3rd Latin America Conference September 2011 México City, México

Transcription

1 3rd Latin America Conference September 2011 México City, México Iris Contreras Hernández MSPH, MD, MSc Mexican Social Security Institute, México City Investigador Instituto Mexicano del Seguro Social, Cuidad de México Economía de la Salud, Instituto Mexicano del Seguro Social, Mexico, D.F, Mexico Unidad de Investigación en

2 Three components 1 : 1. Private sector serves about 2 % of the population but accounts for a disproportionate share of the health care resources. 2. Social security serves about 55% of the population operates its own health care facilities and employs its own medical and nursing staff covers all wage earners outside the government (including relatives), agricultural laborers during the work season, federal civil servants, and the armed forces. The institutional entity that directs most of the activity within this segment of the health care system is the Mexican Institute of Social Security (IMSS). 3. Seguro Popular Public assistance to the rural and urban poor and the unemployed 1 PROGRAMA DE ACCIÓN ESPECÍFICO Evaluación de Tecnologías para la Salud Primera edición. Secretaria de Salud. México.

3 National Level Ministry of Health is the governing institution 2 responsible to elaborate Mexican official norms of the sector, coordinates the research oriented ten National Institutes of Health to concentrate the sanitary statistics. State Level Council of General Salubrity The governing and legislative area of the Ministry of Health, elaborates, reviews and maintains permanently updated the data and basic health consumptions catalogues, receives, studies and solves the requests for updating the consumptions catalogue, that formulates the institutions service providers of health, scientific organizations and suppliers. 2 Ley General de Salud. Nueva ley publicada en el Diario Oficial de la Federación el 7 de Febrero de l984. Texto vigente última reforma publicada DOF

4 Based on General law of health 3 each new technology must first obtain a sanitary registry. Made to the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) 4, Commission evaluates the security and effectiveness of the product Acceptance allows use in the Public System of Social Security the product must be in the Basic Formulary Medications and medicine catalogue. The private part of the system of national health has freedom to use consumptions that are not in Basic Formulary Medications. 3 Op cit 4 Comisión Federal Para la Protección Contra los Riesgos Sanitarios. accesed: July, 2009

5 Proposals Sent to Council of General Salubrity Providers of health, scientific groups or suppliers Appraisal of Protocols Committees medicines, healing material, aids diagnosis, instruments and equipment Recommendation for Ministry of Health Approval of new drug/technology Distributed by the Public Healthcare System (SUS)

6 Institutes of Health each evaluate for their own Basic Formulary Medications Evaluation lasts 3 to 6 months institutions announce public licitations to acquire the new technologies To acquire the new technology MoH authorizes acceptance of new technology

7 Description of the product Scientific evidence Clinical studies in phase I, II and III, Pharmacokinetics, pharmacodynamic, the profile of security and effectiveness of the product Pharmacoeconomics

8 Medicines, healing material, aids diagnosis, instruments and equipment. Experts in the area to study Represent each one of the institutions that compose the National System of Health.

9 Each committee issues a report within 3 months These committees are integrated by clinician experts in every one of the areas to study and represent each one of the institutions that compose the National System of Health. The analysis and results of their evaluation are published in the Diario Oficial de la Federación and a copy is sent to the instance who propose the technology If the decision is not favorable: the applicant can send a new request when 4 months from the date of the opinion passed Only if new elements are contributed to justify it. Updates in the Basic Formulary Medications and medicine catalogue Published in the Official Newspaper of the Federation Each institute reviews product for their Basic Formulary Medication and medicine catalogue Process can take 3 6 months

10 2003 mandate pharmacoeconomics study that exactly says: that can be from minimisation of costs, cost utility, costeffectiveness analysis, from cost benefit and unitary prices, 5 reason why it gave freedom to an ample variability in the quality of the studies Guide for the conduction of studies of economic evaluation for the update of the Basic Formulary Medications of consumptions of the health sector in Mexico 6 systematization to the information that appears to the Council of General Salubrity Integrates an associated group with representativeness of the institutions of health, the academy and the pharmaceutical industry 5 Reglamento interior de la Comisión Interinstitucional del Cuadro Básico de Insumos del Sector Salud. Diario Oficial de la Federación May 27, Dirección general adjunta de priorización. 8_2_ech.pdf. accesed: july, 2009.

11 1. The study of economic evaluation is validated in a standardized way by the reviser committees of the Council of General Salubrity 2. The economic evaluation is also included in the Basic Formulary Medications appraisal 3. Budget impact analyses is not required in the Council of General Salubrity

12 Early feedback from LA health authorities on study designs, endpoints, and comparators Under development Definition of the comparators, Endpoints that would allow national and international comparisons Access to official results is through Scientific journals Courses and conferences