References
- Kantarjian H, Rajkumar MD, Vincent S, et al. Why are Cancer drugs so expensive in the United States, and what are the solutions? Mayo Clin Proc. 2015 Apr;90(4):4.
- WHO. Technical report: pricing of cancer medicines and its impacts. Geneva: World Health Organization; 2018.
- Reyna VF, Nelson WL, Han PK, et al.Decision making and cancer. Am Psychol. 2015 Feb-Mar;70(2):105–118.
- European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications 19 August 2019 EMA/940451/2011 Committee for Human Medicinal Products (CHMP). [cited 2021 Apr]. Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-procedural-advice-users-centralised-procedure-similar-biological-medicinal_en.pdflast assessed on Apr, 2021
- Mustaqeem Siddiqui MD, Vincent Rajkumar S. The high cost of cancer drugs and what we can do about it Mayo Clin. Proc.October. 2012;87(10):935–943.
- Kumar H, Fojo T, Mailankody S. An appraisal of clinically meaningful outcomes guidelines for oncology clinical trials. JAMA Oncol. 2016;2(9):1238–1240.
- Ellis LM, Bernstein DS, Voest EE, et al. Schnipper American society of clinical oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J clin oncol. 2014 APRIL 20;32(12):1277–1280.
- Fojo T, Mailankody S, Lo A. Andrew Lo Unintended consequences of expensive cancer therapeutics—the pursuit of marginal indications and a me-too mentality that stifles innovation and creativity. JAMA Otolaryngol Head Neck Surg. 2014 December;140(12):1225.
- Wayant C, Margalski D, Vaughn K, et al. Evaluation of spin in oncology clinical trials. Crit Rev Oncol Hematol. 2019 December;144:102821.
- Unger JM, Barlow WE, Ramsey SD, et al. The scientific impact of positive and negative phase iii cancer clinical trials . JAMA Oncol. 2016 Jul 1;2(7):875–881.
- Carter TC, He MM. Review article challenges of identifying clinically actionable genetic variants for precision medicine Hindawi publishing corporation. J Healthc Eng. 2016;14. Article ID 3617572.
- Davis C,Naci H, Gurpinar E, et al. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European medicines agency: retrospective cohort study of drug approvals 2009–13. BMJ. 2017;359:j4530.
- Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154–2164.
- Grössmann N, Wild C. Between January 2009 and April 2016, 134 novel anticancer therapies were approved: what is the level of knowledge concerning the clinical benefit at the time of approval? ESMO Open. 2017;1(6):e000125.
- Gyawali B, Tessema FA, Jung EH, et al. Assessing the justification, funding, success, and survival outcomes of randomized noninferiority trials of cancer drugs: a systematic review and pooled analysis. JAMA Network Open. 2019 Aug 2;2(8):e199570. PMID: 31469391; PMCID: PMC6724156.
- Saad ED, Buyse M. Non-inferiority trials in breast and non-small cell lung cancer: choice of non-inferiority margins and other statistical aspects. Acta Oncologica. 2012;51(7):890–896.
- Hoekman J, Klamer TT, Mantel-Teeuwisse AK, et al. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU. Br J Clin Pharmacol. 2016;82(1):213–226. 10.1111/bcp.12940 26992001.
- Wieseler B, McGauran N, Kaiser T. New drugs: where did we go wrong and what can we do better? BMJ. 2019;366:l4340.
- Hirsch B, Califf R, Cheng S, et al. Characteristics of oncology clinical trials: insights from a systematic analysis of Clinicaltrials.gov. JAMA Intern Med. 2013;173(11):972–979.
- Salas-Vega S, Iliopoulos O, Mossialos E. Assessment of overall survival, quality of life, and safety benefits associated with new cancer medicines. JAMA Oncol. 2017;3(3):382–390.
- Apolone G, Joppi R, Bertele V, et al. Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to find a balance between different pressures. Br J Cancer. 2005;93(5):504–509. www.bjcancer.com.
- Goldman DP, Jena AB, Lakdawalla DN, et al. The value of specialty oncology drugs. Health Serv Res. 2010 Feb;45(1):115–132.
- Goldman DP, Joyce GF, Lawless G, et al. Benefit Design and Specialty Drug Use. Health Affairs. 2006;25(5):1319.
- Keyhani S, Diener-West M, Powe N. Are development times for pharmaceuticals increasing or decreasing? Health Affairs. 2006;25(2):461–468.
- Donald W, Light, Warburton R. Demythologizing the high costs of pharmaceutical research. BioSocieties. 2011;6(1):34–50.
- Prasad V, De Jesús K, Mailankody S. The high price of anticancer drugs: origins, implications, barriers, solutions NATURE REVIEWS. Clin Oncol. 2017 JUNE;14:381.
- Experts in Chronic Myeloid Leukemia. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood. 2013;121(22):4439–4442.
- Kantarjian H, Patel Y. High cancer drug prices 4 years later-Progress and prospects. Cancer. 2017 April 15;123(8):1292.
- Howard DH, Bach PB, Berndt ER, et al. Conti pricing in the market for anticancer drugs. J Econ Perspect. 2015 Winter;29(1):139–162.
- Tefferi A, Hagop Kantarjian S, Vincent Rajkumar LH, et al. In support of a patient-driven initiative and petition to lower the high price of cancer drugs. Mayo Clin Proc. 2015 August;90(8):996–1000.
- Howard DH, Bach PB, Berndt ER. Pricing in the market for anticancer drugs. J Econ Perspect. 2015;29(1):139–162.
- Prasad V, Wang R, Salma MS. H Afifi, Sham Mailankody, the rising price of cancer drugs—a new old problem?. JAMA Oncology. 2017;3(Number):2. February.
- Ronak Saluja VS, Arciero SC, McDonald E, et al. Examining Trends in Cost and Clinical Benefit of Novel Anticancer Drugs Over Time. J Oncol Pract. 2018 May;14(5):e280-294.
- Hillner BE, Smith TJ. Efficacy does not necessarily translate to cost effectiveness. A case study in the challenges associated with 21st century cancer drug pricing. J Clin Oncol. 2009;27(13):2111–2113.
- Mailankody S, Prasad V. Five years of cancer drug approvals: innovation, efficacy, and costs. JAMA Oncol. 2015;1(4):539–540.
- Vokinger KN, Hwang TJ, Grischott T, et al. Prices and clinical benefit of cancer drugs in the USA and Europe: a cost–benefit analysis. Lancet Oncol. 2020 May;21(5):664–670. London.
- Barnes TA, Eitan Amir AJ, Templeton AJ. Templeton, Susana Gomez-Garcia, Beatriz Navarro, Bostjan Seruga, Alberto Ocana Efficacy, safety, tolerability and price of newly approved drugs in solid Tumors. Cancer Treat Rev. 2017;56:1–7.
- Satoh E, Sasaki Y, Ohkuma R, et al. Lack of correlation between the costs of anticancer drugs and clinical benefits in Japan. Cancer Sci. 2018 Dec;109(12):3896–3901. Epub 2018 Nov 27. PMID: 30315613; PMCID: PMC6272097.
- Darrow Jerry JJ, Avorn J, Kesselheim AS. New FDA breakthrough-drug category — implications for patients. N Engl J Med . 2014 March 27;370(13):1252–1258.
- Carpenter D, Ph. D, Zucker EJ, et al. Drug-review deadlines and safety problems. N Engl J Med . 2008 March 27;358(13):1354–1361.
- Light DW, Lexchin J. Joel Lexchin Why do cancer drugs get such an easy ride? Rushed approvals result in a poor deal for both patients and cancer research. BMJ. 2015;350(apr23 1):h2068.
- Kordecka A, Walkiewicz-Zarek E, Lapa J, et al. Selection of endpoints in clinical trials trends in European marketing authorization practice in oncological indications. Value Health. 2019;22(8):884–889.
- Buyse M, Burzykowski T, Carroll K, et al. Progression-free survival is a surrogate for survival in advanced colorectal cancer. J clin oncol. 2007 November 20;25(33):5218–5224.
- Andrew W. Pharmaceuticals: value over volume. Financial Times. 2015 Sep;24.
- Gronde Tvd, Uyl-de Groot CA, Pieters T. Addressing the challenge of high-priced prescription drugs in the era of precision medicine: a systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks. PLoS ONE. 2017;12(8):e0182613.
- Οδυσσέας Ελύτης, Εκ του πλησίον Εκδόσεις Ικαρος, Αθήνα,1999
- Petrou P. Value-based pricing and the end of pharmaceutical pricing as we know it? A case study on sorafenib and axitinib. Pharmacol Res. 2017;124:160–163.
- Petrou P. Is it a Chimera? A systematic review of the economic evaluations of CAR-T cell therapy. Expert Rev Pharmacoecon Outcomes Res. 2019;19(5):529–536.
- Risha Gidwani-Marszowski AL, Nevedal DW, Blayney MP, et al. Oncologists’ views on using value to guide cancer treatment decisions. Value Health. 2018;21(8):931–937.
- Tefferi A, Hagop Kantarjian S, Vincent Rajkumar LH, et al. Adamson in support of a patient-driven initiative and petition to lower the high price of cancer drugs mayo. Clin Proc. 2015 August;90(8):996–1000.
- Shih Y-CT, Chien C-R. A review of cost communication in oncology: patient attitude, provider acceptance, and outcome assessment. Cancer. 2017 May 15;123(6):928–939.
- Mehlis K, Witte J, Surmann B, et al. The patient-level effect of the cost of Cancer care – financial burden in German Cancer patients. BMC Cancer. 2020;20(529). DOI:10.1186/s12885-020-07028-4
- Petrou P. The quest for the in medio stat virtus price in the oncology sector. J Med Econ. 2018;21(10):1023–1025.