Improving Access for Quality-Assured TB Medicines and Diagnostics Dr Kaspars Lunte Team Leader Sourcing and Special Projects, GDF Copenhagen, IPC Meeting 18 June 2015 Update on GDF Procurement

Change of the hosting agreement from WHO to UNOPS as from January ChangeChange

3 Live Report reatments+supplied+-+method+Injectable+standard dose+Rev+3.0&userid=GDF_ro&password=gdfread1 SLD Patient treatments supplied by year SLD cumulative Patient treatments supplied per year 6 months IP until 2012, 8 months thereafter SLD Patient treatments supplied per year by regions MDR Treatments delivered

GDF has been able to dramatically reduce the price of Cycloserine capsule, by -66.6% since last 5 years GDF has ensured sustainable supplies of Cs API: there are 3 API manufacturers (Dong A, Shasun and Macleods), with new supplier of South Korea expected to file API PQ around Q Median Cost in USD per capsule Median EXW Price, USD ITB (India) Average weighted price for 2015 ITB (Rest of the World) Price, USD vs 2010 (%) Median Price % Median Price % 2015 ITB (India) % 2015 ITB (ROW) % GDF and Cs price evolution

GDF price reductions: regimen examples

6 Bedaquiline donation program - 1 Bedaquiline will be provided to GDF for provision to patients and organizations in eligible countries- Agreement between USAID and Janssen Janssen : - Provide, free of charge, 30,000 courses of treatment of bedaquiline (100 mg) over a period of 4 years - Make a contribution of additional “gift funds” to be used to help implement the program. - Provide documentation, medical information, and /or education as require to implement donation. USAID : -Finance technical assistance through partners -Provide forecasts to Janssen -Report to Janssen any Adverse Events or special situations

Country eligibility: - GF eligible countries under conditions that they reasonably meet the requirements set out in the WHO Interim Guidance -Donation must be in compliance with all applicable country local laws and regulations -No quota per countries except in CIS countries (still to be determined by Janssen) -No donation in European countries (for instance, Romania, Latvia) Accessing BDQ donation through GDF: - Same process than others SLD (through GDF procurement agent) - Procurement request Form +Annex 1 to be completed - Drugs free of charge but transport + insurance + PA procurement fee still need to be budgeted -Separate Form to be completed in case of need for Technical Assistance (sent to USAID) More detailed information: Bedaquiline donation program - 2

The interim guidance lists five conditions that must be in place if bedaquiline is used to treat adults with MDR-TB: Effective treatment and monitoring: Treatment must be closely monitored for effectiveness and safety, using sound treatment and management protocols approved by relevant national authorities. Proper patient inclusion: Special caution is required when bedaquiline is used in people aged 65 and over, and in adults living with HIV. Use in pregnant women and children is not advised. Informed consent: Patients must be fully aware of the potential benefits and harms of the new drug, and give documented informed consent before embarking on treatment. Adherence to WHO recommendations: All principles on which WHO-recommended MDR-TB treatment regimens are based, must be followed, bedaquiline alone should not be introduced into a regimen in which the companion drugs are failing to show effectiveness. Active pharmacovigilance and management of adverse events: Active pharmacovigilance measures must be in place to ensure early detection and proper management of adverse drug reactions and potential interactions with other drugs. 8 WHO interim guidance on the use of bedaquiline to treat MDR-TB

Challenges continue remain same Less than 3 eligible suppliers per product: -Paediatric formulations (FDCs), RH150/150mg, H300mg -Km, Cm, Clfz, Lnz, Pth, Trz Short shelf life (24 months only): -100% of paediatric formulations (FDCs), -2 out 4 suppliers manufacturing adult FDCs -40% of SLDs Registration related issues: - slow; limited quantities; complex NRA requirements Old drugs: - 2 new anti-TB drugs (Bedaquiline and Delamanide) entered the market in over 35 years

Thank You for Your attention 10