Economic and societal impact of direct-acting antiviral therapy in Hepatitis C Zoltán Kaló

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1 Economic and societal impact of directacting antiviral therapy in Hepatitis C Zoltán Kaló Professor of Health Economics ISPOR 19th Annual European Congress November 2 nd 2016 ATHCV Concerns related to societal benefits of medical innovation Primary care Limited unmet public health need Metoo products have limited added value Shortterm value is often not translated to longterm benefits (e.g. glitazones, renin inhibitors) Oncology Real unmet need Products target narrower and narrower population Health benefit is often minimal compared to budget impact Orphan drugs Huge unmet medical need But pricing of products is not evidence based 1

2 What does society want? especially in the CEE region Justification of reimbursement and formulary listing decisions Innovation in disease areas with public health priority Real (i.e. guaranteed) health outcomes Value for money (lower prices compared to Western European countries; costeffectiveness evidence) Affordability In the US, all new DAAs are costeffective in GT1 patients Total costs, lifeyears, QALYs, and costeffectiveness of treatments Overall GT1 Total cost ($) Lifeyears QALYs ICER $ (vs no treatment) NT 48, D ± RBV 100, ,677 SOF/LDV 108, ,538 SMV + PR 116, ,838 SOF + SMV 190, ,670 DAAs: directacting antiviral agents; GT: genotype; QALYs: qualityadjusted life years; NT: no treatment; 3D: ompitasvir/paritaprevir/ritonavir+dasabuvir; RBV: ribavirin; SOF: sofosbuvir; LDV: ledipasvir; SMV: simeprevir; PR: peginterferon+ribavirin. Saab S, et al. J Med Econ 2016; epubahead of print. 2

3 A systematic review of 26 CEA studies shows the costeffectiveness of novel HCV therapies globally Global systematic literature review of 26 CEA studies published between (227 ICERs, 11 drugs and 11 countries) At list price, 88% of analysis found 2ndGen DAAs to be costeffective or costsaving vs the prior standard of care 1 st Gen DAAs (BOC/TVR); 2 nd Gen DAAs (All DAAs approved after 1 st Gen DAAs) Chhatwal J, et al. PharmacoEconomics (2016) 34: DOI /s DAA HCV therapies Unmet need YES Public health priority YES Significant and immediate health benefit YES Costeffectiveness MOST LIKELY Affordability (budget impact)??? 3

4 Liverrelated deaths HCVrelated healthcare costs* (million ) $ $ $25 $ $ $10 $5 0 No intervention IFN + RBV + PI for F2 F4 IFNbased DAAs for F2 F4 All oral, IFNfree DAAs for All oral, IFNfree DAAs for F2 F4 F0 F4 Ethgen et al., Public health impact of comprehensive hepatitis C screening and treatment in the French babyboomer population, Journal of Medical Economics., Sep (link) $0 Expanding screening is more valuable to society, and value increases with more comprehensive treatment 20year Net Social Value Relative to line (Billions of 2015 USD) 2022 years to break even 89 years to break even $376 $421 $464 $669 $752 $824 0 ($2) $1 Treat F3F4 Treat F2F4 Treat F0F4 HCV Treatment Coverage Policy Current Screening Full Adherence to Screening Guidelines Screen All Value of one QALY = 150,000 US$ Linthicum et al., Value of Expanding HCV Screening and Treatment Policies in the United States, AJMC, May

5 ICER (incremental cost/qaly gained) 30,000 25,000 22,986 25,832 20,000 15,000 10,000 Incremental cost: 55.4 million Incremental QALYs: 2,410 Incremental cost: 60.4 million Incremental QALYs: 2,339 5,000 0 Alloral IFNfree DAAs for F0 4 vs IFNbased DAAs for F2 4 Alloral IFNfree DAAs for F0 4 vs alloral IFNfree DAAs for F2 4 Ethgen et al., Public health impact of comprehensive hepatitis C screening and treatment in the French babyboomer population, Journal of Medical Economics., Sep (link) Do you believe that innovative medicines can contribute to the sustainability of healthcare systems? 5

6 Budget impact Budget impact Stage 1 Stage 2 Stage 3 Alzheimer s disease, rare diseases with no treatments Innovation stages in different diseases Biologicals for cancer; autoimmune diseases; MS; HPV vaccination; orphan drugs hypertension, dyslipidaemia, depression, osteoporosis organ transplantation Availability of effective treatment Budget impact of treatment Unmet medical need Limited Yes (original products) Yes (offpatent products) Low High Low High Depends on accessibility Low Inotai A, Petrova G, Vitezic D, Kaló Z. Expert Rev Pharmacoecon Outcomes Res 2014; 14: Delaying innovation may cement healthcare costs at a higher level Stage 1 Stage 2 Stage 3 Innovation stages in different diseases Inotai A, Petrova G, Vitezic D, Kaló Z. Expert Rev Pharmacoecon Outcomes Res 2014; 14:

7 Conclusion DAA HCV therapies represent what society expects from medical innovation However, if patient access remains limited, disease eradication will never happen Differential pricing improves patient access in lower income countries with increased health care need Budget impact must be addressed: Financing protocol for objective prioritization of patients Followup of drug utilization and patient outcomes in a patient registry Volume related discounts facilitate HCV eradication National plan has to be developed in many countries to eradicate HCV by involving all stakeholders (payers, clinicians, patients, manufacturers, health economists, professional organisations) Economic Impact of HCV Elimination H. Razavi November 2, 2016 ATHCV160999a

8 Case Studies Saudi Arabia» High income country» Access to branded DAA s ($50,000$70,000 per patient today)» Prevalence of 0.5% or 103,000 HCV infections in 2015 Ethiopia» Low income country» Access to generic DAA s (~$1,300 per patient today)» Prevalence of 0.6% or 611,000 HCV infections in Case Study: Saudi Arabia 8

9 In absence of interventions, the total viremic infections is expected to stay constant but morbidity & mortality to increase by % 120,000 Total Infected Cases (Viremic) Saudi Arabia 600 Liver related Deaths Saudi Arabia 100, , , ,000 20, HCC Saudi Arabia 1,600 1,400 1, 1, Decompensated Cirrhosis Saudi Arabia 17 To achieve elimination in Saudi Arabia, an increase in screening and treatment of HCV patients is required 120, , , Treatment Cascade 80,000 60,000 40,000 20,000 22,150 19,940 5, Total Infected Diagnosed Eligible Unrestricted Treated Treated 1, ,000 7,900 7,900 Newly Diagnosed 2,000 2,000 2,000 4,000 8,000 8,000 New Infections 2,300 2, 2,150 1, Fibrosis Stage F0 F3 F3 F0 F0 F0 Treated Age Cure Rate 50% 87% 87% 95% 95% 95% 18 9

10 DALY With an elimination strategy, treatment and screening costs will increase but healthcare costs will decrease Tx & Lab Costs Screening Costs Elimination 2 Elimination 2 1,600 1,400 Healthcare Costs 1,600 1,400 Direct Costs 1, 1, , 1, Elimination 2 Elimination 2 19 Longer life expectancy and less disability will lead to a reduction in indirect costs and a positive ROI after ,000 DALYs 300 Indirect Costs 12,000 10,000 8,000 6,000 4,000 2, Elimination 2 Elimination 2 1,800 1,600 1,400 1, 1, Direct & Indirect Costs 30,000 25,000 20,000 15,000 10,000 5,000 Cumulative Direct & Indirect Costs Elimination 2 Elimination

11 Case Study: Ethiopia In the absence of intervention, HCV related mortality and morbidity will double over the next 15 years 700, , , , ,000, ,000 0 Total Infected Cases (Viremic) Ethiopia 5,000 4,000 3,000 2,000 1,000 0 Liver related Deaths Ethiopia 5,000 4,000 3,000 2,000 1,000 0 HCC Ethiopia 10,000 8,000 6,000 4,000 2,000 0 Decompensated Cirrhosis Ethiopia 22 11

12 To achieve elimination in Ethiopia, a large increase in screening and treatment is required 700, , , , Treatment Cascade 400, ,000, ,000 19,470 9,680 5, Total Infected Diagnosed Eligible Unrestricted Treated Treated ,500 10,000 50,000 Newly Diagnosed 1,900 1,900 11,000 28,000 42,000 42,000 New Infections 14,500 11,600 7,000 4,000 2,500 1,300 Fibrosis Stage F1 F0 F0 F0 F0 F0 Treated Age Cure Rate 48% 95% 95% 95% 95% 95% 23 The cost of treatment and screening is offset by savings in future healthcare costs Tx & Lab Costs Total Screening Cost Total WHO Target WHO Target Healthcare Costs Total Total Direct Costs WHO Target WHO Target Source: Polaris Observatory 24 12

13 Utilization % Utilized DALYs Incorporating indirect costs in Ethiopia has little impact due to the very low GNI per capita in the country DALYs Total Indirect Costs 50, , , , , , , , , ,000 2 WHO Target WHO Target Total Direct & Indirect Costs Cumulative Total Direct & Indirect Costs 300 6, ,000 4, , , ,000 WHO Target WHO Target Source: Polaris Observatory 25 From an economic impact point of view, the barrier to HCV elimination is the required upfront investment to save money later % of Public Health Insurance Spent on HCV Public Health Insurance Budget Utilization Saudi Arabia 1.0% 0.9% 0.8% 0.7% 0.6% 0.5% 0.4% 0.3% 0.2% 0.1% 0.0% Public Health Insurance Budget Utilization Ethiopia 2.5% 2.0% 1.5% 1.0% 0.5% 0.0% Elimination 2 WHO Target Conclusions: This analysis does not imply that countries do not need to negotiate prices However, the key barrier to HCV elimination remains the upfront investment required to screen and treat the infected population The same barrier will be faced with other curative therapies HBV and HIV 26 13

14 SIHEALTH 2016 ATHCV160999b Alignment 14

15 HCV burning platform is still burning! Different impact dimensions Public health problem Complex situation Policy level : sustainability! 15

16 SILOS SILOS SILOS GETTING BEYOND SILOS 16

17 Different responses to HCV CLINICAL APPROACH COMPREHENSIVE APPROACH Action plans: Comprehensive approach HCV CURE and CONTROL 17

18 Why is an HCV plan necessary for countries? To cure and control the disease in public health terms Be comprehensive To broaden the perspective of the policy makers and stakeholders: engage in planning, not only in drug provision To align and coordinate the different stakeholders toward a common goal, increasing their capacity Plans: Comprehensive approach PRIMARY PREVENTION 1. Raising awareness 2. Education and Training 3. Epidemiological monitoring 4. Prevention programs 5. Counseling 6. Regulations/ Policy 7. Research 8. Safety systems EARLY DETECTION 1. Epidemiological monitoring 2. Screening the general population 3. Screening riskgroups and specific population cohorts 4. Early detention: test 5. Defining a care pathway to promote referrals to care 6. Training of health professionals 18

19 Plans: Comprehensive approach CLINICAL MANAGEMENT FOLLOWUP 1. Defining a care pathway that ensures continuity of care 2. Access to treatment 3. Defining a clinical pathway 4. Training of health professionals 5. Reinforce infrastructure 1. Defining a pathway that ensures continuity of care 2. Defining a clinical pathway for nonresponders to treatment 3. Specific counseling and education of patients, families and caregivers Window of opportunity opens and closes A PLAN KEEPS IT OPEN! 19

20 & TREAT KNOWN PATIENTS GO COMPREHENSIVE COM PLAN PLANS TEND NOT TO IMPLEMENT THEMSELVES! NEED TO CREATE A RECEPTIVE CONTEXT FOR THE IMPLEMENTATION 20

21 Creating a receptive context for implementation 5 main factors to be considered: Having an approach and method for implementation greatly increases the chances of success! Tools developed by Deusto 21

22 SIHEALTH