Procurement update: StopTB Partnership - Global Drug Facility (GDF)

Transcription

1 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

2 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

3 1. GDF Overview, Stop TB Mission, and GDF Goal

4 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 Clients: governments with domestic funds, Global Fund principal recipients, National TB Programs & w/other donor funding, NGOs, UNITAID projects Funded largely by USAID United Nations UNOPS Stop TB U Partnership GDF

5 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

6 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 Manager - Demand Country Supply Country Supply Officers Demand and Technical Assistance Consultant Roster Chief Strategy/Policy Medicines Diagnostics Knowledge Mgt Manager - Supply Procurement Sourcing Quality assurance Diagnostics SRS Business Intel. IT & Business intelligence Data Management

7 2. GDF Timeline: Procurement of TB Medicines & Diagnostics

8 Evolution of TB Products Procured by GDF Medicines were first products procured by GDF Added diagnostics procurement onto medicines platform First-Line Drugs Second- Line Drugs First-Line Pediatric Drugs Microscopy LPA, MGIT Xpert First-Line Pedi FDCs Delamanid Re-dosed, First-Line Pedi FDCs LAMP LAM Bedaquiline Second- Line Pediatric Drugs

9 GDF Quality Assurance Policy and Quality monitoring program (DQMP) Visual inspection Artwork & documentation review Randomisation Protocol Routine and Ad hoc Routine testing Standard CoA review Method transfer Critical CoA review compendial

10 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 drugresistant TB (around 28 medicines from multiple sources). icines_catalog_2018_webv3.pdf

11 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 stics_catalog_2018_web.pdf

12 GDF Trends in Procurement of Medicines & Diagnostics 12,000,000 # Cartridges US $ Millions Value of GDF orders delivered, # Xpert cartridges procured worldwide, * ,000,000 8,000,000 6,000,000 4,000,000 GDF accounted for 41% of Xpert market in 2017 Rest of World India FLD Diagnostics SLD 2,000,000,, *Public sector procurement under concessional pricing South Africa

13 Estimated # of FLD treatment delivered per country

14 Estimated # of SLD treatments delivered per country (without India)

15 Countries where GDF has delivered laboratories equipment/commodities until 2017

16 Countries where GDF has delivered GeneXpert until Cartridges, Machines, Consumables and Services

17 3. Beyond Traditional Procurement: GDF Tools, Services, and Market Coordination

18 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 FLDs & SLDs FLDs & SLDs Contracted procurement agent Strategic Rotating Stockpile (SRS) New SRS Diagnostics Contracted procurement agent In-house procurement & supply Flexible Procurement Fund (FPF)

19 GDF Success in Second-Line Drugs Market 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 As of 31 August 2018

20 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 drugresistant 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 ( ) 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

21 GDF Policy Development, Market Shaping and Coordination 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 qualityassured 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.

22 4. Recent changes to TB treatment regimens and challenges for GDF

23 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 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 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).

24 The revised grouping of TB medicines recommended for use in longer MDR-treatment regimens:

25 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.

26 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) 2018 GDF estimated prices* for new MDR-TB Regimens These new all-oral regimens are approximately 2- to 3- times more costly than the previously recommended longer regimens for MDR-TB *Weighted average according to volumes allocated to suppliers in 2018 tender ** As per WHO recommendations on operational research

27 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.

28 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

29 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

30 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.

31 Thank you Magali Babaley