Grote winst met nieuwe antivirale middelen Waar gaan we naar toe? Joost PH Drenth, MDL-arts 2de Nationale HCV symposium Amsterdam, 14 September 2014

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1 Grote winst met nieuwe antivirale middelen Waar gaan we naar toe? Joost PH Drenth, MDL-arts 2de Nationale HCV symposium Amsterdam, 14 September 2014

2 Vragen Waar komen we vandaan? Waar staan we nu? Waar gaan we naar toe? Wat moet dat kosten?

3 Waar komen we vandaan?

4 HCV treatment success HCV genotype 1 vs 2/3

5 HCV guideline Neth J Med

6 SVR: effect on survival Van der Meer JAMA 2012

7 HCV Treatment Netherlands 1500 Users Peg-alfa-2a Ribavirine Peg-alfa-2b Year Estimated ~1400 treatments yearly based on peginterferon sales

8 Waar staan we nu?

9 HCV euphoria: Hepatitis C Drug Raises Cure Rate in Late Trial An experimental drug for hepatitis C from Vertex Pharmaceuticals Telaprevir sharply increased the cure rate in a clinical trial, while reducing the time needed for treatment. About 75 percent of patients in the trial who got the standard dose of Vertex s drug in combination with the existing treatment were essentially cured, compared with 44 percent of those who got only the existing therapy NYT May 25, 2010

10 Protease inhibitors Telaprevir Boceprevir

11 Sustained Virologic Response in G1 (SVR) HCV Treatment (r)evolution Estimated 65-70% % % 35% ribavirin + + PEG-IFN +/- Prot Inhibitor 0 1 st Stage 2 nd Stage 3 rd Stage 4 th Stage present

12 HCV guideline Neth J Med

13 Boceprevir & Telaprevir Unique users in 2012 & Telaprevir Boceprevir Users Estimated ~400 treatments yearly based on telaprevir and boceprevir sales Total spend ~ 14 million; ~ 17K per patients

14 Temporary wave 1500 Introduction Protease inhibitors Users Peg-alfa-2a Ribavirine Peg-alfa-2b Year

15 Warehousing effect Wave: additional 10% patients (n=150) Peginterferon Users Protease inhibitors

16 Protease inhibitor phase 12 Lessons learned 1. Difficult : futility rules 2. What about genotype 2,3,4? 3. No dose reduction 4. No retreatment 5. Resistance is a problem and limit is treatment success 6. Shorthening in a minority 7. Ribavirin is needed 8. Interferon, still in the mix 9. Drug-drug interactions are a headache 10. High maintenance treatment 11. HCV therapy = worse than chemotherapy 12. Toxicity hemolysis, skin, renal function, death

17 Protease inhibitor issues FDA Issues Safety Warning for Severe Skin Rashes From HCV Drug Telaprevir (dec 2012)

18 Protease inhibitor sales fall sharply Telaprevir sales fall

19 Waar gaan we naar toe?

20 HCV natural history Fibrosis distribution (Belgium) Hepatology 2013 ; 57:

21 HCV natural history Fibrosis distribution (Belgium) 2000 Hepatology 2013 ; 57:

22 HCV natural history Fibrosis distribution (Belgium) Hepatology 2013 ; 57:

23 Drie middelen kloppen op de deur

24 Sustained Virologic Response in G1 (SVR) HCV Treatment (r)evolution 100 Estimated % % 35% ribavirin % + PEG-IFN Estimated 65-70% + Prot Inhibitor Protease Inhibitor 1 st Stage 2 nd Stage 3 rd Stage 4 th Stage 5 th Stage present NS5a inhibitors +/- +/- +/- NS5b inhibitors

25 End of interferon therapy Belofte 1. Geen interferon 2. Korter 3. Geen bijwerkingen N Engl J Med 2013; 368:

26 Sofosbuvir Genotype 2 & 3 (12 & 24 weeks) Zeuzem S et al. N Engl J Med 2014;370:

27 What are our options? 1 0 weeks Sim + Sof +/- Riba Sim + Sof +/- Riba SVR 90% (n=77/85) 93% (n=77/82) 1 DCV+ Sof +/- Riba DCV + Sof +/- Riba 98% (n=81/82) 99% (n=84/85) 2 DCV + Sof +/- Riba 92% (n=24/26) 3 DCV + Sof +/- Riba 89% (n=16/18) Lancet Jul 26. pii: S (14) ; ; N Engl J Med Jan 16;370(3):211-21

28 Goedkeuringsproces in Nederland Sofosbuvir Daclatasvir Simeprevir EMA Zorginstituut NL VWS

29 Three upcoming phases of HCV treatment Phase 1 Phase 2 Phase 3 Fibrosis score Duration from diagnosis to treatment Years

30 Clean out the warehouse Treatment Make choices for standard regimen Start to treat well known patients with HCV Patients More severe liver disease (advanced cirrhosis) Child Pugh (A) B, C Drugs Discovery of side effect profile of these drugs

31 Three upcoming phases of HCV treatment Phase 1 Phase 2 Phase 3 Fibrosis score Duration from diagnosis to treatment Years

32 Consolidation phase : Treatment Time between diagnosis and therapy will decrease in this phase, Development of standard paths of treatment chains Selection of preference for 1 th and 2 nd line treatment Adaptation of guidelines for treatment failures Fine tuning of standard of care Patients Growth of proportion of treatment naives Small but growing pool of patients who failed therapy in the first phase Severity of liver disease will decrease. Start to treat special populations (renal failure etc) Drugs Discovery of side effect profile of these drugs Appreciate the differences among the drugs. Market entry of novel drugs

33 Three upcoming phases of HCV treatment Phase 1 Phase 2 Phase 3 Fibrosis score Duration from diagnosis to treatment Years

34 Expansion Phase 2019 onwards Treatment Standard of care, little variation One size fits all? Decrease time window of diagnosis to treatment Patients Effective screening programs Detection of HCV unaware patients Lower fibrosis score Drugs Little change in standard of care

35 Wat gaat dat kosten?

36 Total prevalence and healthcare costs Hepatology 2013 ; 57:

37 Dure geneesmiddelen Sofosbuvir Kosten 4000/ week per pil Behandelduur weken: tot Euro Combinatie met een ander middel (daclatasvir /simeprevir) leidt mogelijk tot een verdubbeling

38 Pricing: 3 different pricing methodologies Cost-based Competitor-focused Value-based Costs= Production + distribution + margin Prices are tactically set based on knowledge of competitor prices, their costs profile and supply/ demand balances Prices are based on the value we provide to our customers via products with unique characteristics and / or services PMM program

39 Value Based Pricing Actually made costs Future costs Company X Cost based State Value based

40 Value Based Pricing Actually made costs Future costs Company X Cost based State Value based $ofosbuvir

41 Costs Kosten Als in de VS iedereen wordt behandeld dan neemt dat 25% van het overheidsbudget in beslag Nederland: 1500 patienten > 150 miljoen per jaar Totale kosten farmaceutische zorg 5224 miljoen Sofosbuvir 3% van totale kosten per jaar Keuze Crohn patienten gedurende 1 jaar Adalimumab of Hepatitis C patienten behandelen met Sofosbuvir

42 Antwoorden Waar komen we vandaan? Peginterferon / Ribavirine Bijwerkingen + Waar staan we nu? Peginterferon / Ribavirine / Telaprevir / Boveprevir Bijwerkingen +++ Waar gaan we naar toe? Pangenotypisch Hogere succeskans Bijwerkingen --- Wat moet dat kosten? (te)veel

43 Grote winst met nieuwe antivirale middelen Waar gaan we naar toe? Joost PH Drenth, MDL-arts 2de Nationale HCV symposium Amsterdam, 14 September 2014

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