INTERACTION OF HTA AND REGULATION IN MEDICAL DEVICES: A TOOL FOR DECISION-MAKING

Transcription

1 INTERACTION OF HTA AND REGULATION IN MEDICAL DEVICES: A TOOL FOR DECISION-MAKING SECOND WHO GLOBAL FORUM ON MEDICAL DEVICES NOVEMBER 2013 MINISTRY OF HEALTH URUGUAY Ana Pérez Galán, MD, MsC

2 REGULATION AND HEATLH TECHNOLOGY ASSESSMENT INCORPORATION OF HIGH TECHNOLOGY PERSPECTIVES

3 BACKGROUND Regulation of license of medical devices since 1999 Health Technology Assesment since 2001: Innovations Selected medical equipment Integrated National Health System of Uruguay (Sistema Nacional Integrado de Salud - SNIS) created in 2007 introduced new policies to promote rational use of health resources. decree authorization to acquire medical equipment in health services by the Ministry of Health

4 REGULATION OF MEDICAL DEVICES LICENSE Free sale certificate ADEQUATED INCORPORATION Which one? How many? Where? EFFICIENT UTILIZATION Adequate utilization Produtivity Outcomes Impact DESINVESTMENT Priotity setting SAFE UTILIZATION: TECHNOVIGILANCE

5 HEALTH TECHNOLOGY ASSESSMENT DURING THE CYCLE-LIFE OF TECHNOLOGIES Katrine B. Frønsdal, Karen Facey, Marianne Klemp, Inger Natvig Norderhaug, Berit Mørland and John-Arne Røttingen (). Health technology assessment to optimize health technology utilization: Using implementation initiatives and monitoring processes. International Journal of Technology Assessment in Health Care, 26, pp

6 REFORM IMPLEMENTATION Ministry of Health started in 2009 a comprehensive analysis of all requests for incorporation of new technologies carried out by a multidisciplinary team. Authorization must be asked for new incorporation of: medical equipment health services of medium and high complexity. Complexity: dynamic concept that is updated periodically

7 AUTHORIZATION OF INCORPORATION Any new incorporation of medical equipment or health services must be approved by the Ministry of Health taking into account, not only the license, but also: evidence regarding its usefulness; demographic and epidemiological data; health services indicators rationale for its geographical location.

8 Examples of medical equipments that require authorization Arc C X Ray Equipment Hyperbaric chamber Lineal Accelerator for radiotherapy Angiography Extracorporeal Circulation Pump Equipment of robotic surgery Gamma Camera Mamographe Magnetic resonator Tomographe Positron Emision Tomographe

9 Examples of health services INTENSIVE CARE UNITS HEMODIALISIS SERVICES CARDIAC SURGERY LABORATORY UNITS FORMS AND INSTURUCTIONAL USE OF FORMS

10 DEVELOPING A TOOL FOR ASSESSMENT OF INCORPORATION Health care services require to submit the form at Ministry of Health in order to obtain the authorization of purchase and installation of new medical equipment. Health Assessment Reports may arise to: no recommendation of the incorporation requested, recommendation after incorporation of amendments and suggestions, recommendation for inclusion under the terms established in the request.

11 MODULES INCLUDED IN THE FORM 1. DESCRIPTION 2. JUSTIFICATION 3. EFFECTIVENESS AND COSTS 4. IMPACT IN HEALTH SERVICES ORGANIZATION 5. ECONOMIC VIABILITY

12 RESULTS Up to now, 112 applications have been analyzed, 82 related to the incorporation of medical equipment and 30 for health services incorporation. The procedure to incorporate new technology has been an innovative experience for the Ministry of Health since each analysis requires A review of general situation regarding needs of each technology, potentiality to develop agreements of share use with other health care services. This procedure tends to avoid duplication of services and promotes complementarity among health care services in the context: budgetary restrictions in Health Sector the statement of the Reform of Health System

13 PERSPECTIVES To improve the tool: NEW VERSIONS OF THE FORM AND RECOMMENDATIONS A WEB CENSUS OF EQUIPMENTE is being implemented nowadays to get updated data of the national situation georreferenced. To develop and implement Adapted Clinical Practice Guidelines (CPG) related with high technology equipment. To define plans of desinvestment taking into account obsolescence, CPG, demographics, epidemiological and utilization data.

14