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Review article: Biomedical intelligence

Vol. 148 No. 3334 (2018)

A buyers’ club to improve access to hepatitis C treatment for vulnerable populations

  • Nathalie Vernaz
  • Alexandra Calmy
  • Samia Hurst
  • Yves Jackson
  • Francesco Negro
  • Arnaud Perrier
  • Hans Wolff
DOI
https://doi.org/10.4414/smw.2018.14649
Cite this as:
Swiss Med Wkly. 2018;148:w14649
Published
22.08.2018

Summary

Hepatitis C is a potentially fatal viral infection that mainly affects vulnerable patient groups. Given the high efficacy of the new direct-acting antivirals (DAAs), the World Health Organization (WHO) aims to eliminate viral hepatitis as a global health threat by 2030. However, due to the high cost of DAAs, this recommendation has put significant pressure on the budgets of countries with mandatory health insurance, such as Switzerland. There are particular challenges related to populations with low socioeconomic status or without residence permits who might not be covered by health insurance, or who forgo health care for economic reasons. This article discusses some of the key issues on this topic, such as reaching the populations most at risk from the hepatitis C virus (HCV) infection, and improving access to care and treatment for underserved, uninsured populations. We suggest a personal importation scheme for unapproved generics of DAA medications, and the use of a buyers’ club as a strategy for improving universal access to hepatitis C medicines among vulnerable populations such as uninsured patients, in order to achieve the WHO goals with minimal disruption of the conventional, patent-based business model.

References

  1. Blach S, Zeuzem S, Manns M, Altraif I, Duberg A-S, Muljono DH, et al.; Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017;2(3):161–76. doi:.https://doi.org/10.1016/S2468-1253(16)30181-9
  2. Zahnd C, Brezzi M, Bertisch B, Giudici F, Keiser O. Analyse de Situation des Hépatites B et C en Suisse: Rapport intégral (sur mandat de l’Office fédéral de la santé publique (OFSP)). Bern: Institut für Sozial und Präventivmedizin, Universität Bern; 2017. Available at: www.bag.admin.ch/situationsanalyse-hepatitis. (Accessed May 2018).
  3. Favrod-Coune T, Baroudi M, Casillas A, Rieder JP, Gétaz L, Barro J, et al. Opioid substitution treatment in pretrial prison detention: a case study from Geneva, Switzerland. Swiss Med Wkly. 2013;143:w13898.
  4. Degenhardt L, Charlson F, Stanaway J, Larney S, Alexander LT, Hickman M, et al. Estimating the burden of disease attributable to injecting drug use as a risk factor for HIV, hepatitis C, and hepatitis B: findings from the Global Burden of Disease Study 2013. Lancet Infect Dis. 2016;16(12):1385–98. doi:.https://doi.org/10.1016/S1473-3099(16)30325-5
  5. Fretz R, Negro F, Bruggmann P, Lavanchy D, De Gottardi A, Pache I, et al. Hepatitis B and C in Switzerland - healthcare provider initiated testing for chronic hepatitis B and C infection. Swiss Med Wkly. 2013;143:w13793.
  6. Negro F, Maistat L. Access to hepatitis C treatment for patients in drug substitution programmes: the fight is far from over. Swiss Med Wkly. 2017;147:w14570.
  7. Bregenzer A, Conen A, Knuchel J, Friedl A, Eigenmann F, Näf M, et al. Management of hepatitis C in decentralised versus centralised drug substitution programmes and minimally invasive point-of-care tests to close gaps in the HCV cascade. Swiss Med Wkly. 2017;147:w14544.
  8. Wolff H, Sebo P, Haller DM, Eytan A, Niveau G, Bertrand D, et al. Health problems among detainees in Switzerland: a study using the ICPC-2 classification. BMC Public Health. 2011;11(1):245. doi:.https://doi.org/10.1186/1471-2458-11-245
  9. Kamarulzaman A, Reid SE, Schwitters A, Wiessing L, El-Bassel N, Dolan K, et al. Prevention of transmission of HIV, hepatitis B virus, hepatitis C virus, and tuberculosis in prisoners. Lancet. 2016;388(10049):1115–26. doi:.https://doi.org/10.1016/S0140-6736(16)30769-3
  10. WHO. Combating Hepatits B and C by 2030. Available at: http://appswhoint/iris/bitstream/10665/206453/1/WHO_HIV_201604_engpdf. (Accessed December 12 2017). 2016.
  11. Vernaz N, Girardin F, Goossens N, Brügger U, Riguzzi M, Perrier A, et al. Drug Pricing Evolution in Hepatitis C. PLoS One. 2016;11(6):e0157098. doi:.https://doi.org/10.1371/journal.pone.0157098
  12. Le Conseil fédéral suisse/Der Schweizerische Bundesrat. Ordonnance sur la lutte contre les maladies transmissibles de l'homme (Ordonnance sur les épidémies, OEp) / Verordnung über die Bekämpfung übertragbarer Krankheiten des Menschen (Epidemienverordnung, EpV). 2016. Available at: https://www.admin.ch/opc/fr/classified-compilation/20133212/index.html
  13. Wolff H, Gaspoz JM, Guessous I. Health care renunciation for economic reasons in Switzerland. Swiss Med Wkly. 2011;141:w13165.
  14. Guessous I, Gaspoz JM, Theler JM, Wolff H. High prevalence of forgoing healthcare for economic reasons in Switzerland: a population-based study in a region with universal health insurance coverage. Prev Med. 2012;55(5):521–7. doi:.https://doi.org/10.1016/j.ypmed.2012.08.005
  15. Yehia BR, Schranz AJ, Umscheid CA, Lo Re V, 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014;9(7):e101554. doi:.https://doi.org/10.1371/journal.pone.0101554
  16. Dhiman RK. Future of therapy for Hepatitis C in India: A Matter of Accessibility and Affordability? J Clin Exp Hepatol. 2014;4(2):85–6. doi:.https://doi.org/10.1016/j.jceh.2014.06.011
  17. Biller-Andorno N, Zeltner T. Individual Responsibility and Community Solidarity--The Swiss Health Care System. N Engl J Med. 2015;373(23):2193–7. doi:.https://doi.org/10.1056/NEJMp1508256
  18. Morlok M, Oswald A, Meier H, Efionayi-Mäder D, Ruedin D, Bader D, et al. Les sans-papiers en Suisse en 2015. B.S.S. Volkswirtschaftliche Beratung, Université de Genève. Available at: https://www.sem.admin.ch/sem/fr/home/aktuell/news/2016/2016-04-25.htmlhttps://www.sem.admin.ch/sem/fr/home/aktuell/news/2016/2016-04-25.html. (Accessed May 2018).
  19. Federal Statistical Office. Imprisonment, Prison population on reference day. Available at: https://www.bfs.admin.ch/bfs/en/home/statistics/crime-criminal-justice/execution-penal-sentences-justice/penal-institutions.assetdetail.4262229.html. (Accessed May 2018).
  20. Schneider EC, Squires D. From Last to First - Could the U.S. Health Care System Become the Best in the World? N Engl J Med. 2017;377(10):901–4. doi:.https://doi.org/10.1056/NEJMp1708704
  21. Country note: how does health spending in Switzerland compare? OCDE 7 July 2015. Available at: https://www.oecd.org/switzerland/Country-Note-SWITZERLAND-OECD-Health-Statistics-2015.pdf. (Accessed September 2017)
  22. Wolff HCA, Rieder JP, Gétaz L. Health care in custody: ethical fundamentals. Bioeth Forum. 2012;5(4):145–51.
  23. Council of Europe. Recommendation No R (98) of the Committee of Ministers to member states concerning the ethical and organisational aspects of health care in prison. 8 April 1998. Available at: https://rm.coe.int/09000016804fb13c. (Accessed December 2017)
  24. OECD (2017), Health spending (indicator). doi:https://doi.org/10.1787/8643de7e-en. (Accessed August 2017). Available at: https://data.oecd.org/healthres/health-spending.htm
  25. Danta M, Ghinea N. The complex legal and ethical issues related to generic medications. Viral hepatitis: a case study. J Virus Erad. 2017;3(2):77–81.
  26. Le Conseil fédéral suisse/Der Schweizerische Bundesrat. Ordonnance sur les les autorisations dans le domaine des médicaments (OAMéd) / Verordnung über die Bewilligungen im Arzneimittelbereich (Arzneimittel-Bewilligungsverordnung, AMBV). Available at: https://www.admin.ch/opc/fr/classified-compilation/20011780/index.html.
  27. Jensen DM, Sebhatu P, Reau NS. Generic medications for hepatitis C. Liver Int. 2016;36(7):925–8. doi:.https://doi.org/10.1111/liv.13120
  28. Freeman JA, Hill A. The use of generic medications for hepatitis C. Liver Int. 2016;36(7):929–32. doi:.https://doi.org/10.1111/liv.13157
  29. Ghinea N, Lipworth W, Day R, Hill A, Dore GJ, Danta M. Importation of generic hepatitis C therapies: bridging the gap between price and access in high-income countries. Lancet. 2017;389(10075):1268–72. doi:.https://doi.org/10.1016/S0140-6736(16)32051-7
  30. Hill A, Jeffreys ASG, et al. HIV Drug Therapy. Glasgow, October 23-26, 2016. AbstractP256. High sustained virological response rates using imported generic direct-acting antiviral treatment for hepatitis C, imported into Australia, UK, Europe and North America.
  31. Gotham D BM, Fortunak J, Pozniak A, Hill A. Abstract A-792-0516-01639. AIDS2016 Durban. 2016.
  32. Uchiyama N, Kamakura H, Masada S, Tsujimoto T, Hosoe J, Tokumoto H, et al. Chemical analysis of counterfeit hepatitis C drug found in Japan. Yakugaku Zasshi. 2017;137(10):1265–76. doi:.https://doi.org/10.1248/yakushi.17-00136
  33. Importations illégales de médicaments 2016: risque élevé concernant les médicaments soumis à ordonnance. Swissmedic Communiqué de presse 07.03.2017.
  34. European Association for Study of Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2014;60(2):392–420. doi:.https://doi.org/10.1016/j.jhep.2013.11.003
  35. Danis M, Sommers R, Logan J, Weidmer B, Chen S, Goold S, et al. Exploring public attitudes towards approaches to discussing costs in the clinical encounter. J Gen Intern Med. 2014;29(1):223–9. doi:.https://doi.org/10.1007/s11606-013-2543-9
  36. Shah HA, Abu-Amara M. Education provides significant benefits to patients with hepatitis B virus or hepatitis C virus infection: a systematic review. Clin Gastroenterol Hepatol. 2013;11(8):922–33. doi:.https://doi.org/10.1016/j.cgh.2013.04.024
  37. Mackey TK, Nayyar G. A review of existing and emerging digital technologies to combat the global trade in fake medicines. Expert Opin Drug Saf. 2017;16(5):587–602. doi:.https://doi.org/10.1080/14740338.2017.1313227
  38. Le Conseil fédéral suisse / Der Schweizerische Bundesrat. Loi fédérale sur les médicaments et les dispositifs médicaux / Bundesgesetz über Arzneimittel und Medizinprodukte. Article 14, paragraph 2LPTH. Available at https://www.admin.ch/opc/fr/classified-compilation/20002716/index.html
  39. WHO prequalified list. Available at: https://extranet.who.int/prequal/content/prequalifiedlists/. (Accessed February 2018).
  40. Zaman B, Siddique F, Hassan W. RP-HPLC Method for Simultaneous Determination of Sofosbuvir and Ledipasvir in Tablet Dosage Form and Its Application to In Vitro Dissolution Studies. Chromatographia. 2016;79(23-24):1605–13. doi:.https://doi.org/10.1007/s10337-016-3179-9
  41. Gupta E, Bajpai M, Choudhary A. Hepatitis C virus: Screening, diagnosis, and interpretation of laboratory assays. Asian J Transfus Sci. 2014;8(1):19–25. doi:.https://doi.org/10.4103/0973-6247.126683
  42. van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F, et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA. 2012;308(24):2584–93. doi:.https://doi.org/10.1001/jama.2012.144878
  43. Swiss Healthcare and Pharmaceutical Market Interpharma. 2017. Available at https://www.interpharma.ch/sites/default/files/swiss_healthcare_and_pharmaceutical_market_2017.pdf
  44. Chemical and pharmaceutical industry. Available at: https://www.eda.admin.ch/aboutswitzerland/en/home/wirtschaft/taetigkeitsgebiete/chemie-und-pharma.html. (Accessed December 2017).
  45. WIPO. The Patent landscape report on ritonavir. Available at: http://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf. (Accessed October 2011).
  46. WIPO. Frequently Asked Questions: Available at: http://www.wipo.int/pct/en/faqs/index.html (Accessed December 2017)
  47. Munos B. Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Discov. 2009;8(12):959–68. doi:.https://doi.org/10.1038/nrd2961
  48. Targum SD, Milbauer AJ. The process of getting new drugs to market. Psychiatry (Edgmont). 2008;5(8):57–60.
  49. Mailankody S, Prasad V. Five Years of Cancer Drug Approvals: Innovation, Efficacy, and Costs. JAMA Oncol. 2015;1(4):539–40. doi:.https://doi.org/10.1001/jamaoncol.2015.0373
  50. Tefferi A, Kantarjian H, Rajkumar SV, Baker LH, Abkowitz JL, Adamson JW, et al. In Support of a Patient-Driven Initiative and Petition to Lower the High Price of Cancer Drugs. Mayo Clin Proc. 2015;90(8):996–1000. doi:.https://doi.org/10.1016/j.mayocp.2015.06.001
  51. Spinello RA. Ethics, Pricing and the Pharmaceutical Industry. J Bus Ethics. 1992;11(8):617–26. doi:.https://doi.org/10.1007/BF00872273
  52. Parker-Lue S, Santoro M, Koski G. The ethics and economics of pharmaceutical pricing. Annu Rev Pharmacol Toxicol. 2015;55(1):191–206. doi:.https://doi.org/10.1146/annurev-pharmtox-010814-124649
  53. Daniel H ; Health and Public Policy Committee of the American College of Physicians. Stemming the Escalating Cost of Prescription Drugs: A Position Paper of the American College of Physicians. Ann Intern Med. 2016;165(1):50. doi:.https://doi.org/10.7326/M15-2768
  54. Brügger U, Horisberger B, Ruckstuhl A, Plessow R, Eichler K, Gratwohl A. Health technology assessment in Switzerland: a descriptive analysis of “Coverage with Evidence Development” decisions from 1996 to 2013. BMJ Open. 2015;5(3):e007021. doi:.https://doi.org/10.1136/bmjopen-2014-007021
  55. Bodenmann P, Wolff H, Bischoff T, Herzig L, Warin P, Chatelard S, et al. Renoncement aux soins: comment appréhender cette réalité en médecine de premier recours? [Patients forgoing health care for economic reasons: how to identify this in a primary care setting?]. Rev Med Suisse. 2014;10(452):2258, 2260–3. Article in French
  56. Edlin BR. Perspective: test and treat this silent killer. Nature. 2011;474(7350):S18–9. doi:.https://doi.org/10.1038/474S18a
  57. Daniels N. Just Health Care. Cambridge: Cambridge University Press. 1985.
  58. Brolan CE, Dagron S, Forman L, Hammonds R, Latif LA, Waris A. Health rights in the post-2015 development agenda: including non-nationals. Bull World Health Organ. 2013;91(10):719–719A. doi:.https://doi.org/10.2471/BLT.13.128173
  59. Chirac P, von Schoen-Angerer T, Kasper T, Ford N. AIDS: patent rights versus patient’s rights. Lancet. 2000;356(9228):502. doi:.https://doi.org/10.1016/S0140-6736(00)02566-6
  60. Charlton V, Littlejohns P, Kieslich K, Mitchell P, Rumbold B, Weale A, et al. Cost effective but unaffordable: an emerging challenge for health systems. BMJ. 2017;356:j1402. doi:.https://doi.org/10.1136/bmj.j1402

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