1. Nov 2004Access to Paediatric ARV formulations ENSURING SECURE and RELIABLE SUPPLY and DISTRIBUTION SYSTEMS in DEVELOPING COUNTRIES, in the CONTEXT OF HIV/AIDS and PMTCT Paediatric ARV Formulations Demand, Supply, Costs – impact on the availability of formulations …. Geneva November 2004 Helene Möller M.Pharm, PhD Supply Division

2. Nov 2004Access to Paediatric ARV formulations Access to paediatric ARV formulations depends on effective supply chain management Demand Supplier Agreements Financing Receipt, Storage, Distribution Forecasting Quality Assurance Effective Use Product Procurement Product Selection Monitoring

3. Nov 2004Access to Paediatric ARV formulations FIRST LINE / PMTCT ARV Formulations are available …… TreatmentProducts availablePrice (US $ / 100ml) PMTCT/ 1st LineInnovatorGenericInnovator *Generic # D4TYesNo4.23 – 18.66 ZDVYes 2.961.53 - 2.10 3TCYes 2.801.68 - 2.00 NVPYesYes #8.752.00 - 2.45 EFVYesNo9.45 - 15.12 * Mostly current ACCESS prices unless range indicated, # Not necessarily WHO prequalified

4. Nov 2004Access to Paediatric ARV formulations SECOND LINE / PMTCT ARV Formulations are available …… TreatmentProducts availablePrice (US $ / 100ml) 2nd LineInnovatorGenericInnovator *Generic # ABCYesNo13.05 ddIYesNo9.64 LPV/rYesNo13.70 – 136.70 NFVYesNo35.00 / 144g * Mostly current ACCESS prices unless range indicated, # Not necessarily WHO prequalified

5. Nov 2004Access to Paediatric ARV formulations MSF Paper: Current situation regarding prices and availability of specific children formulations … Cost of treatment drops when switching to adult formulations: Peak around 14kg bodyweight Using tablets for a child (20 kg) reduces the cost per treatment per year nearly 8 times: – (d4T / 3TC / NVP ) Best generic price/y$ 566$224 Best innovator price/y $1,706$631 Managing the switch – increases complexities in resource poor settings

6. Nov 2004Access to Paediatric ARV formulations ARV liquid formulations can become expensive.. Regimen Paediatric Cost per monthCost per dayTotal Cost / y originalgenericoriginalgeneric original generic ZDV+3TC+ NVP (±3kg) 21.6916.910.720.56 256.32 200.67 ZDV syr +3TC+NVP (±10kg) 53.6143.351.791.44637.24 514.36 ZDV caps +3TC+NVP (±10kg) 24.94 18.350.830.61295.48 217.75

7. Nov 2004Access to Paediatric ARV formulations PREVENTION : Appropriate formulations to provide the infant dose …. For Prevention of Mother to Child Transmission: For infant: Zidovudine (ZDV)4mg/kg 2x daily, for 1 week, 4-6 weeks Nevirapine (NVP)single dose 0,6ml Lamivudine (3TC)2mg/kg 2x daily, for 1 week

8. Nov 2004Access to Paediatric ARV formulations PREVENTION : Appropriate formulations to provide the infant dose …. PMTCT formulations Cost ( $ ) Productdoseformulation per dose per pack nevirapine 0.6ml 20mlfree nevirapine240ml0.2217.50 zidovudine 2,5ml bd, 7d 200ml1.78*7.10* zidovudine (generic)100ml0.771.53 BAXA syringe( free with donation )0.25 * Price incl delivery

9. Nov 2004Access to Paediatric ARV formulations Are there other costs that affect the price / cost of Paediatric ARV Formulations ?

10. Nov 2004Access to Paediatric ARV formulations Other cost factors to consider … Minimum order quantities: Nelfinavir CHF 10,000 Abacavir, etc 24 bottles per order The pipeline : Balancing lead times, holding stock, emergency stock needs – need to develop local drug supply strategies to prevent hoarding, expiry and potential stock outs – procedures for accessing ‘emergency’ supplies need to be clear to all What about distribution costs ? Shipping ? What about costs to the patient ?

11. Nov 2004Access to Paediatric ARV formulations Access to paediatric ARV formulations depends on effective supply chain management Demand Creation Supplier Agreements Financing Receipt, Storage, Distribution Forecasting Quality Assurance Effective Use Product Procurement Product Selection Monitoring Calculating the number of bottles we should/can buy … We need partners to complete the cycle