1. Introducing New POC Devices in National Programs: Focus on Early Infant Diagnosis July 2014

2. 2 Gradualism vs. Punctuated Equilibrium: Status quo vs. Near term advances? Miguel Chavez, 2008, http://en.wikipedia.org/wiki/File:Punctuated- equilibrium.svg

3. Agenda 3 Product Selection Methodology Country Case Studies Site Selection Implementation

4. Why is a product selection process necessary? 4 Comprehensive product information –Historically, in the diagnostics sector, decision-makers have lacked sufficient information to make fully informed product selection decisions - –Suppliers provide MOHs with extensive marketing materials, but they often lack comprehensive and unbiased information to pick the products that are most appropriate for their countries Public procurement principles –Public funding requires that public procurement principles be observed in the procurement of commodities. MOHs have an obligation to demonstrate that a rational and transparent process has been followed to select products for procurement. There is a role to play for neutral 3 rd parties to facilitate the development of a rational and transparent product selection process.

5. Key Principles of Product Selection: 5 1.MOH-led 2.Involvement all key stakeholders to drive consensus 3.Rational and transparent criteria 4.Good documentation of the process 5.Allow flexibility for each country to customize according to its needs 6.Be an iterative process

6. Select products for Pilot/scale-up Select products for evaluation Site selection tool Product selection tool Selection tools can play an important role but the overall process is important for sound and transparent decision making 6 Convene TWG Conduct evaluations Review product information Convene TWG Review evaluation results Pilot/Scale-up Product selection tool

7. Facilitation of the product selection process has included both quantitative scoring and qualitative discussion among MOHs, TWGs, etc. 7 Determine key criteria o Determine the most important ~5 – 10 criteria when selecting POC products o Discuss how these criteria should be weighted against each other in each segment o Determine if any of these is critical i.e. must be met (e.g. connectivity or electricity-free) Review product pipeline and assign scores to products o Review all available information for each product o Assign scores for each of the products for the criteria determined in step 2 Select POC products o Review scores for each product in the various segments o Hold discussions across all stakeholders to consider scores and other relevant factors o Select products for evaluation and/or scale-up o Repeat process periodically to include new products and new information Understand current testing landscape o Understand the current gaps in testing coverage in the country:  What segments have the poorest access to testing?  At what level of the health system do most patients seek care?  Which segments of the health system would be best served by POC? 1 2 3 4

8. Agenda 8 Product Selection Methodology Country Case Studies: Product Selection Site Selection Implementation

9. Case Study: Uganda CD4 POC 9 Attendance: Central Public Health Laboratory (CPHL/MOH), SURE (USAID), CHAI Understand current testing landscape for CD4 o CHAI presented on the current access to on-site testing in Uganda o The group focused on:  Largest segments where patients seek HIV care and treatment  Segments with poor access to on-site testing 1 Determine key criteria for CD4 POC selection o The group identified all the factors that should be considered when selecting POC o The top 10 criteria were determined o The group discussed the percentage weights to be given to each criteria: 2 Performance Criteria>0 and <=5>5 and <=10>10 and <=20>20 Tests Offered 5%10% Quantitative/Semi-Quantitative 5% Device/Device-Free5% Throughput 15%25% Power Source20% 10% Connectivity10% 20%15% Device Cost20% 10%5% Reagent Cost10% Ease of Use15% 5% After-Sale Support20% 15%

10. Case Study: Uganda CD4 POC 10 Review product pipeline and assign scores to products for CD4 POC o CHAI presented the available information on each of the products o The group discussed features and advantages of each of the products o The group determined scores for each of the products against each of the 10 criteria 3 Product profiles Product 1Product 2Product 3Product 4Product 5Product 6Product 7Product 8 Tests Offered1.0 5.01.0 2.0 Quantitative/Semi- Quantitative 5.0 1.05.0 3.0 5.0 Device/Device-Free1.0 5.03.01.0 3.01.0 Throughput1.22.14.7 3.52.1 3.5 Power Source1.0 5.01.0 5.01.0 Connectivity5.0 1.05.01.0 5.0 Device Cost1.02.25.03.41.04.74.02.2 Reagent Cost3.91.05.0 3.91.0 3.9 Ease of Use5.04.53.32.74.52.71.04.5

11. Case Study: Uganda CD4 POC 11 Select CD4 POC products o The tool provides scores for each product in each segment o The group discussed the resulting scores: o Which products scored best in each segment? o Were the results expected? If not, what was missed? o What additional data is required to improve the accuracy of the scores? o Are the differences between various top scoring products significant? o How many products are needed in the country? o The group, led by MOH, documented its selections with formal meeting minutes o The group made plans to repeat this process in the future 4 Product Scores Product>0 and <=5>5 and <=10>10 and <=20>20 Product 13.1 3.32.9 Product 22.2 2.62.3 Product 34.3 3.73.6 Product 42.6 3.23.3 Product 52.6 3.03.3 Product 62.4 2.11.9 Product 72.9 2.2 Product 82.5 3.23.0

12. Agenda 12 Product Selection Methodology Country Case Studies: Product Selection Site Selection Implementation

13. Select products for Pilot/scale-up Select products for evaluation Site selection tool Product selection tool Hand in hand with product selection, appropriate deployment is critical to successful utilization of POC devices 13 Convene TWG Conduct evaluations Review product information Convene TWG Review evaluation results Pilot/Scale-up Product selection tool

14. There is a sweet spot for sites where laboratory based and POC testing make economic sense based on throughput, cost and complexity Actual share of the market will depend on: 1.Country preference Leverage current laboratory based platforms? 2.Price points for device/reagents Cost of POC test vs laboratory based + sample transport 3.Throughput of POC/near-POC # of machines required to meet patient need vs. burden on health workers 4.Guidelines on DBS Without DBS, laboratory based may not be able to reach peripheral sites Highest volume sites Lowest volume sites Suited to laboratory basedSuited to POC

15. Criteria Provincial Hospitals District HospitalsHealth CentersTOTAL >10 Tests per Day 1%8%2%11% 5-10 Tests per Day 2%6%3%11% 2-5 Tests per Day 1%5%8%14% 1-2 Tests per Day 0%5%11%16% 0-1 Tests per Day 0%7%41%48% TOTAL 4%31%65%100% Site-level data can be used to identify gaps in testing coverage and target opportunities to use POC to maximize linkage to treatment 15 Market Segmentation by facility level and EID sample volumes Most sites test only 0-1 patients per day. Some combination of district hospitals and health centers with extremely poor access may be the best use cases for EID POC. Note: This is sample data from an analysis of 3 high HIV-burden countries in SSA and assumes each HEI should get 2 DNA-PCR tests.

16. Key Principles of Site Selection 16 1.MOH-led 2.Involvement all key stakeholders to drive consensus 3.Should be driven by the country’s unique diagnostic testing priorities, including such factors as: a.Patient volumes b.Access challenges (low-volume sites with long turnaround times and/or sites that are located far from centralized testing labs) c.Alternative entry points for testing (i.e., pediatric wards for EID) 4.Well documented

17. CHAI has developed a tool and guidance to aid in identifying the sites best suited for POC 17 Determine parameters for key criteria The following criteria for scoring sites can be weighted as per country preference: 1. Price per test – preference given to sites where cost per test on POC is the lowest 2. # of patients covered – preference given to sites with a large number of patients 3. “Distance from hub” or “Current turnaround time” – preference given to sites farther away or with long turnaround times Score and select sites for POC placement In the CHAI tool, sites are given three scores based on above criteria and can be selected for POC placement of: 1. “EID only” – If POC is used only for EID 2. “VL only” – if POC is used only for VL 3. “Both EID/VL” – If POC is used for EID and VL The tool suggests the best suited product for each site selected, as well as the total cost in first year and annual reagent cost and the impact on coverage for EID and VL. Understand current testing landscape o Understand the current gaps in testing coverage in the country:  What segments (types of health facilities) have the poorest access to testing?  At what level of the health system do most patients seek care?  Which segments of the health system would be best served by POC? 1 2 3

18. Site Selection: Countries map all sites by key criteria and select sites most appropriate for POC diagnostics deployment based on country priorities Mozambique: Key criteria used to select sites most appropriate for POC diagnostics deployment Key criteria Availability of onsite CD4 Patient volumes at each site Distance from a regional lab ART coverage rate CD4 coverage rate HIV prevalence Road quality Country Priorities Prioritizing more remote within each province Kenya: Mapping sites by district to prioritize for POC diagnostics deployment based on key criteria Potential key criteria Patient volumes Access to labs Others

19. Agenda 19 Product Selection Methodology Country Case Studies: Product Selection Site Selection Implementation

20. Malawi Task force formed by MOH in February 2012 to draft strategy Strategy was for CD4, EID, VL, chemistry, hematology, opportunistic infections such as TB, etc. Strategy defines POC, provides guidelines and criteria for selecting products and sites for deployment, and encourages “competition in the marketplace Includes a roadmap for product-agnostic systems for training, quality assurance, supply chain and distribution, service and maintenance, data management, and M&E Strategy approved in June 2012. Implementation guidelines: Driven by country’s overall plan Point-of-Care Implementation Guidelines Directing Scale-up of Point-of-Care Testing for HIV-related Diagnostics in Malawi June 2012 Point-of-Care Implementation Guidelines Directing Scale-up of Point-of-Care Testing for HIV-related Diagnostics in Malawi June 2012 GOVERNMENT OF MALAWI MINISTRY OF HEALTH

21. Implementation: A number of processes required for new products 1 Product/Site Selection 2 Procurement/ Tendering 3 Training 4 QA/QC 5 Patient Flow 6 Data Management 7 Data Analysis 8 Mentoring/s upervision For effective POC testing, product agnostic systems are needed Objective selection criteria Transparent process Volume discounts and leasing Service and maintenance Standardized sample collection Systems training on clinic workflow Participation in global EQA schemes Daily internal controls Timing of ART and OI treatment Patient movement through services Open data systems to manage devices Data transmitted remotely by modem Tracking volumes for forecasting Program mgmt with real time data Regular site level follow up Problem solving w/ real-time data