scholar
• Elbasha EH, Chhatwal J. Theoretical foundations and practical applications of within-cycle correction methods. Med Decis Making. 2016;36(1):115–131.
   PubMed Web of Science ®Google Scholar
• Latimer N. NICE DSU technical support document 14: survival analysis for economic evaluations alongside clinical trials-extrapolation with patient-level data report by the decision support unit; 2011 [cited 2020 Aug 28]. Available from: www.nicedsu.org.uk
   Google Scholar
• Chow GC. Tests of equality between sets of coefficients in two linear regressions. Econometrica. 1960;28(3):591.
   Web of Science ®Google Scholar
• Guigay J, Aupérin A, Fayette J, et al. Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2021;22(4):463–475.
   PubMed Web of Science ®Google Scholar
• Bossi P, Miceli R, Locati LD, et al. A randomized, phase 2 study of cetuximab plus cisplatin with or without paclitaxel for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Ann Oncol. 2017;28(11):2820–2826.
   PubMed Web of Science ®Google Scholar
• Friesland S, Tsakonas G, Kristensen C, et al. Randomised phase II study with cetuximab in combination with 5-FU and cisplatin or carboplatin versus cetuximab in combination with paclitaxel and carboplatin for treatment of patients with relapsed or metastatic squamous cell carcinoma of the head and neck (CETMET trial). J Clin Oncol. 2018;36(15_suppl):6032–6032.
   Web of Science ®Google Scholar
• Burtness B, Goldwasser MA, Flood W, et al. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005;23(34):8646–8654.
   PubMed Web of Science ®Google Scholar
• U.S. Departement of Health and Human Services. Common terminology criteria for adverse events (CTCAE) Version 4.0; 2009 [cited 2020 Oct 30]. Available from: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/Archive/CTCAE_4.0_2009-05-29_QuickReference_8.5x11.pdf
   Google Scholar
• Medi-Span Price Rx; 2020 [cited 2021 Jan 20]. Available from: https://go.wolterskluwer.com/medispan-price-rx-bcom.html
   Google Scholar
• U.S. Food & Drug Administration-Center for Drug Evaluation and Research. Highlights of prescribing information – ERBITUX® (cetuximab); 2019 [cited 2021 Jun 23]. Available from: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm
   Google Scholar
• U.S. Food & Drug Administration-Center for Drug Evaluation and Research. Highlights of prescribing information – Cisplatin; 2019 [cited 2021 Jun 23]. Available from: www.fda.gov/medwatch
   Google Scholar
• U.S. Food & Drug Administration-Center for Drug Evaluation and Research. Highlights of prescribing information – PARAPLATIN® (Carboplatin) [cited 2021 May 20]. Available from: www.fda.gov/medwatch
   Google Scholar
• U.S. Food & Drug Administration-Center for Drug Evaluation and Research. Highlights of prescribing information – TAXOTERE (Docetaxel); 2020 [cited 2021 Jun 23]. Available from: www.fda.gov/medwatch
   Google Scholar
• U.S. Food & Drug Administration-Center for Drug Evaluation and Research. Highlights of prescribing information – ABAXANE (paclitaxel); 2020 [cited 2021 Jun 23]. Available from: www.fda.gov/medwatch
   Google Scholar
• U.S. Food & Drug Administration-Center for Drug Evaluation and Research. Highlights of prescribing information – Fluorouracil; 2016 [cited 2021 Jun 23]. Available from: www.fda.gov/medwatch
   Google Scholar
• Centers for Medicare and Medicaid Services (CMS). Current procedural terminology. 4th ed.; 2020. Available from: https://www.cms.gov/apps/physician-fee-schedule/search/search-criteria.aspx
   Google Scholar
• Centers for Medicare and Medicaid Services (CMS). ICD-10-CM/PCS MS-DRG v37.0 definitions manual. Available from: https://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_cms/P0002.html
   Google Scholar
• Nash Smyth E, La E, Talbird S, et al. Treatment patterns and health care resource use (HCRU) associated with repeatedly treated metastatic squamous cell carcinoma of the head and neck (mSCCHN) in the United Kingdom (UK); 2015.
   Google Scholar
• American Academy of Professional Coders (AAPC). Current procedural terminology – codify by AAPC. Available from: https://www.aapc.com/codes/cpt-codes-range?rf=aapc
   Google Scholar
• Enomoto LM, Schaefer EW, Goldenberg D, et al. The cost of hospice services in terminally ill patients with head and neck cancer. JAMA Otolaryngol Head Neck Surg. 2015;141:1066–1074.
   PubMed Web of Science ®Google Scholar
• Guigay J, Fayette J, Mesia R, et al. TPExtreme randomized trial: TPEx versus extreme regimen in 1st line recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). J Clin Oncol. 2019;37(15_suppl):6002–6002.
   Google Scholar
• Cohen EEW, Soulières D, Le Tourneau C, et al. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. Lancet. 2019;393(10167):156–167.
   PubMed Web of Science ®Google Scholar
• Fayette J, Wirth L, Oprean C, et al. Randomized phase II study of duligotuzumab (MEHD7945A) vs. cetuximab in squamous cell carcinoma of the head and neck (MEHGAN study). Front Oncol. 2016;6:232.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Institute for Clinical and Economic Review. 2020–2023 Value assessment framework; 2020. Available from: https://icer.org/wp-content/uploads/2020/10/ICER_2020_2023_VAF_102220.pdf
   Google Scholar
• Ramakrishnan K, Liu Z, Baxi S, et al. Real-world time on treatment with immuno-oncology therapy in recurrent/metastatic head and neck squamous cell carcinoma. Future Oncol. 2021;17(23):3037–3050.
   PubMed Web of Science ®Google Scholar
• Borse R, Hu P, Ramakrishnan K, et al. Validity of long-term oncology modeling extrapolations: a case study in recurrent or metastatic head and neck cancer. POSA132,2021-11; 2021.
   Google Scholar