IATT Optimal List of Paediatric ARV Formulations: Background and Update
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1 IATT Optimal List of Paediatric ARV Formulations: Background and Update Nandita Sugandhi Clinton Health Access Initiative, USA PADO/IATT Update for ARV Manufacturers October 19, 2015
2 Overview Rationale for Optimization of Paediatric ARV Formularies Criteria for selection of optimal formulations Creation of optimal list and limited use list PAPWG and collaborations Next review of formulary list
3 Pediatric ARV market is small but complex. 93 adult patients All ages & weight bands One pill, once-aday 7 paediatric patients Multiple ages and weight bands Multiple formulations and regimens
4 Wide variety of Paeds ARV formulations 65+ Products and counting NRTI ABC Tablet (disp,scored) as sulfate 60 mg ABC Tablet (scored) as sulfate 60 mg ABC Oral liquid as sulfate 100mg/5ml AZT Tablet (dispersible, scored) 60 mg AZT Oral liquid 50mg/5ml AZT Tablet (scored) 60mg AZT Capsule 100 mg AZT Tablet 100 mg 3TC Oral liquid 50mg/5ml 3TC Tablet (dispersible) 30mg 3TC Tablets 30mg D4T Capsule 15mg D4T Capsule 20mg D4T Powder for Oral solution 5mg/5ml DDI Cap, unbuffered, enteric coated 125 mg DDI Cap, unbuffered, enteric coated 200 mg DDI Tab (buffered, chewable, disp) 25mg DDI Tablet (buffered, chewable, dispersible) 50 mg DDI Tablet (buffered, chewable, dispersible) 100 mg DDI powder for Oral liquid (Buffered) 2g, 4g bottle FTC Oral liquid 10 mg/ml TDF Oral powder 40mg/scoop TDF Tablet (unscored) 150 mg TDF Tablet (unscored) 200mg NNRTI EFV Tablet (scored) 200mg EFV Tablet 50mg EFV Tablet (unscored) 200 mg EFV Tablet (disp) 100mg EFV Capsules 50 mg EFV Capsules 100 mg EFV Capsules 200 mg EFV Oral liquid 150mg/5ml Tablet (dispersible, NVP scored) 50mg NVP Tablet (non dispersible) 50mg NVP Tablet (non dispersible) 100mg NVP Oral liquid 50mg/5ml NVP Tablet (dispersible) NVP Tablet (nondispersible) ETV Tablet ETV Tablet PI 100 mg 20mg 25mg 100mg LPV/r Tablet (hs) 100mg/25mg LPV/r Oral liquid 80/ 20 mg/ml LPV/r Oral pellets 40mg/10mg/cap RTV Oral liquid 400mg/5ml DRV Tablets 75 mg DRV Tablets 150 mg DRV Oral liquid 500mg/5ml ATV caps as sulfate 100 mg ATV caps as sulfate 150 mg ATV Powder 50mg ATV caps as sulfate 200 mg PI cont d TPV Oral liquid 500mg/5mL FPV Oral liquid 250mg/5mL Integrase Inhibitors RAL chewable Tabs (scored) 100 mg RAL chewable Tabs 25 mg RAL Packets for oral susp 100mg FDC s Tablet (disp AZT/3TC scored) 60/30 mg AZT/3TC Tablet (scored) 60/30 mg Tablet (disp AZT/3TC/NVP scored) 60/30/50 mg Tablet (disp D4T/3TC/NVP scored) 6/30/50 mg Tablet (disp, D4T/3TC/NVP scored) 12/60/100 mg Tablet (disp, D4T/3TC scored) 6/30 mg Tablet (dispersible, D4T/3TC scored) 12/30 mg Tablet(disp, ABC/3TC scored) 60/30 mg Tablet (disp, ABC/3TC scored) 120/60 mg ABC/3TC Tablet (scored) 60/30 mg Tablet (non disp, 4 ABC/3TC/AZT scored) 60/30/60mg
5 Why Optimize Paediatric ARV Formularies Illustrative example of orders needed by country to fill a minimum batch 25,000 20,000 # Packs 15,000 10,000 5,000 0 Minimum batch size
6 2011: First IATT Optimal Paediatric ARV Formulary In mid-2011, the IATT began a selection process for optimal paediatric formulations given the following: Proliferation of product choices and market fragmentation leading to instability in the paediatric marketplace Normative guidance was needed on the best options to deliver all required first- and second- line regimens for paediatric HIV patients An optimal formulary can serve as guidance for national programs, procurement agencies, manufacturers To be updated and revised when the WHO updates regimen guidance or when new products and formulations become available in low-income settings
7 2013 Revision: Defining the Formularies Optimal Minimum number of ARV formulations needed to provide all currently recommended preferred and alternative 1 st and 2 nd line WHO recommended regimens for all paediatric weight bands Limited-use IATT ART Formulary Formulations that may be needed during transition and /or for special circumstances Non-essential Everything else (not needed) 7
8 Evaluation Criteria Criteria WHO recommended Available in resource limited settings SRA/WHO PQ approved User friendly Optimizes supply chain Dosing flexibility Comparative cost Description Safety and efficacy established In country registration Reliable supply 1 quality assured product available Easy for HCW s to prescribe Easy for caregivers to administer Supports adherence in children Easy to transport Easy to store Easy to distribute Allows for the widest range of dosing options Cost should NOT be the deciding factor in selection of a drug but comparative cost of similar drugs/drug formulations should be considered 8
9 Comparison of of 2011, 2013 and 2014 Optimal Formulary Products Drug Class Drug Formulation Dose NRTI AZT Oral liquid 50 mg/5ml NNRTI EFV Tablet (scored) 200 mg NNRTI NVP Tablet (disp, scored) 50 mg NNRTI NVP Oral liquid 50 mg/5ml PI LPV/r Tablet (heat stable) 100 mg/25mg PI LPV/r Oral liquid 80 mg/20 mg/ml FDC AZT/3TC Tablet (disp, scored) FDC AZT/3TC /NVP Tablet (disp, scored) FDC ABC/3TC Tablet (disp, scored) FDC ABC/AZT /3TC 2013 Tablet (non disp, scored) 10 Products 60 mg/30 mg 60 mg/30 mg/50 mg 60 mg/30 mg 60 mg/60 mg/30 mg Drug Class Drug Formulation Dose NNRTI EFV Tablet (scored) 200 mg NNRTI NVP Tablet (disp, scored) 50 mg NNRTI NVP Oral liquid 50 mg/5ml, 100ml PI LPV/r Tablet (heat stable) 100 mg/25mg PI LPV/r Oral liquid 80 mg/20 mg/ml FDC AZT/3TC Tablet (disp, scored) 60 mg/30 mg FDC AZT/3TC/NV P 2014 Tablet (disp, scored) 60 mg/30 mg/50 mg FDC ABC/3TC Tablet (disp, scored) 60 mg/30 mg, 120mg/60mg 9 Products
10 Comparison of of 2011, 2013 and 2014 Limited-use lists 2011 Drug Formulation Dose ABC Oral liquid 100mg/5ml ATV Solid oral dosage form 11 Products 100mg, 150mg DRV Oral liquid 500mg/5ml 75mg, DRV Tablet 150mg ddi Powder for oral liquid* 2g, 4g bottle 3TC Oral liquid 50mg/5ml RTV Oral liquid* 400mg/5ml RTV d4t Tablet (heat stable) Powder for oral liquid* 100mg 5mg/5ml Products 2014 Drug Class NRTI AZT Oral liquid 50 mg/5ml- 100ml Drug Formulation Dose Rationale for use NRTI ABC Tablet (dispersible, scored) NRTI TDF Tablet (unscored) Infant prophylaxis during PMTCT for replacement fed infants 60mg For children <3 years undergoing TB treatment requiring triple nucleoside regimen 200 mg Older children <35 kg until FDC available NNRTI ETV Tablet 25 mg Special circumstances NNRTI ETV Tablet 100 mg Special circumstances PI DRV Tablet 75 mg Special circumstances PI RTV Oral liquid 400 mg/5ml PI ATV Solid oral dosage form PI ATV Solid oral dosage form Int Inh RAL Chew tab (scored) 10 Products For boosting nonco-formulated PI s 100 mg Alternative 2 nd line 150 mg Alternative 2 nd line 100 mg Special circumstances
11 2014 IATT Optimal Pediatric ARV Formulary Drug Class Drug Formulation Dose NNRTI EFV Tablet (scored) 200 mg NNRTI NVP Tablet (disp, scored) 50 mg NNRTI NVP Oral liquid* 50 mg/5ml, 100ml PI LPV/r Tablet (heat stable) 100 mg/25mg PI LPV/r Oral liquid 80 mg/20 mg/ml FDC AZT/3TC Tablet (disp, scored) 60 mg/30 mg FDC AZT/3TC/NV P Tablet (disp, scored) 60 mg/30 mg/50 mg FDC ABC/3TC Tablet (disp, scored) 60 mg/30 mg, 120mg/60mg * Oral liquid for infant prophylaxis in PMTCT 11
12 2014 Limited Use List Drug Class Drug Formulation Dose Rationale for use NRTI AZT Oral liquid* 50 mg/5ml- 100ml Infant prophylaxis during PMTCT for replacement fed infants NRTI ABC Tablet (dispersible, scored) 60mg For children <3 years undergoing TB treatment requiring triple nucleoside regimen NRTI AZT Tablet (dispersible, scored) 60mg For children <3 years undergoing TB treatment requiring triple nucleoside regimen NRTI TDF Tablet (unscored) 200 mg Older children <35 kg until FDC available NNRTI ETV Tablet 25 mg Special circumstances NNRTI ETV Tablet 100 mg Special circumstances PI DRV Tablet 75 mg Special circumstances PI RTV Oral liquid 400 mg/5ml For boosting nonco-formulated PI s PI ATV Solid oral dosage form 100 mg Alternative 2 nd line PI ATV Solid oral dosage form 150 mg Alternative 2 nd line Int Inh RAL Chew tab (scored) 100 mg Special circumstances * Oral liquid for infant prophylaxis in PMTCT 12
13 The IATT list is a living document that will reviewed on a regular basis Normative Guidance Revision in accordance with WHO Guidelines Endorsed by major financers and buyers of Paediatric ARVs Paediatric AIDS Procurement Working Group (PAPWG) Coordination at global procurement level Trends in procurement and supply Communications to disseminate new information to programmes 13
14 March 2015: Procurement Consortium Forecast IATT Formulary Profile 2015 Planned Procurements Limited-Use 0% Unreviewed 0% Optimal - PMTCT 8% Non- Essential 7% Optimal 85% Courtesy of Wesley Kreft and the PAPWG, WHO AMDS Meeting, Geneva Switzerland March 2015
15 IATT and PAPWG Collaboration: Policy Briefs
16 2016 Revision of the IATT Optimal Paediatric Formulary and Limited Use List Scheduled to follow release of 2015 WHO Guidelines: 2016 Q1 Formulations to review LPV/r oral pellets RAL paediatric dosage forms TDF 200 mg ETV 25mg, 100mg ATV 100mg, 150mg For further discussion Inclusion of 3 rd line Limited-use products
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