Making health markets work Kickstarting sustainable HCV treatment models in Africa
3rd International Viral Hepatitis Elimination meeting December 3rd, 2016 - Amsterdam Agenda
1. PharmAccess background 2. The daunting complexity of health 3. Facts on Health in developing countries 4. HCV in developing countries - challenges and opportunities
1 PharmAccess Group History: Starting private, growing public (I)
THE START 1995-2000
• HIV-AIDS research: Joep Lange publishing mother - child transmissions studies in Africa and developing and testing a new combination therapy to treat HIV-infected patients
• With the mother – child transmissions studies Lange changed the perspective that HIV/AIDS is not only a disease related to sexual life style in the West but also linked to poverty in Africa
• Treatment was only introduced in developed countries, not in Africa. “WHY IS IT THAT WE ARE ALWAYS TALKING ABOUT THE PROBLEM OF DRUG DISTRIBUTION, WHEN THERE IS VIRTUALLY NO PLACE IN AFRICA WHERE ONE CANNOT GET A COLD BEER OR A COCA-COLA.”
JOEP LANGE
2 2001 PharmAccess Access to HIV treatment in the absence of funding
. PharmAccess: in absence of public funding work through private sector (“going private to grow public”) . Sufficient financial means, infrastructure and human capacity at the Heineken breweries . Well-defined group of beneficiaries (workers + families: 35,000 people) . PharmAccess represents a trusted HIV-specialist for a multinational company . Guaranteed confidentiality and privacy through separate databases and management structures . PharmAccess is liaison with pharmaceutical companies to procure and distribute ARVs . Coordinated international database provides real-time patient data demonstrating clinical success . Data analyses lead to good publications in peer-reviewed journals, contributing to reputation and motivating other workplace initiatives 3 PharmAccess Group History: Starting private, growing public (II)
KICKSTARTING FIRST HIV TREATMENTS IN AFRICA
• By convincing private companies to act (Heineken, Unilever, CelTel) and make treatment available for their labourers and families, he proved that starting private can positively influence public services
• Public initiatives like PEPFAR and Global Fund started subsequently to support the public health sector with grants, crowding out private sector delivery and private investments. Every solution comes with a price “WHY IS IT THAT WE ARE ALWAYS TALKING ABOUT THE PROBLEM OF DRUG DISTRIBUTION, WHEN THERE IS VIRTUALLY NO PLACE IN AFRICA WHERE ONE CANNOT GET A COLD BEER OR A COCA-COLA.”
JOEP LANGE
4 Agenda
1. PharmAccess background 2. The daunting complexity of health 3. Facts on Health in developing countries 4. HCV in developing countries - challenges and opportunites
5 The daunting complexity of health
First law of health economics Second law of health economics
Poor countries spend little on Poor countries have a high healthcare share of out-of-pocket costs When GDP per capita is known, When you are poor, you are health expenditures per capita on your own Problem can be predicted with more than 95 percent accuracy
Increase health spending Decrease out-of-pocket costs = = Stimulate economic development Stimulate risk pooling & crowding in . In general, economic development is the only way to increase . Reduce individual risk for users by (subsidized) risk pooling
Solution healthcare spending through insurance schemes . Otherwise, create situation where private investment increases as well as government spending
Source: A new paradigm for increased access to healthcare in Africa, 2007 – Onno Schellekens et al – FT/IFC Award; WHO NHA data 2009/2010
6 Agenda
1. PharmAccess background 2. The daunting complexity of health 3. Facts on Health in developing countries 4. HCV in developing countries - challenges and opportunites
7 High burden of disease, lack of investments
> 15% 25% < 2% of the world’s of the total global of global total health population burden of diseases expenditure (47% of communicable diseases)
Population Burden diseases Total health expenditure (Millions) (Million DALYS) (Million USD) 98.11 1.136 8 660
6.102 2.083 6.354. 308
Africa Rest of the world Africa Rest of the world Africa Rest of the world
World Population Data Sheet 2014 WHO Global Health Estimates 2014 WHO Global Health Expenditure Database 2010
8 Health funding in developing countries
In most countries most funding of health is private 50% in lowest income quintile receive healthcare from private or non-state providers Source of health care by wealth quintiles in sub-Saharan Africa 52 51 51 51 52 100% 49 49 49 50 48 48 private sector 40 75%
public 30 50%
public 20 private sector 25% 10
0% 0
poorest poorer middle richer richest
Kenya
Ghana
Nigeria
Zambia
Malawi
Uganda
Rwanda
Namibia
Tanzania
Zimbabwe Mozambique Source: National Health Accounts 2012 (Zimbabwe 2001), PharmAccess analysis Analysis of DHS surveys, latest available year included, Montagu, 2010 Source: World Bank/IFC (2011), Healthy Partnerships, How governments can engage the private sector to improve health in Africa
9 Lack of investment in the health sector
In one decade World Bank Group only invested $ 12M in Sub-Saharan Africa out of $ 12.8B WBG spending on health.
Size of IFC’s investments in health by region (loans and equity 1997-2007) (million USD)
266
109 98 95
12
Asia Lat Am Eur Middle E SSAfrica
Improving effectiveness and outcomes for the poor in health, nutrition & population, World Bank 2009
10 Low share of insurance coverage
Only 5.5% of total health expenditure in Africa is financed through health insurance
Percent of total health expenditure 50%
45%
40%
35%
30%
25%
20%
15% Social security funds as % of THE 10% Private insurance as % of THE 5%
0%
Togo
Niger
Benin
Kenya
Sudan
Congo
Ghana
Gabon
Liberia
Guinea
Nigeria
Zambia
Malawi
Gambia
Senegal
Burundi
Djibouti
Rwanda
Ethiopia
Namibia
Tanzania
Botswana
Swaziland
Cameroon
Mauritania
Madagascar
South Africa South
South Sudan South
Côte d'Ivoire Côte
Burkina Faso Burkina
Mozambique
Cabo Verde Rep. Verde Cabo
Dem. Rep. of the… Rep. Dem. of Centr. African Rep. African Centr. WHO Global Health Expenditure Database 2013
11 Our analysis: the vicious cycle of health
African health systems are stuck in a vicious circle of low demand, poor supply, and limited investments, because trust in the system is low and risks are (seen as) high.
12 The challenges
• Health is a (semi) public good, requiring large government intervention • Developping countries are in different stages of development • State capabilities are often limited. They have a lack of enforcement, a weak tax collection system and large informal sector • In such environments, the private sector is by default the main actor, also for the poor, but often neglected in development policies • Institutional failures result in high transaction costs • Low solidarity is a result: the rich are not paying for the poor
Without sufficient supply there is limited demand Without pre-payment there is no willingness to invest Without investments there is no health infrastructure development
13 How to turn a vicious cycle of health in Africa into a virtuous one?
Health insurance Research and Government and Institutions Loans Equity and savings Advocacy
Higher Financing
Demand Higher Trust Higher Supply Quality standards
Higher Delivery
Patients
mHealth Access to treatment mHealth
14 And today it is possible to include everybody at zero marginal cost
Vision: Digitalization will transform global health, poverty and development
Mission: Making Inclusive Health Markets Work
Addressing market failures in health
• Redistribution of income through trust, identification and enforcement • Address asymmetry of information and transparency of claims and data • Real time connecting demand and supply with zero marginal cost leading to reduced risk, increased investments and financial inclusion
15 Towards a virtuous cycle in a digital space connecting demand and supply real time
Health insurance Research and Government and Institutions Loans Equity and savings Advocacy
Higher Financing
Demand Higher Trust Higher Supply Quality standards
Higher Delivery
Patients
mHealth Access to treatment mHealth
16 Agenda
1. PharmAccess background 2. The daunting complexity of health 3. Facts on Health in developing countries 4. Kickstarting HCV Treatment Facts, challenges & step by step approach towards sustainability
17 Facts on hepatitis C* similarities and differences with HIV-AIDS
Epidemiology Transmission mostly through blood / contaminated • 60-80 million Hepatitis C patients worldwide (est.) (hospital) equipment Estimates are still very unreliable • Inadequate sterilized medical equipment • Leading cause of liver diseases • Unsafe injection practices • Mortality burden: 350,000 people die yearly of liver • Transfusion of blood and blood products cirrhosis or liver cancer due to Hepatitis C • Highest prevalence top 3: Egypt, Cameroon, Burundi (est.)
Pattern Prevalence • Infection mostly asymptomatic until decades • High prevalence linked to historical events/circumstances • 10 -30% cures spontaneous Mass treatment programs (e.g. Egypt, Cameroon) Intravenous drug use (e.g. USA) • Prevalence is dynamic with age group re time of infection
Dynamic course of HCV infection in the US
http://www.nature.com/nm/journal/v19/n7/full/nm.3184.html SOURCES: DR. M van der Valk (Internal medicine and infectious disease specialist AMC), WHO PanAfr Med J. 2013; 14:44, Lavanchy, Clinical Microbiology and Infection 2011 17, 107-115
18 HCV cure: opportunities & challenges in developing countries
Opportunities Challenges
• New DAA drugs have become available with • Slow registration of DAAs in LMICs, e.g. Africa exceptionally high cure rates (>95%) • Slow SRA quality approvals/WHO pre-qualification of generic DAAs • In 2000 HIV Aids treatment >10,000 USD/Yr • Limited access to diagnostics; need for genotyping, Now differential pricing mechanism of DAAs has leading to high costs – differential pricing for diagnostics been established for >100 LMIC’s is still not available HCV LIMC treatment prices are 900-1,200 USD • No funding mechanisms in place • Generic versions of DAAs for LIMCs are rapidly being developed – increased affordability of • HCV prevalence data scarce, e.g Cameroon treatment • Prevalence of 13.8 % but confidence interval between 0 and 40% (Pan Afr Med J. 2013; 14: 44) • New pan-genotyping HCV drugs are being • Experts say figures may be lower than initially thought; 1% developed, precluding expensive diagnostics among young adults rising to 10% among 55-59 years (National Demographic Survey)
• Where to find the patients? • Long asymptomatic period of patients • Risk groups are mostly historic (patients infected 15-25 years ago – age specific cohorts are dominant) 19 HCV treatment challenges in a glance
Mainly OOP or Government and Institutions Limited No Research and state driven - Slow registration and SRA / Pre Q procedures Loans Equity Advocacy - Prevalence data is unreliable - LIMC treatment results still scarce
Low
Demand Financing - No financing Supply mechanisms in + New DAA drugs at place low Risk Low affordable prices Quality - Historic - Diagnostics: low dependence on access / high cost Standards multi-lateral Low or absent grants
Low Delivery
Patients
No tested, standardized protocols for LIMC’s Finding patients is a challenge
20 HCV treatment – step by step towards a solution
1. Create common standards A. Hep-C protocol development for resource poor settings and data platform B. Design and implement a digital platform for doctors, patients and payers
2. Catalyze treatment: Create A. Treatment partnership: Contract leading clinics, labs and researchers public-private partnerships B. Access Partnership: Make available and procure drugs & diagnostics
3. Implement in an evidence A. Find and target patients: start with F3/F4 – discuss policy on F0-F2 based program B. Costing of the treatment: agree on treatment costs, co-payment and reimbursement
A. State of health financing: current policy, political will to engage, what is the economic effect to cure HCV? 4. Financing B. Select start up financing and provider payment model: public good approach, performance based or insurance?
21 1. Create common standards and data platform Coordinated clinical protocol for Hep C in LMIC
Activities started since Addis meeting in June Clinical Protocol (draft) • Hepatitis C antibody
Pre-treatment screen • Global network of specialists mobilized, e.g. • Patient information collection Pre-treatment • Leading hepatologists from Nigeria, Kenya, • information Physical exam Ethiopia, Senegal, Cameroon, Uganda • Complete Blood Count • Hepatic functional panel • Duke University, AMC, AIGHD, CHAI Pre-treatment • Creatinine/Calculated • assessment glomerular filtration rate (GFR) Chair: Roel Coutinho supported by • HCV RNA nucleic acid test (NAT) Andrew Muir, Susanna Naggie, Tobias • HCV Genotype Therapy • Test for hepatitis B & HIV Rinke de Wit, Marc van der Valk, Janke • Pregnancy test Schinkel Assessment after 4 weeks therapy • Adherence support • First site to test protocol in Cameroon with Assessment after 8 weeks therapy • HCV RNA nucleic acid test (NAT) Prof Njoya, Faculty of Medicine and Assessment after 12 • Adherence support Biomedical Sciences weeks therapy
• END OF TREATMENT Assessment 12 weeks post treatment • HCV RNA nucleic acid test (NAT) • Counselling
22 1. Create common standards and data platform Real-time mobile platform for patients, providers, and payers
Some characteristics of the treatment, research & payment platform • Evidence-based mobile platform for low-resource settings • Gain transparency into on the ground activities with health worker monitoring reports and linked supervisory apps • Register and track individual patients and access patient data online or via external database • Enable real-time payments ― performance- / outcome-based • Reach patients with targeted SMS tools that supports case management • Gain visibility into on-the-ground activities with real-time data & analytics • Online & offline, Android & Nokia Series 40, Integrates with web & SMS
23 2. Catalyze treatment: Create public-private partnerships A first example - Cameroon
Local partners
MINISTÈRE DE LA SANTÉ PUBLIQUE Prof Oudou Njoya Faculty of Medicine and Biomedical Sciences Professor of Gastroenterology
Operational partners
Implementing organisations & funders Investor Prof Roel Coutinho 1st 1000 treatments at a discount Professor of Epidemiology Impact Bond Chair Medical Board PharmAccess
24 3. Implement in an evidence based program Example of Cameroon
Patients Drugs Doctor Financing >500 patients ready for Harvoni , generic 6 clinics/doctors PharmAccess and JLI immediate treatment sofosbuvir (Mylan), willing to join forces Outcome payer (TBC) ribavirin
Regulatory Diagnostics Protocol Quality Government signed Institute Pasteur ready submitted by Prof Njoya WHO pre-qualification MOU, committed to for all lab work based on PharmAccess generic sofosbuvir national approach standard expected by Q4
Essential elements in place to start by December 2016
25 4. Financing State of HCV health financing: current policy, political will to engage, what is the economic effect to cure HCV?
Characteristics of treatment cost and financing of elimination strategies
Some financing options • Public good financing models focus on centralized purchasing and reducing transaction cost • Insurance models cater for pre-payment and risk sharing in the population reducing risks and enabling investments • Performance based options can catalyze treatment by taking out the execution risk as payers only pay for outcome • Impact bonds pre-fund treatment costs and Financing risk of execution and treatment cost is at the are repaid based on outcomes / cures payer / patient – benefits follow later • Suppliers for drugs and diagnostics in future to be reimbursed on outcomes?
26 4. Kick-starting a sustainable approach Example: the HCV impact bond
Investor Attractive intervention: • Straight forward intervention (treatment
Administrator protocol) with potential for scale • Causal relationship between intervention Implementing Outcome Payer Organization and outcome
Attractive outcome: • Simple outcome metric: SVR sustained Service Service Service Evaluator provider provider provider virological response • Causal relationship between outcome and future government savings
Target population Attractive Investment • Short intervention cycle (12+12 weeks) Funds Conditional Service Data payment • High cure rates (>95%)
27 4. Kick-starting a sustainable approach Stepwise approach: test and scale in Cameroon
Phase 1: Test (pending final approvals) Phase 2: roll out Set up operational, administrative and Government (potentially in combination with donors) contractual structure for first HCV impact bond join as outcome payers Proof and fine-tune concept and structure Outcome investors provide short/medium term capital Collect input/data to structure for roll out for roll out Advocate to attract players for roll out International Fin. Institutions provide long term capital to secure outcome payments
JLI Outcome International Fin Institutions Investor Investors e.g. Hep C Fund, DFIs?
Administrator Administrator
PAI + local PAI DEF MoH, Donors partner IO Donor Outcome Payer Outcome Payer IO
Dr. Njoya Dr. Njoya
Service Service Service CPC Service Service Service CPC provider provider provider Evaluator provider provider provider Evaluator
150 HCV patients [#] HCV patients Target population Target population
Funds Conditional Service Data payment 4. Kick-starting a sustainable approach Phase out grants, reduce prevalence
Bond model 12.000.000 0,90%
0,80% 10.000.000 0,70%
8.000.000 0,60%
0,50% 6.000.000 0,40% Minus 4.000.000 0,30% 91.4%
0,20% 2.000.000 0,10%
- 0,00% 0 1 2 3 4 5 6 7 8 9 10 Grants Investment Outcome payment Prevalence Rate without Intervention Prevalence Rate with Intervention
29