Priority setting: the case of new drugs. Parallel session: Universal Health Coverage, costing and prioritization

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1 Priority setting: the case of new drugs Parallel session: Universal Health Coverage, costing and prioritization Dr Jeremy Lauer Health Systems Governance and Financing 1 Department of Health Systems Governance and Financing

2 Priority Setting Asks: What's the best that can be done? (includes all kinds of benefit attributable to the health system see next slide). Is indifferent to what has already been done (so past history is not 'baked in'). Thus, not done at the margin (in economic terms, all constraints relaxed). 2 Department of Health Systems Governance and Financing

3 Priority setting and UHC Universal Health Coverage (UHC): Priority setting within and across the 3 dimensions of the 'UHC cube': 1. Which population groups should be covered first. WHO? 2. Cover more services for the people already covered (and/or increase quality). WHAT (i.e. which services)? 3. Reduce out of pocket payments further for people currently covered with a set of services. HOW MUCH does it cost? Real choices involve a combination of dimensions. 3 Department of Health Systems Governance and Financing

4 UHC cube 4 Department of Health Systems Governance and Financing

5 Decision making Asks "What is the 'next' thing to do?" Or, What do we do now? Depends on what's already been done (past history is be 'baked in'). Done at the margin. 5 Department of Health Systems Governance and Financing

6 Strategic planning Intermediate between Priority setting and Decision-making. Asks, "Given a set of Priorities and a set of Activities, how can we make our activities look more like our priorities?" Looks at time in 'bite-size chunks' (usually 3-10 years). Can be thought of as Decision making that takes account of priorities in forming objectives. Multiple constraints addressed (incl. Affordability). 6 Department of Health Systems Governance and Financing

7 OneHealth Tool for strategic planning Uses results from Priority Setting exercise to set objectives. Allows decision makers (DMs) to quantify: Impact of their national plans on population health Cost of the national plans (Does not currently have a Hepatitis B/C module.) Allows DMs to confirm presence of the necessary: financial resources health workers and health system infrastructure etc. 7 Department of Health Systems Governance and Financing

8 That's the Theory. Now comes the hard part: Practice. 8 Department of Health Systems Governance and Financing

9 New medicines availability Highly effective, highly costly new medicine => 'cost effective' new treatment. Should it be introduced? Depends on: What else it displacing? (not good if it displaces more CE activities => going backwards ) Is it affordable? (will it absorb all available public funding)? Availability of health system platform for delivery and follow up? Etc. 9 Department of Health Systems Governance and Financing

10 Conclusions Keep in mind: Medicines price is a variable, not a constant. Assuming priority etc. has been established, it's useful to ask: At what price will the new therapy become as cost effective as existing alternatives? as cost effective as what is displaced? 10 Department of Health Systems Governance and Financing

11 Health system implications New medicines have important implications for basic health services, which may be weak and under-developed. More cost-effective interventions in such settings include: strengthening early detection and effective treatment. Same implications for many new therapies: Cost effective but not affordable. 11 Department of Health Systems Governance and Financing

12 Cost per year per one million population (I$, log scale) Price analysis: HPV vaccine Cost-effectiveness of cervical cancer interventions Afro-D 10,000,000 I$ 1000/DALY ~current vaccine price CVC-11 CVC-12 1,000, ,000 1-year PAP (I$4220) CVC-2 CVC-6 CVC-13 CVC-14 1-year PAP + treatment (I$1664) (I$ 1 per capita) CVC-7 CVC-16 I$ 100/DALY CVC-3 CVC-15 CVC-10 5-year PAP + treatment (I$637) CVC-9 CVC-19 CVC-18 CVC-22 CVC-1 CVC-24 CVC-8 CVC-30 current scenario (I$ 4179) HPV 35, 40, 45 (I$1445/DALY) CVC-28vaccination + treatment (I$233) CVC-17 CVC-21 CVC-5 VIA, PA 35, 40, 45 (~I$675/DALY) treatment (I$ 209/DALY) CVC-29 I$ 10/DALY CVC-4 vaccination 2 (I$ 288/DALY) VIA 40 (I$ 434/DALY) CVC-27 vaccination 1 (I$ 114/DALY) 10, ,000 10,000 DALYs averted per year per one million population (log scale) 12 Department of Health Systems Governance and Financing

13 The end Thank you! 13 Department of Health Systems Governance and Financing

14 Presenter: Universal Health Coverage (UHC) Costing and Prioritization Regional Plan of Action for the Prevention and Control of Viral Hepatitis in the Americas Massimo N. Ghidinelli Pan American Health Organization/World Health Organization (PAHO/WHO)

15 Viral Hepatitis in the Americas Hepatitis A Hepatitis B Hepatitis C Estimates for the Americas Antibodies to HAV North America: 10% Caribbean: 50% Latin America: 70-90% 7.6 M chronic HBV infection Latin America: 2-4% Amazon Basin: 8% USA, South America : <2% 13 M Caribbean: ~0.7 M (2.1%) North America: ~4.4M(1.3%) Latin America: ~7.6 M (1.2%-2%) 109,000 death/year related to Hepatitis (4) Source: 1. World Health Organization. The global prevalence of hepatitis A. Virus Infection and susceptibility: a systematic review [Internet]. Geneva: WHO; Franco E, Bagnato B, Marino MG, Meleleo C, Serino L, Zaratti L. Hepatitis B: Epidemiology and prevention in developing countries. World J Hepatol Mar 27;(3): World Health Organization. Guidelines for the screening care and treatment of persons with hepatitis C infection. Geneva: WHO; WHO/ PAHO Mortality Information System (updated in July 2013). 5. Aparna S, Johannes Ho, Rafael T M, Ge rard K, Jo rdis J Ott. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and The Lancet July, 2015

16 % American Member States with routine surveillance for viral hepatitis HAV HBV HVC HDV HEV surveillance of acute hepatitis Source: WHO. Global policy report on the prevention and control of viral hepatitis. Geneva, 2013 PAHO, Situation analysis, Washington DC 2015 (Preliminary data)

17 HepB Vaccine: 3d dose coverage in infants, 2013 Source: Pan American Health Organization. Hepatitis vaccine coverage map, Available at : cine-coverage-map&catid=4217%3afgl03-hepatitis-vaccine-feature&itemid=4329&lang=es

18 Emerging framework for elimination targets by 2030 Focus Indicator Target (reduction from 2010 baseline) Impact Incidence Incidence of Hepatitis B Incidence of Hepatitis C Impact Mortality Deaths due to Hepatitis B Deaths due to Hepatitis C HBV Coverage Infant vaccination Birth dose vaccine Hepatitis B treatment (cascade) 70-90% reduction by % reduction by % + 80% 90, 90, 90 HCV Coverage Risk of medical exposure (in and outside facility) Harm reduction for injecting drug users Hepatitis C treatment (cascade to cure) 75% 50% 90, 90, 90

19 Regional Plan of Action for Viral Hepatitis, Strengthening of strategic information Promotion of an integrated comprehensive response Goal Equitable access to prevention Strengthening lab capacity to support Dx, surveillance & safe blood supply Strengthen regional public health responses to VH Reduction in morbidity and mortality related to VH Fostering equitable access to clinical care

20 PAHO s Plan of Action for Prevention and Control of Viral Hepatitis Promoting an integrated comprehensive response Indicator Baseline Target Number of countries that have a structured and budgeted national strategy or plan related to prevention, treatment, and control of viral hepatitis 10 in 2015 a Number of countries with goals of elimination of hepatitis B and Hepatitis C as public health problems 0 in 2015 a Number of countries with goals of elimination of mother-to-child transmission of hepatitis B Number of countries that commemorate World Hepatitis Day through awareness campaigns or major thematic events 1 in 2012 b 5 10 in 2015 a 20

21 PAHO s Plan of Action for Prevention and Control of Viral Hepatitis Fostering equitable access to preventive care Indicator Baseline Target Number of countries that maintain high HBV coverage (95% or above) as part of the routine childhood vaccination schedule (below 1 year of age) 15 in 2013 c Number of countries that have included immunization of newborns against HBV within the first 24 hours in their vaccination programs Number of countries that have conducted HAV epidemiological, burden of disease, and health technology assessment, such as cost-effectiveness analyses to inform vaccine introduction 18 in 2013 c 25 5 in 2013 d Number of countries with measures for the prevention of hepatitis B among health workers 13 in 2015 a Number of countries with viral hepatitis prevention and control strategies, such as HBV vaccine targeting key populations 8 in 2015 a 20

22 PAHO s Plan of Action for Prevention and Control of Viral Hepatitis Fostering equitable access to clinical care Indicator Number of countries that have developed guidelines for prevention, care, and treatment of hepatitis B in line with latest WHO recommendations Number of countries that have developed guidelines for screening, diagnosis, care, and treatment of hepatitis C in line with latest WHO recommendations Baseline Target 16 in 2012 b 25 6 in 2015 a Number of countries that have started offering publicly funded HBV diagnosis and treatment 11 in 2015 a Number of countries that have started offering publicly funded HCV diagnosis and treatment 6 in 2015 a Number of countries that include in their national essential medicine lists and/or formularies one or more drugs recommended in WHO 2015 guidelines for HBV treatment Number of countries that include in their national essential medicine lists and/or formularies one or more drugs recommended in WHO 2014 guidelines for HCV treatment Number of countries that have updated their antiretroviral treatment criteria, including the recommendation of initiating antiretroviral therapy (ART) regardless of CD4 count in HIV patients with severe HBV-related chronic liver disease 10 in 2015 a 15 8 in 2015 a in 2014 e 30

23 PAHO s Plan of Action for Prevention and Control of Viral Hepatitis Strengthening strategic information Indicator Baseline Target Number of countries that report cases of acute and chronic hepatitis B Number of countries that report cases of hepatitis C infection Number of countries conducting surveys on prevalence of viral hepatitis B or C in general population and/or key populations Number of countries that have published a national report on viral hepatitis 8 in 2015 a in 2015 a in 2015 a 18 8 in 2015 a 15

24 PAHO s Plan of Action for Prevention and Control of Viral Hepatitis Strengthening laboratory capacity to support diagnosis, surveillance, and a safe blood supply Indicator Baseline Target Number of countries that implement standardized and effective technologies for HBV patient monitoring, 10 in 2015 a Number of countries that implement standardized and effective technologies for HCV confirmation, genotyping, and patient monitoring 8 in 2015 a Number of countries that screen 100% of blood transfusion units for HBV and HCV 39 in 2014 f 41

25 Regional Framework for Surveillance and Monitoring of HBV and HCV Case reporting Case based surveillance with unique identifiers Serologic surveillance Surveillance of outcomes Monitoring of response Population-based studies Sub-population studies: pregnant women, MSM, SW, IDU, indigenous, blood banks Chronic liver disease surveillance Hepatic carcinoma incidence Liver transplant surveillance Mortality due to hepatic carcinoma, cirrhosis, liver failure Immunization HBV Testing coverage Linkage and retention in care Treatment Sustained virological response Care & Treatment cascade for people with chronic HCV infection Chronic HCV infection Diagnosis+ confirmation (HCV-RNA) Linked to care (staging) Eligible for treatment Treatment for HCV Sustained virological response

26 Cost of HCV associated diseases, , , ,000 Hep Encephalopathy HCC Liver TX 55,000 5,000 Americas Asia Pacific Europe USA Source: A. C. El Khoury, W. K. Klimack, C. Wallace, H. Razavi. Economic burden of hepatitis C-associated diseases in the United States. Journal of Viral Hepatitis, 2012, 19, A. C. El Khoury, W. K. Klimack, C. Wallace, H. Razavi: Economic burden of hepatitis C-associated diseases: Europe, Asia Pacific, and the Americas. Journal of Medical Economics Vol. 15, No. 5, 2012,

27 Hepatitis C Treatment costs (12 weeks) 100,000 90,000 80,000 70,000 60,000 50,000 40,000 30,000 20,000 10, weeks Source: University of Washington. Hepatitis C online,

28 Total estimated cost to fully vaccinate a child against Hepatitis B in the Americas Vaccine Schedule (birth dose) Doses/ child Cost/ dose Wastage Total cost Hepatitis B* 1+0 (infant dose) 1 $ $ 0.27 DPT-Hepatitis B-Hib (Pentavalent)* 3+0 (2, 4 and 6 mo) 3 $ $ 7.15 VACCINE ONLY $ 7.42 with CIF, syringe and safety box** 4 $ 3.28 $ with all other delivery costs** 4 $ 6.20 $ OTHER ONLY $ TOTAL COST PER CHILD (Vaccine, supply, delivery, other) $ * Vaccine price/dose represents PAHO RF prices for 2015 ** CIF, syringe, safety box and delivery costs data based on facility-based costing exercise in Honduras (Janusz et al. 2015)

29 Hepatitis B Cost estimates (30 days) Medicine Generic* R&D * Entecavir $ $ $ ,00 Tenofovir $ $99.00 $ *Canada Source:

30 Acknowledgments Laura Alves PAHO/VH Mónica Alonso PAHO/VH Alba Maria Ropero PAHO/IM Cara Janusz PAHO/IM Homie Razavi CDA

31 Universal health coverage, costing and priorization Presenter: Marcelo C. Moscoso Naveira, MD MPH General Coordinator of Viral Hepatitis Ministry of Health of Brazil

32 Brazil & The Unified Health System 1988 Constitution: Unified Health System (SUS) Health: a citizen s right and an obligation of the state Universal access to health services Equality of access to health care Integrality and continuity of care Decentralization Social Participation

33 The Process Multiple levels of care Improvements + Sustainability Priorities defined by epidemiological data Hepatitis B: 1989 Hepatitis C: 2002 Constant monitoring and evaluation

34 Steps Social Mobilization Right to Vote Hep B Vaccine Harm Reduction Family Health Strategy Blood Safety PEG-IFN, 3TC, TDF National Program for Viral Hepatitis Mais Médicos Rapid Tests Entecavir Boceprevir/Telaprevir Daclatasvir Simeprevir Sofosbuvir

35 Epidemiology & UHC Hepatitis B cases, Brazil Hepatitis C cases, Brazil

36 Trends & UHC VH hospitalizations and deaths, Brazil HCC hospitalizations and deaths, Brazil ,000 10,000 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1, ,000 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,

37 Costs & UHC Rapid Testing: 5 USD Over 5 million tests distributed in 2014 Hepatitis B treatment (TDF/ETV): USD/mo Approximately 50,000 treatments/year Hepatitis C treatment (DAAs): 9,425 9,625 USD Accumulated over 100,000 treatments since 2002 Over 15,000 treatments in 2014

38 Costs & UHC Liver Transplant: 54,698 75,434 USD Over 1,700 transplants/year 8,000 new HCC/cases/year Family Health Strategy: R$ 5,00/per capita/mo less than 1 Approximately 50 million people

39 Big Picture Liver failure and transplant Comorbidities Indications for treatment Access to treatment and fibrosis assessment Diagnosis Awareness Careful evaluation of new technologies Several actors, administrative responsibility Commitment

40 HCV Perspectives Sustained Virological Response (SVR) >90% 40% INTERFERON- FREE SOF+DAC/SIM (2015-) PR/PR+BOC/TEL ( ) F3/F4 (F2)* Treatments/year F3/F4 (F2), HIV, Pr/P Tx... Population

41 Obrigado