Have new initiatives to improve availability made a difference?

Transcription

1 Have new initiatives to improve availability made a difference? Evidence from the ARV field on changes in the pediatric medicines market Brenda Waning WHO/UNITAID 5 November, 2010 American Society of Tropical Medicine & Hygiene Meeting Atlanta Slide 1

2 Presentation Objectives Provide background to pediatric HIV/AIDS treatment scale-up Present research revealing success & ongoing challenges in the development, production, and uptake of pediatric formulations for HIV/AIDS Suggest how lessons learned from HIV/AIDS experience might be relevant for pediatric malaria and other diseases Slide 2

3 Provide background to pediatric HIV/AIDS treatment scale-up Page 3

4 Overview of Pediatric Scale-up* Lots of recent progress, but many more children still need treatment Total # childre en in need of ART 1,500,000 1,000, , % of 1,270, ,000 10% of 660,000 38% of 725,000 66, , , , , # children in need of ART # children on ART *Source WHO and UNAIDS HIV/AIDS Annual Update Reports Compared to ~ 52% (5 million) coverage of 14 million adults in need 2009 (36% coverage using 2009 WHO STG) Slide 4

5 Pediatric HIV/AIDS Scale-Up lags Behind Adult Some reasons for low scale-up include: Health systems issues in identifying HIV+ infants & children Complicated infant HIV diagnosis & high loss to follow-up Lack of innovation and development of pediatric ARVs thought to play a major role in low scale-up Insufficient # of ARV treatment options - limited research to support pediatric ARV use Inappropriate dosages Inappropriate formulations Slide 5

6 Lots of Pressure Applied to Manufacturers to Develop & Produce Pediatric ARVs Examples of international efforts: 2000 onward Médecins Sans Frontières advocacy campaigns 2004 UNICEF/WHO Technical Consultancy 2005 Unite for Children, Unite Against AIDS st WHO Model Essential Medicines List for children 2007 Make Medicines Child Size Slide 6

7 Present research revealing success & ongoing challenges in the development, production, and uptake of pediatric formulations for HIV/AIDS Page 7

8 UNITAID s Pediatric HIV/AIDS Project In partnership with Clinton HIV/AIDS Initiative (CHAI) Disbursed >$ 235 million since 2006 Pooled procurement of pediatric ARVs for 40 countries Assurance of funding and good customer purchases provided incentives for manufacturers to develop new pediatric products Lots of dialogue with industry on volume estimation, etc. On-the ground efforts to incorporate new products into programs ~ 3/4 children on treatment are funded through UNITAID Substantial price reduction and 5 new formulations Slide 8

9 Boston University Database Overview* Multi-Source Data on Market, Policies, STG Multi-Source ARV Transactional Data Disease burden & coverage WHO Prequal. FDA GFATM PQR WHO GPRM CHAI/ UNITAID SCMS Manufacturers; Procurement agencies; Drug Regulatory Authorities Create ARV Product Intelligence MSF CHAI Combine all ARV Transactional Data WHO Treatment Guidelines IMF and World Bank Merge ARV Product Intelligence and ARV Transactional Data remove duplicate transactions limit to pediatric formulations remove transactions with invalid product remove transactions with invalid price Final dataset of ARV market intelligence with 7,989 pedi ARV transactions Slide 9 *Waning et al. Global Pedi ARV Market; BMC Pediatrics 2010;10:74

10 Most Pedi FDC ARVs have only 1 quality-assured supplier Number of manufacturers certified & reported to supply each pediatric ARV fg 6 mfg 7 mfg 8 mfg 1 mfg 2 mfg 3 mfg 4 mfg 5 mf Reported WHO/FDA Reported WHO/FDA Reported WHO/FDA Reported WHO/FDA Reported WHO/FDA Reported WHO/FDA Reported WHO/FDA Reported WHO/FDA FDC formulations: 6 with 1 manufacturer 2 with 2 manufacturers 1 with 3 manufacturers solid single liquid solid & dispersible FDCs *Waning et al. Global Pedi ARV Market; BMC Pediatrics 2010;10:74 Slide 10

11 WHO Priority Pediatric ARVs* Demand signals to manufacturers Manufacturers invested in development & production of some early WHO-recommended pedi ARVs whose doses were almost immediately changed, dropped from the list, and no longer purchased # WHO priority AR RVs Slide 11 *ARVs recommended on WHO treatment guidelines & priority lists Waning et al. Global Pedi ARV Market; BMC Pediatrics 2010;10:74

12 Very few countries report pediatric ARV FDC purchases outside UNITAID UNITAID 2009 MISC SCMS GFATM UNITAID Liquid Solid Single Solid FDC Dispersible FDC 2008 MISC SCMS GFATM # Countries Reporting Purchases of Pediatric ARV Dosage Forms 2009 reporting incomplete *Waning et al. Global Pedi ARV Market; BMC Pediatrics 2010;10:74 Slide 12

13 UNITAID accounts for nearly all pediatric FDC ARV purchases 2009 Market share (volume) by funder/purchaser* ABC 60mg / 3TC 30mg 3TC 30mg / d4t 6mg 3TC 60mg / d4t 12mg 3TC 30mg / ZDV 60mg 3TC 30mg / NVP 50mg / d4t 6mg 3TC 60mg / NVP 100mg / d4t 12mg 3TC 30mg / NVP 50mg / ZDV 60mg LPV 100mg / RTV 25mg 0% 20% 40% 60% 80% 100% GFATM SCMS UNITAID Misc Page 13 *Waning et al. Global Pedi ARV Market; BMC Pediatrics 2010;10:74

14 Pediatric FDCs are cheaper than liquids but can be more expensive than other alternatives 2009 Price comparisons (price/person/year in USD) ARV Liquid Pedi FDC Part of Adult FDC ABC60/3TC TC30/d4T TC60/d4T TC30/ZDV LPV100/RTV TC30/NVP50/d4T TC60/NVP100/d4T TC30/NVP50/ZDV Page 14 *Waning et al. Global Pedi ARV Market; BMC Pediatrics 2010;10:74

15 Differentiating need from demand * 1.27 million children with HIV/AIDS in need of treatment? How do we best estimate REAL demand 356,00 children on treatment. How do we best measure actual # countries & children using ARVs? Need Perceived Demand Realized Demand What are the factors that prevent or delay those in need from accessing new products? Countries unaware of new products; Reluctance to use new products; Regulatory barriers; Registration costs & issues; Need to revise guidelines & retrain staff & caregivers; Long-term purchase contracts; Minimum volumes for purchase; Supply chain difficulties; Long lag time to switch products More expensive than alternatives Page 15 Framework adapted from Yadav & Kopczak 2010

16 Suggest how lessons learned from HIV/AIDS experience might be relevant for pediatric malaria and other diseases Page 16

17 Lessons learned (1) Lots of disincentives for manufacturers to develop & produce pediatric medicines May require additional research Need to invest in development technology Low & unpredictable volumes Slide 17 Improvements in PMTCT will reduce demand Large transaction costs for selling Low margins on generic products Expected revenues < Expected Costs where revenue = price x volume The more a manufacturer tailors a medicine (dose, formulation, etc.) & the more regimens/products recommended by WHO, the smaller the market

18 Lessons learned (2) Even if we provide the right incentives for manufacturers, availability of better products does not ensure uptake and access Need to understand & address country barriers to uptake Need better estimation of uptake: need not demand & need to monitor uptake regularly WHO treatment guidelines & priority lists must take into account market considerations to avoid excessive market splintering & development of unused products Malaria presents even more challenges than HIV/AIDS Lower volumes due to short duration of treatment Most treatment is in retail sector consumption unknown and harder to coordinate with producers Slide 18

19 Thank you. Especially to MMV. Acknowledgements United Kingdom Department for International Development for funding. Boston University School of Medicine Research team Reference Slide 19 Waning et al. Global pediatric antiretroviral market: challenges in product development and country uptake. BMC Pediatrics 2010;10:74. Contact information Brenda Waning Coordinator, Market Dynamics WHO/UNITAID