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Drug profile

Cost-effectiveness of nivolumab in advanced melanoma: a drug review

Pages 13-28 | Received 04 Feb 2019, Accepted 29 Oct 2020, Published online: 06 Dec 2020

References

  • Dummer R, Hauschild A, Lindenblatt N, et al. Cutaneous melanoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sept;26(Suppl 5):v126–v132.
  • Dummer R, Keilholz U. appendix 2: cutaneous melanoma (2): eUpdate published online September 2016 (http://www.esmo.org/Guidelines/Melanoma). Ann Oncol. 2016 Sept;27(suppl 5):v136–v137.
  • https://www.ema.europa.eu/documents/assessment-report/opdivo-epar-public-assessment-report_en.pdf.2019.
  • Seymour L, Bogaerts J, Perrone A, et al. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 Mar;18(3):e143–e152.
  • Brahmer JR, Drake CG, Wollner I, et al. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol. 2010 Jul 1;28(19):3167–3175.
  • Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012 Jun 28;366(26):2443–2454.
  • Topalian SL, Sznol M, McDermott DF, et al. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol. 2014 Apr 1;32(10):1020–1030.
  • Callahan MK, Kluger H, Postow MA, et al. Nivolumab plus ipilimumab in patients with advanced melanoma: updated survival, response, and safety data in a phase I dose-escalation study. J Clin Oncol. 2018 Feb 1;36(4):391–398.
  • Zhao X, Suryawanshi S, Hruska M, et al. Assessment of nivolumab benefit-risk profile of a 240-mg flat dose relative to a 3-mg/kg dosing regimen in patients with advanced tumors. Ann Oncol. 2017 Aug 1;28(8):2002–2008.
  • Long GV, Tykodi SS, Schneider JG, et al. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Sept 12;29:2208–2213.
  • Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015 Jan 22;372(4):320–330.
  • Long GV, Atkinson V, Ascierto PA, et al. Effect of nivolumab on health-related quality of life in patients with treatment-naive advanced melanoma: results from the phase III CheckMate 066 study. Ann Oncol. 2016 Oct;27(10):1940–1946.
  • Ascierto PA, Long GV, Robert C, et al. Survival outcomes in patients with previously untreated BRAF wild-type advanced melanoma treated with nivolumab therapy: three-year follow-up of a randomized phase 3 trial. JAMA Oncol. 2019 Feb 1;5(2):187-194
  • Postow MA, Chesney J, Pavlick AC, et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med. 2015 May 21;372(21):2006–2017.
  • Hodi FS, Chesney J, Pavlick AC, et al. Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. Lancet Oncol. 2016 Nov;17(11):1558–1568.
  • Larkin J, Hodi FS, Wolchok JD. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015 Sept 24;373(13):1270–1271.
  • Wolchok JD, Rollin L, Larkin J. Nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2017 Dec 21;377(25):2503–2504.
  • Hodi FS, Chiarion-Sileni V, Gonzalez R, et al. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1480–1492.
  • Schadendorf D, Larkin J, Wolchok J, et al. Health-related quality of life results from the phase III CheckMate 067 study. Eur J Cancer. 2017 Sept;82:80–91.
  • McDermott DF, Shah R, Gupte-Singh K, et al. Quality-adjusted survival of nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma: a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis. Qual Life Res. 2019;28(1): 109.
  • Long GV, Weber JS, Larkin J, et al. Nivolumab for patients with advanced melanoma treated beyond progression: analysis of 2 phase 3 clinical trials. JAMA Oncol. 2017 Nov 1;3(11):1511–1519.
  • Lebbe C, Meyer N, Mortier L, et al. Initial results from a phase 3b/4 study evaluating two dosing regimens of nivolumab (NIVO) in combination with ipilimumab (IPI) in patients with advanced melanoma (CheckMate 511). Ann.Oncol. 2018;29(Issue_8):LBA45.
  • Weber JS, Gibney G, Sullivan RJ, et al. Sequential administration of nivolumab and ipilimumab with a planned switch in patients with advanced melanoma (CheckMate 064): an open-label, randomised, phase 2 trial. Lancet Oncol. 2016 Jul;17(7):943–955.
  • Robert C, Schachter J, Long GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015 Jun 25;372(26):2521–2532.
  • Larkin J, Minor D, D’Angelo S, et al. Overall survival in patients with advanced melanoma who received nivolumab versus investigator’s choice chemotherapy in checkmate 037: a randomized, controlled, open-label phase III trial. J Clin Oncol. 2018 Feb 1;36(4):383–390.
  • Weber JS, D’Angelo SP, Minor D, et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):375–384.
  • Hamid O, Puzanov I, Dummer R, et al. Final analysis of a randomised trial comparing pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory advanced melanoma. Eur J Cancer. 2017 Nov;86:37–45.
  • Ribas A, Puzanov I, Dummer R, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015 Aug;16(8):908–918.
  • Schadendorf D, Dummer R, Hauschild A, et al. Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma. Eur J Cancer. 2016 Nov;67:46–54.
  • Long GV, Atkinson V, Lo S, et al. Combination nivolumab and ipilimumab or nivolumab alone in melanoma brain metastases: a multicentre randomised phase 2 study. Lancet Oncol. 2018 May;19(5):672–681.
  • Tawbi HA, Forsyth PA, Alqazi A, et al. Combined nivolumab and ipilimumab in melanoma metastatic to the brain. N Engl J Med. 2018;379(8):722–730.
  • Larkin J, Lao CD, Urba WJ, et al. Efficacy and safety of nivolumab in patients with BRAF V600 mutant and BRAF wild-type advanced melanoma: a pooled analysis of 4 clinical trials. JAMA Oncol. 2015 Jul;1(4):433–440.
  • https://www.ema.europa.eu/en/medicines/human/EPAR/opdivo#assessment-history-section. 2019.
  • Haanen JBAG, Carbonnel F, Robert C, et al. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv119–iv142.
  • Brahmer JR, Lacchetti C, Schneider BJ, et al. Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: american society of clinical oncology clinical practice guideline. J Clin Oncol. 2018 Jun 10;36(17):1714–1768.
  • Puzanov I, Diab A, Abdallah K, et al. Managing toxicities associated with immune checkpoint inhibitors: consensus recommendations from the society for immunotherapy of cancer (SITC) toxicity management working group. J Immunother Cancer. 2017 Nov 21;5(1):95.
  • Leitinger M, Varosanec MV, Pikija S, et al. Fatal necrotizing encephalopathy after treatment with nivolumab for squamous non-small cell lung cancer: case report and review of the literature. Front Immunol. 2018;9:108.
  • Baird-Gunning JJD, Weerasinghe D, Silsby M, et al. Miller fisher syndrome associated with immunotherapy for metastatic melanoma. Neurohospitalist. 2018 Oct;8(4):191–193.
  • Tanaka R, Maruyama H, Tomidokoro Y, et al. Nivolumab-induced chronic inflammatory demyelinating polyradiculoneuropathy mimicking rapid-onset Guillain-Barre syndrome: a case report. Jpn J Clin Oncol. 2016 Sept;46(9):875–878.
  • Mehta JJ, Maloney E, Srinivasan S, et al. Myasthenia gravis induced by nivolumab: a case report. Cureus. 2017 Sept 20;9(9):e1702.
  • Kimura T, Fukushima S, Miyashita A, et al. Myasthenic crisis and polymyositis induced by one dose of nivolumab. Cancer Sci. 2016 Jul;107(7):1055–1058.
  • Chen YH, Liu FC, Hsu CH, et al. Nivolumab-induced myasthenia gravis in a patient with squamous cell lung carcinoma: case report. Medicine (Baltimore). 2017 Jul;96(27):e7350.
  • Suzuki S, Ishikawa N, Konoeda F, et al. Nivolumab-related myasthenia gravis with myositis and myocarditis in Japan. Neurology. 2017 Sept 12;89(11):1127–1134.
  • Sakai K, Mochizuki H, Mochida K, et al. A case of nivolumab-induced severe mononeuropathy multiplex and rhabdomyolysis. Case Rep Med. 2017;2017:1093858.
  • Bilen MA, Subudhi SK, Gao J, et al. Acute rhabdomyolysis with severe polymyositis following ipilimumab-nivolumab treatment in a cancer patient with elevated anti-striated muscle antibody. J Immunother Cancer. 2016;4:36.
  • Chen Q, Huang DS, Zhang LW, et al. Fatal myocarditis and rhabdomyolysis induced by nivolumab during the treatment of type B3 thymoma. Clin Toxicol (Phila). 2018 Jul;56(7):667–671.
  • Rambhia PH, Honda K, Arbesman J. Nivolumab induced inflammation of seborrheic keratoses: a novel cutaneous manifestation in a metastatic melanoma patient. Melanoma Res. 2018 Oct;28(5):475–477.
  • Cho M, Nonomura Y, Kaku Y, et al. Scleroderma-like syndrome associated with nivolumab treatment in malignant melanoma. J Dermatol. 2019 Jan;46(1):e43-e44.
  • Haikal A, Borba E, Khaja T, et al. Nivolumab-induced new-onset seronegative rheumatoid arthritis in a patient with advanced metastatic melanoma: A case report and literature review. Avicenna J Med. 2018 Jan;8(1):34–36.
  • Nakamagoe K, Moriyama T, Maruyama H, et al. Polymyalgia rheumatica in a melanoma patient due to nivolumab treatment. J Cancer Res Clin Oncol. 2017 Jul;143(7):1357–1358.
  • Laroche A, Alarcon CE, Bourgeault E, et al. Erythema nodosum as the initial presentation of nivolumab-induced sarcoidosis-like reaction. J Cutan Med Surg. 2018;22(6):627-629.
  • Lopez AT, Geskin LA. Case of nivolumab-induced bullous pemphigoid: review of dermatologic toxicity associated with programmed cell death protein-1/programmed death ligand-1 inhibitors and recommendations for diagnosis and management. Oncologist. 2018 Oct;23(10):1119–1126.
  • Anastasopoulou A, Papaxoinis G, Diamantopoulos P, et al. Bullous pemphigoid-like skin lesions and overt eosinophilia in a patient with melanoma treated with nivolumab: case report and review of the literature. J Immunother. 2018 Apr;41(3):164–167.
  • Sundaresan S, Nguyen KT, Nelson KC, et al. Erythema multiforme major in a patient with metastatic melanoma treated with nivolumab. Dermatol Online J.2017 Sep 15;23(9):13030/qt2513974h.
  • Edwards C, Fearfield L. Nivolumab-induced lichenoid dermatitis occurring in a patient with metastatic melanoma successfully treated with alitretinoin. Clin Exp Dermatol. 2018 Jul;43(5):609–610.
  • Komori T, Honda T, Irie H, et al. Lichen planus in irradiated skin during nivolumab treatment. Acta Derm Venereol. 2017 Mar 10;97(3):391–392.
  • Nayar N, Briscoe K, Fernandez PP. Toxic epidermal necrolysis-like reaction with severe satellite cell necrosis associated with nivolumab in a patient with ipilimumab refractory metastatic melanoma. J Immunother. 2016 Apr;39(3):149–152.
  • Lakhmiri M, Cavelier-Balloy B, Lacoste C, et al. Nivolumab-induced alopecia areata: a reversible factor of good prognosis? JAAD Case Rep. 2018 Sept;4(8):761–765.
  • Andres-Lencina JJ, Burillo-Martinez S, Aragon-Miguel R, et al. Eosinophilic fasciitis and lichen sclerosis in a patient treated with nivolumab. Australas J Dermatol. 2018 May 24;59:e302-e304.
  • Parker MJ, Roberts ME, Lorigan PC, et al. Autoimmune fasciitis triggered by the anti-programmed cell death-1 monoclonal antibody nivolumab. BMJ Case Rep.2018 Feb 8;2018:bcr2017223249.
  • Aburahma A, Aljariri AN, Elounais F, et al. Antiphospholipid antibody induced by nivolumab. Case Rep Hematol. 2018;2018:3106852.
  • Yuki A, Takenouchi T, Takatsuka S, et al. A case of pure red cell aplasia during nivolumab therapy for cardiac metastatic melanoma. Melanoma Res. 2017 Dec;27(6):635–637.
  • Yamaguchi S, Morimoto R, Okumura T, et al. Late-onset fulminant myocarditis with immune checkpoint inhibitor nivolumab. Can J Cardiol. 2018 Jun;34(6):812.
  • Tajmir-Riahi A, Bergmann T, Schmid M, et al. Life-threatening autoimmune cardiomyopathy reproducibly induced in a patient by checkpoint inhibitor therapy. J Immunother. 2018 Jan;41(1):35–38.
  • Loricera J, Hernandez JL, Garcia-Castano A, et al. Subclinical aortitis after starting nivolumab in a patient with metastatic melanoma. A case of drug-associated aortitis? Clin Exp Rheumatol. 2018 Mar;36 Suppl 111(2):171.
  • Remond AL, Barreau E, Le HP, et al. [Bilateral uveitis associated with nivolumab therapy]. J Fr Ophthalmol. 2018 Jun;41(6):536–539.
  • Theillac C, Straub M, Breton AL, et al. Bilateral uveitis and macular edema induced by Nivolumab: a case report. BMC Ophthalmol. 2017 Dec 1;17(1):227.
  • Baughman DM, Lee CS, Snydsman BE, et al. Bilateral uveitis and keratitis following nivolumab treatment for metastatic melanoma. Med Case Rep (Wilmington). 2017;3(2).
  • Richardson DR, Ellis B, Mehmi I, et al. Bilateral uveitis associated with nivolumab therapy for metastatic melanoma: a case report. Int J Ophthalmol. 2017;10(7):1183–1186.
  • Kanno H, Ishida K, Yamada W, et al. Uveitis induced by programmed cell death protein 1 inhibitor therapy with nivolumab in metastatic melanoma patient. J Infect Chemother. 2017 Nov;23(11):774–777.
  • Matsuo T, Yamasaki O. Vogt-Koyanagi-Harada disease-like posterior uveitis in the course of nivolumab (anti-PD-1 antibody), interposed by vemurafenib (BRAF inhibitor), for metastatic cutaneous malignant melanoma. Clin Case Rep. 2017 May;5(5):694–700.
  • Abdel-Rahman O, Oweira H, Petrausch U, et al. Immune-related ocular toxicities in solid tumor patients treated with immune checkpoint inhibitors: a systematic review. Expert Rev Anticancer Ther. 2017 Apr;17(4):387–394.
  • Arai T, Harada K, Usui Y, et al. Case of acute anterior uveitis and Vogt-Koyanagi-Harada syndrome-like eruptions induced by nivolumab in a melanoma patient. J Dermatol. 2017 Aug;44(8):975–976.
  • Karlin J, Gentzler R, Golen J. Bilateral anterior uveitis associated with nivolumab therapy. Ocul Immunol Inflamm. 2018;26(2):283–285.
  • de VG, Bermas B, Choueiri TK. Autoimmune arthropathy and uveitis as complications of programmed death 1 inhibitor treatment. Arthritis Rheumatol. 2016 Feb;68(2):556–557.
  • Delanoy N, Michot JM, Comont T, et al. Haematological immune-related adverse events induced by anti-PD-1 or anti-PD-L1 immunotherapy: a descriptive observational study. Lancet Haematol. 2019 Jan;6(1):e48-e57.
  • Wang DY, Salem JE, Cohen JV, et al. Fatal toxic effects associated with immune checkpoint inhibitors: a systematic review and meta-analysis. JAMA Oncol. 2018 Sept 13;4:1721.
  • Schadendorf D, Wolchok JD, Hodi FS, et al. Efficacy and safety outcomes in patients with advanced melanoma who discontinued treatment with nivolumab and ipilimumab because of adverse events: a pooled analysis of randomized phase II and III trials. J Clin Oncol. 2017 Dec 1;35(34):3807–3814.
  • Pike E, Torkilseng EB, Saeterdal I, et al. Oslo, Norway: Knowledge Centre for the Health Services at The Norwegian Institute of Public Health (NIPH); 2015 Nov. Report from Norwegian Knowledge Centre for the Health Services (NOKC) No. 22-2015..
  • Meng Y, Hertel N, Ellis J, et al. The cost-effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England. Eur J Health Econ. 2018 Mar 9;19:1163–1172.
  • Bohensky M, Pasupathi K, Gorelik A, et al. Analysis of nivolumab compared to ipilimumab for the treatment of braf wild-type advanced melanoma in Australia. Value Health. 2015 Nov;18(7):A340.
  • Oh A, Tran DM, McDowell LC, et al. Cost-effectiveness of nivolumab-ipilimumab combination therapy compared with monotherapy for first-line treatment of metastatic melanoma in the United States. J Manag Care Spec Pharm. 2017 Jun;23(6):653–664.
  • Kohn CG, Zeichner SB, Chen Q, et al. Cost-effectiveness of immune checkpoint inhibition in brief wild-type advanced Melanoma. J Clin Oncol. 2017 Apr 10;35(11):1194–1202.
  • Quon PL, Xiao Y, Sorensen S, et al. Economic evaluation of nivolumab plus ipilimumab combination as first-line treatment for patients with advanced Melanoma in Canada. Pharmacoecon Open. 2019 Jan 8;3:321–331.
  • Uyl-de Groot CA, Lowenberg B. Sustainability and affordability of cancer drugs: a novel pricing model. Nat Rev Clin Oncol. 2018 Jul;15(7):405–406.
  • The L. Cancer drugs in China: affordability and creativity. Lancet. 2018 May 12;391(10133):1866.
  • Gyawali B, Sullivan R. Economics of cancer medicines: for whose benefit? New Bioeth. 2017 Apr;23(1):95–104.
  • Goldstein DA, Clark J, Tu Y, et al. A global comparison of the cost of patented cancer drugs in relation to global differences in wealth. Oncotarget. 2017 Sept 22;8(42):71548–71555.
  • Dranitsaris G, Zhu X, Adunlin G, et al. Cost effectiveness vs. affordability in the age of immuno-oncology cancer drugs. Expert Rev Pharmacoecon Outcomes Res. 2018 Aug;18(4):351–357.
  • Cuomo RE, Seidman RL, Mackey TK. Country and regional variations in purchase prices for essential cancer medications. BMC Cancer. 2017 Aug 24;17(1):566.
  • Chivukula MV, Tisocki K. Approaches to improving access to essential cancer medicines in the WHO South-East Asia Region. WHO South East Asia J Public Health. 2018 Sept;7(2):62–66.
  • Bentley C, Peacock S, Abelson J, et al. Addressing the affordability of cancer drugs: using deliberative public engagement to inform health policy. Health Res Policy Syst. 2019 Feb 7;17(1):17.
  • Bekelman JE, Joffe S. Three steps toward a more sustainable path for targeted cancer drugs. JAMA.2018;319:2167-2168.
  • Tartari F, Santoni M, Burattini L, et al. Economic sustainability of anti-PD-1 agents nivolumab and pembrolizumab in cancer patients: recent insights and future challenges. Cancer Treat Rev. 2016 Jul;48:20–24.
  • da Veiga CRP, da Veiga CP, Drummond-Lage AP. Concern over cost of and access to cancer treatments: a meta-narrative review of nivolumab and pembrolizumab studies. Crit Rev Oncol Hematol. 2018 Sept;129:133–145.
  • American Society of Clinical Oncology. American Society of Clinical Oncology position statement on addressing the affordability of cancer drugs. J Oncol Pract. 2018 Mar;14(3):187–192.
  • https://clinicaltrials.gov/.2019.
  • Long GV, Dummer R, Hamid O, et al. Epacadostat plus pembrolizumab versus placebo plus pembrolizumab in patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252): a phase 3, randomised, double-blind study. Lancet Oncol. 2019 Jun 17;20:1083–1097.
  • Mitchell TC, Hamid O, Smith DC, et al. Epacadostat plus pembrolizumab in patients with advanced solid tumors: phase I results from a multicenter, open-label phase I/II trial (ECHO-202/KEYNOTE-037). J Clin Oncol.2018 Nov 10;36(32):3223-3230.

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