Background to Medicines for Malaria Venture & the Antimalarials Pricing Study in Uganda Pricing Seminar, Kampala 28th Sept 2007

Transcription

1 Background to Medicines for Malaria Venture & the Antimalarials Pricing Study in Uganda Pricing Seminar, Kampala 28th Sept 2007 Renia Coghlan, Associate Director Global Access, MMV

2 Medicines for Malaria Venture (MMV) at a glance A nonprofit organization with a mission to Discover Develop Deliver safe and effective antimalarials Operating model: Effective public-private partnerships Diversified funding base: Government agencies, private and corporate foundations, international organizations, corporations, Largest-ever pipeline of antimalarial drugs Over 30 projects ranging from discovery stage to Phase III

3 MMV Portfolio 1 st Q 2007 Exploratory Discovery Preclinical Development Regulatory Lead Lead Identification Optimization Phase I Phase II Phase III PSAC antagonists Novel Liver Stage Antimalarials Next Generation OZ Tafenoquine Chlorproguanil - dapsone (Lapdap ) - artesunate (CDA) Pf enoyl-acp reductase (Fab I) Immucillins Dihydrofolate reductase (DHFR) Isoquine (an improved aminoquinoline) Coartem Dispersible Tablet Natural Products Whole-Cell HTS TDR22093 Series 4(1H)- pyridones Back ups Dihydroartemisininpiperaquine 4(1H)- pyridone GSK DHA + PQP Novartis Institute for Tropical Diseases Collaboration mini-portfolio 9 active projects Falcipain (cysteine protease) MK-4815 Pyronaridine Artesunate PYRAMAX Broad Institute of MIT/Harvard Genzyme Collaboration miniportfolio 5 active projects Novel Macrolides Intravenous Artesunate Natural Products as New Prototypes Dihydroorotate dehydrogenase inhibitors Project in the GSK mini-portfolio Projects under contract negotiation Unfunded approved projects Project Success Rates at each Phase 30% 65% 55% 55% 70% 50% 65% 95%

4 Why did MMV get involved in Access? Four products supported by MMV likely to enter the market in next few years Coartem dispersible DHA PIP Pyronaridine Artesunate Lapdap Artesunate But the market often fails to deliver drugs to the poor Our products will only achieve health impact if available Immediately when needed At the right price At the right place With the right information iv artesunate?

5 MMV Access strategy is designed to address key challenges Access Objectives 1. Support adoption of appropriate MMV products at international and national levels Key activities 1 Collect and analyze information 2. Help expand the reach of MMV products beyond existing ACT delivery channels in a responsible manner 3. Help shape MMV product development based on market insights 2 Build awareness and advocate 3 MMV product support

6 Focus of MMV s Access Activities Objectives 1 Collect and analyze information A B Help expand C Support adoption product reach Map regulatory and policy processes Identify barriers to rapid uptake Focused market research Supply and pricing surveys in informal sector Studies of treatment behavior Shape product development Gather market data to feed back to future target product profiles and packaging Demand forecasting Assess impact of OTC rescheduling Activities 2 Build awareness and advocate Information meetings with policy makers Advocate for policy changes to remove uptake barriers Advocate for improved market information and sustainable financing Highlight need for early OTC rescheduling Advocate for norms and branding to protect ACT 3 Support MMV products Support inclusion of registered products into guidelines Work with decision makers to support product launch Phase IV studies to compare treatments Product access/launch plans for MMV target segments Supply chain support = MMV lead = MMV supportive Participate in product development teams Label extension studies Improve packaging and user instructions Pharmacovigilance studies Monitor drug resistance

7 Outreach to endemic countries and decision makers A Support adoption Increasing awareness of MMV and products Understanding critical path to adoption Meetings with MoH: Tanzania, Kenya, Mozambique (May 07) Roadshow with Francophone African authorities Oct 07) Survey of regulatory processes with partners Regular engagement with WHO (GMP, EDL, PQ, etc.) Sharing information with financing and procurement agencies (GFATM, UNICEF, PMI, JSI etc.) Accelerated product adoption

8 Learning through engagement to inform product launch in informal sector* B Expand reach Understanding the market Responsibly providing a low priced ACT through the informal sector Pricing Study (WHO, HAI, MoH) Supply chain survey (WHO, HAI, MoH Uganda) Market demand survey (PSI) Training Adapted packaging Social marketing Monitor Impact Product access plans developed with Pharma partners *with Ministry of Health and other partners in Uganda

9 What do we know about the Antimalarials Market? 2006 Antimalarial Treatment volumes (M) 100% CQ Total = 546 Private = 406 Public = 140 Other CQ SP ESTIMATES SP ACTs 0 Artemisinin Monotherapy ACTs Note: Estimates of actual malaria treatments (vs. fever) are between 25%(BCG) and 40%(WHO). Other category includes MQ, AQ, etc.. P. Vivax treatment included (90M CQ treatments). ACT numbers updated after manuf. Interviews from 82M (WHO) to 90M public sector, and from 8M to 10M in private sector. Source: Biosynthetic Artemisinin Roll-Out Strategy, BCG/Institute for One World Health, Dalberg

10 Overview of the Pricing Study All anti-malarials registered in Uganda (N=203) Mapping of all outlets for malaria treatment Public, private, informal GIS coordinates, characterization of outlets Range of products sold Anti-malarials, medicines and other items Prices Distribution networks / product flows Sources of information Insight into intervention design - distributing subsidised ACT Baseline data for process indicators for operational research 6 regions: 3 indepth + 3 standard surveys

11 Our activities are starting a virtuous cycle of increased access to ACTs Access Supporting adoption Increased access to MMV s ACTs Helping expanding reach Shaping product development Health impact

12 Acknowledgements Ministry of Health Uganda Pharmacy Department NMCP Uganda National Drug Authority WHO Uganda and Headquarters HEPS Survey Managers M. Auton, Aziz Maija The data collection teams Local Pharmaceutical Supply Chain WE Consult Government of the Netherlands

13 Thank You Renia Coghlan, Associate Director Global Access