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Procurement update:
StopTB Partnership -
Global Drug Facility (GDF)
Magali BABALEY Strategic Procurement and Business Intelligence Manager Stop TB Partnership, Global Drug Facility (GDF) team joint UNICEF-UNFPA-WHO meeting, 25 September 2018, Copenhagen, Denmark
www.stoptb.org
Presentation Outline
1. GDF Overview, Stop TB Mission, and GDF Goal
2. GDF Timeline: Procurement of TB Medicines & Diagnostics
3. Beyond Traditional Procurement: GDF Tools, Services, and Market Coordination
4. Recent changes to TB treatment regimens and challenges for GDF
www.stoptb.org
1. GDF Overview, Stop TB Mission, and GDF Goal
www.stoptb.org
GDF Overview
• Established in 2001
• Part of the United Nations
• Unit within the Stop TB Partnership which is hosted by United Nations Office for Project Services (UNOPS)
• Original mandate: pooled procurement mechanism to facilitate access to quality-assured first-line drugs
• Subsequent expansion of products & services
• On-line order system since 2005
• ISO 9001 certified
U
UNOPS
Stop TB Partnership
GDF
United Nations
• Clients: governments with domestic funds, Global Fund principal recipients, National TB Programs & w/other donor funding, NGOs, UNITAID projects
• Funded largely by USAID
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Stop TB Mission, GDF Goal
Stop TB Partnership Mission: To serve every person who is vulnerable to TB and ensure that high-quality diagnosis, treatment, and care is available to all who need it
• Umbrella organization of >1,500 partners in >100 countries • Advocacy for TB funding, TB care, civil society; Strong convening power • Governed by a Coordinating Board (Chaired by Minister Motsoaledi, South
Africa, Wide representation, including private sector delegation
GDF Goal: To facilitate world-wide, equitable access to TB medicines & diagnostics – including new tools – across public and private sectors
• To meet this goal, GDF conducts itself via a “partnership model” with clients, suppliers, policy makers, and other key TB stakeholder
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GDF Organization
• Headquarters in Geneva at Global Health Campus
• 36 staff plus consultants • 30 staff in Geneva
• 6 regional staff across the world
• Consultant roster(s) for technical assistance
• Consultants for specific tasks
• Organized into 3 teams • Strategy/Policy
• Demand
• Supply
Chief
Strategy/Policy •Medicines •Diagnostics • Knowledge Mgt
Manager - Supply Manager - Demand
Country Supply Country Supply Officers
Demand and Technical Assistance
Consultant Roster
Procurement • Sourcing •Quality
assurance •Diagnostics • SRS
Business Intel. • IT &
Business intelligence
•Data Management
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2. GDF Timeline: Procurement of TB Medicines & Diagnostics
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Evolution of TB Products Procured by GDF
First-Line Drugs
Second- Line Drugs
First-Line Pediatric
Drugs
LPA, MGIT
Beda-quiline
Delamanid
2001 2007 2010 2015 2016
Re-dosed, First-Line Pedi FDCs
2008
Microscopy
2017 2018
LAMP LAM Xpert
2011
First-Line Pedi FDCs
Second-Line
Pediatric Drugs
• Medicines were first products procured by GDF • Added diagnostics procurement onto medicines platform
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GDF Quality Assurance Policy and Quality monitoring program (DQMP)
Visual inspection
Artwork & documentation review
Randomisation Protocol
Routine and Ad hoc
Standard CoA review
▸ Critical CoA review compendial
▸ Routine testing
▸ Method transfer
http://www.stoptb.org/assets/documents/gdf/drugsupply/gdf%20qa%20policy%20and%20procedures.pdf
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GDF medicine Catalogue Today
First Line Drugs (FLDs) and related products, required for the treatment of drug-susceptible TB or for the prevention of active TB (around 20 medicines from multiple sources);
Second Line Drugs (SLDs) and related products required for the treatment of all forms of drug-resistant TB (around 28 medicines from multiple sources).
http://www.stoptb.org/assets/documents/gdf/Medicines_Catalog_2018_WEBv3.pdf
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GDF Diagnostics Catalogue Today
• > 500 items • Includes a full-range of diagnostic equipment and
reagents, laboratory supplies, and ancillary devices to equip and supply a wide range of laboratories
Decentralized facilities that perform smear microscopy, automated molecular testing, and rapid antigen detection tests
Reference laboratories that perform line probe assays, mycobacterial culture, drug susceptibility testing, and species identification http://www.stoptb.org/assets/documents/gdf/Diagnostics_Catalog_2018_WEB.pdf
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GDF Trends in Procurement of Medicines & Diagnostics
Rest
of
World
South
Africa ,,0
2,000,000
4,000,000
6,000,000
8,000,000
10,000,000
12,000,000
2010 2011 2012 2013 2014 2015 2016 2017
India
# C
artr
idge
s
# Xpert cartridges procured worldwide, 2010-2017*
GDF accounted for 41% of Xpert market in 2017
*Public sector procurement under concessional pricing
0 -
100
200
300
2011 2013 2015 2017
FLD Diagnostics SLD
Value of GDF orders delivered, 2010-2017
US
$ M
illio
ns
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Estimated # of FLD treatment delivered per country 2001 - 2017
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Estimated # of SLD treatments delivered per country 2007 - 2017 (without India)
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Countries where GDF has delivered laboratories equipment/commodities until 2017
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Countries where GDF has delivered GeneXpert until 2017 - Cartridges, Machines, Consumables and Services
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3. Beyond Traditional Procurement: GDF Tools, Services, and Market Coordination
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GDF Procurement Evolution: to Improve Efficiency & Shape Markets
New operating models and tools to continuously improve GDF’s performance, optimize market efficiency
• End 2015, switch from contracted procurement agent to GDF in-house procurement & supply TB diagnostics
• 2017 launch of new strategic rotating stockpile (SRS) for second-line drugs to dramatically decrease delivery lead time & smoothen production cycles; addition of first-line drugs in 2019
• Establishment of flexible procurement fund - bridge procurement costs when funds not readily available
2001 2015 2016
Contracted procurement agent
2017
FLDs & SLDs
Diagnostics Contracted procurement agent In-house procurement & supply
FLDs & SLDs Strategic Rotating Stockpile (SRS)
2010
New SRS
Flexible Procurement Fund (FPF)
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GDF Success in Second-Line Drugs Market
As of 31 August 2018
Market Establishment
GDF has ensured a strong suppliers base for at least 3 suppliers per product for most TB medicines. While the suppliers base for FLDs is stable and thus did not significantly change, GDF has demonstrated significant improvements strengthening the SLD suppliers base and supply security
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GDF Success in Drugs Market
Market Efficiency: • As an outcome of GDF ’s recent competitive tender, savings of approximately US$ 31 million
for TB medicines are expected in the April 2018 to March 2019 period Equal to 960,000 drug-sensitive TB medicines, or 53,000 shorter regimens for drug-
resistant TB (STR), or up to 37,000 conventional regimens for drug-resistant TB. • Despite various challenges over the years, GDF succeeded in decreasing the price of
expensive drug-resistant TB treatment regimens MDR-TB conventional treatment cost: US$2,000 to US$ 812 (2012 to 2018), and US$ 779 to US$ 571 (2016-2018) for shorter MDR-TB treatment regimens
• Lead times: >6 months to < 3months (2012 to 2017); examples of delivery in 2 weeks • Uptake of new medicines, diagnostics:
Shorter regimens for MDR-TB, USAID-Janssen bedaquiline donation program, Otsuka-delamanid, Liquid culture, LPA, Xpert
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• GDF spearheaded the creation of the TB Procurement and Market-Shaping Action Team (TPMAT), an interagency working group comprised of major buyers, donors, technical partners and civil society, working to ensure a stable and affordable supply of quality-assured TB products.
• GDF engaged the WHO Prequalification of Medicines Programme in 2017 to ensure that 84% of TB medicines are exempt from WHO prequalification annual fees, given low profit margins.
• Together with other partners, GDF negotiated a 40% price reduction for rifapentine, a key new tool for preventative treatment of latent TB.
• GDF and partners negotiated an expansion of the list of countries that have access to concessional prices for BD MGIT liquid culture diagnostic commodities from 45 to 85 countries.
• GDF coordinated efforts of TB and HIV stakeholders to strengthen service and maintenance for GeneXpert diagnostic equipment.
GDF Policy Development, Market Shaping and Coordination
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4. Recent changes to TB treatment regimens and
challenges for GDF
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WHO Rapid Communication: Key changes to the treatment of multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB), 22 August 2018
The changes are based on recommendations of the WHO Guideline Development Group which met in July 2018. The new rapid communication marks the first time in history that WHO recommends injection-free regimens for the treatment of MDR-TB. The full WHO guideline update is expected to be released later in 2018.
Main changes recommended The rapid communication calls for a re-grouping and reprioritization of the medicines used to treat MDR/RR-TB • Kanamycin and capreomycin are no longer in the regimen to treat MDR/RR-TB; • Bedaquiline and linezolid (together with levofloxacin or moxifloxacin) have been upgraded
and prioritized in the regimen to treat MDR/RR-TB; • The new, all-oral, regimen for MDR/RR-TB treatment is less toxic, more efficacious, and
reduces the need for hospitalization; and • In the shorter regimen for MDR/RR-TB, kanamycin and capreomycin should be replaced
with amikacin (or bedaquiline under operational research conditions).
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The revised grouping of TB medicines recommended for use in longer MDR-treatment regimens:
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Change in Demand for medicines used in new MDR-TB regimens
• WHO advises countries to rapidly adjust their national treatment policies, drug procurement plans and monitoring system to quickly switch to the new priority regimens.
• As it is not possible to effect these changes immediately, national TB programmes should immediately develop transition plans to address these critical issues.
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2018 GDF estimated prices* for new MDR-TB Regimens
*Weighted average according to volumes allocated to suppliers in 2018 tender ** As per WHO recommendations on operational research
Changes in prices for new MDR-TB regimens
The new, all oral, 20-month MDR-TB regimens range from US $1,600* (using bedaquiline and linezolid for 6 months and levofloxacin as the fluoroquinolone) to US $2,100* (using linezolid for 12 months and moxifloxacin as the fluoroquinolone)
These new all-oral regimens are approximately 2- to 3-times more costly than the previously recommended longer regimens for MDR-TB
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Changes in TB diagnostics
The new WHO rapid communication will require expanded laboratory capacity given the critical role that drug-susceptibility testing (DST) plays in ensuring patients are put on the most effective treatment regimen. Capacity for culture DST methods and line probe assays for second-line drugs require further scale-up. This entails a comprehensive set of interventions including:
• Procurement and installation of necessary testing equipment and supplies; • Infrastructure improvements to ensure biosafety; • Training of technicians on new DST testing methods; and • Strengthening of specimen referral systems to allow for the efficient, centralized
testing of patient samples and the rapid return of results.
Demand for pure drug substances is expected to increase in line with medicines demand as countries develop the capacity to perform DST for these drugs.
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Next steps and challenges for GDF (1)
1. Ensure the supply security of TB medicines and diagnostics and laboratory commodities
GDF has currently 3 to 4 suppliers per TB medicine, except for Clofazimin for which
and thanks to GDF’s supplier engagement, 2 additional suppliers are expected soon (under WHO PQP evaluation) and Bedaquiline for which the supplier has confirmed that they are ready for increased demand,
Provide updated GDF’s demand forecasts to suppliers to allow them to update their production planning
Monitor current GDF’s orders with suppliers and review available options in case of country request for cancellation of orders or significant increase of quantities of new priority products ordered by countries
Update GDF strategic procurement according to the changes in Demand
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Next steps and challenges for GDF (2)
2. Provide support to countries
to develop transition and procurement plans (for the phase out of older regimens and phase in of new regimens)
to estimate cost implications including for expected wastage and financial gap to develop accurate quantification, which is obligatory for successful phase-in and
phase out plan. to increase procurement frequency for better flexibility to changes while minimizing
waste. to review current country orders with GDF and available options depending on how
far the order has been processed, on other medicines included in the same order and on country programmatic needs (e.g., risk of stock outs)
to accelerate the registration of the TB medicines used in the new regimens, if not yet done
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Summary of GDF’s support
GDF continues to serve as a one-stop shop for TB medicines and diagnostics. All country programmes are eligible to access quality-assured medicines and diagnostics from GDF. What GDF offer: • Lowest available prices on the market for quality-assured products; • Shortest lead times for medicines because Stop GDF holds a physical stock of TB medicines in
GDF’s Strategic Rotating Stockpile; • Support to national TB programmes with quantification and supply chain management to
expedite the phase-out of older regimens and phase-in of new regimens - as with the launch of other new tools;
• Provision of regular, updated medicines forecasts to suppliers to guide production planning and product lifecycle management;
• Support for national registration of medicines included in the new WHO recommendations; and • Access to concessional prices for TB diagnostics.
