International Meeting for HTA- Emerging Countries Ankara, March 4-6 2009 HTA in Argentina

1. International Meeting for HTA- Emerging Countries Ankara, March 4-6 2009 HTA in Argentina Prof. Andres Pichon-Riviere MD MSc PhD Executive Director - Director of Health Technology Assessment and Economic Evaluations Institute for Clinical Effectiveness and Health Policy – IECS Argentina

2. Argentina Population: 40 million Surface: 2,766,890 Km2 Urban population: 89% Life expectancy: 76,1 years Literacy rate: 98.1% Population density: 14inhabitants per Km2

3. Argentine Health system • MoH low regulatory influence in the health care system • Fragmented decisions on health coverage • Regulatory framework for drug marketing authorization BUT No fourth hurdle system in place for coverage policy decisions

4. Drug marketing authorization, coverage and health technology assessment Quality ANMAT, equivalent to FDA and other drug regulatory agencies Safety (Efficacy) Social Security and Private System 65% of Argentine population Drug marketing authorization Mandatory coverage for all available drugs: 100% for inpatient drugs 40%-50% ambulatory drugs Mandatory Coverage/ Reimbursement HTA

5. IECS Institute for Clinical Effectiveness and Health Policy IECS is an independent, non-profit organization, created by professionals from the medical and social sciences devoted to research, education and technical support with the main goal of improving efficiency, equity, and quality of health care systems and policies. • Main HTA Agency from Argentina • INAHTA member since 2005 • Argentine Cochrane Center • Runs the Master Program in Clinical Effectiveness of the University of Buenos Aires

6. The Superintendence of Social Security (SSS) The Superintendence of Social Security depends on the MoH. It is the Regulatory Board of Social Health Insurance in Argentina. In 2000 the IECS was called to analyze critically the services included in the PMO. It was concluded that: A high percentage of the services included in the PMO should be revised through a formal process of HTA. The coverage of many services should be restricted to specific clinical conditions It was necessary to define a formal and explicit process to adopt and incorporate a new service into the PMO. In 1996 was responsible to set the first mandatory benefit package (PMO) covered by the social security that included more than 2.000 services

7. Impact of the first HTA Program on reimbursement decisions Mandatory benefit package (PMO) covered by the social security (more than 2.000 services and technologies) 10% of the technologies were excluded because of lack of effectiveness Brain Spect Lotmar test Billary Stent Conformal radiation therapy In 67%, the coverage was limited to specific clinical conditions Growth hormone - Implantable Cardio-defibrillator Bone densitometry – Spect - Laser photocoagulation Peripheral stenting - Lithotripsy Source: Pichon Riviere A, Augustovski F, Torres R, Roa R, Rubinstein A. Impact of a Health Technology Assessment (HTA) Program on reimbursement decisions of Social Health Insurance in Argentina. International Meeting of Health Technology Assessment, Krakow, July 2004.

8. Mandatory package of drugs for the social security • During 2003/2004 the SSS defined a mandatory formulary list of drugs to be reimbursed by the social security with 3 levels of coverage: • 100% of drug’s cost for inpatient care • 100% for selected ambulatory drugs (insulin, oncology, tuberculosis, etc) • 70% for selected treatments of chronic ambulatory conditions (hypertension, cholesterol, asthma, etc) • 40% for other ambulatory drugs • For the definition of this first formulary some HTA-principles were used • It was the first step to officially define a forth hurdle between drug marketing authorization and reimbursement • BUT: it is more a “positive listing” of drugs where coverage is mandatory. Situation of drugs not explicitly included in this formulary is still ambiguous and patients argue in the media and in the courts for access to new drugs.

9. Decision Makers and Economic Evaluations • Objectives: to explor health decision-makers' knowledge and attitudes about economic evaluations (EE) and whether health technology assessment (HTA) were used for decision making. • Methods: A qualitative design based on semistructured interviews and focus groups was used to explore how decision makers belonging to different health sectors implement resource allocation decisions. Rubinstein et al. International Journal of Technology Assessment in Health Care, 23:2 (2007), 169–176.

10. Decision Makers and Economic Evaluations Results • Informants were mostly unaware of EE. • The most important criteria mentioned to adopt a treatment were evidence of effectiveness, social/stakeholder demand, or resource availability. • Despite general positive attitudes about EE, knowledge was rather limited. • Cost considerations were widely accepted by purchasers and managers, but clinicians argued as interfering with the doctor–patient relationship. • Other barriers to HTA were lack of confidence in the transferability of studies, institutional fragmentation of the Argentine healthcare system. • The new macroeconomic context was cited as a justification of implicit rationing measures. • Although explicit priority setting was implemented by many purchasers and managers, HTA was not used to improve technical and/or allocative efficiency.

11. The Institute for Clinical Effectiveness and Health Policy (IECS – Argentina) Local level – HTA and EE projects • National MoH - Superintendence of Social Security (responsible to set the mandatory benefit package - PMO) • Governments, MoHs and Social Security Organizations in the main provinces of Argentina • HMOs • Pharmaceutical industry (mainly EE)

12. R&D Areas IECS Epidemiology& Statistics Data Management EE & HTA Unit Health Policy & Management Mother & Child Health Research HRQoL Research Cochrane Collaboration center 2 Directors 2 Operative Coordinators 8 Researchers 1 Documentalist 4 Administrative Cochrane Group External consultants

13. Documents published • 60% Rapid Response Documents • Rapid response to a specific inquiry. The analysis is mainly based on secondary sources of information such as HTA repots from other agencies, systematic reviews, meta-analysis, CPG and coverage policies in other countries. • 24% Brief Technical document • More comprehensive reports based on a literature search and a critical review of the evidence gathered. • 12% Complete Health Technology Assessment • This reports included analysis of local data with cost-effectiveness evaluation: (i.e. drug eluting coronary stents, Laparoscopic Hernia repair, laparoscopic apendicectomy, new antipsychotic drugs and antibiotics, vaccines) • 4% Revision and commentary of HTA documents from other agencies • Brief commentary about a HTA document elaborated by other agencies

14. IECS reports

15. Field of HTA Field of HTA reports More than 70% of the Pharmaceuticals reports were concentrated in the fields of Oncology, Cardiovascular and Infectious diseases

16. Indicators of performance of HTA Indicators of Performance Structure Process Outcomes IECS´s HTA production Network of Institutions (commissioning HTAr) Network of Decision Makers (accessing HTAr) IECS’s HTA dissemination process Application of IECS’s HTA reports to decision making Survey to decision makers and regular users of HTA reports

17. Results (cont.) 98%

18. Indicators of performance of HTA Indicators of Performance Structure Process Outcomes 62% Application of IECS’s HTA reports to decision making • Are IECS´s HTA reports useful for decision making? • To what extent IECS´s HTA reports answered the specific policy question? 76%

19. Indicators of performance of HTA Indicators of Performance Structure Process Outcomes Application of IECS’s HTA reports to decision making

20. The Institute for Clinical Effectiveness and Health Policy (IECS – Argentina) Regional level • HTA, EE and other research projects in Argentina, Bolivia, Chile, Colombia, Brazil, Uruguay, Mexico and Peru. • Technical cooperation agreements in HTA/EE with the governments of Brazil (ANVISA and MoH), Chile (MoH) and Uruguay and academic&technical support in Peru, Colombia and Panama. • Members of LatinCLEN (INCLEN Trust) • Annual Course in HTA/EE (introductory and advance modelling)

21. Distance learning course in HTA/EE The IECS is developing a Distance Learning course in HTA and EE aimed to Latin-American researchers and decision makers The course will be available in April 2009 • Spanish and Portuguese • 250 hours (6 months) • Funding: Global Health Research Initiative (CIDA and IDRC Canada) • The course counts with the support of PAHO and INAHTA. Pan-American Health Organization

22. HTA in the region In Latin America, there are INAHTA HTA agencies in Argentina, Brazil, Chile and Mexico. Advanced programs of HTA in Colombia and Uruguay. Peru, Panamá and others countries had began HTA initiatives Nevertheless, HTA is still in the first stages of development in the region.

23. Government support for HTA activities was considered to be intermediate (31%) or low (53%) by the majority of respondents. Demand/Utilization of HTA reports Government support to HTA activities HTA in Latin-America and the Caribbean In 2007, in collaboration with INAHTA and PAHO, we performed a survey to Latin-American researchers and decision makers to evaluate the development level of HTA in the region ant to analyze the facilitators and barriers for international collaboration. Source:Andres Pichon-Riviere, Rosa María Ceballos, Eduardo Briones.HTA in Latin-America and the Caribbean (LAC), facilitators and barriers for international collaboration: A survey. V Annual Meeting Health Technology Assessment International (HTAi), Montreal, Canada, July 2008.

24. HTA in Argentina (Conclusions) • HTA demand increased dramatically after Argentina´s crises in 2001, with overlapping needs from different stakeholders (from public institutions of low income provinces to private HMOs). • Social Security, Public and Private Sector Decision makers became more aware of HTA reports and its relevance on decision making. • Though there had been “good intentions”, HTA has had a limited albeit important impact to evaluate efficiency of the services covered in Argentina. • What is needed in Argentina is a clear political will to formally incorporate HTA into the decision making process

25. Final remarks Challenges for HTA in Argentina (and Latin-America or other developing countries ) (I) 1) Lack of political continuity for HTA projects Projects and initiatives tied to the times of one administration. Under this scenario, a large central agency with broad responsibilities and functions could be a too ambitious project. Alternative model: a small sized central agency more focused on appraisal and responsible of setting priorities and commissioning reports to outside organizations. In this model, NGO (Universities/Research&Academic Institutions) in developing countries could play an important role in the promotion and generation of HTA.

26. Final remarks Challenges for HTA in Argentina (and Latin-America or other developing countries ) (II) 2) Fragmentation of the health system - MoH with low regulatory influence - Fragmented decisions on health coverage Efforts into creating central structures (National HTA agencies) could not be enough. It is also important to work in the different levels and subsectors of the health system in order to raise awareness among decision makers and other stakeholders. Informed decision makers will demand, promote and implement HTA in their workplaces

27. Thank you very much for your attention! Prof. Andres Pichon-Riviere MD MSc PhD Executive Director - Director of Health Technology Assessment and Economic Evaluations Institute for Clinical Effectiveness and Health Policy – IECS Argentina IECS web-page: www.iecs.org.ar e-mail: apichon@iecs.org.ar