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Access to Assured-Quality Praziquantel for the Control of Human Schistosomiasis

Access to Assured-Quality Praziquantel for the Control of Human Schistosomiasis. Dr. Valerio Reggi - Department of Control of Neglected Tropical Diseases. Global distribution of schistosomiasis. disease caused by worms of the genus Schistosoma. 90% of infected people

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Access to Assured-Quality Praziquantel for the Control of Human Schistosomiasis

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  1. Access to Assured-Quality Praziquantel for the Control of Human Schistosomiasis Dr. Valerio Reggi - Department of Control of Neglected Tropical Diseases

  2. Global distribution of schistosomiasis disease caused by worms of the genus Schistosoma 90% of infected people 76% of population at risk From: Gryseels et al. Human schistosomiasis. Lancet 2006; 368: 1106–18

  3. Control of schistosomiasis is based on preventive chemotherapy interventions targeting the entire at-risk population

  4. Schistosomiasis - estimated infected population and population treated in 2008* * As reported to WHO/NTD

  5. How much praziquantel is required/committed? donor-funded demand in recent years: ~ 50 million tablets* * B&M Gates Foundation/Schistosomiasis Control Initiative and Merck KGaA Sudden demand increase: from 50 to >220 million tablets/year

  6. Praziquantel is made in large 600mg tablets Each 600mg Praziquantel tablet requires 640mg of API (assuming 94% yield) ~141 tonnes of API required for ~220 million tablets/year for the next 5-6 years

  7. Key concerns Current manufacturers of assured-quality API and finished product may be unable to match demand increase RISKS higher prices • interruption of supply • scale-up failure substandard quality Donor-driven demand and tight deadlines draw 'new' manufacturers into play

  8. Proposed approach Current players: DFID, USAID/RTI, WHO JOINT PLANNING OF NATIONAL REQUIREMENTS COORDINATED PROCUREMENT OF PZQ QUALITY ASSURANCE POLICY FOR THE PROCUREMENT AND PROVISION OF PRAZIQUANTEL TABLETS* * adapted from Global Fund Quality Assurance Policy For Pharmaceutical Products - http://www.theglobalfund.org/en/procurement/quality/?lang=en

  9. QUALITY ASSURANCE POLICY FOR THE PROCUREMENT AND PROVISION OF PRAZIQUANTEL TABLETS FOR HUMAN SCHISTOSOMIASIS CONTROL (a) authorized for marketing by a stringent MRA; (b) listed as prequalified by the WHO Prequalification Programme; (c) positive opinion under Art. 58 of the EU Regulation 726/2004. Interim Measure establish an expert review panel similar to that established by the Global Fund

  10. Expected advantages and benefits of PQ of PZQ API and finished products • PQ of APIs would attract more generic manufacturers and increase competition • PQ of APIs would enable local manufacture in large endemic countries • Compared to stringent MRA's regulatory approval, PQ (both API and FP) can be faster and more flexible (e.g. no jurisdiction limitations, technical advice, capacity building) • PZQ used in preventive chemotherapy of assured quality is reassuring for national authorities engaging in mass treatment campaigns • Donor and national funding not wasted on poor-quality PZQ • PQ capacity building component leads to more effective involvement of MRAs of endemic countries in development of new NTD medicines.

  11. Thank you

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