A Call to Action Children The missing face of AIDS

Transcription

1 A Call to Action Children The missing face of AIDS

2 OVERVIEW OF PRESENTATION Introduction : lessons learnt Availability ; implications of making paediatric formulations available Remaining challenges in scaling up

3 CURRENT COVERAGE needs by 2010 Intervention Current Coverage Number in need in 2010 Costs in US$ (through 2008) Care and support for OVC 15%* 19.7 million 6 Billion PMTCT (prong 3) 3% 2.9 million 800 million Cotrimoxazole prophylaxis 1% 5.1 million ART for children 2% 1.2 million All prevention 29 billion VCT 1% 51.5 million 1.7 billion Harm Reduction 4% 7.2 million 440 million SW interventions 16% 17.6 million 1.6 billion MSM interventions 11% 21.8 million 1.2 billion Youth in school 50% 122 million 313 million Youth out of school <10%? 145 million 2.8 billion * Estimated to receive some services, not full package

4 Where are the high burden populations? Country 1. Nigeria 2. South Africa 3. Tanzania 4. Ethiopia 5. India Estimated nr of Children living with HIV 290, , , , ,000

5 Where are the high burden populations? Country 6. Zimbabwe 7. DRC 8. Kenya 9. Mozambique 10. Zambia Estimated nr of Children living with HIV 120, , ,000 99,000 85,000

6 Paediatric Care and treatment: Practical implications of making available appropriate formulations

7 COTRIMOXAZOLE PROPHYLAXIS DOSE Syrup (40mg/ 200mg) Paediatric tablet (20 mg/100 mg) Single Strength Adult Tablet (80 mg/400mg) Double Strength Adult Tablet (160 mg/800 mg) < 6 months 20 mg TMP/100 mg SMX 2.5ml 1 n/a n/a 6 months 5 years 40 mgtmp/200mg SMX 5 ml 2 1/2 n/a > 6 14 years 80 mg TMP/400 mg SMX 10 ml 4 1 1/2 > 15 years(or >35 kg ) 160 mg TMP/800 mg SMX n/a n/a 2 1

8 Main complexities in procurement of ARVs lie in international / national law, registration, availability, secure supply chain systems and patient compliance Demand Forecast Availability Patents & Registration Funding Procurement / Distribution Systems Compliance ??

9 CURRENT STATUS Formulations exist, situation improved As reported in 2004, paediatric formulations exist for first and second line List for children < 13 yrs expanded: 21 First line formulations (incl 8 adult formulations) 11 Second line formulation (incl 4 adult formulations) 2004 RECOMMENDATION HOLDS: Children eligible for treatment should be treated as a priority

10 CURRENT STATUS ARV Formulations exist, situation improved EFV 30mg/ml ABC 20mg/ml sol EFV 200mg caps EFV 50mg caps NVP 10mg/ml susp 3TC 100mg tabs 3TC 10mg/ml sol d4t 15mg caps d4t 1mg/ml sol ZDV 10mg/ml sol d4t 20mg caps ZDV 100mg caps No. of approved Suppliers 1 Oct No. of approved Suppliers 1 Oct. 2006

11 Paediatric Care and treatment: More formulations are available; Is it good news?

12 Minimum Product Package 1 st Line ADULT Single and 2 FDCs FDC zdv 300mg + 3TC 150mg FDC d4t 30mg + 3TC 150mg FDC d4t 40mg + 3TC 150mg 3 FDCs FDC zdv 300mg + 3TC 150mg + NVP 200mg FDC d4t 30mg + 3TC 150mg + NVP 200mg FDC d4t 40mg + 3TC 150mg + NVP 200mg NVP 200mg EFV 600mg TOTAL : 9 formulations ABC 300mg + 3TC 150mg + ZDV 300mg

13 Minimum Product Package 1 st Line PAEDIATRIC < 10 kg liquid kg tabs/caps > 14kg ABC 20mg/ml ZDV 10mg/ml 3TC 10mg/ml NVP 10mg/ml ZDV 300mg ABC 300mg 3TC 150mg NVP 200mg d4t 15mg, 20mg, 30mg TOTAL : 15 formulations, 14 additional 2FDC ZDV 300mg + 3TC 150mg 2FDC d4t 30mg + 3TC 150mg 3FDC d4t 30mg + 3TC 150mg + NVP 200mg 3FDC ABC 300mg + 3TC 150mg + ZDV 300mg

14 Simplified forecast for infants/children total number of infants to treat in the next 3 months % Nr on option zdv 100 Nr on option d4t Nr on option nvp Nr on option evf % of infants < 2 years / 5kg % of infants < 5 years / 10kg % of infants > 5 years: 20kg on liquids only % of infants > 5 years: 20kg on solid dose % of children on option 1(zdv), 2 (d4t) 70 30

15 Simplified forecast for infants/children [ Minimum ± 1,700 bottles per 3 month (200ml+) ] zdv liquid d4t susp 3TC liq Product patent generic patent generic patent generic Volume Estimate for 3 months total mls/day total packs nvp susp patent generic

16 Simplified forecast for 100 adults for 3 months per 100 adults on treatment FDC d4t [ 30mg or 40mg ] + 3TC 150mg + NVP 200mg 60 tablets per pack nr of packs / 3 months 300

17 Paediatric Care and treatment: More formulations are available; Is it good news?

18 Freight cost is affected by order size, destination, other. Lamivudine oral sol.10mg/ml /BOT-100ml Lamivudine oral sol.10mg/ml /BOT-240ml Nevirapine oral sol.10mg /ml/bot-240ml Stavudine oral sol. 1mg/ml/ BOT-200ml Zidovudine oral sol. 10mg/ml/ BOT-100ml Minimum (Values are the freight costs expressed as a % over the supply value) 6.4 Maximum Average

19 How do we ensure adherence in children? Dispensing - and adherence strategies not well defined Communicating dispensing instructions to caregivers complicated use colour coding of dispensing aids Difficult to assess adherence

20 Dispensing aids and in-use stability impact on forecasting Aseptic dispensing implies decanting - waste Instruction to discard opened containers after a period ultimately leads to waste

21 Relying on cutting tablets in half is not always feasible c

22 Regulatory requirements can be challenging Reduced doses, scored tablets for the young, FDC for paediatrics need to pass regulatory hurdles Justification for dose changes from 6h to twice a day Justification of weight bands Justification of breakability of tablets, i.e., distribution of active ingredient in tablets with low drug loads

23 Procurement and Supplies Management The need for Optimising Supply and Demand

24 Challenges affecting supply strategies supporting global disease programmes Product selection is driven working groups, consultants and prequalification efforts Lack of consideration of product specifications, e.g. expiry dates, weights and volume Lack of consideration of storage and distribution requirements Lack of consideration of performance characteristics, e.g. refrigeration needs Lack of consideration of costs and cost drivers, buffer stock

25 Challenges affecting supply strategies supporting global disease programmes Traditional planning methods are focussed on pushing products downstream towards end users, rarely with an understanding of the true demand at the first level of care Push to place orders Items move from under-stock to overstock in no time, expire, move back to undersupply Erratic demand Affecting private sector as much as public

26 Delivery Systems & Management structures drive supply and demand Unclear scientific data on effective models for delivery of paediatric care in resource limited settings Chronic care management of sick children limited in most settings However, best practices from programmatic experiences are emerging

27 Procurement and Supplies Management What can industry to today to improve access

28 Striving for more appropriate Research priorities formulations Need for pharmacokinetic data For ARVs when co-administered with rifampicin:, e.g., Efavirenz Nevirapine, Lopinavir/r, Abacavir Dose requirements in young children ( efavirenz in under 3 years, nevirapine under 6 months Daily dosing in children? The impact of nutritional status on the use of ARVs Pharmacovigilence systems supporting safety of medicines in children

29 Striving for more appropriate formulations Innovative formulations Need for scored tablets Need for FDCs, with approved indications to half tablets Need to easy to use formulations / dispensing aids to improve adherence Need for formulations that allow us to make distribution chains more efficient weight, volume Need to make heat stable formulations available as widely as possible

30 We need you to advise us Thank You on best innovations!