Improving Access for Quality-Assured TB
Medicines and Diagnostics
Update on GDF Procurement
Dr Kaspars Lunte
Team Leader Sourcing and Special Projects, GDF
Copenhagen, IPC Meeting
18 June 2015
Change
Change of the hosting agreement from WHO to
UNOPS as from January 1 2015
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MDR Treatments delivered
6 months IP until 2012, 8 months thereafter
SLD Patient treatments supplied by year
SLD cumulative Patient treatments supplied per year
SLD Patient treatments supplied per year by regions
Live Report 20.02.2015
https://extranet.who.int/sree/Reports?op=vs&path=/WHO_HQ_Reports/G1/PROD/INT/Shared/MDR+Patient+t
reatments+supplied+-+method+Injectable+standard+180240dose+Rev+3.0&userid=GDF_ro&password=gdfread1
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GDF and Cs price evolution 2010-2015
Median Cost in USD per capsule
2010 2011 2012
Median EXW Price, USD
0.599 0.593 0.591
2015 ITB (India)
Average weighted price for 2015 ITB
(Rest of the World)
2013
0.43
2014
0.42
0.42
0.42
2015
0.26
Median Price 2010
Median Price 2014
2015 ITB (India)
2015 ITB (ROW)
Price, USD
vs 2010 (%)
0.599
0%
0.42
-30%
0.26
-57%
0.20
-67%
0.20
• 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 Q3 2015
GDF price reductions: regimen examples
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
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Bedaquiline donation program - 2
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:
http://www.stoptb.org/gdf/drugsupply/bedaquilineDonation.asp
WHO interim guidance on the use of bedaquiline to
treat MDR-TB
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.
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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
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