Making Interventions Scalable and Cost-Effective Benny Kottiri USAID MTN Meeting Cape Town, October 6, 2015
Programmatic Context UNAIDS Targets for 2020 90-90-90 PEPFAR Targets for 2017 DREAMS – 40% reduction in HIV incidence VMMC – 13 million (cumulative) ART – 18.5 million (jointly with other efforts) New WHO Guidance, September 2015 Treat ALL – all adults living with HIV (at any CD4) PrEP as a prevention option for people at substantial risk of HIV 2
ART Scale-Up: What We Need to Achieve Total Need 36.0 Know Status 16.0 2013 12.9 2012 9.7 2011 8.0 2010 6.6 2009 5.3 2008 4.1 2007 3.0 2006 2.0 2005 1.3 2004 0.7 2003 0.4 2002 0.3 0 10 20 30 40 Millions of Individuals Global Report. UNAIDS Results Report 2014.
Critical interventions have historically faced slow uptake and low coverage Global Health Scale-up Illustration 1 100% Typical Pharmaceutical ILLUSTRATIVE Company U.S. Drug Launch % of target utilization Global health launches face Skilled Birth Attendance DOTS many challenges: ORTs HBV Vaccine 50% • Often take decades to reach significant numbers of end-users • Disproportionately affects the poor • Successes to learn from – child mortality has been cut in half over Hib Vaccine the past decade 0% 0 4 12 16 20 24 28 8 Years from availability 1) Adapted from Bill & Melinda Gates Foundation and Boston Consulting Group analysis
Integrated Delivery – Theoretical Model Introduction Roll out continues iteratively throughout the program Implementation Continuing activities Year 0 1 2 3 4 10 Sustainability Upfront introduction & scale-up with sustainability in mind Scale-up Upfront introduction with scale-up in mind Continuing activities Institutionalization Upfront introduction , implementation & scale-up with institutionalization in mind 0 1 2 3 4 10 Year Learning: Program monitoring, Knowledge Management & Research Courtesy - Rashad Massoud, URC, 2014
Product R&D, Introduction and Field Implementation Courtesy – Neal Brandes, USAID
Oral PrEP- Implementation Timeline
From Trial World to Real World • Provided to trial participants and, sometimes, their communities, after trial & Post-trial access before product is available for widespread use Open label • Available in follow-on protocol in which participants from previous RCT know extensions they are receiving active intervention • Product use in people who are aware of potential benefit Open label/ Implementation • Protocols similar to above but enrolling new participants studies • “Road test” use of new option in real-world settings – not in trial site Demonstration • Can address both infrastructure needs to deliver intervention and ways projects individuals integrate it into daily activities and decision making. • Can help answer core questions about for whom and how Product • Complex process of formally making new options widely available. Can introduction include meeting regulatory requirements, WHO prequal, various country- specific requirement, logistical challenges • Ramping up access to new options for all who need them – mobilization of Scale-up resources for procurement, distribution, delivery, worker training and costs associated with rollout; quick ID and resolution of bottlenecks Courtesy – Mitchell Warren, AVAC, 2015
PrEP Demonstration Studies (AVAC Map, 2015)
Applications of Demonstration Project Data Developing and testing adequacy of intervention Assessing whether the intervention is realistic and workable Identifying near-real-world implementation issues Assessing the feasibility of scaling up Collecting preliminary data on cost and cost-effectiveness Determining resource needs (finance, staff, systems) Assessing initial steps toward program integration Trying out innovations and novel delivery approaches Convincing stakeholders that the intervention is feasible
The Cost of Adding PrEP to ART Services The cost of adding PrEP to HIV services Total cost per Incremental Estimated Number couple cost of PrEP additional cost Program Change of including addition per of integrating Couples PrEP Couple one year of Baseline 769 $1,058 $408 PrEP into With public-sector staff salaries 769 $1,005 $370 current With reduced medication cost 769 $720 $254 programs at With fewer laboratory tests† 769 $497 $101 public health prices = $92 With task-shifting 1111 $453 $92 300 Incremental Cost per Couple 250 200 The incremental cost declines as (USD) 150 more couples are serviced by the 100 public health system 50 0 Number of Couples at Month 12 Ying et al. (Partners’ Demo), JIAS 2015
IDEA TO IMPACT designed to support better planning for introduction and scale The “GUIDE”: • Framework Overview IDEA TO IMPACT • Priority Activities • Case studies • Project Management tool Practitioner’s • Track progress and increase Workbook coordination • Dynamic set of examples and Toolkit templates for many of the priority activities www.usaid.gov/cii
All activities are iterative throughout STAGE 3 STAGE 1 STAGE 2 STAGE 4 Identify Begin Plan for Introduce Needs and Research & Introduction & Scale Design Development Evaluate market feasibility Develop and execute an Monitor execution Define problem and design and potential for scale and optimize requirements operational launch plan Market and user understanding Manufacturing and distribution Policy and advocacy Clinical and regulatory
Activity-level details across four stages
Bottleneck analysis: tool developed to assess country-specific product uptake challenges… PRODUCT PROFILE / PROCUREMENT DISTRIBUTION DELIVERY / ADOPTION MANUFACTURING • Efficacy and • Public/donor purchaser’s • Geographic access • End users’ awareness, acceptance, effectiveness awareness, acceptance, willingness ‐ Public channel willingness to pay and adherence • Ease of use to pay ‐ Private channel • Awareness and acceptance of ‐ Side effects • Inclusion in, and specificity of, ‐ Nonprofit and faith‐ influencers: ‐ Reactions with WHO guidelines based organization ‐ Family Demand other treatment • Inclusion in and clarity of national channel ‐ Opinion leaders, cultural • Ease of administration EML and guidelines (and norms ‐ Toxicity risks subnational, as applicable) • Referral system and practices, • Cost‐effectiveness • Recency of guidelines update including attrition • Effectiveness of inventory • Use and clarity of community‐based tracking, quantification and case management procurement • Consistency between de facto practice and national guidelines • • • • Permitted level of facility to stock Ease and quality of Demand characteristics Profit opportunity for supply • Permitted level of health care production ‐ Fragmentation chain actors, such as: • Availability of inputs ‐ Consistency vs Fluctuation ‐ Distributor provider to administer • • Health care providers’ (and Storage and cold chain ‐ Clarity/Certainty ‐ Retailer • • requirements Registration process for new Availability (vs stockouts) professional associations’) • Required accessory suppliers ‐ Public channels awareness, acceptance and • products (e.g., sterile Intellectual property landscape ‐ Private channels confidence to administer, including Supply • water, syringes, etc.) Quality of available products ‐ Variation by facility level possible wastage concerns • • • Proportion of providers with Required training of Adequate procurement of ‐ Availability of required providers accessory products (e.g., accessories adequate training (by cadre as • Production cost (COGS) syringes) ‐ Supply chain performance: applicable) • • Manufacturing Purchaser reliability (e.g., infrastructure, planning, margins/profit payment timeliness) data management, etc. • • Manufacturing capacity Contracting terms (e.g., timelines • Availability of suppliers for delivery) • ‐ Current and Management of product potential donations ‐ Opportunity for local production 15
Healthy Markets For Global Health: A Market Shaping Primer 1 The Primer presents a flexible, five-step framework… 2 3 …and match potential …to identify 5 major market shortcomings… interventions to the market inefficiencies they address. A Pragmatic, Flexible Approach Affordability To Shaping Healthcare Markets Reduce Transaction Costs • Created in partnership with technical experts Availability across health sectors, disciplines and organizations including CHAI, DFID, BMGF, Increase Market RHSC, GAVI, UNICEF and others Assured Quality Information • Draws on examples from HIV, malaria, family planning, immunization and other health Appropriate Design sectors Balance Supplier & • Incorporates input and best practices from Buyer Risks practitioners at USAID Awareness
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