HIV TREATMENT
2020
Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
1. Ensure priority formulations are appropriately communicated to suppliers, including in regular meetings with suppliers, GDF tenders, and at GDF’s supplier meetings.
2. Include priority formulations in the TB Medicines Dashboard.
3. Identify and implement mechanisms to derisk suppliers who invest in development of child-friendly formulations.
Continuously monitor and project demand for pediatric formulations to identify when the market would benefit from additional suppliers.
72. Lead the external review of the Global Fund’s Expert Review Panel Expression of Interest (GF ERP EOI) through TPMAT and suggest prioritization of formulations for expedited review.
73. Monitor the development pipeline and work with the Global Fund to expedite access to new formulations and medicines.
74. Develop a strategy/roadmap for countries on TB paediatric drug registration that is linked to procurements and procurement goals.
105. Lead the TB Procurement and Market-Shaping Action Team (TPMAT) to coordinate global TB stakeholders and develop implementation roadmaps for new formulations.
106. Work to build, stabilize and maintain access to small-volume products including child-friendly formulations for drug-resistant TB.
107. Continue to use the Launchpad Approach to support the introduction and scale-up of paediatric formulations in programmes.
Commitment 1:
March 2022
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Priority formulations were highlighted in the latest GDF supplier meeting and will be included in the upcoming tender
April 2021
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GDF communicates priority product development needs in its regular bilateral meetings with suppliers. GDF successfully completed its tender process in December 2020 which included global forecasts for many of the priority products. GDF continues to monitor the product development pipeline closely, while simultaneously planning for new product introduction.
Commitment 2:
April 2021
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The TB Medicines Dashboard is updated quarterly and includes all medicines for the prevention and treatment of TB. The Dashboard is available here: http://stoptb.org/gdf/medicinesdashboard/#:~:text=Developed%20and%20updated%20by%20the,procurement%2C%20and%20use%20of%20TB. Analysis of the Dashboard identifies opportunities to improve harmonization across WHO and Global Fund guidance and policy documents as well as the GDF Product Catalog; and encourages consistent messaging to suppliers on products to develop. Analyses of the Dashboard have recently been used to update the Global Fund’s Expert Review Panel’s Expression of Interest for new medicines and the World Health Organization’s Model Essential Medicines List and Essential Medicines List of Children.
Commitment 3:
March 2022
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GDF added pediatric TB medicines to its Strategic Rotating Stockpile (SRS) – which creates regular and consistent orders for suppliers to plan production and ensures product is available when orders are placed
April 2021
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GDF coordinated demand across >50 countries and then coordinated with suppliers to buy small-volume, child-friendly formulations of medicines for Drug-Resistant TB by the production batch size. This derisks the supplier by ensuring all product from a batch is procured and product is not wasted which helps to reduce the price of these products. Recently, GDF has begun to include key child-friendly formulations in GDF’s Strategic Rotating Stockpile, physical inventory that is owned by GDF. Regular orders for the SRS helps suppliers to better plan production and improves availability for programmes.
Commitment 4:
April 2021
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GDF closely monitors suppy security and supplier production capacity/plans for these products. GDF’s in-country Regional Technical Advisors support countries to plan and monitor introduction of new medicines and formulations. Visibility on both the supply and the demand side allows GDF to identify when additional suppliers should be encouraged to develop specific products. This is monitored closely and communicated to suppliers in regular meetings, via GDF’s tender, and via the different lists of needed products identified in the TB Medicines Dashboard (e.g., GF ERP EOI, WHO EML, WHO Prequalification EOI, etc.)
Commitment 5:
April 2021
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TPMAT supported the work to consolidate rifapentine formulations towards a single, 150mg scored dispersible tablet for children which will accommodate multiple uses for both prevention and treatment.
Commitment 6:
March 2022
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GDF and TPMAT led a full review of the TB section of the WHO Model Essential Medicines List (EML) and EML for children (EMLc) in 2020 and 2021
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Key products added to EMLc– delamanid 25mg DT, bedaquiline 20mg DT, rifapentine 300mg tablets, 3HP FDC
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Key products deleted – non-dispersible child-strength tablets, oral liquid formulations will be removed in the next round (Expert Committee wanted additional transition time for programmes)
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Six rounds of Global Fund Expert Review Panel Expression of Interest review – latest is round 24 in Q3 2021
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All recommendations available on TPMAT webpage: https://www.stoptb.org/market-partner-coordination/stakeholder-coordination-and-tpmat
April 2021
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GDF and TPMAT reviewed the Dashboard and used the results to make recommendations to the Global Fund on products to include and prioritize for the Expert Review Panel Expression of Interest Round 23 (Q4 2020). The Dashboard review also guided the update of the TB section of the WHO Model EML and EML for children in Q4 2020 with 13 products being recommended for deletion and 5 applications for inclusion of new products being submitted.
Commitment 72:
March 2022
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GDF and TPMAT have led 6 rounds of review, most recent was Round 24 in Q3 2021
April 2021
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GDF and TPMAT have led the review of the last five rounds of the ERP EOI, most recently in Q4 2020.
Commitment73:
March 2022
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3 child-friendly products were priority reviewed by the ERPin 2021
April 2021
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GDF monitors the pipeline and works with Global Fund and TPMAT to ensure priority formulations are indicated on the ERP EOI and prioritized for ERP review once submitted.
Commitment 105:
March 2022
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Paediatric formulations have been a standing agenda item at the most recent TPMAT meetings
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Now that formulations for DRTB are readily available and introduced in programmes, discussions are focused on how to identify and diagnose more children with DRTB globally
April 2021
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The TPMAT met in February 2021 to review updates on peds DR-TB formulations in development and progress on implementation of formulations in programmes.
Commitment 106:
March 2022
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GDF added pediatric TB medicines to its Strategic Rotating Stockpile (SRS) – which creates regular and consistent orders for suppliers to plan production and ensures product is available when orders are placed
April 2021
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GDF’s unique approach, which includes in-country procurement and supply chain technical assistance, pooled procurement, and the Strategic Rotating Stockpile, helps ensure that GDF can match the demand with the supply (e.g., meeting minimum order quantities and matching batch sizes) for these small volume products.
Commitment 107:
March 2022
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GDF, with funding from USAID and the Government of Japan, continues to use the launchpad approach to introduce and scale-up new formulations as they become available
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100 countries have ordered the paeds FDCs
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74 countries have ordered the generic child formulations for DRTB
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41 countries have ordered child-friendly bedaquiline 20mg DT
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26 countries have ordered child-friendly delamanid 25mg DT
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April 2021
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To date, 71 countries have procured the 8 formulations of child-friendly DR-TB medicines. GDF continues to use the launchpad approach, with funding from USAID and the Government of Japan, to support additional formulations as they become quality-assured (e.g, bedaquiline 20mg).