Vision and strategies to Increase Access to Innovative HIV Diagnostic Technologies. Willy Urassa. AMD STAKE HOLDERS MEETING 7-8 May 2013

Transcription

1 Vision and strategies to Increase Access to Innovative HIV Diagnostic Technologies Willy Urassa 1

2 Outline Definition Introduction Vision Broad strategies Progress so far Recent experience 2

3 Expansion of HIV case management through ART has far outpaced access to diagnostic monitoring of HIV patients in RLS 3

4 HIV testing menu Make initial diagnosis of HIV infection (Antibodies/Antigen, DNA (Early Infant Diagnosis), Vaccine Induced Seroreactivity (VISR) Assess eligibility for ART initiation (CD4 testing, VL) Monitor treatment response (VL, CD4, HIV Resistance, Toxicity) Opportunistic Infections Surveillance (HIV incidence assays) 4

5 The life span of a Diagnostic test Product development Product registration Patient/Client Testing Appropriate product selection, financing, validation studies Premarket assessment followed by registration Correct placement, Functional Lab HS, QA, Post market surveillance (PMS) 5

6 What is the missing link Lack of appropriate tests at each level Complexity, affordability, Conducive testing environment, sample collection and transportation Weak laboratory health system Poor Infrastructure (VCT centers) Lack of Strategy for Training and Retention of Personnel (negative impact of incentives) Lack of Quality Assurance Testing Lack of Referral Laboratory Network [e.g. role of Reference Laboratory testing, (training, supervision, QA)] Vertical nature of National programs (HIV, Tb, Malaria) Lack of Regulatory Framework for IVD ( In-country registration, regulation and validation for these technologies, PMS) 6

7 Vision To make available accurate, easy to operate, and affordable HIV tests at all levels of health care for Patient management (Serology, CD4, IED, VL, RT and Monitoring toxicity) Prevention Surveillance 7

8 The Current situation of HIV laboratory testing LEVEL I LEVEL II LEVEL III/IV Assays HIV Serology Yes Yes Yes RTD, ELISA, WB (QA, Algorithms) CD4 None Yes Yes POC, dedicated, classical FC, QA Viral Load NA None Yes Lab based PCR EID NA None Yes Lab based PCR Toxicity None Yes Yes Lab based Bioch, Heam Opportunistic Infections None Yes Yes Simple and lab based HIV resistance NA NA None? Lab based Yes: technologies are available but coverage is not adequate 8

9 The ideal situation of HIV testing LEVEL I LEVEL II LEVEL III/IV Assays HIV Serology Yes Yes Yes Rapid assays, ELISA, WB VISR CD4 testing NA? Yes Yes POC, dedicated, classical FC Viral Load NA - Yes PCR, medium, POC EID NA - Yes PCR, medium, POC Toxicity - Yes Yes Lab based Bioch medium, POC Opportunistic Infections - Yes Yes Simple and lab based medium, POC HIV resistance NA NA Yes PCR, medium, POC Yes: technologies are available but coverage is not adequate 9

10 Broad Strategies - 1 Definition: A plan of action intended to accomplish a specific goal Develop appropriate tests for low and high prevalence areas (POC, Load-and-Go for CD4) Disease prevalence and infrastructure must be considered during the development of appropriate diagnostic interventions. Define what is required: (Scientist community including WHO) Provide Funding to support innovation, release, price negotiation Develop thermostable controls and reagents Consider: Specimen collection, sample stabilization and robust data collection 10

11 Example of Point-of-care testing Provide same-day results Decrease loss to follow-up Allow early identification of treatment failure Reduce cost to patients. May have short half-life QA/QC oversight is challenging. Equipment maintenance and service is difficult, Increase workload health care workers Supply-chain logistics of reagents and supplies Generally low throughput testing and may not be cost-effective Does not eliminate the need to improve/ strengthen lab systems Where should we place POC tests? 11

12 Broad Strategies (cont.) Establish National Quality Assurance programs Internal quality Control Establish National EQA Scheme Establish SOPs Establish National testing algorithms Create conducive environment to introduce the tests Strengthen IVD Regulatory framework (WHO, IMDRF) PMA, in-country registration, PMS 12

13 Strategies (cont.) Strengthen laboratory health systems (Training, Personnel, maintenance,) Data reporting. Establish Laboratory Information System Instrument connectivity (Investment in cellular networks to permit data exchange of results between various levels,. Integrate Disease programs in General Health Care Services 13

14 Progress: Funding Funding development of POC tests available for few technologies Engage with suppliers to accelerate market entry and negotiate pricing Conduct operational research to support normative guidance on the impact, cost-effectiveness, and appropriate use of POC Support national planning processes for introduction of POC 14

15 Progress: WHO PQ Seen an incremental number of Product prequalified Need to widen the scope? Working with manufacturers of innovative products Streamlined the PQ process Strengthening Regulatory capacity of diagnostics in member states (5 pilot countries) Regulations Batch testing Provide Normative guidance (TWG meeting for POC CD4 Technologies: 6-7 May 2013) 15

16 Streamlined PQ process for Innovative technologies 16

17 Progress: Summary Appropriate selection, financing, validation studies Verification studies, Registration Correct placement, Functional Lab HS, QA, PMS Product development Product registration Patient/Client Testing Moderate progress in CD4, but not VL, resistance testing IED, Toxicity, VISR Scope of PQ, No NRA, Weak LS, QA, No Post Market Surveillance, 17

18 A lot more need to be done!! Develop and introduce appropriate diagnostic tests in all levels Strengthen Laboratory Health System (QA, personnel, referral etc.) Establish Supportive National systems (Health services integration, regulatory framework, maintenance etc.) 18

19 Changes may be slow: Recent example? Mission July 2011: Broken un-serviced CD4 instruments, expired reagents, vertical systems, No functional laboratory network, no QA, unmotivated staff: 7 strong recommendations Mission July 2012: Instrument serviced: still No CD4 testing in the whole country: Training of 22 Lab techs Mission April 2013: 2/7 recommendations implemented, 2 instrument providing services, Serious plans to: integrate, establish QA, redistribute the instruments according to needs, identify Reference laboratory, thinking about VL, IED, resistance testing, monitoring test, etc. 19

20 The Day has just started and there is a lot more to be done before we finally rest!!!. Thank you for your attention 20