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The IATT Optimal Paediatric ARV Formulary: Global Perspective and Country Implementation

The IATT Optimal Paediatric ARV Formulary: Global Perspective and Country Implementation. Summary. Introduction WHO Paediatric ART recommendations Rationale for Paediatric ARV Formulary Optimization Revised Optimal and Limited-use Paediatric ARV formularies Country level implementation Q&A.

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The IATT Optimal Paediatric ARV Formulary: Global Perspective and Country Implementation

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  1. The IATT Optimal Paediatric ARV Formulary: Global Perspective and Country Implementation

  2. Summary • Introduction • WHO Paediatric ART recommendations • Rationale for Paediatric ARV Formulary Optimization • Revised Optimal and Limited-use Paediatric ARV formularies • Country level implementation • Q&A

  3. What is the IATT? Intra-agency Task Team on Prevention of HIV Infection in Pregnant Women, Mothers and their Children IATT Overview • Established in 1998 and included 5 UN agencies working in HIV and health (WHO, UNICEF, UNFPA, UNAIDS, World Bank) • 2003: membership expanded to include global partners in PMTCT and HIV care and treatment in children (23 agencies currently involved) • Provides a forum for: • Information sharing • Consensus building IATT Subcommittees Paediatric Working Group Infant feeding Working Group Paediatric Working Group • Sub-committee of the main IATT • Focused on issues related to paediatric care and treatment issues • 2011 restructuring of IATT: consolidation of 2 working groups + Developed Child Survival Working Group Optimal Paediatric Formulary List

  4. Agenda and Speakers • Introductions IATT Secretariat • WHO Paediatric ART guidelines Martina Penazzato, IATT Secretariat, WHO • Rationale for optimization UNICEF, AtienoOjoo, IATT PSM WG, UNICEF • Revised Optimal and Limited use list David Jamieson, IATT PSM WG, PFSCMS • Implementation at country level NanditaSugandhi, IATT CSWG, CHAI • Q&A Session Marianne Guval, IATT CSWG, CHAI & Jessica Rodrigues, IATT Secretariat

  5. Choosing a PreferredPaediatric Regimen: Many Options Possible But at the national program level fewer choices may be easier to implement: • Simplifies guidance for HCW • Streamlines procurement and supply chain

  6. WHO Recommendations on ARV Formulations The principles that were followed in developing the WHO simplified tables include: • It is preferable to use an age-appropriate FDC for any regimen if available • Oral liquid or syrup formulations should be avoided especially if volumes are large • Dispersible tablets (or tablets for oral solution) are the preferred solid oral dosage forms • Young children should be switched to available solid oral dosage forms as soon as possible • Where adult formulations have to be used by children, care must be taken to avoid underdosing. Adult tablets that are scored are more easily split. For those tablets that are not easily split, WHO recommends that this be done in the dispensing pharmacy using appropriate tablet cutters. • Some tablets such as LPV/r heat stable tablets are made in a special embedded matrix formulation and should not be cut, split or crushed as they lose bioavailability. • Different dosing between morning and evening doses should be avoided. • Children have to be weighed at each clinic visit, and dose changes are required as children grow and/or gain weight.

  7. Availability of Drug Formulations Impacts Implementation of Regimen Recommendations • Two formulations of LPV/r are available: LPV/r 100 mg/25 mg heat-stable tablet for children >10 kg and LPV/r oral liquid 80/20 mg per 1 ml for use among infants. • TDF is currently available in 3 different formulations for use across weight bands but a TDF-containing FDC is yet to be developed

  8. Paediatric ARV Market is Small (but complex) 93 adultpatients One pill,once-a-day Allages&weightbands 7 paediatricpatients Multipleages and weightbands Multipleformulations

  9. There are Over 61 Different Paediatric ARVs on the Market

  10. Low Volumes and Fragmentation are Problematic • Suppliers are limited by minimum batch requirements • Manufacturers produce a minimum of generally several thousand packs of a particular product, called the “minimum batch requirement” • A product will not be produced until orders are meet the minimum batch requirement; otherwise, supplier risks incurring losses from carrying stocks which fall below country shelf-life requirements • Supply timelines can become highly unstable without ordering coordination Minimum batch size

  11. The Market Risks Market risks include… Who is at greatest risk… • Inability to procure low volume formulations • Highly fragmented low volume products may not be supplied (e.g. non-essential IATT list) • Limited registration coverage • Suppliers have lower incentives to register products in low volume markets • Limited new product options • Creates further challenges to suppliers realizing a return on investment for new products • Low or medium volume country • Procuring a large number of formulations including multiple/redundant formulations for the same patient population • Procuring formulations or drugs considered clinically inferior that most countries have transitioned away from (e.g. liquid formulations, ddI etc..)

  12. Low Volumes of Multiple Redundant Formulations Make the Paediatric ARV Marketplace Unstable Patients on ART (in millions) Adult AZT Formulations AZT 300 mg AZT/3TC 300/150 mg AZT/3TC/NVP 300/150/200 mg Paediatric AZT Formulations AZT 50 mg/5 ml AZT 60 mg,100 mg AZT/3TC 60/30 mg AZT/3TC 60/30 mg dispersible AZT/3TC/NVP 60/30/50 mg AZT 300 mg AZT/3TC 300/150 mg AZT/3TC/NVP 300/150/200 mg et plus

  13. 7 Consolidation of Demand Around aSubset of Optimal Paediatric ARV Formulations is Essential To Ensure a Sustainable Supply EXAMPLE: AZT+3TC+NVP regimen for 3 - 24.9 kg weight band Product Fragmentation Product Consolidation (to improved formulations) • Improve patient outcomes • Limit supply risks • Decrease costs • Multiple formulations procured for one regimen AZT syrup AZT single AZT syrup AZT single 3TC syrup 3TC single 3TC syrup 3TC single NVP syrup NVP single NVP syrup NVP single AZT/3TC dual FDC (non-dispersible) AZT/3TC dual FDC (non-dispersible) AZT/3TC dual FDC (dispersible) AZT/3TC dual FDC (dispersible) Meets minimum batch size requirement AZT/3TC/NVP triple FDC AZT/3TC/NVP triple FDC

  14. Until Recently, Guidance on Formulation Selection For Paediatric ART Has Been Limited… 2013 WHO Treatment Guidelines • The 2013 WHO treatment guidelines provide specific guidance on preferred and alternative first- and second-line regimens • However, guidance on specificformulation selection is not included WHO Model Essential Medicines List (EML) • Identifies medicines that satisfy the needs of the majority of the population, to be available at all times, affordable, and in appropriate dosage forms • Broad: organized into 29 therapeutic classes (e.g., antibiotics, anti-malarials…) • Next update: begins July 2014 and will be completed by Q2 2015 • Evidence based process for selection and revision adopted • ARV’s added to EML • First model list for children developed • First adult EML list published • Adult 17th & Paediatric 3rd Ed. released

  15. 2011: First IATT Optimal Paediatric ARV Formulary Created by IATT Optimal Paediatric Formulary List 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 1st and 2nd 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

  16. IATT Paediatric ART Formulary: 2013 Revision IATT ART Formulary

  17. There are Over 61 Different Paediatric ARVs on the Market- Far Too Many To Serve This Patient Population or Commercially Viable For The Manufactures

  18. Evaluation Criteria

  19. Aim of the List: Address Both Adherence and Market Challenges For Paediatric HIV Treatment • Decreases pill burden and eases administration for caregiver and patient • Promotes adherence with simplified regimens, fewer bottles, fewer liquids, more temperature tolerance • Decreases costs over time • Improves availability by reducing complications in procurement, storage and distribution • Simplifies and clarifies the market for suppliers

  20. 2013 IATT Optimal Paediatric ARV Formulary * Oral liquid to be used to provide infant prophylaxis for PMTCT

  21. 2013 IATT Limited-Use Paediatric list

  22. The IATT List is a Living Document That Will Be Reviewed on a Regular Basis Revision triggers: • Major Review every 2 years when WHO issues new recommendations for paediatric ART • Minor Review every 6 months to evaluate if: • New and better paediatric ARV products available • New paediatric drug/formulation SRA or WHO pre-qual approvals • Actual or anticipated supplier side changes • Significant shifts in HIV paediatric treatment practices • Use of list (e.g., d4T-based formulations; ABC/AZT/3TC; AZT syrup; DRV)

  23. The List is Now Used by Multiple Stakeholders Paediatric ARV Procurement Working Group (PAPWG) which now coordinates across: • Major agencies funding paediatric ARVs • Major buyers of paediatric ARVs • Ministries of Health, national drug regulatory agencies, national HIV/AIDS programmes and procurement offices • Civil society stakeholders in paediatric HIV • Community organization of people living with HIV • Manufacturers of paediatric ARVs

  24. National Level Adoption • The IATT formulary is meant as a model list • However since paediatric volumes are small overall- global and regional trends are critical to understand • Country programs should consider options and select the formulations most relevant to their needs

  25. Steps To Consider For Country Adaptation of the IATT Formulary • Why should countries rationalize their paediatric formularies • When should countries rationalize their formularies • Who are the stakeholders involved • How should the formulary be rationalized • What should be done after rationalization

  26. Why: Country Advantages To Optimization of Paediatric ARV Formulary • Ensure quality of care (right doses and right drugs) • Ease administration to support adherence • Simplify prescribing practices • Streamline supply chain management • Potential for cost savings • Ensure demand so manufacturers continue to make paediatric formulations • Incentivize manufacturers to invest in R&D for new drugs

  27. When: After Treatment Guidelines Have Been Updated • Ensure National paediatric ART recommendations are up to date • Optimization of regimens also essential to simplify treatment • Identify regimens and products that can be phased out of formulary (eg. d4T, ddI) Consolidate regimens used 2013 WHO Recommended Paediatric ART Regimens

  28. Who: Country Stakeholders • National HIV/AIDS Program- to lead the process • National Essential MedicinesCommittee • PaediatricTechnicalWorking Group • Procurement and Supply Chain (Logisitics) • Central Medical Store • National Drug Authority • Finance • HCW (Prescribers) • Pharmacists (Dispensers) • Others Supply Chain Cycle

  29. How: Country Optimization 1 • Bring together stakeholders • Explain rationale for formulary optimization • Review prescribing and dispensing practices • Develop criteria for evaluation based on country resources, needs, preferences • Anticipate changes/transitions • Review current procurement list • Identify suboptimal drugs/products • Identify duplications • Identify optimal new products to be added to procurement 2 3 4 5 6

  30. Case study of AZT fixed-dose combination optimization in Malawi Country Example: Malawi 8 24

  31. Optimization Opportunities • Consolidate around optimal FDC formulations: e.g. d4T/3TC/NVP 6mg/30mg/50mg triple FDC • Remove outdated drugs: e.g. ddI • Identify duplicative formulations: e.g. AZT 100mg capsule • Limit use of liquid formulations : e.g. 3TC 50mg/5ml liquid • Distinguish between optimal and non-essential formulations: e.g. EFV 200mg scored tablet

  32. Optimization is Not Enough So What Next? • Consensus • Dissemination and communication • Advance planning • Low volume products • Lead times • Drug/product transitions • Registration • Intellectual property considerations • Coordinated procurement (PAPWG)

  33. Steps For Country Programs: • Select the most optimal paediatric ARV products prior to procurement • Forecast & quantify paediatric ARVs • Generate supply plans (annually at a minimum) • Use the coordinated/pooled procurement mechanism or follow the quarterly order cycle timeline

  34. Key Points • The IATT Optimal Formulary is designed to guide selection and procurement of paediatric ARV’s around a subset of optimal products • Consolidation of demand stabilizes supplies of paediatric ARVS • Success will require global consensus, regional collaboration and country implementation to ensure paediatric ARV’s will continue to be available to children in need • Country process for optimization should include: • Regimen selection • Product selection • Coordinated procurement • PAPWG is the global body created to support and coordinate procurement of paediatric ARV’s

  35. Feedback and Questions • Further resources • 2013 Optimal Formulary Meeting report: http://www.emtct-iatt.org/wp-content/uploads/2014/04/IATT-Sept-2013-Updated-Paediatric-ART-Formulary-Report1.pdf • Chapter 10, WHO March 2014 supplement: http://www.who.int/hiv/pub/guidelines/arv2013/arvs2013upplement_march2014/en/ • For additional information or technical assistance please contact: • AtienoOjoo (aojoo@unicef.org) • David Jamieson (djamieson@pfscm.org) • Nandita Sugandhi (nsugandhi@clintonhealthaccess.org) • Marianne Gauval (mgauval@clintonhealthaccess.org) • GitanjaliSakhuja (gsakhuja@unicef.org) Thank you!

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