Procurement, selection, prequalification, pricing and monitoring of medicines

Transcription

1 Procurement, selection, prequalification, pricing and monitoring of medicines Richard Laing Medicines Information and Evidence for Policy, Essential Medicines and Pharmaceutical Policies World Health Organization 1

2 Procurement, prequalification, pricing, availability of drugs Selection Quantification Quality Assurance Pricing Monitoring 2

3 Selection First edition 1977 Revised every two years Now contains 423 medicines including children's medicines Patent status NOT considered in selection Over time has contained 5% to 10% patent protected medicines See 3

4 Quantification Estimating requirements is a challenge when expanding programmes or when data collection is weak Two methods used Morbidity based Consumption based Combination of approaches usually used 4

5 Quality Assurance Prequalification Dossier Review GMP Inspection Laboratories Training and Capacity development Regulatory Support Norms and Standards Country Support See 5

6 Dossiers submitted HIV IN Malaria TB RH HIV Malaria TB RH HIV Malaria TB RH IN HIV Malaria TB RH IN HIV Malaria TB RH IN DI HIV Malaria TB RH DI H H H H H H2 2009

7 Number of inspections FPP API CRO QCL total

8 List of WHO Prequalified Medicinal 9 July 2010 Products 275 HIV/AIDS 27 Tuberculosis 17 Malaria 7 Influenza 5 Reproductive health HIV/AIDS TB Malaria Influenza RPHP Total 331 8

9 Prequalified / interested laboratories May QCLs Prequalified QCLs Interested May-10 Prequalified QCLs: South Africa, RIIP+CENQAM (2005) Algeria, LNCPP (2005) South Africa, Adcock Ingram (2007) Morocco, LNCM (2008) Kenya, NQCL (2008) India, Vimta Labs (2008) France, CHMP (2008) Vietnam, NIDQC (2008) Kenya, MEDS (2009) Singapore, HSA (2009) Singapore, TÜV (2009) Canada, K.A.B.S. Laboratories (2010) Ukraine, CLQCM (2010) Ukraine, LPA (2010) 9

10 PQ Outcomes... Recognition: Donors (Gates, UNITAID) also supported by the Global Fund (QA policy), World Bank etc Transparent: Positive and negative outcomes published, Suspension and withdrawals when needed Sampling and testing programmes monitor and prove good quality medicines Ongoing inspections and investigations, maintenance of products Harmonization, cooperation (e.g. agreements including with FDA) By rotating national inspectors through PQ unit and involvement in dossier review and GMP inspections national regulatory capacity built 10

11 Medicines Pricing Sources of Information about prices WHO website - International and national sites Procurement Information Exchange (PIE) from Western Pacific Region WHO/HAI Pricing Project Pricing Analysis of ARVs 11

12 ernational_medicine_price_guidesprice_lists.pdf 12

13 es/national_medicine_price_sources.pdf 13

14 Price Information Exchange for Selected Medicines in the Western Pacific Region (also in.net,.org) The website provides comparative information on procurement prices that countries can use in influencing actions to make medicines more affordable and in negotiating with suppliers. Presentation: round 1 (2009) 31 medicines, 18 countries round 2 (2010) 40 medicines, countries (in process) Browsing by medicine the unit price of medicines (brand, branded generic, generic) in comparative charts Each bar unfolds details on pack size, price per pack, product name, manufacturer, supplier and quantity International and Regional median in vertical lines (generics only) Browsing by country brief description of countries medicines procurement. Link to countries health information profiles Other features description of PIE, glossary, external resources, forum & data collection form 14

15 WHO/HAI Pricing Project 15

16 Generic and Brand ARV Prices: some findings refute conventional wisdom $1.95 $ Price per smallest unit ($) $ $ G 11x B 20x G 6x B 13x G 5x B 12x G 17x B 51x G 5x B391x G 10x B 33x G 79x B 28x ddi 100mg ddi 200mg ddi 50mg EFV 200mg IDV 400mg NFV 250mg NVP 200mg Prices shown are per tablet 7/05-6/06 16

17 Ratio of highest price paid to lowest price paid, antiretroviral medicines in low-income countries 2008* Generic Version Brand Version *Waning et al. Temporal Trends in Brand and Generic Prices of Antiretroviral Medicines 17 Procured with Donor Funds in Developing Countries. Journal of Generic Medicines 2010;7: ABC 300mg ddi 25mg ddi 50mg ddi 100mg ddi 200mg ddi 250mg ddi 400mg 3TC 150mg d4t 15mg d4t 20mg d4t 30mg d4t 40mg TDF 300mg ZDV 100mg ZDV 300mg d4t30+3tc150 d4t40+3tc150 TDF300+FTC200 ZDV300+3TC150 EFV 50mg EFV 200mg EFV 600mg NVP 200mg d4t30+3tc150+nvp200 d4t40+3tc150+nvp200 ZDV300+3TC150+NVP200 IDV 400mg NFV 250mg LPV133.3+RTV 33.3 LPV200+RTV50 RTV 100mg SQV 200mg NRTI NNRTI & 2NRTI+NNRTI FDC PI High:Low Price Ratio

18 Ratio of highest price paid to lowest price paid, antiretroviral medicines in middle-income countries 2008* Generic Version Brand Version *Waning et al. Temporal Trends in Brand and Generic Prices of Antiretroviral Medicines Procured 18 with Donor Funds in Developing Countries. Journal of Generic Medicines 2010;7: ABC 300mg ddi 25mg ddi 50mg ddi 100mg ddi 200mg ddi 250mg ddi 400mg 3TC 150mg d4t 15mg d4t 20mg d4t 30mg d4t 40mg TDF 300mg ZDV 100mg ZVD 300mg d4t30+3tc150 d4t40+3tc150 TDF300+FTC200 ZDV300+3TC150 EFV 50mg EFV 200mg EFV 600mg NVP 200mg d4t30+3tc150+nvp200 d4t40+3tc150+nvp200 ZDV300+3TC150+NVP200 IDV 400mg NFV 250mg LPV133.3+RTV33.3 LPV200+RTV50 RTV 100mg SQV 200mg NRTI NNRTI & 2NRTI+NNRTI FDC PI High:Low Price Ratio

19 Regression found only 6 of 19 solid dosage forms showed relationship between volume and price -found no relationship in highest volume products Dosage Form zidovudine 100mg sta40+lam +nvp sta30+lam +nvp stavudine 30mg stavudine 40mg efavirenz 600mg Low Vol. Middle Vol. High Vol. 7.2% ref 13.3% 13.7% ref 10% 13.3% ref 13.3% ref 16.7% 15.2% ref 14.3% linear regression nevirapine 200mg generic p=0.35 brand p=

20 Regression analyses: no relationship between purchase volume & price for 19 of 24 antiretroviral medicines* Median Price/Person/Year (USD) Median Price/Person/Year (USD) No No price-volume price-volume relationship of of ARVs ARVs No price-volume relationship relationship 19 of 24 ARVs high volume price greater than low high or volume medium price volume greater price than low or medium volume price 1 of 24 ARVS 1 of 24 ARVS high volume price greater than low or medium volume price 1of24ARVS high high volume volume price price less less than than low low or or medium medium volume volume price price 4 of of ARVS ARVS high volume price less than low or medium volume price 4 of 24 ARVS 0 0 Low Volume Medium Volume High Volume Low Low Volume Volume Medium Medium Volume Volume High High Volume Volume *Waning et al. Analysis of Global Strategies to Reduce Prices of Antiretroviral Medicines: 20 Evidence from a Transactional Database. Bull World Health Organ 2009;87(7):

21 Monitoring Consumption & Prices In collaboration with IMS Health WHO has been tracking the impact of the global recession on pharmaceutical consumption, expenditure and prices in 83 countries Data shows that only Baltic and eastern European countries have been substantially impacted Methods could be used to monitor the impact of policy changes e.g. Data exclusivity See 21

22 Source 22

23 Source 23

24 Source 24

25 Source 25

26 1,25 Price per IMS Standard Unit Global, EURO, Baltics (Evolution on Q1 08) 1,20 1,21 1,15 1,10 1,05 1,00 1,08 1,02 1,01 0,95 0,90 0,85 0,93 0,92 0,85 Q1 07 Q2 07 Q3 07 Q4 07 Q1 08 Q2 08 Q3 08 Q4 08 Q1 09 Q2 09 Q3 09 Q4 09 GLOBAL EURO Estonia Latvia Lithuania Source 26

27 Comparing Prices and Total Pharmaceutical Expenditure Switzerland has highest prices Spain and France have lower prices than OECD average Source OECD 2008 Pharmaceutical Pricing Policies in a Global Market 27

28 Comparing Prices and Total Pharmaceutical Expenditure Spain and France have the highest per capita pharmaceutical expenditures in OECD Switzerland has lower per capita pharmaceutical expenditures than 28 OECD average

29 Despite low prices both China and India spend more than other low and middle income countries on pharmaceuticals Medicine price, TPE per capita and GDP per capita, 2004 (at PPP, low and middle income countries) Median price ratio India Philippines Mongolia El Salvador R 2 =0.04 Syrian Arab Republic China Peru TPE per capita at PPP India Mongolia El Salvador R 2 = China Syrian Arab Republic Philippines Peru GDP per capita at PPP MPR Linear prediction GDP per capita at PPP TPE per capita at PPP Linear prediction 29

30 Conclusion There is much to procurement beyond patents, copyright and data exclusivity Data resources and methods currently available allow evaluation of policy or programmatic actions at global, regional or national levels Many opportunities to cooperate at a technical and at a country support level 30

31 Citations Waning B, Kyle M, Diedrichsen E, Soucy L, Hochstadt J, Bärnighausen T, Moon S. Intervening in global markets to improve access to HIV/AIDS treatment: an analysis of international policies and the dynamics of global antiretroviral medicines markets. Globalization and Health 2010:6:9. Waning B, Kaplan W, Fox MP, Boyd-Boffa M, King AC, Lawrence DA, Soucy L, Mahajan S, Leufkens HG, Gokhale M. Temporal Trends in Brand and Generic Prices of Antiretroviral Medicines Procured with Donor Funds in Developing Countries. Journal of Generic Medicines 2010;7: Waning B, Kaplan W, King AC, Lawrence DA, Leufkens HG, Fox MP. Analysis of Global Strategies to Reduce Prices of Antiretroviral Medicines: Evidence from a Transactional Database. Bull World Health Organ 2009;87(7):