Lessons learned from catalyzing and sustaining access to Pediatric HIV treatments. Dr. David Ripin IOM Workshop: Aug , Washington DC

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1 Lessons learned from catalyzing and sustaining access to Pediatric HIV treatments Dr. David Ripin IOM Workshop: Aug , Washington DC

2 In 2006, the pediatric ARV market was nascent with very few HIV+ pediatric patients accessing treatment CHAI became the implementing partner for a UNITAID-funded project to scale pediatric HIV treatment and catalyze the pediatric ARV and EID markets Environment Lower volume, fragmented market Fewer treatment alternatives (e.g. regimens) More formulations per regimen Coverage rates and total patients significantly below adults on treatment Lack of product registrations in country Lack of quality manufacturers Project Goal Provision of pediatric ARVs to countries: at reasonable and consistent lead times with access to all clinically needed products at reduced pricing Increase number of children on ART Incentivize development of the right pediatric ARVS CHAI and UNITAID developed various practices over the course of the program to respond to challenges, however continued action is needed to sustain the market 2

3 A number of challenges and characteristics of pediatric ARV procurement are relevant to MDR-TB drugs Procurement challenges that have, or continue to, threaten pediatric ARV treatment: Proliferation of products available for treatment 1 Low volume orders and products 2 3 Long and variable lead times 4 Need for new products For each, we will cover: Description of the challenge Approach taken Impact/results Parallels for MDR-TB drugs 3

4 Challenge 1: Currently 45+ unique products are available and used by countries, fragmenting already relatively small pediatric demand Adopted Practice Formulation Guidance WHO, through IATT, developed and will update formulation recommendations to complement broader treatment guidelines Treatment 2.0 to provide further guidance to suppliers of short, medium and long term development priorities, including for pediatric therapy Formulation optimization incountry Evaluate programs to identify pediatric optimization opportunities Adopt national formulary, ideally around upcoming WHO list Impact A coalition of 23 global health organizations has recommended a rationalized list of Pediatric ARVs to serve all recommended WHO regimens across all weight bands; (adoption by countries is the key next step) IATT Optimal, For Limited Use and Non-Essential Pediatric Antiretrovirals 15 optimal products serve all regimens and all weight-bands (including 2 syrups for PMTCT) Significant reductions in formularies in several countries after focused intervention 4

5 MDR-TB drugs also suffer from fragmentation and would benefit from consolidation and rationalization Between different countries: Different regimens Countries have guidelines for regimens based on different drugs: Kanamycin vs. Capreomycin PAS-Acid vs. Na PAS Cycloserine vs. Terizidone Different quality standards / procurement streams Some HBCs use GDF / WHO PQ medicines, and some countries do not (~13k vs. 40k patients in 2010, respectively) Within the same country: Some HBCs include 5+ standard MDR regimens in guidelines, likely with many more permutations used in reality Individual countries conduct separate procurement cycles for individual funding sources (i.e. GFATM vs. domestic) Detailed product-level procurement data should be analyzed to identify high-impact opportunities for harmonization 5

6 # Packs (Thousands) # Packs Challenge 2: Most countries place orders below minimum batch sizes and global aggregated demand is insufficient for some products Individual country orders are well-below manufacturers batch sizes 25,000 20,000 15,000 10,000 5,000 0 LPV/r (100/25mg): # Packs ordered in Q by country Minimum batch size for LPV = 13.3k packs and When global aggregated orders do not meet >2 batch sizes, long lead times ensue Minimum batch size for ABC 60mg crushable = 10k packs ABC (60mg) #Packs Ordered by Quarter Minimum batch size for ABC 60mg dispersible = 5k packs Q Q Q Q Q Q Burundi D R Congo Ethiopia Lesotho Mozambique Rwanda Uganda Zimbabwe 6

7 Low volume orders and low volume products (2 of 2) Adopted Practice Coordinated procurement: Set 4 quarterly ordering dates to aggregate demand Quicker order turnaround time from country to supplier (~ 2 weeks) to align orders Re-distribution to manage shortages when needed Sole supplier selected in annual tender process with pool of others available for backup Consolidate demand around fewer number of formulations Parallels for MDR-TB Drugs Impact Greater access to low volume products Lower risk of stock-outs; more consistent lead times; improves shelf live expiry issues Supplier feedback: they prefer this system and would rather lose volumes than be pressured to supply at a loss Increase obligation & accountability to supply selection of two primary suppliers can worsen the challenge as they may both point to the other to supply Historical demand for key products has been well below minimum production thresholds at the API and formulator levels 7

8 Challenge 3: Lead times from order placed to finished production vary by supplier: average 114 days but the range is days Adopted Practice Forecasting: encouraged robust forecasting by countries, to enable suppliers to plan production Non-Price Factors: Average lead-time included in evaluation criteria to win tender Quicker order turnaround time commitment from country to supplier (~ 2 weeks) Troubleshoot on a case by case basis Impact Lower lead times Decreased supply volatility Continues to be a challenge Parallels for MDR-TB Drugs Country programs regularly complain about long and variable lead times (anecdotal) 8

9 Other best practices include considering non-price factors in your bid evaluation process Improvements in delivery times by including PAST performance as a factor in CHAI / UNITAID tender*: % On-time deliveries** Average length of delays*** 100% 15 50% 60% +17% 70% weeks -52% 6 weeks 0% 2009 Tender 2010 Tender Tender 2010 Tender *2 010 data based on orders placed in first three quarters to December 2010 ** Based on total # of bottles delivered on time. *** Based on orders that were previously delayed (delivered after 13 weeks, the average lead time) 9

10 # Packs (Thousands) Challenge 4: New product introduction and/or supplier entry can be difficult to facilitate Three batch sizes required for validation meant larger order volumes were required to get a product initially supplied. New suppliers often have a higher cost for existing products NVP 50mg #Packs Ordered by 2011 Quarter Q1 Q2 3 batches for NVP 50 mg Cameroon D R Congo Kenya Uganda 10

11 Case Study Benefits of splitting tenders on price Splitting tenders facilitated the entry of additional suppliers into the market Market Share allowing them to lower prices leading the primary supplier to reduce its price for the first time Per Patient Per Year Price $765 $493 $567 $7.3M in cost savings $441 $434 $ Primary supplier Secondary supplier Other Despite an initial investment ~$2 million for a premium price, this strategy led to a broader supply base and significant and sustainable price reductions Source: CHAI-UNITAID order data; price for LPV/r (200mg/50 mg); cost savings based on patient volumes and price reductions relative to the innovator s original price ($500 pp/py).

12 Targeted actions on the supply- and demand-side can help address the need for new or optimal products/supplier entry to existing ones Adopted Practice Quarterly update on product availability timelines Worked to place the initial order in the same quarter, stimulating adequate demand for validation batches TA support to programs to revise guidelines, adjust formularies and manage inventory for shifts Ability to pay premium at time of product introduction Impact New FDCs and dispersible introduced and demand / orders / uptake at patient level has increased dramatically Improvement in cost and ease of dosing Accelerated patient access to new products Parallels for MDR-TB Drugs Facilitating supplier switch/entry to produce existing products (i.e. from Cs bottle to Cs blister) Accelerating uptake of new compounds when they are ready 12

13 Much progress has been made through the UNITAID pediatric project to increase access to pediatric ARVs, complemented by incountry programmatic activities Over the past five years, the UNITAID project has mitigated key market challenges by: Increasing transparency into demand Increasing availability of pediatric products through supply competition Assisting countries to introduce new products Product optimization, encouraging the phase out of older formulations Coordinating procurement by pooling volumes on quarterly order dates These efforts have realized many improvements in the pediatric ARV market: Rapid scale-up of pediatric ART and EID testing Substantial cost reductions Improved treatment through introduction of new formulations, such as FDCs and dispersible tablets Shorter lead times and greater reliability of supply, leading to more consistent treatment Improved access in low-volume countries through non-price factors to encourage registration HOWEVER: As the UNITAID project comes to an end, the pediatric ARV marketplace faces challenges that threaten the reliable supply of pediatric ARVs 13

14 Appendix

15 The size and the fragmented nature of the pediatric ARV market make it inherently risky and difficult to sustain The pediatric market is relatively small: ~456,000 on ART in 2010 Small volumes are further fragmented into sub-groups by age and weight bands A large number of duplicative pediatric formulations can serve within a given regimen and weight band Patients on ART (in millions) Adults Receiving ART Children Receiving ART Adult AZT Formulations 1. AZT 300 mg 2. AZT/3TC 300/150 mg 3. AZT/3TC/NVP 300/150/200 mg 6.2M 4.9M 3.8M 2.8M 0.197M 0.275M 0.355M 0.456M Pediatric AZT Formulations 1. AZT 50 mg/5 ml 2. AZT 100 mg 3. AZT/3TC 60/30 mg 4. AZT/3TC 60/30 mg dispersible 5. AZT/3TC/NVP 60/30/50 mg 6. AZT 300 mg 7. AZT/3TC 300/150 mg 8. AZT/3TC/NVP 300/150/200 mg 15

16 Patients on ART A dramatic scale-up of children on ART has been achieved with improved treatment options introduced over the past five years Yet pediatric ART coverage is less than half that of adult ART coverage Children Receiving ART Coverage % - Children 0.456M +45% CAGR 0.355M 0.197M 0.275M 21% 23% Coverage % 0.126M 0.072M Source: WHO TUAPR , published November

17 Additional factors and challenges in providing supply security in a low-volume market Registrations Coverage 5 Challenge: low incentives for suppliers to broadly register products Approach: non-price factors includes registration coverage as criteria to win tender Facilitating downward price pressure 6 Challenge: Ongoing tension between maintaining supply security and price reductions Approach: Informal evaluation on trade-offs/implications of price reductions 7 Forecasting accuracy Challenges: Despite support country forecasts have wide variance: only 10% of forecasts within 30% accuracy in 2010 Approach: Ongoing TA both in country and by UNITAID team. forecasts vetted for accuracy and revisions requested 17

18 Currently 45+ unique products are available and used by country programs today, fragmenting a relatively smaller pediatric population 1. 3TC (150mg) 22. d4t (15mg) 2. 3TC (150mg) + AZT (300mg) 23. d4t (1mg/ml) 3. 3TC (150mg) + AZT (300mg) + NVP (200mg) 24. d4t (20mg) 4. 3TC (150mg) + d4t (30mg) 25. d4t (30mg) 5. 3TC (150mg) + d4t (30mg) + NVP (200mg) 26. DDI (100mg) 6. 3TC (30mg) + ABC (60mg) 27. DDI (125mg) EC 7. 3TC (30mg) + AZT (60mg) 28. DDI (200mg) 8. 3TC (30mg) + AZT (60mg) + NVP (50mg) 29. DDI (200mg) EC 9. 3TC (30mg) + d4t (6mg) 30. DDI (250mg) EC 10. 3TC (30mg) + d4t (6mg) + NVP (50mg) 31. DDI (25mg) 11. 3TC (50mg/5ml) 32. DDI (2g or 10mg/ml) 12. 3TC (60mg) + d4t (12mg) 33. DDI (50mg) 13. 3TC (60mg) + d4t (12mg) + NVP (100mg) 34. EFV (100mg) 14. ABC (20mg/ml) 35. EFV (200mg) 15. ABC (300mg) 36. EFV (200mg) - Scored Tab 16. ABC (60mg) 37. EFV (30mg/ml) 17. ABC (60mg) dispersible 38. EFV (50mg) 18. AZT (100mg) 39. LPV/r (133/33mg) 19. AZT (300mg) 40. LPV/r (200/50mg) 20. AZT (50mg/5ml) 41. LPV/r ( mg / ml) 21. AZT (60mg) 42. LPV/r (100/25mg) 43. NVP (200mg) 44. NVP (50mg/5ml) 45. NVP (50 mg) dispersible Note: List combines ARVs ordered through UNITAID and The Global Fund. 18

19 A coalition of 23 global health organizations has recommended a rationalized list of Pediatric ARVs to serve all recommended WHO regimens across all weight bands; adoption by countries is the key next step IATT Optimal, For Limited Use and Non-Essential Pediatric Antiretrovirals Item Formulation Dose(s) Optimal ABC Tablet (dispersible, scored) 60mg ABC+3TC Tablet (dispersible, scored) 30+60mg ddi Capsule (unbuffered, enteric coated) 125mg, 200mg ddi Tablet (buffered, chewable, dispersible) 25mg EFV Tablet (scored) 200mg AZT+3TC+NVP Tablet (dispersible, scored) mg AZT+3TC Tablet (dispersible, scored) 60+30mg d4t+3tc+nvp Tablet (dispersible, scored) mg d4t+3tc Tablet (dispersible, scored) 6+30mg LPV/r Oral liquid* 80+20mg/ml LPV/r Tablet (heat stable) mg NVP Tablet (dispersible, scored) 50mg NVP Oral liquid** 50mg/5ml AZT Oral liquid** 50mg/5ml LimitedUse ABC Oral liquid 100mg/5ml ATV Solid oral dosage form 100mg, 150mg DRV Oral liquid 500mg/5ml DRV Tablet 75mg, 150mg ddi Powder for oral liquid* 2g, 4g bottle 3TC Oral liquid 50mg/5ml RTV Oral liquid* 400mg/5ml RTV Tablet (heat stable) 100mg d4t Powder for oral liquid* 5mg/5ml * Requires cold chain (2-8*C) for transport and/or storage and is not adapted for resource limited settings where refrigeration may not be accessible. ** Use should be reserved for PMTCT ONLY. 15 optimal products serve all regimens and all weight-bands (including 2 syrups for PMTCT) LPV/r is the only pediatric treatment syrup on the optimal list outside of PMTCT use 19

20 Low, fragmented volumes continue to be a challenge; continued stable access to commodities for pediatric HIV care is critical to maintaining gains and securing the evolving pediatric ARV market Recognizing the risk of supply disruptions post-unitaid, global stakeholders have prioritized the implementation of coordinating mechanisms and certain strategic interventions to ensure sustained, reliable supply of pediatric ARVs Context Many individual country orders do not meet manufacturer volume requirements for production which may lead to supply risks and treatment disruptions Country Concerns Supply security and competitive pricing Procurement issues (lead times, quality, registration) Market Coordination Required Establish a sustainable market mechanism Reduce fragmentation and secure reliable and consistent commodity supply for low- to medium-volume countries Increase demand transparency to improve supply of commodities Maintain or improve pricing Provide incentives to bring new optimal products to market 20

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