The Global Crisis of Drug-Resistant Tuberculosis and the Leadership of the BRICS Countries: Challenges and Opportunities,

Transcription

1 The Global Crisis of Drug-Resistant Tuberculosis and the Leadership of the BRICS Countries: Challenges and Opportunities, January 16-18, 2013 Beijing, China Day 3, Session VI Professor Rifat Atun Professor of International Health Management and Head, Health Management Group Imperial College London Professor Rifat Atun. Imperial College London 2013

2 Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis

3 Uninterrupted supply of quality assured drugs when needed

4 Availability of selected medicines in public and private health facilities Source WHO 2008 & UN

5 Supply Chain Management (1) Manufacturer 1 Manufacturer 2 Storage Service Patient Manufacturer 3

6 Supply Chain Management (2) Manufacturer 1 Manufacturer 2 Storage Service Patient Manufacturer 3 Distributor Retailer

7 Supply Chain

8 Supply Chain Upstream Activities

9 Pharmaceutical R&D Process IND: Investigational new drug NDA: New drug approval Research IND submission Development NDA submission Launch Phase 4 Phases Phase 3 Regulatory Phase 2 Phase 1 Pre clinical Discovery 0 4 Time from start in years 10 12

10 R&D Feasibility: Probability of success at each stage Research IND submission Development NDA submission Launch P=0.75 Phase 4 Phases P=0.50 P=0.85 Phase 3 Regulatory P=0.75 Phase 2 P=0.9 Phase 1 P=0.6 Pre clinical Discovery 0 Probabilities: Lehman Brothers 4 Time from start in years 10 12

11 The R&D Process And Risk : Go No Go Decisions R & D Stages Discovery & Research Pre-clinical Testing Human Trials I Human Trials II Human Trials III Reg. Review & Approval Main Activity Basic Research on Disease Process & Molecules Lab & Animal Testing Healthy Volunteer Safety Studies Safety And Efficacy Testing On Patients Large Scale Efficacy & Safety Trials Assemble Evidence Package Duration - Years Chance Of Success Less Than 1% Of Patented Pre-clinical Molecules Go Into Human Trials I Of Molecules Entering Human Trials, 70% Complete Phase I 33% Complete Phase II 25% Complete Phase III 20% Get Market Approval

12 Supply Chain (1)

13 Supply Chain (2)

14 Supply Chain (3)

15 Supply Chain Management (2) Manufacturer 1 Manufacturer 2 Storage Service Patient Manufacturer 3 Distributor Retailer

16 Failed Market Dynamics Demand Demand and Supply Volumes Supply Production Plan Procurement Orders Time

17 How to achieve uninterrupted supply of quality assured drugs when needed? Systems View

18 Push and pull mechanisms with Supply side incentives enabling platforms Institutions Demand creation Signalling Push strategies Adoption system Pull strategies Enabling platforms Health Systems Empowerment Institutionalisation

19 Push and pull mechanisms with R&D Tax breaks PPDPs Fast track approval enabling platforms Institutions Global Fund; GAVI AMC; IFFIm; Impact bonds; volume guarantees Push strategies Adoption system Pull strategies Enabling platforms Atun, Knaul, Frenk, Lancet 2012 Regulatory environment PHC/Community Care PPM Outsourcing

20 The Global Crisis of Drug-Resistant Tuberculosis and the Leadership of the BRICS Countries: Challenges and Opportunities, January 16-18, 2013 Beijing, China Professor Rifat Atun Professor of International Health Management and Head, Health Management Group Imperial College London Professor Rifat Atun. Imperial College London 2013

21 Affordable Medicines Facility malaria Multiple eligible ACT manufacturers Co-payment First line buyers Private Buyers (e.g. National Wholesalers) NGO Buyers (e.g. PSI, MSF) Public Buyers (e.g. Ministry of Health) Wholesalers Distributors Central medical stores Medicines Money Retailers, private clinics and public providers Patients

22 Global Fund Case Study

23 Procurement and Supply Chain Support Service VPP: Simplifies Procurement Process Reduce timelines for ordering and deliveries Ensure compliance with Quality assurance policy Facilitates timely payment Meet the needs of Principal Recipients CBS/SCMA: Addresses challenges in Supply Chain Management Through provision of Technical Support To strengthen existing capacities / systems Focus- Quantification, Storage, Distribution, Logistics Management Information activities In collaboration with development partners Secretariat Principal Recipients CBS/SCMA Technical support for incountry management and delivery of health products Technical Support Providers Consulting /TA agencies The Global Fund Procurement Support Service Participating PRs TA Services Procurement Agents Suppliers/ Manufacturers VPP Orders / Information PQR Data input VPP Procurement and Delivery of health products

24 Price and Quality Reporting The Global Fund Principal Recipient Price Quality Delivery Conditions Monitor Price Comparison Quality Monitoring Market Information Reports Principal Recipients General Public Partners Verify Data Local Fund Agent

25 Global Fund Voluntary Pooled Procurement Core & Non Core Product Orders ( ) Value: US$ Proportion by No. of orders Value Core 34% 85% Non Core 66% 15% No. of Orders

26 Impact of PQR on Procured Drug Prices At or below international reference ranges Prices at or below international references, 91% 1% 0.7% 1% 2% Generic products in 100 countries Likely data quality issues Prices above reference sources, 9% 1% Branded products in add't 54 countries 4% Branded products in 10 UMI Countries Branded products in China Branded products in Russia

27 Reducing Costs of Antiretrovirals

28 Proposed ceiling prices to reported unit prices and trends - Efavirenz 600 mg Points scaled by the quartile of the quantity ordered Lowess curve f=0.2 Source: PRM and PQR reported orders as of 1 March There are previously documented issues with the completeness and accuracy of reporting; reported orders may not be a representative sample of all orders. Note: orders have been reported with a variety of Incoterms (freight, insurance). In general, 40% did not report the Incoterms associated with the price; of those where Incoterms were reported, the majority were inclusive of freight and insurance. To make a fairer comparison between ceiling price (ex-works) and reported orders, the ceiling price is also presented with 10% and 25% increases to provide a reasonable range for ceiling price with typical Incoterms. Grant/country code is displayed for orders above 75 th percentile for 2007 and Unit Price Unit Price (USD, (USD, nominal) Efavirenz Efavirenz 600 mg 600 mg Unit Prices of Reported Orders and Proposed V Unit Prices of Reported Orders and Proposed V Reported Order Proposed Ceiling Ceiling + 10% Ceiling + 25% Prior CHAI ceiling? Date of Order Date of Order Linear trend line Moving median (21 orders)

29 PQR reported Efavirenz 600mg prices compared to other price information sources USD/ppy Efavirenz 600mg: Comparison of Prices Reported by GF, Other Sources, and MSF Manufacturer Survey YTD $700 GF Reported Median WHO Reported Median (excluding GF) $600 MSF Lowest Manufacturer Reported $500 $400 $300 $200 $ $

30 Imperial College Business School