Is Treatment cost effective HCV and Organ Transplantation

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1 Is Treatment cost effective HCV and Organ Transplantation Dr Kosh Agarwal Institute of Liver Studies King s College Hospital Barcelona 2016

2 Disclosures: BoJo Pharma support: AbbVie/Achillion/ Astellas/ BI/ BMS/ Gilead/ GSK/ Intercept/Janssen/ Merck/ Novartis/ Roche I am not an health economist! Thanks to S Faguioli and S Verma

3

4 HCV treatment landscape 2016 Approved or imminent approvals: Protease, NS5B # and NS5A* inhibitors IFN-free 95% cure rate In ALL populations Safe EASL 2016 Sofosbuvir # + Daclatasvir* Sofosbuvir # + Simeprevir Sofosbuvir # + Ledipasvir* ± RBV Sofosbuvir # Sofosbuvir + RBV # Ombitasvir * Paritaprevir Ritonavir Dasabuvir # ± RBV Sofosbuvir # Ledipasvir* ± RBV Asunaprevir Daclatasvir* Beclabuvir # ± RBV? Sofosbuvir # GS-5816* GS5816*? Grazoprevir Elbasvir* + Elbasvir* MK3682 # + MK-3682 # With IFN and RBV Jan Jan Jan Jan Jul Dec Jul Dec Jul Dec Jul Dec Jul Dec Jun Jun Jun Jun Telaprevir Boceprevir Triple therapy Sofosbuvir # Simeprevir (GT 1, 4) Daclatasvir* (GT 4)? Feeney ER, Chung RT. BMJ 2014;348:g3308; Pawlotsky JM. Gastroenterology 2014;146: GT: genotype; IFN: interferon; RBV: ribavirin

5 Some general observations Initial PI based therapy $200,000/ cure Monitoring costs were significant Combo DAAs cost effective Side effects minimal Costs of Rx moving downwards Elimination/ eradication Younossi Dig Liv Disease 2014

6 Ann Intern Med 2015

7 Ann Intern Med 2015

8 Ann Intern Med 2015

9 ILC Cost saving $73K

10 Dilemma is to treat for transmission vs treat to avoid complications 20% - 1 PWID prevents 2 1 death early 13 treated NMB net monetary benefit NK Martin J Hepatol 2016

11 Differential costs for stages of liver disease NK Martin J Hepatol 2016

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13 Opportunities to treat HCV in patients undergoing liver transplantation Biggins SW, Terrault NA. Infect Dis Clin N Am 2006; 20:155

14 Natural history of HCV post LT D Joshi et al, Nat Rev Gas Hep, 2015

15 LT & HCV - timing of treatment is flexible What is the cost of failure? Role of ribavirin? Duration 12 vs 24 weeks? Early treatment post transplant 6-12 months Timing in relation to LT MELD purgatory [Terrault] vs death Are we overstating salvage? Recipient- donor match Renal impairment

16 Increase in number of deceased donors Donors after brain death (DBD) Donors after circulatory death (DCD) Number DCD 2.5 organs per donor DBD 3.9 organs per donor

17

18 10,000E/ per 10% gain in SVR Transplant International 2013

19 Peg interferon therapy is cost-effective. 50,000E/QALY Transplant International 2013

20 Decision problem/ modelling Is pre-transplant sofosbuvir treatment cost-effective? Comparator is no treatment on the waiting list Model structure: Agarwal 2014 ILTS

21 Model flow Pre-transplant treatment Efficacy Costs Post-transplant outcomes Costs and health outcomes associated with: Recurrent HCV (rapid or standard progression) FCH ptvr Cost-effectiveness Incremental cost of treatment versus post-transplant cost savings Main outcome: incremental cost-effectiveness ratio (cost per incremental quality-adjusted life year)

22 Model assumptions The model considers a cohort of patients who undergo a successful liver transplant A proportion of patients treated with sofosbuvir achieves ptvr These patients are assumed to be cured of HCV Patients with HCV recurrence post-lt fall into three groups Standard recurrent HCV progressors (60%) Rapid recurrent HCV progressors (35%) Patients with fibrosing cholestatic hepatitis (FCH) (5%) Currently, post-transplant HCV treatment is not considered Patient survival is dependent on disease stage patients progress through HCV health states (F0-F4 and decompensated cirrhosis) Patients may only be re-transplanted if they develop decompensated cirrhosis FCH patients are not assumed to be re-transplanted Health state costs for non-transplanted patients are inflated to reflect the post-transplant setting (+20%) Biopsy costs are considered to be additional costs for HCV patients (2 in first year posttransplant, annually thereafter until development of cirrhosis)

23 Results Results indicate that sofosbuvir treatment in pre-olt patients is highly cost-effective *QALY = quality-adjusted life year. 1 QALY = 1 year lived at perfect quality of life. Agarwal 2014 ILTS

24 AJT 2015

25 Retrospectively 1794 Northern Italy transplant program 12/24 wks pre vs on demand 14K euro side effect 30K euro ICER Base case 37K euro Vitale Transplant International 2015

26 Vitale Transplant International 2015

27 Monte Carlo simulation drivers: strategy A vs B Vitale Transplant International 2015

28

29 Max $170K WTP 100,000$

30 Issues with the data / field Rapidly changing field! Rapidly changing DAA cost Heterogeneity of access models for DAA Heterogeneity in donor allocation models Lack of sophistication in costings and not easily translated Multiple drivers in progression/ survival Absence of post DAA clinical course Different methodologies Different thresholds for CE

31 How do you balance cost, risk and innovation?

32 The greatest obstacle to knowledge is not ignorance, it is the illusion of knowledge Daniel Bronstein Historian

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