Economic challenges of oncological diseases’ pharmacotherapy
Abstract
Oncological diseases rank high in the structure of population morbidity and mortality. They entail considerable direct and indirect economic costs. In the past decades, the cost of oncotherapy has increased significantly, which is largely conditioned by high prices of antitumor drugs, which on average increased by ten times in the past ten years. At the same time, many innovative medications have only minor advantages over cheaper old medications because they are registered based on the data on the achievement of the surrogate endpoint – extension of progression-free survival. The high cost of oncotherapy is associated with financial toxicity that affects negatively the patients’ quality of life, their adherence to treatment and consequently survival. To reduce the cost of oncotherapy, it is necessary to conduct pharma-economic analysis, the results of which can serve as the basis to negotiate price-cutting with the manufacturers, as well as to use high-quality generics and biosimilars as effective and safe as their originals, and to monitor effectiveness and safety of all antitumor drugs within the pharmacovigilance framework.
About the Authors
E. A. Ushkalova
Peoples’ Friendship University of Russia
Russian Federation
Russian Federation
Elena A. Ushkalova – MD, Dr Sci Med, Professor, Department of General and Clinical Pharmacology
Researcher ID: A-4765-2017. Scopus Author ID: 56633092200. RISIN SPIN-code: 7722-5802
S. K. Zyryanov
Peoples’ Friendship University of Russia; City Clinical Hospital No. 24 of the Moscow Department of Health
Russian Federation
Russian Federation
Sergey K. Zyryanov – MD, Dr Sci Med, Professor & Head, Department of General and Clinical Pharmacology; Deputy Chief Medical Officer, Clinical Hospital No. 24
Researcher ID: D-8826-2012. RISIN SPIN-code: 2725-9981
I. A. Gopienko
Peoples’ Friendship University of Russia
Russian Federation
Russian Federation
Irina A. Gopienko – Postgraduate student, Department of General and Clinical Pharmacology
RISIN SPIN-code: 8192-4441
References
1. GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990–2013: A systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015; 385: 117– 171. DOI: https://doi.org/10.1016/S0140-6736(14)61682-2.
2. Злокачественные новообразования в России в 2018 году (заболеваемость и смертность). Под ред. А.Д. Каприна, В.В. Старинского, Г.В. Петровой М. 2019; 250 с. [Malignant neoplasms in Russia in 2018 (morbidity and mortality). Ed. A.D. Kaprin, V.V. Starinsky, G.V. Petrova. Moscow. 2019; 250 p. (in Russ)].
3. Torre L.A., Siegel R.L., Ward E.M., Jemal A. Global cancer incidence and mortality rates and trends – an update. Cancer Epidemiol Biomarkers Prev. 2016; 25: 16–27. DOI: https://doi.org/10.1158/10559965.EPI-15-0578.
4. Cancer – World Health Organization [Electronic resource] URL: https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed: 20.01.2020.
5. Farmer P., et al. Expansion of cancer care and control in countries of low and middle income: a call to action. Lancet. 2010; 376: 1186–93. DOI: https://doi.org/10.1016/S0140-6736(10)61152-X.
6. Torre L.A., et al. Global cancer statistics, 2012. CA Cancer J Clin. 2015; 65 (2): 87-108. DOI: https://doi.org/10.3322/caac.21262.
7. Bray F., et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018; 68 (6): 394-424. DOI: https://doi. org/10.3322/caac.21492.
8. Soerjomataram I., et al. Global burden of cancer in 2008: A systematic analysis of disability-adjusted life-years in 12 world regions. Lancet. 2012; 380: 1840–1850. DOI: https://doi.org/10.1016/S01406736(12)60919-2.
9. Prager G.W., et al. Global cancer control: responding to the growing burden, rising costs and inequalities in access. ESMO Open. 2018; 3 (2): e000285. DOI: https://doi.org/10.1136/esmoopen-2017-000285.
10. Transforming our world: the 2030 Agenda for Sustainable Development [Electronic resource] URL: https://sustainabledevelopment. un.org/post2015/transformingourworld. Accessed: 20.01.2020.
11. Greenberg D., et al. When is Cancer Care Cost-Effective? A Systematic Overview of Cost–Utility Analyses in Oncology. J Natl Cancer Inst. 2010; 102 (2): 82–8. DOI: https://doi.org/10.1093/jnci/djp472.
12. Global Oncology Trends 2018 [Electronic resource] URL: https:// www.iqvia.com/insights/the-iqvia-institute/reports/global-oncologytrends-2018. Accessed: 20.01.2020.
13. Understanding the Global Cancer Burden [Electronic resource] URL: https://old.cancer.org/acs/groups/content/@internationalaffairs/ documents/document/acspc-026203.pdf. Accessed: 20.01.2020.
14. Elkin E.B., Bach P.B. Cancer’s next frontier: addressing high and increasing costs. JAMA. 2010; 303 (11): 1086–1087. DOI: https://doi. org/10.1001/jama.2010.283.
15. Barchuk A., et al. Productivity losses associated with premature mortality due to cancer in Russia: A population-wide study covering 2001-2030. Scand J Public Health. 2019 Jul; 47 (5): 482–491. DOI: https://doi.org/10.1177/1403494819845565.
16. Ignatyeva V.I., Derkach E.V., Avxentyeva M.V., Omelyanovsky V.V. The Cost of Melanoma and Kidney, Prostate, and Ovarian Cancers in Russia. Value Health Reg Issues. 2014; 4: 58–65. DOI: https://doi.org/10.1016/j.vhri.2014.07.002.
17. Runyan A., Banks J., Bruni D.S. Current and Future Oncology Management in the United States. J Manag Care Spec Pharm. 2019; 25 (2): 272–281. DOI: https://doi.org/10.18553/jmcp.2019.25.2.272.
18. Kelly R.J., Smith T.J. Delivering maximum clinical benefit at an affordable price: Engaging stakeholders in cancer care. Lancet Oncol. 2014, 15, e112–e118. DOI: https://doi.org/10.1016/S14702045(13)70578-3.
19. Prasad V., De Jesús K., Mailankody S. The high price of anticancer drugs: origins, implications, barriers, solutions. Nat Rev Clin Oncol. 2017; 14 (6): 381–390. DOI: https://doi.org/10.1038/nrclinonc.2017.31.
20. de Souza J.A., et al. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017; 123 (3): 476–484. DOI: https://doi.org/10.1002/cncr.30369.
21. Mariotto A.B., et al. Projections of the cost of cancer care in the United States: 2010–2020. J Natl Cancer Inst. 2011; 103: 117–128. J Natl Cancer Inst. 2011 Jan 19; 103 (2): 117–28. DOI: https://doi. org/10.1093/jnci/djq495.
22. Prasad V., Mailankody S. How should we assess the value of innovative drugs in oncology? Lessons from cost-effectiveness analyses. Blood. 2015; 126: 1860–1. DOI: https://doi.org/10.1182/ blood-2015-07-657478.
23. Cheung W.Y., et al. The economic impact of the transition from branded to generic oncology drugs. Curr Oncol. 2019; 26 (2): 89–93. DOI: https://doi.org/10.3747/co.26.4395.
24. Kantarjian H.M., Fojo T., Mathisen M., Zwelling L.A. Cancer drugs in the United States: Justum Pretium – the just price. J Clin Oncol. 2013; 31 (28): 3600–4. DOI: https://doi.org/10.1200/ JCO.2013.49.1845.
25. Fojo T., Mailankody S., Lo A. Unintended consequences of expensive cancer therapeutics – the pursuit of marginal indications and a me-too mentality that stifles innovation and creativity: the John Conley Lecture. JAMA Otolaryngol Head Neck Surg. 2014; 140: 1225– 1236. DOI: https://doi.org/10.1001/jamaoto.2014.1570.
26. Kumar H., Fojo T., Mailankody S. An appraisal of clinically meaningful outcomes guidelines for oncology clinical trials. JAMA Oncol. 2016; 2 (9): 1238–40. DOI: https://doi.org/10.1001/ jamaoncol.2016.0931.
27. Del Paggio J.C., et al. Do contemporary randomized controlled trials meet ESMO thresholds for meaningful clinical benefit? Ann Oncol. 2017; 28 (1): 157–162. DOI: https://doi.org/10.1093/annonc/ mdw538.
28. Mitchell A.P., et al. Clinical trial participants with metastatic renal cell carcinoma differ from patients treated in real-world practice. J Oncol Pract. 2015; 11 (6): 491–7. DOI: https://doi.org/10.1200/ JOP.2015.004929.
29. Sanoff H.K., et al. Sorafenib effectiveness in advanced hepatocellular carcinoma. Oncologist. 2016; 21 (9): 1113–20. DOI: https://doi.org/10.1634/theoncologist.2015-0478.
30. Prasad V., Massey P.R., Fojo T. Oral anticancer drugs: how limited dosing options and dose reductions may affect outcomes in comparative trials and efficacy in patients. J Clin Oncol. 2014; 32 (15): 1620–9. DOI: https://doi.org/10.1200/JCO.2013.53.0204.
31. Mailankody S., Prasad V. Overall Survival in Cancer Drug Trials as a New Surrogate End Point for Overall Survival in the Real World. JAMA Oncol. JAMA Oncol. 2017; 3 (7): 889–890. DOI: https://doi. org/10.1001/jamaoncol.2016.5296.
32. Aggarwal A., et al. Do patient access schemes for high-cost cancer drugs deliver value to society?-lessons from the NHS Cancer Drugs Fund. Ann Oncol. 2017 Aug 1; 28 (8): 1738–1750. DOI: https:// doi.org/10.1093/annonc/mdx110.
33. Trotta F., et al. Anticancer drug prices and clinical outcomes: a cross-sectional study in Italy. BMJ Open. 2019; 9 (12): e033728. DOI: https://doi.org/10.1136/bmjopen-2019-033728.
34. Jiang D.M., et al. Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations. Cancer Med. 2019; 8 (4): 1584–1593. DOI: https://doi.org/10.1002/cam4.2058.
35. Schrag D. The price tag on progress – chemotherapy for colorectal cancer. N Engl J Med. 2004; 351: 317–319. DOI: https://doi. org/10.1056/NEJMp048143.
36. Goldstein D.A. The ethical and practical challenges of valuebased cancer care at the patient’s bedside. JAMA Oncol. 2016; 2 (7): 860–1. DOI: https://doi.org/10.1001/jamaoncol.2016.0535.
37. Savage P., Mahmoud S., Patel Y., Kantarjian H. Cancer drugs: an international comparison of postlicensing price inflation. J Oncol Pract. 2017; 13: e538–e542. DOI: https://doi.org/10.1200/JOP.2016.014431.
38. Bower H., Björkholm M., Dickman P.W., et al. Life expectancy of patients with chronic myeloid leukemia approaches the life expectancy of the general population. J Clin Oncol. 2016; 34 (24): 2851–7. DOI: https://doi.org/10.1200/JCO.2015.66.2866.
39. Bach P.B. Limits on Medicare’s ability to control rising spending on cancer drugs. N Engl J Med. 2009; 360 (6): 626–33. DOI: https:// doi.org/10.1056/NEJMhpr0807774.
40. Nardi E.A., et al. Value, Access, and Cost of Cancer Care Delivery at Academic Cancer Centers. J Natl Compr Canc Netw. 2016; 14 (7): 837–47. DOI: https://doi.org/10.6004/jnccn.2016.0088.
41. Knaul F., Frenk J., Shulman L. Closing the Cancer Divide: A Blueprint to Expand Access in Low and Middle Income Countries. In Social Science Research Network; Harvard Global Equity Initiative: Boston, MA, USA, 2011.
42. Goss P.E., et al. Challenges to effective cancer control in China, India, and Russia. Lancet Oncol. 2014; 15 (5): 489–538. DOI: https:// doi.org/10.1016/S1470-2045(14)70029-4.
43. Zafar Y., et al. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient’s experience. Oncologist. 2013; 18 (4): 381–90. DOI: https:// doi.org/10.1634/theoncologist.2012-0279.
44. Mahon F.X., et al. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010; 11 (11): 1029-35. DOI: https://doi.org/10.1016/S1470-2045(10)70233-3.
45. Carrera P.M., Kantarjian H.M., Blinder V.S. The Financial Burden and Distress of Patients with Cancer: Understanding and Stepping-Up Action on the Financial Toxicity of Cancer Treatment. CA Cancer J Clin. 2018; 68 (2): 153-165. DOI: https://doi.org/10.3322/caac.21443.
46. Spencer J.C., et al. Oncology navigators’ perceptions of cancerrelated financial burden and financial assistance resources. Support Care Cancer. 2018; 26 (4): 1315-1321. DOI: https://doi.org/10.1007/ s00520-017-3958-3.
47. Zafar S.Y., et al. Population-based assessment of cancer survivors’ financial burden and quality of life: a prospective cohort study. J Oncol Pract. 2015; 11: 145–150. DOI: https://doi.org/10.1200/ JOP.2014.001542.
48. Lathan C.S., et al. Association of financial strain with symptom burden and quality of life for patients with lung or colorectal cancer. J Clin Oncol. 2016; 34 (15): 1732–40. DOI: https://doi.org/10.1200/ JCO.2015.63.2232.
49. Kale H.P., Carroll N.V. Self-reported financial burden of cancer care and its effect on physical and mental health-related quality of life among US cancer survivors. Cancer. 2016; 122 (8): 283–9. DOI: https://doi.org/10.1002/cncr.29808.
50. Ramsey S.D., et al. Financial insolvency as a risk factor for early mortality among patients with cancer. J Clin Oncol. 2016; 34 (9): 980– 6. DOI: https://doi.org/10.1200/JCO.2015.64.6620.
51. Bhoo-Pathy N., et al. Financial Toxicity After Cancer in a Setting With Universal Health Coverage: A Call for Urgent Action. J Oncol Pract. 2019; 15 (6): e537–e546. DOI: https://doi.org/10.1200/ JOP.18.00619.
52. Renner L., Nkansah F.A., Dodoo A.N. The role of generic medicines and biosimilars in oncology in low-income countries. Ann Oncol. 2013; 24 Suppl 5: v29–32. DOI: https://doi.org/10.1093/annonc/ mdt326.
53. Witte J., et al. Methods for measuring financial toxicity after cancer diagnosis and treatment: a systematic review and its implications. Ann Oncol. 2019; 30 (7): 1061–1070. DOI: https://doi. org/10.1093/annonc/mdz140.
54. Cherny N.I., et al. Comparative Assessment of Clinical Benefit Using the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO Value Framework Net Health Benefit Score. J Clin Oncol. 2019; 37 (4): 336–349. DOI: https://doi. org/10.1200/JCO.18.00729.
55. Bentley T.G.K., et al. Measuring the Value of New Drugs: Validity and Reliability of 4 Value Assessment Frameworks in the Oncology Setting. J Manag Care Spec Pharm. 2017; 23 (6-a Suppl): 34–48. DOI: https://doi.org/10.18553/jmcp.2017.23.6-a.s34.
56. Shah R.R., Stonier P.D. Repurposing old drugs in oncology: Opportunities with clinical and regulatory challenges ahead. Pharm Ther. 2019; 44 (1): 6–22. DOI: https://doi.org/10.1111/jcpt.12759.
57. Conti R.M., Padula W.V., Larson R.A. Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the USA and the EU. Ann Hematol. 2015; 94 Suppl 2: S249–57. DOI: https://doi.org/10.1007/s00277-015-2319-x.
58. Godman B., et al. Pricing of oral generic cancer medicines in 25 European countries; findings and implications. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019; 8 (2): 49–70. DOI: https://doi.org/10.5639/gabij.2019.0802.007.
59. Choy E., Jacobs I.A. Biosimilar safety considerations in clinical practice. Semin Oncol. 2014; 41 Suppl 1: S3–14. DOI: https://doi. org/10.1053/j.seminoncol.2013.12.001.
60. Kabir E.R., Moreino S.S., Sharif Siam M.K. The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy. Biomolecules. 2019; 9 (9). pii: E410. DOI: https://doi.org/10.3390/biom9090410.
61. Yang Y.T., Nagai S., Chen B.K., et al. Generic oncology drugs: are they all safe? Lancet Oncol. 2016; 17 (11): e493–e501. DOI: https:// doi.org/10.1016/S1470-2045(16)30384-9.
62. American Society of Clinical Oncology. American Society of Clinical Oncology Position Statement on Addressing the Affordability of Cancer Drugs. J Oncol Pract. 2018; 14 (3): 187–192. DOI: https:// doi.org/10.1200/JOP.2017.027359.
63. European Medicines Agency. Products for which the marketing authorisations are recommended for suspension by the CHMP on 22 January 2015.
For citation:
Ushkalova E.A., Zyryanov S.K., Gopienko I.A. Economic challenges of oncological diseases’ pharmacotherapy. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2020;13(1):64-70. (In Russ.) https://doi.org/10.17749/2070-4909.2020.13.1.64-70
Views: 476
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Email this article 