Z Gastroenterol 2015; 53(12): 1414-1421
DOI: 10.1055/s-0041-109630
Originalarbeit
© Georg Thieme Verlag KG Stuttgart · New York

Kosteneffiziente medikamentöse Therapie der Hepatitis C durch neue Vergütungsmodelle – pay for cure

Cost-effective medical therapy of hepatitis C employing novel compensation models – pay for cure
F. Foerster
,
M. A. Wörns
,
P. R. Galle
,
J. M. Schattenberg
Weitere Informationen

Publikationsverlauf

28. Juni 2015

16. November 2015

Publikationsdatum:
14. Dezember 2015 (online)

Zusammenfassung

Neue direkt-antiviral wirkende Substanzen zur Therapie der chronischen Hepatitis C erreichen sehr hohe Heilungsquoten von bis zu 100 %. Gleichzeitig ist ihr Einsatz mit hohen Arzneimittelkosten verbunden. Die Behandlung aller Hepatitis-C-Virusträger in Deutschland würde je nach eingesetztem Präparat schätzungsweise zwischen 19 und 37 Mrd. EUR kosten. Hiervon wären die Arzneimittelkosten der erfolglos behandelten Patienten als vergeblich aufgewendete Gesundheitsausgaben zu bewerten – diese liegen je nach Behandlungsregime zwischen 0,9 und 2,15 Mrd. EUR. In schwierig zu behandelnden Patientenkollektiven, gekennzeichnet durch Leberzirrhose oder Vortherapie, können sich die Arzneimittelkosten aufgrund längerer Behandlungsdauer erhöhen. Gleichzeitig liegen die Heilungsquoten in diesen Patientengruppen teilweise deutlich niedriger, sodass die verlorenen Therapiekosten besonders hoch sind. Qualitätsorientierte Vergütungsmodelle sind im Gesundheitswesen als Maßnahmen zur Qualitätssteigerung und Kostenbegrenzung anerkannt. In Deutschland werden sie bislang im Hinblick auf die Erbringung von Gesundheitsdienstleistungen angewendet (Disease-Management-Programme). Dagegen erfolgt die Vergütung der pharmazeutischen Industrie weiterhin nach abgegebener Medikamentenpackung (pay for pill). Die Verknüpfung der Vergütung des Arzneimittelherstellers mit dem Heilungserfolg durch die eingesetzte medikamentöse Therapie (pay for cure) stellt einen neuartigen Ansatz dar, der im Allgemeinen und bei den neuen Hepatitis-C-Therapeutika im Besonderen den erfolgreichen Einsatz eines Arzneimittels belohnt, verlorene Arzneimittelausgaben zu begrenzen hilft und im Sinne des „shared risk“ alle Beteiligten involviert. Unter den Annahmen, dass jährlich 20 000 Hepatitis-C-Virusträger behandelt und durchschnittliche Heilungsquoten gemäß der aktuellen Studienlage von 95,4 % erreicht werden, ergeben sich abhängig von den in der Population eingesetzten Therapieregimen Einsparpotenziale zwischen 45 und 107 Mio. EUR pro Jahr. Insbesondere in schwierig zu behandelnden Patientenkollektiven werden so ökonomische Fehlanreize, die zum Nachteil der Patienten wären, reduziert.

Abstract

Direct acting antivirals (DAAs) have increased cure rates for chronic hepatitis C infection up to nearly 100 %. At the same time treatment costs have risen significantly. Treating all HCV infected patients in Germany with DAAs would generate medication costs ranging between 19 and 37 billion EUR depending on the drug regimen used. Expenses in patients who fail to respond to treatment would amount to approximately 0.9 to 2.15 billion EUR. In difficult to treat patient populations that are characterized by prior failure to treatment or advanced liver disease, lost drug expenses are particularly high due to lower cure rates and longer treatment duration. Outcome-based reimbursement schemes are used to improve the quality of care and to reduce costs in the health care system. In Germany, disease management programs have been implemented for defined chronic diseases. However, drug reimbursement is still based on packages sold (pay for pill). In this context, it would be appealing to link reimbursement and treatment success (pay for cure) in order to reward successful treatment, limit lost drug spending and develop a shared risk environment that would involve all concerned parties. Under the assumption that 20 000 patients with HCV are treated each year in Germany and that cure rates are 95.4 %, the saved treatment costs would amount up to 45 and 107 million EUR per year. By this approach, economic incentives to withhold therapy from difficult to treat patients could be avoided.

 
  • Literatur

  • 1 Mullard A. New drugs cost US$2. 6 billion to develop. Nat Rev Drug Discov 2014; 13: 877
  • 2 Ankowitsch E, Flintrop J, Osterloh F. Pay for Performance: Umsetzung noch in weiter Ferne. Dtsch Arztebl International 2014; 111: 1444-1446
  • 3 Greb S et al. Financial incentives for disease management programmes and integrated care in German social health insurance. Health Policy 2006; 78: 295-305
  • 4 Schoonveld E. The price of global health: drug pricing strategies to balance patient access and the funding of innovation. Farnham, Surrey; Burlington, VT: Gower; 2014
  • 5 Westbrook RH, Dusheiko G. Natural history of hepatitis C. J Hepatol 2014; 61: S58-S68
  • 6 Kalra A, Siddiqui Z. Gilead signs hepatitis C pact to cut drug cost for poor. 2014. Available from: http://www.reuters.com/article/2014/09/15/us-gilead-sciences-india-idUSKBN0HA0TT20140915
  • 7 Robert Koch Institut. Zur Situation wichtiger Infektionskrankheiten in Deutschland: Virushepatitis B, C und D im Jahr 2005. Epidemiologisches Bulletin 2006; 46: 399-410
  • 8 Huppe D et al. Epidemiology of chronic hepatitis C in Germany – an analysis of 10,326 patients in hepatitis centres and outpatient units. Z Gastroenterol 2008; 46: 34-44
  • 9 Sarrazin C et al. Aktuelle Empfehlung zur Therapie der chronischen Hepatitis C [S3 guideline hepatitis C addendum]. Z Gastroenterol 2015; 53: 320-334
  • 10 Razavi H et al. The present and future disease burden of hepatitis C virus (HCV) infection with today's treatment paradigm. J Viral Hepat 2014; 21 (Suppl. 01) 34-59
  • 11 Zur Situation bei wichtigen Infektionskrankheiten in Deutschland: Virushepatitis C im Jahr 2013. Epidemiologisches Bulletin 2013; 31: 275-288
  • 12 Younossi ZM et al. Treatment with ledipasvir and sofosbuvir improves patient-reported outcomes: Results from the Ion-1, 2 and 3 clinical trials. Hepatology 2015; 61 : 1798-1808
  • 13 Morgan TR et al. Outcome of sustained virological responders with histologically advanced chronic hepatitis C. Hepatology 2010; 52: 833-844
  • 14 Singal AG et al. A sustained viral response is associated with reduced liver-related morbidity and mortality in patients with hepatitis C virus. Clin Gastroenterol Hepatol 2010; 8: 280-288, 288 e1
  • 15 Gordon SC et al. Impact of disease severity on healthcare costs in patients with chronic hepatitis C (CHC) virus infection. Hepatology 2012; 56: 1651-160
  • 16 Jensen D, O'Leary J, Pockros P. Safety and Efficacy of Sofosbuvir-Containing Regimens for Hepatitis C: Real-World Experience in a Diverse, Longitudinal Observational Cohort, in American Association for the Study of Liver Diseases (AASLD) 65th Annual Meeting 2014. Boston: MA.
  • 17 Sulkowski M. Safety and Efficacy of Sofosbuvir (SOF) in Combination with Simeprevir (SIM) + Ribavirin (RBV) in Patients with Genotype 1: Interim Results of a Prospective, Observational Study, in American Association for the Study of Liver Diseases (AASLD) 65th Annual Meeting 2014. Boston: MA.
  • 18 Korzilius H. Arzneimittel: Fragwürdige Preispolitik der Industrie. Dtsch Arztebl International 2014; 111: 1748-1750
  • 19 Grabar E. Wie viel darf die Gesundheit kosten?. in ZEIT ONLINE. 2014: http://www.zeit.de/wissen/gesundheit/2014-08/hepatitis-medikament-krankenkassen-teuer
  • 20 Galle PR. Das Dilemma des medizinischen Fortschritts, in Frankfurter Allgemeine Zeitung. 2014 http://www.faz.net/aktuell/wissen/medizin/das-dilemma-des-medizinischen-fortschritts-13155437.html
  • 21 Deutsche Leberstiftung. Deutsche Leberstiftung startet Register zur Verbesserung der Hepatitis C-Therapie. Available from: http://www.deutsche-leberstiftung.de/aktuelles/presseportal/pressearchiv/Pressemeldung_Register
  • 22 Fried MW et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002; 347: 975-982
  • 23 Manns MP et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001; 358: 958-965
  • 24 Di Bisceglie AM et al. Ribavirin as therapy for chronic hepatitis C. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 1995; 123: 897-903
  • 25 Dusheiko G et al. Ribavirin treatment for patients with chronic hepatitis C: results of a placebo-controlled study. J Hepatol 1996; 25: 591-598
  • 26 Bacon BR et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011; 364: 1207-1217
  • 27 Poordad F et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011; 364: 1195-1206
  • 28 Jacobson IM et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011; 364: 2405-2416
  • 29 Sherman KE et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med 2011; 365: 1014-1024
  • 30 Zeuzem S et al. Telaprevir for retreatment of HCV infection. N Engl J Med 2011; 364: 2417-2428
  • 31 Lawitz E et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368: 1878-1887
  • 32 Jacobson IM et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013; 368: 1867-1877
  • 33 Manns M et al. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet 2014; 384: 1597-1605
  • 34 Jacobson IM et al. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet 2014; 384: 403-413
  • 35 Manns M et al. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2014; 384: 414-426
  • 36 Forns X et al. Simeprevir with peginterferon and ribavirin leads to high rates of SVR in patients with HCV genotype 1 who relapsed after previous therapy: a phase 3 trial. Gastroenterology 2014; 146: 1669-1679 e3
  • 37 Afdhal N et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 2014; 370: 1483-1493
  • 38 Afdhal N et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014; 370: 1889-1898
  • 39 Kowdley KV et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med 2014; 370: 1879-1888
  • 40 Reddy KR et al. Ledipasvir/Sofosbuvir With Ribavirin for the Treatment of HCV in Patients With Post-Transplant Recurrence: Preliminary Results of a Prospective, Multicenter Study, in American Association for the Study of Liver Diseases (AASLD) 65th Annual Meeting 2014. Boston, MA:
  • 41 Townsend KS et al. High Efficacy of Sofosbuvir/Ledipasvir for the Treatment of HCV Genotype 1 in Patients Coinfected With HIV on or off Antiretroviral therapy: Results from The NIAID ERADICATE Trial, in American Association for the Study of Liver Diseases (AASLD) 65th Annual Meeting 2014. Boston: MA.
  • 42 Feld JJ et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014; 370: 1594-1603
  • 43 Zeuzem S et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014; 370: 1604-1614
  • 44 Andreone P et al. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology 2014; 147: 359-365 e1
  • 45 Ferenci P et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med 2014; 370: 1983-1992
  • 46 Poordad F et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med 2014; 370: 1973-1982
  • 47 Kwo P et al. A Phase 3, randomised, open-label study to evaluate the efficacy and safety of 12 and 8 weeks of simeprevir (SMV) plus sofosbuvir (SOF) in treatment-naïve and -experienced patients with chronic HCV genotype 1 infection without cirrhosis: OPTIMIST-1, in The European Association for the Study of the Liver (EASL) 50th Annual Meeting. 2015 Vienna:
  • 48 Sulkowski MS et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 2014; 370: 211-221
  • 49 Lawitz E et al. A Phase 3, open-label, single-arm study to evaluate the efficacy and safety of 12 weeks of simeprevir (SMV) plus sofosbuvir (SOF) in treatment-naïve or experienced patients with chronic HCV genotype 1 infection and cirrhosis: OPTIMIST-2, in The European Association for the Study of the Liver (EASL) 50th Annual Meeting 2015. Vienna:
  • 50 Poordad F et al. Daclatasvir, sofosbuvir, and ribavirin combination for HCV patients with advanced cirrhosis or posttransplant recurrence: Phase 3 ALLY-1 study, in The European Association for the Study of the Liver (EASL) 50th Annual Meeting 2015. Vienna:
  • 51 Bourliere M et al. An Integrated Safety and Efficacy Analysis of >500 Patients With Compensated Cirrhosis Treated With Ledipasvir/Sofosbuvir With or Without Ribavirin, in American Association for the Study of Liver Diseases (AASLD) 65th Annual Meeting 2014. Boston: MA.
  • 52 Zeuzem S et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med 2014; 370: 1993-2001
  • 53 Nelson DR et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology 2015; 61: 1127-1135
  • 54 Gane EJ et al. Sofosbuvir/ledipasvir fixed dose combination is safe and effective in difficult-to-treat-populations including genotype-3 patients, decompensated genotype-1 patients, and genotype-1 patients with prior sofosbuvir treatment experience. Journal of Hepatology 2014; 60: S3-S4
  • 55 Gane EJ et al. High Efficacy of LDV/SOF Regimens for 12 Weeks for Patients With HCV Genotype 3 or 6 Infection, in American Association for the Study of Liver Diseases (AASLD) 65th Annual Meeting 2014. Boston: MA.