1. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Antiretroviral purchasing and prescription practices in Mexico: constraints, challenges and opportunities 8th International AIDS Economics Network Pre-Conference Meeting July 19, 2014 - Melbourne, Australia Claire Chaumont (1), Sergio Bautista Arredondo (1), Juan José Calva (2), Roberto Bahena González (1), Gerda Hitz (1), Arturo González de Araujo (3), Mauricio Hernández-Ávila (1) (1) National Institute of Public Health, Mexico, (2) National Institute of Medical Sciences and Nutrition Salvador Zubirán, Mexico, (3) COFAPI, Mexico

2. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Outline of the presentation Background & Objectives Methodology Results Discussion Take-away messages

3. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud HIV Treatment and Care in Mexico Concentrated epidemic – HIV Prevalence: 0.24%, mostly among IDU, MSM, SW (1) – Number of PLHIV: 179,478 in 2011 (1) Universal access to ART guaranteed through main public institutions – High level of coverage: 85% in 2011 (1) – 60% provided through the Ministry of Health-Popular Health Insurance (PHI or Seguro Popular) & 30% through the main social security institution (IMSS), with independent procurement and distribution processes Emerging challenges – New WHO guidelines soon to be adopted by the country – Expected increase in number of patients due to early treatment and better detection practices

4. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Challenges related to ARV expenditures ARV drugs account for roughly 75% of the care and treatment budget for the average LAC country (2) Evidence suggests that ARV prices paid by Mexico are on average 8 times higher than similar upper-middle income countries (3) In 2008, creation of the Coordinating Commission for Negotiating the Price of Medicines and other Health Inputs (CCPNM) (4) – Substantial reductions in ARV prices obtained in early years but further reductions have been less effective Financial pressure on the MoH’s budget might ultimately threaten universal access to ART – In 2011, spending related to HIV-AIDS accounted for 32.4% of the Fund for Protection against Catastrophic Expenditures of the PHI (5) Urgent need to understand the characteristics of ARV purchases and prescriptions in Mexico

5. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Study Objective To understand the characteristics of ARV purchases and prescriptions in Mexico, both in terms of procured prices, volumes and type of purchased and prescribed drugs, as well as in terms of current and futures trends. – Analysis of ARV prescriptions for the MoH/PHI – Analysis of prices and volumes of generic and patented drugs procured by the Mexican National Agency for Prevention and Control of HIV/AIDS (CENSIDA) for the MoH/PHI for the period 2007-2012 and tendencies scenarios based on current spending by CENSIDA – Comparison between ARV annual costs paid by Mexico and by countries with similar income

6. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Methodology Analysis of the types and volumes of ARV combinations prescribed to patients between 2008 and 2013 – Based on SALVAR, a database used by the Ministry of Health to monitor ARV prescriptions for patients covered by the Popular Health Insurance Retrospective analysis of procurement prices, volumes and type of ARVs procured by the MoH/PHI between 2007 and 2012 Comparison between annual ART costs for the 7 most important patented drugs in Mexico and procurement data from the WHO’s Global Price Reporting Mechanism (GPRM) database

7. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Main results: Prescription practices There is a tendency towards a simplification of the prescription: – Out of 53,357 MoH patients under ARV treatment in 2013, 90% took any of 22 most commonly prescribed drug combinations – Out of these 22 combinations, 95% are in accordance with ARV therapy official national guidelines

8. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Main results: Procurement prices and volumes of ARV drugs Between 2010 and 2012, CENSIDA spent a total of USD 400.39 millions for the purchase of close to 3 million packs of antiretroviral medicines Out of 35 generic and patented drugs, only 8 patented drugs represented 78% of total expenditures The combination Efavirenz+Emtricitabina+Tenofovir, either taken as one or two pills represented 45% of total expenditures Reductions in procurement prices obtained by the CCPNM in the first years and at the 2008 IAS Conference were substantial but further reductions were much smaller Simple projections show that the current decrease in ARV prices will not be sufficient to compensate future increase of new patients

9. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Main results: Procurement prices and volumes of ARV drugs

10. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Evolution of total annual ART costs and number of patients on treatment between 2008 and 2018 (observed and forecasted) for ART patients in the MoH/PHI scheme (nominal USD)

11. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Projected and Observed ARV public expenditures, as based on prescriptions tendencies for patients of the MoH/PHI scheme between 2008 and 2013 (nominal USD)

12. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Main results: Comparison with international procurement prices Annual costs of treatment in Mexico are higher than costs supported by similar countries for the majority of the drugs studied – Costs are also similar or higher than costs reported by high-income countries in the database (when the information is available) – Costs often remain higher even when considering only originator drugs bought directly to the pharmaceutical company owning the patent

13. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Comparison for selected drugs AtazanavirEfavirenz+Emtricitabine+Tenofovir Emtricitabine+TenofovirLopinavir+Ritonavir High income countries High milddle income countriesLow milddle income countries

14. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Discussion: Legal and political options available to bring prices down are limited Limitations due to international treaties – Mexico is a signatory of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement – Mexico can’t make use of the TRIPS flexibilities (compulsory licenses) due to its compliance with the North American Free Trade Agreement Limitations due to Mexico’s intellectual property and procurement laws – Mexico can’t import patented drugs – Current regulations regarding clinical data availability limit new entrants in the market after patent expiration (data protection) Limitation due to Mexico’s commercialization mechanisms – The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) does not consider cost-effectiveness when awarding approval for the commercialization of new medicines.

15. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Discussion: Only long-term safeguards can curb expenditures Need to consider deeper structural changes in its drug policies: – Consolidate the role of the CCPNM in order to strengthen its negotiation power with pharmaceutical companies – Better take into account the economic impact of new drugs when making them available to patients – Improve procurement and distribution processes within the MoH and better understand the costs associated with each step of the process – Consolidate public institutions negociation power and technical capacity – Review intellectual and property laws to facilitate the entry of new actors in the market

16. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Take-away messages Mexico continues to pay relatively high prices for ARV drugs Most of the expenditure is concentrated on a small number of patented drugs, for which procurement and purchasing are tightly regulated There is an extremely limited current set of legal and structural options available to policy makers to bring patented drugs prices down Policy-makers need to focus on long-term legal and political safeguards to counter the high prices imposed by pharmaceuticals

17. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Acknowledgments We would like to thank the Mexican National Agency for Prevention and Control of HIV/AIDS (CENSIDA) for funding this study

18. Instituto Nacional de Salud Pública Centro de Investigaciones en Sistemas de Salud Selected references 1.Centro Nacional para la Prevención y el Control de VIH/SIDA (2012). El VIH/SIDA en México en 2012, Mexico. 2.Pan American Health Organization (2013). Antiretroviral treatment in the spotlight: a public health analysis in Latin America and the Caribbean. Washington, D.C. 3.Adesina A, Wirtz V & Dratler S (2012). Reforming antiretroviral price negotiations and public procurement: the Mexican experience. Health Policy and Planning 2012;1–10 4.Gómez-Dantés O, Wirtz V, Reich M, Terrazasc P & Ortiz M (2012). A new entity for the negotiation of public procurement prices for patented medicines in Mexico, Bull World Health Organ 2012;90:788–792 5.Comisión Nacional de Protección Social en Salud. Fideicomiso del Sistema de Protección Social en Salud. Auditoría Financiera y de Cumplimiento N° 11-0-12U00-02-0428 DS-056