04 dragana atanasijević hta in serbia 2012 sa€¦ · 25.11.2012 sva prava pridržana u skladu sa...

25.11.2012

Sva prava pridržana u skladu sa Zakonom o autorskim i srodnim pravima BiH (Sl. glasnik BiH 63/10) 1

Health Technology Assessment in Serbia

Dragana Atanasijevic MD, MSc Ministry of Health of Serbia

[email protected]

Sarajevo, November, 23rd

Overview

Introduction Health Reform Preparatory Phase Serbia Health Project

Organizational arrangements Commissions as a form of institutionalization

MoH Committees HIF Committees

Other institutional arrangements Cross-sectoral communication and consultations Regulation Current practice Issues and challenges Lessons learned Recommendations


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Indexes that measure the development of a country

GDP per capita - Life expectancy - Literacy rate - …..

HDI - the level of human development • Life expectancy at birth, as an index of population health and

longevity • Knowledge and education, as measured by the adult literacy rate and

the combined primary, secondary, and tertiary gross enrollment ratio • Standard of living as measured by the natural logarithm of GDP per

capita at PPP

World map indicating the Human Development Index

0.950 and over 0.900–0.949 0.850–0.899 0.800–0. 849

0.750–0.799 0.700–0.749 0.650–0.699 0.600–0.649 0.550–0.599 0.500–0.549

0.450–0.499 0.400–0.449 0.350–0.399 under 0.350 Data unavailable

Source: UN Development Program , Human Development Report 2009, compiled on the basis of data from 2007

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Some European countries by Human Development Index

10 lowest HDIs 10 highest HDIs

Source: UN Development Program , Human Development Report 2009, compiled on the basis of data from 2007

Income divisions

Source: Valerie Moran, Human Development Network, World Bank, 2009

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Predominance of formal HTA agencies in high-income European countries

Source: EUNETHTA WP8. Systems to support Health Technology Assessment (HTA) in member states with limited institutionalization of HTA

Health Reform Preparatory Phase

No expertise or capacity to carry out health technology assessment or cost-effectiveness studies.

Strong commitment from the Ministry of Health side to make

significant progress. Serbia Health Project - project development objective “to build

capacity to develop a sustainable, performance oriented health care system where providers are rewarded for quality and efficiency and where health insurance coverage ensures access to affordable and effective care”


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Bottlenecks, HD Banta

•To provide HTA with necessary legal basis, either through introducing in existing laws or through producing law specific to HTA. •Mandates of the MoH and HIF that need to be clarified and possibly changed to contain the introduction of HTA. •Health Technology Committee with no formal procedures and criteria. (Recommendation to renew and strength the Committee itself and expand its roles and responsibilities. No recommendations was given to the CPG Committee)


Serbia Health Project, first phase 2006/7 5-day crash course in EBM, HTA and CPG- 40 people 6 months “Problem Based Learning” training

– Around 20 completed the entire training programme

– 3 HTA Reports – Guideline on How To Prepare Clinical Practice

Guidelines – Agree instrument adapted for Serbian conditions

Involvement of HTA in new Health Care Law and establishment of new department for HTA in the National Health Insurance Fund.


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Stage One Results

Capacity building for policy makers, decision makers and analysis implementators

4 articles in the Helath Care Act, 2005 40 participants at a five-day course on EBM and HTA, 19 completed full education and training programme


• Feasibility study on HTA institutionalization with three proposed models of future Agency (heavy, light, mixed), with Business plans with respect to each one of them,

• Criteria to inclusion and exclusion from the basic benefit package, with algorithm of the process

Serbia Health Project, second phase 2007/8


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Results of Stage Two

HTA report made by the applicant

Instructions for developing a HTA

report

Assessment made in the institution/

agency itself (heavy model)

Checking the quality of the report

(light model of institution/agency )

Committee Min.

Health and/or Committee of RHIF and/or HTA

institution (agency)

Assessment/ Recommendation

Ministry of Health, Republic Health

Insurance Fund

Decision taking on reimbursement/inclusion in the health service

package


SHP – Sustainability of the results

Responsibilities split across Ministry of Health and the Health Insurance Fund.

The use of HTA - applied in a limited way within these two key

organizations,. Legislative changes - movement in the positive direction of

regulation of methods and procedures regarding the reimbursement of drugs


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Since 2006, The Ministry of Health of Serbia

Participates in the EUnetHTA project as collaborating partner

Inclusion of the MoH and RPC for health technology assessment in the work

of the“EUnet HTA Joint Action”

After the Project Activities

Joint Action on HTA Collaborating Partner Form

2010-2012 WP 8

Facilitating the establishment and continuous development of HTA institutions


Commissions as a form of institutionalization

MoH Committees HTA Committee CPG Committee

HIF Committees Central Expert Committee for Medicinal Products (CEC)

14 Sub-Committees defined by ATC classification of drugs Committee for Pharmacoeconomics


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HTA Committee

Health care institution or private practice must apply to the Ministry for the license for the use of new health technologies. Under the new health technologies are understood all technologies that are being introduced for the first time for use in health facilities in Republic of Serbia, for certain levels of care, and health technologies for the first time used by a health institution or private practice.

Assessment is done on the basis of analysis of medical,

ethical, social, and economic consequences and effects of development or use of the technologies in health care.


CPG Committee

New CPG Committee placed at Agency for Accreditation of Health Care Institutions in Serbia (AZUS). The Agency provides professional, technical and organizational support to the Committee.

According to the results that the Committee has (18 CPGs in

two years), it is one of the most active committees at the Ministry of Health.

It seems that the illusion of institutionalization, is a key factor

of successful work of that Committee.


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HIF Committees

“The Rule book on the criteria, methods and procedures for

placing or removing drugs from the list of drugs that are prescribed and dispensed at the expense of the compulsory health insurance” requires that anyone who wants to have the drug at the List must apply for that with full supporting documentation.


HIF Committees

Central Expert Committee for Medicinal Products (CEC) The application considers the Central Expert Committee for Medicinal Products.

Expert opinion of relevant Sub-Committees for drugs in the areas defined by ATC classification of drugs (of which there are 14) and the opinion of the Committee for Pharmacoeconomic.

14 Sub-Committees defined by ATC classification of drugs and Committee for Pharmacoeconomics These Sub-Committees provide opinion and assessment for placing or removing

drugs from the list of drugs that are prescribed and dispensed at the expense of the compulsory health insurance in accordance with the Rule book. Additionally, the Committee for Pharmacoeconomic analyzes and gives an opinion on feasibility of putting drugs on the List of drugs that are prescribed and dispensed at the expense of the compulsory health insurance according to financial possibilities of the Health Insurance Fund.


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Other institutional arrangements

Medicines and Medical Devices Agency of Serbia-ALIMS (with mission to license only quality, safe and effective drugs and medical devices, providing adequate information them);

Health Care Institution chamber (within the Department of Health Economics performs (among others) preparation of initial proposals for the adoption of normative of human resources, working standards, standards of health services and take other measures aimed at rational use of resources, health facilities);

Orphan Drug Committee; National Institute of Public Health (that has Section for health

technology under the Centre for analysis, planning and organization of health care);

Agency of Accreditation of HCI (hosting CPG Committee) etc.


Other institutional arrangements, cont’d At least three Medical faculties (Belgrade, Kragujevac and Novi

Sad) and Faculty of Pharmacy in Belgrade have curricula covering pharmacoeconomics, health economics and evidence based medicine, plus

Non-governmental organizations such as Pharmacoeconomics section and ISPOR Serbia chapter

The pools of experts stand mostly unused by the system but they are welcomed by Pharma industry .

This indirect approach to the progress is the result of better-trained personnel in the pharmaceutical industry that put pressure on state institutions.

The state institutions answer by increasing the number of legislative

acts although not by more appropriate structure of employees or better coordination of the whole process.


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Cross-sectoral communication and consultations

Inadequate and limited focus on policy content at both expert

and political levels. Multiplication of Committees wastes the time of

professionals. Some of them operating on paper while they do not produce

information. This is the case of a Pharmacoeconomics committee advising the director of the Health Insurance Fund while drug prices are decided by the Minister in charge of Trade.


Drug Workflow There is no evidence of the existence of a process that would

allow co-ordination and linkage between the activities of individual committees involved in HTA, drugs assessment, pricing, design of a basic benefit package, and a general strategic orientation of the MoH

Marisavljevic D, 2012 Sarajevo, November, 23rd

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Regulation Several Laws (on Health Care, on Health Insurance, on Medicines and

Medical devices, on Chambers) and their sub-laws more or less define place and role of health technologies assessment in the broadest meaning of that word.

In the narrowest sense, health technology assessment concerns the formulation of the basic benefit package and placing the technologies (drugs, devices or services) in a positive or negative list according to certain criteria. In that way, roughly speaking Serbia has inherited a health system that undertakes to provide easy access to comprehensive health services for all the population. In principle, insurance coverage is granted to:

– all employees, pensioners, self employed and farmers paying their contributions,

– coverage is extended to the spouse of the contributor as well as his/her dependent children and elderly parents.


Basic Benefit Package in Serbia


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Institutional framework for the undertaking of HTA and the incorporation of economic evaluation in

healthcare decision making Still unclear for all parts of BBP

The best regulations in place are for drugs and medical devices. The Law on Medicines and Medical Devices has been harmonized with the latest EU directives, as well as Guidelines for Good Manufacturing Practice, Good Clinical Practice and Good Distribution Practice. The most significant changes (compare to the previous one) are related to the: Licensing of drug, Potential license holders of drug Possibility of registration in the Register of traditional herbal and homeopathic

medicines Registration in the Register of Medical Devices Advertising Organizing pharmacovigilance of medications and medical devices


Few more newly developed Books of Rules (under the Health Insurance Law) going with

EU Transparency Directive

• Regulation of medical-technical devices that can be funded by mandatory health insurance

• Regulation on referral to abroad treatment • Regulations on medical rehabilitation in inpatient health

care facilities • Rules on the criteria, methods and procedures for placing or

removing drugs from the list of drugs that are prescribed and dispensed at the expense of health insurance - first time shows pharmacoeconomics criteria:

1) pharmacotherapeutic indicators of the necessity of application of a drug in treatment of insured persons;

2) pharmacoeconomic indicators confirm the economic feasibility drug, or a cost-benefit analysis (effectiveness);


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Current practice

• Scope of work of HTA Committee covers (the highest number of requests) new equipment first time placed in particular institution

• Lower number of requests is concerned about new services, but mostly request for permission to use particular procedure in particular institution.

• There is no defined application format as well as the appealing process is not clearly defined.

• The Committee meets once a month discussing on appropriateness of particular technology, very often making decisions “on site”


Current practice cont’d

• The scope of work of Central Drug Committee is much closer to the concept of health technology assessment, but is still just about drugs.

• All its work is based on very “rapid assessment” but with very limited resources in a term of finances as well as experts capacity.

• Sometimes there is no proof that decisions are evidence based (when it comes to clinical effectiveness) or they take into account cost effectiveness.

• No evidence that decision making process about getting some equipments or procedures at the reimbursement list is based on any analysis either of clinical or cost effectiveness.


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Getting the permissions by MoH and HIF


Issues and challenges

There are missing Acts that must clarify the roles, responsibilities, working procedures, and membership (qualification requirements and conflict of interest disclosure) of different committees.

At a higher level, the Book of rules should define the relationship

between the assessment committees and the MoH, the Health Insurance Fund and the parliamentary commissions in charge of preparing the healthcare financing laws (healthcare budget).

Clear separation between the technical (currently missing assessment)

level and the political level (appraisal and reimbursement decisions) is the option chosen in most EU countries. This implies that the reports (assessments) form the technical committees are transparently appraised by the decision makers who have the ultimate responsibility for resource allocation.


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Recommendations

Whatever the organisation of HTA/CPG system would be, the

following general principles apply: governance, accountability, transparency, sustainability.


General

• In situation of continuation the overall health reform particularly reform of financing in health care, the emphasis must be on promoting evidence based medicine and the application of HTA and CPG.

• Population needs assessment is the preliminary step to decide not only on health policy priorities but also on the prioritisation of HTA and CPG reports.

• The cornerstones remain on strengthening existing structures, improving working processes and as much capacity building as possible.


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Institutional

• Prioritization of “institutionalisation” and practical organisation of HTA and CPG. HTA Agency has been considered through the previous WB project as a functionality of the system, this functionality may be addressed by establishment of a single HTA Agency or by many institutions paying the role of HTA Agency.

• Not political appointees but professionals should be charged at least with technical level of HTA and CPG.

• There should also be clear rules established about the disclosure of conflict of interest of committee members, as well as formalized debate on the HTA reports and clear procedures and criteria for decision-making.


Legal

• Numerous legal problems that are mostly related to discrepancies or inconsistencies between laws, regulations, future HTAs, existing and future CPGs and subsequent decision-making by the MoH and HIF deserve serious elaboration and recommending corrective actions that will clarify place and role of each particular component of the system.


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International cooperation

• It is fact that many of the HTA or CPG reports that have been developed by agencies throughout the world can be adapted to the Serbian context.

• The rules for adaptation or adaptation should be harmonized with broadly accepted EU rules. In that sense it is necessary to update the link with European network of HTA agencies (EUnetHTA) and to make several new with other international organizations (INAHTA). For that purpose, there is again need of well structured national system.

• Regional cooperation


04 dragana atanasijević hta in serbia 2012 sa€¦ · 25.11.2012 sva prava pridržana u skladu sa...

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