Revisions to the April 8, 2015, version of the guidelines are largely based on findings from two large, randomized controlled trials that addressed the optimal time to initiate antiretroviral therapy (ART)—START (Strategic Timing of Antiretroviral Therapy) and TEMPRANO. Both studies demonstrated approximately a 50% reduction ...
The Prequalification of Medicines Programme (PQP)
• A United Nations Programme managed by WHO
• Started in March 2001 as a Pilot Project: Focus on HIV/AIDS
• Partners included WHO, UNICEF, UNFPA, UNAIDS and supported by World Bank
• Quickly expanded to include Tuberculosis, Malaria, Reproductive Health, Influenza and ...
PEPFAR’s Evolution. From Emergency Response to Sustainable Impact for an AIDS-free Generation.
2003-2007: PEPFAR 1
Emergency Response
Delivering prevention, care and treatment services
Building and strengthening health systems to deliver HIV services
2008-2012: PEPFAR 2
Shift to sustainable response
Shared responsibility and country driven programs
Scaling up core interventions (ART, PMTCT, and VMMC) ...
Purpose of the new PQ financing strategy:
• Maintain the overall objective of PQ to provide assured safe, efficacious and quality drugs, vaccines, diagnostics and devices while increasing supply and access;
• Need for an innovative, practical and sustainable funding approach for the WHO PQ programme;
• Reduce ...
Currently does not include estimates of number of people who may need PrEP (e.g. number of IDUs at high risk of HIV acquisition) or TasP
• Borrows average usage forecast from currently available forecasts till 2018
• Borrows epidemiological estimates from available estimates till 2018
• Assumptions:
– Linear ...
Background:
Extent and timing of public health usage of ARVs, especially new drugs, was a key area for the MPP to understand when we commenced our licensing work with originator and generic companies
• MPP started its forecasting exercise in 2011, including all ARVs but focusing on ...
WHO/UNAIDS Consultation with manufacturers. March 2015, Geneva, Switzerland
Key Points
• The IATT Optimal Formulary is designed to guide selection and procurement of paediatric ARV’s around a subset of optimal products
• Consolidation of demand stabilizes supplies of paediatric ARVs
• Success requires global consensus, cooperation with the manufacturers, ...
Update on the Global Fund’s Procurement Strategy. WHO UNAIDS Annual Meeting with Pharmaceutical Stakeholders
Key outcomes
The long term collaborative agreements will support continuous supply through improved lead times and better delivery performance
Supply risks mitigated with multiple awardees per product and diversification of API sources
...
Objectives:
Promote access to life saving medicines and informed the WHO guideline Process;
Work with all concerned parties to remove or minimize obstacles for medicines entering the market and facilitate their uptake;
Provide partners and players in the field of SCM with reliable data to ...
Forecast numbers of patients on ARVs and demand for individual ARVs in low and middle-income countries for 2014 to 2018 using best available evidence. Data sources include:
• WHO ARV Survey
• GPRM procurements
• CHAI forecasts
• UNAIDS estimates of need for ART
• Global Fund quantification of ARV ...