Jorge Augusto Diaz Rojas, MSc, PhD candidate

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1 3rd ISPOR Latin America September 2011 México City, México Jorge Augusto Diaz Rojas, MSc, PhD candidate Associate professor Universidad Nacional de Colombia, Bogotá, D.C.,Colombia.

2 Population Projection (millon) YEAR TOTAL

3 YEAR GDP (millions) % GDP PER CAPITA LEB ,899 6, ,338 6, ,182 6, ,700 6, ,570 6, ,919 6, ,678 6, ,318 5, ,017 6, Source: The World Bank Per capita US Dollar LEB: Life expentancy at birth.

4 Government Ministry of Health Law 100 of 1993 Coordination, control, direction Fund of Solidarity and Guarantees (FOSYGA) Management of financial resources Health insurance (Health promoting entities) (EPS) Management, collect financial resources Contributory System (people with formal employment) Subsidized System (Low-income population) Health providing institutions (IPS) Hospitals, clinics, clinical laboratories, pharmaceutical services, etc.

5 Systems Total % Total % Affiliates % % Contributory % % Subsidized % % Source: DANE ECV Expanded data with population projections, based on 2005 Census results The percentage missing to complete the 100% corresponds to the "Do not know ECV= Quality of Life survey.

6 System based on compulsory insurance. UPC = premium that the system pays to the EPS to finance POS Compulsory health plan (POS). Services, procedures, pharmaceuticals, etc. ( ) POS contributory POS subsidized. Constitutional Court, Sentence T-760/2008 (POSc = POSs). Health Regulation Commission (CRES), it was created by Law 1122 (2007) Colombian Congress and replaced the National Council of Social Security in Health.

7 To define and modify the Compulsory Health Care Plan (POS). To define the unit of capitation payment (premium that the system pays to the EPS to finance POS) for the contributory and subsidized systems per annum. To define the payment criteria for the payments provided in order to regulate the access to health services. To establish and update on an annually basis a unified system of fees, including fees for health professionals.

8 Everything not included in the benefit plan (POS) is reimbursed by the Fund for Solidarity and Guarantees - FOSYGA

9 Ways for Reimbursement. Via legal action for protection of fundamental rights (Tutelas) Via Scientific Panel (Comisión Técnico Científica) Reimbursement of No POS services (Colombian pesos) $ 300 billion $ 2400 Billion 25% of the reimbursement by the FOSYGA in Colombia is illegal. 18% of reimbursement obtained via Tutelas, correspond to POS services.

10 MINISTRY OF SOCIAL PROTECTION. RESOLUTION NUMBER 3026/ Maximum reimbursement values due to pharmaceuticals not included in the benefit plans made by the Fund for Solidarity and Guarantee - FOSYGA MINISTRY OF SOCIAL PROTECTION. October/2010 Bill passed to Senate; Statutory Law in Health. To eliminate reimbursement

11 Colombia has never made pharmacoeconomic analysis to determine the reimbursement dossier. Currently there is a Methodological Guideline for the development of evidence-based clinical practice guidelines. This methodological guideline includes a chapter in economic evaluation of clinical recommendations (not reimbursement) pdf

12 MoH/Decision authorities willing to have pre-meetings (NO) Ability for pre-dossier submissions/reviews (NO) Centers of excellence being established within the country, Law 1438 of 2011 (January 19) which amends the Social Security System in Health. Chapter V. Article 92. Institute for Health Technology Assessment. Empowers the Ministry of Social Protection, to create an Institute for Health Technology Assessment, which is to be a non-profit and private- public institution. Access to database sets, Access to patient level data. There are a few: drug pricing, reimbursement, affiliates to system. They are restricted and have low quality data.

13 The impact of economic and humanistic data is currently only considered for clinical practice guidelines A budget impact analysis was done to update the POS, but was not used by the CRES. There aren t centers of excellence in Colombia, but only small groups with some experience. At this time NICE has great influence, they are the official consultants for the development of clinical practice guidelines. %2023%2011% pdf

14 Process for submission: Comprehensive Care Guidelines (GAI) for the Social Security System in Health, selected among those presented to the Call from COLCIENCIAS and the Ministry of Social Protection. Data included: Effectiveness from systematic reviews, local cost data. What models/econ evaluation were included (BIM and/or CE). CE Decision process: N/A Any discussion with authorities for an agreement of sorts: Compulsory Health Insurance. Re-insurance of High cost diseases. Maximum price for the reimbursement of medicines Are authorities relying on other country decisions. No

15 The concept of risk sharing proposals and whether there are discussions in the country as part of reimbursement negotiations is more in the sense of state of risk sharing programs per country. I believe that the closest thing to a risk sharing program is the Re-insurance of high cost diseases. There are a number of methods for risk adjustment such as co-payment and premium adjustment by age, region, and gender. Like in Argentina, Colombia has no experience in payment for performance contracts or conditional reimbursement with the Device or Pharmaceutical Industry.

16 The future for pharmacoeconomics / pharmacoeconomic evaluation in pursuit of reimbursement is uncertain given the current political and legal conditions of Colombia (Statutory law in health). There would be no application for economic analysis in the reimbursement process. The creation of the Institute of Health Technology Assessment would provide a good opportunity for the participation in the development and fulfillment of the objectives of this institute and generate inter-institutional agreements.

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