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November 19th, 2015
Final Conference – London
Jaime Espín, PhD – Professor. EASP
ADVANCE_HTA – WP6 Leader
HTA in Emerging Settings – Mapping Exercise and Toolbox
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WP 6. Project Objectives
Research objectives:
1.To identify the use and capacity of HTA in emerging settings. This includes the identification of HTA mechanisms and techniques that apply in emerging countries of Europe and Latin America and the Caribbean.
2.To encourage the use of HTA for decision-making by developing appropriate tools for supporting the implementation of HTA in emerging settings.
3. To enable and facilitate exchange of HTA reports and economic evaluation, reducing efforts duplication, between EU countries with a strong HTA tradition and the Americas/Eastern Europe.
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WP 6. Project Activities
– 6.1a: Mapping exercise of the use of HTA (activities, networks
and capacity) in Emerging countries (18 Latin America and Caribbean Countries – LAC- & 24 Central, Eastern and South-Eastern Europe – CESEE-)
– 6.1b: Case studies on decision-making informed by HTA, with a view to producing recommendations for strengthening and implementing HTA as a decision-making tool
– 6.2: Toolbox outlining best practices and recommendations on HTA and decision-making
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CESEE • Albania • Belarus • Bosnia & Herzegovina • Bulgaria • Croatia • Cyprus • Czech Republic • Estonia • Greece • Hungary • Latvia • Lithuania • Macedonia • Moldova • Poland • Romania • Russian Federation • Serbia • Slovakia • Slovenia • Turkey • Ukraine
LAC • Barbados • Belize • Bermuda • Costa Rica • Dominica • Dominican
Republic • El Salvador • Guatemala • Guyana • Honduras • Jamaica • Nicaragua • Panama • St. Lucia • St. Maarten • Suriname • Trinidad & Tobago • Venezuela
Note: Tableau map created by author.
Mapping: countries included in the study
| Capacity to perform HTA systematically and regularly: refers to in opinion of the respondent his/her country has the capacity to perform HTA systematically and regularly.
Capacity perform
HTA
Funding limitation
Skills Training
Access to HTA network Institutional support Domestic International
Albania Yes 1 1 0 0 0 Belarus Yes 0 1 0 1 0 Bulgaria Yes 3 3 1 2 0 Croatia Yes 2 2 0 0 0 Czech R. Yes 2 0 1 0 0 Latvia Yes 0 0 0 0 0 Lithuania NO 3 3 0 0 2 Moldova YES 2 1 0 1 0 Poland YES 0 1 1 1 0 Romania NA 2 2 0 0 1 Russia YES 1 1 0 0 0 Slovenia NO 3 2 0 0 1 Turkey YES 1 1 0 0 0 Ukraine YES 1 1 0 1 0 Hungary YES 3 2 1 1 1
Total --- 24 21 4 7 5
Obstacles mentioned by respondents by countries
Capacity to perform HTA in CESEE
|
Task 6.1. Mapping in Emerging Countries (CESEE & LAC)
Findings: Criteria for selecting Health Technology to be assessed
64%
64%
18%
36%
45%
18%
55%
36%
65%
65% 52%
43%
39%
39%
35%
30%
0% 10% 20% 30% 40% 50% 60% 70%
Prevalence/ Incidence
Burden of disease
Ethical, legal or social implications
Medical practice variations
Cost of illness
Public and media concern
Political concern
No Criteria
Other
LACCEE
|
HTA and decisión making process
SK LV GR PL CZ CR LT RU EE SI BU HU RS
Legislation establishing HTA reports must be considered in the decision-making process as MANDATORY
√ √ √ √ √ √
Legislation establishing HTA reports should be considered to support coverage decisions as RECOMMENDATION
√ √ √
There no specific legislation, but HTA reports have been used to support policy making.
√ √ √ √
Decisions are not informed by HTA √
Link between HTAs and decision
|
SK LV GR PL CZ CR LT RU EE SI BG HU
Pharmaceuticals (include vaccines and other biological products.) √ √ √ √ √ √ √ √ √ √ √
Medical devices (include diagnostic products) √ √ √ √ √ √ √
Medical procedures √ √ √ √ √
E-health technologies √
Public health interventions √ √ √ √
Technologies are assessed in HTA
Countries with HTA Guidelines: Slovakia, Latvia, Poland, Croatia, Estonia, Slovenia, Hungary Countries with Economic Evaluation Guidelines: Slovakia, Latvia, Poland, Checz Republic, Croatia, Bulgaria, Slovenia, Hungary
Use of HTA
|
Internal reports produced
by the MoH, Social Security, or HTA agency
Reports commissioned externally by the Government
Information presented by the industry requesting the technology
SK Always Never Always LV Frequently Never Frequently GR NA NA NA PL Frequently Never Regulary CZ Always Never Frequently CR Alway Never Frequently LT Frequently Regulary NA RU NA NA Always EE Frequently Rarely Regulary SI Never Never Always
BU Always Regulary Always HU Regulary rarely Always RS Frequently NA Regulary
Decisiones are based on
HTA and decision-making
|
Criteria used for priority setting/defining the benefits package. MEDICINES MEDICAL DEVICES INTERVENTIONS Explicit criteria Implicit
criteria No
criteria Explicit criteria
Implicit criteria
No criteria Explicit criteria Implicit criteria
No criteria
Efficacy (SK); (LV); (PO); (CZ); (CR); (RU); (ES); (BU);
(SI)
(SK); (PO); (CR); (ES); (HU)
(LV); (CZ) (SI) (LV); (PO); (ES); (HU)
(SK); (CZ) (SI)
Effectiveness (SK); (CR); (RU); (ES);
(HU); (SI) (LV); (PO); (CZ); (HU);
(BU)
(SK); (CR); (ES) (LV); (PO); (HU)
(CZ); (SI) (LV); (ES) (SK); (PO); (HU)
(CZ); (SI)
Safety (SK); (LV); (PO); (CZ);
(CR); (RU); (ES); (HU); (BU); (SI)
(SK); (PO); (CZ); (CR); (ES);
(HU)
(LV) (SI) (LV); (PO); (ES); (HU)
(SK); (CZ) (SI)
Quality of Life (SK); (CR); (RU); (ES); (BU); (SI)
(LV); (PO); (HU)
(CZ) (SK); (CR); (ES) (LV); (PO); (HU)
(CZ); (SI) (LV); (ES); (HU) (SK); (PO) (CZ); (SI)
Cost-Effectiveness
(SK); (LV); (PO); (RU); (ES); (HU); (SI)
(CZ); (CR); (BU)
(SK); (PO); (ES) (HU) (LV); (CZ); (CR); (SI)
(PO); (ES); (HU) (SK); (LV) (CZ); (CR); (SI)
Budget Impact (SK); (LV); (PO); (CR); (ES); (HU); (BU); (SI)
(CZ) (SK); (PO); (CR); (ES); (HU)
(CZ); (RU) (LV); (SI) (PO); (ES); (HU) (SK); (LV) (CZ); (SI)
Ethical, Equity, and Social Issues
(CR); (ES) (SK); (LV); (PO); (HU)
(CZ); (BU); (SI)
(ES) (SK); (PO); (HU)
(LV); (CZ); (SI)
(ES); (HU) (SK); (LV); (PO) (CZ); (SI)
Organizational Impact
(ES) (SK); (LV); (PO); (ES);
(HU)
(CZ); (BU); (SI)
(ES) (SK); (PO); (HU)
(LV); (CZ); (SI)
(ES); (HU) (SK); (LV); (PO) (CZ); (SI)
Innovation/Industrial Development/Technology transf
(SI); (SK); (LV); (PO); (CZ); (ES); (HU);
(BU)
(SK); (LV); (PO); (CZ); (ES); (HU);
(SI)
(SK); (LV); (PO); (CZ); (ES)
; (HU); (SI)
Geographical Budget Allocations
(HU); (SI) (SK); (LV); (PO); (CZ); (ES); (BU)
(HU) (SK) ; (LV) ; (PO) ; (CZ) ;
(ES); (SI)
(HU) (SK); (LV); (PO); (CZ); (ES); (SI)
Impact on Vulnerable Groups[1]
(ES) ; (SK); (LV); (PO); (CZ);
(HU); (BU); (SI)
(SK); (CZ); (ES); (HU)
(LV); (SI) (HU) (SK); (LV); (ES) (CZ); (SI)
Burden of Illness (LV); (PO); (CR);
(RU); (ES); (HU); (SI) (SK); (CZ) ; (BU) (PO); (CR);
(ES); (HU) (SK) ; (LV); (CZ);
(SI) (PO); (ES); (HU) (SK); (LV); (CZ); (SI)
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Type of study/type of evidence preferred or required for the decision-making process
SK LV PL CZ CR LT RU EE SI BU HU RS
Complete HTA
Rapid or mini-HTA
Comparative efficacy
Comparative effectiveness
Indirect comparison
Full economic evaluation
Cost-minimization
Cost analysis
Budget impact analysis
Systematic review
Meta-analysis
Epidemiological and other observational studies
Expert opinion
Group judgment
HTA and decision-making
AlwaysMost of the times Sometimes Rarely Never
|
Question related to Economic Evaluation
Is an economic evaluation required for the decision-making process?
How often is an economic evaluation explicitly considered in the decision-making process?
Are there explicit ‘thresholds’ for cost-effectiveness? If not, what other approaches are used to decide whether an intervention is potentially cost-effective?
What is the perspective normally used of the economic evaluation?
SK It is mandatory
based on the law 363/2011.
Always WTP 1 is 24 x average monthly salary
€ / QALY; WTP 2 is 35 x average monthly salary € / QALY
Third-party payer
LV Yes Always
The ICER for an additionally obtained year of life or progression-free year of life shall not exceed the ICER of
pharmaceuticals already included in the Positive list.
Third-party payer
GR Not Yet. Rarely Not applicable Not definded yet
PO Yes Always (for
reimbursement submissions)
3x GDP per capita for ICUR/QALY or ICER/LYG Public Sector
CZ Yes ALWAYS NO( 3xGDP per QALY is used as reference) Third-party payer
CR NO. Only BIA NEVER No No answer LT No answer No answer No answer No answer RU Yes Frequently No Public Sector
EE Yes Always NO. (1-3 GDP per capita is used as reference) Third-party payer
SI No rarely Yes Third-party payer BU Yes Always No Third-party payer HU Yes Always Yes Third-party payer
|
Limitations
Main barriers in the decision making process of evaluation of health technology
Organizational / Institutional
Economical / Financial
Information/ Comunication
Human Resources Other
BU √ √ √ √
CR √ √ (a)
CZ √ √ √
EE √ √
GR √ √ √
HU √ √ √
LT √ √
LV √
PO √ (b)
RU √ (c)
SI √ √ √ √ (d)
SK √
|
Task 6.1. Mapping in Emerging Countries (CEE & LAC)
Conclusion: Lack of HTA capacity was identified in both
LAC & CEE countries Lack of Guidelines/ methodologies/ standard
procedures No legislagion that support HTA as formal a
tool for decision making
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Task 6.2. Case Studies on decision-making informed by HTA
• Objective: To produce recommendations for the strengthening and implementation of HTA as a decision-making mechanism in emerging settings.
• Methods: • Case study countries were benchmarked against advance HTA
setting countries. • What was compared?: Structure of HTA activities, Methods for
the conduct of HTA, Appropriate processes for the conduct of HTA and use of HTA in decision-making.
|
Conceptual framework for the Case Study – LAC&CEE
•Medicine •Medical Device
•Vaccine
1 Product •2 LAC •2 CEE
Emerging Setting
•Canada •UK
Mature Setting
Case Studies on decision-making informed by HTA
|
STAGE 1. Countries and health technologies selection
LAC Canada, Brazil, Colombia, Mexico and Uruguay
CEE United Kingdom, Sweden, Scotland, France, Austria & Germany
Web searches of the technologies evaluated in the past 10 years
A. Technology selection
Comprehensive listing
“experienced” and “emerging” HTA countries
“experienced” HTA countries
First selection
First list of technologies Final decision
Selection of comparator (experienced HTA setting)
B. Country selection
Selection of emerging HTA setting (case studies)
Canada & UK (NICE & CADTH): Medicine & Medical DeviceJCVI: Vaccine
One vaccine
One medicine
One medical device
Invitation by email to key informants identified 7 EUNetHTA countries 8 Non EUNetHTA countries
First country selection Brazil & Colombia (LAC)
Polonia & Albania (CEE)
Incorporated: Estonia (CEE)
Case Studies on decision-making informed by HTA
Method
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Case Studies on decision-making informed by HTA
Sweden The Dental and Pharmaceutical Benefits Board (TLV)The Swedish Council on Health Technology Assessment (SBU)
Scotland
National Institute for Health and Clinical Excellence (NICE)
France The Haute Autorité de Santé (HAS) Committee for Evaluation and Diffusion of Innovative Technologies (CEDIT)
Austria Ludwig Boltzmann Institut Health Technology Asessment (LBI-HTA)
Germany Institute for Quality and Efficiency in Health Care (IQWiG)
11 Medical Devices7 + 1 Medicines
10 Other technology
12 Medical Devices181 Medicines
1 Other TechnologyEngland
Scottish Health Technologies Group (SHTG)7 Medical Devices
5 Medicines11 Other Technology
7+49 Medical Devices1 Medicines
24 + 229 Other Technology
22 Medical Devices70 +6 Medicines
8 Other Technology
62 Medical Devices162 Medicines
62 Other Technology
Canada Canadian Agency for Drugs and Technologies in Health (CADTH)4 Medical Devices
42 Medicines16 Other Technology
Colombia Instituto de Evaluación Tecnológica en Salud (IETS)
Mexico
Brazil Agência Nacional de Vigilância Sanitária (ANVISA)Comissão Nacional de Incorporação de Tecnologias no SUS (CONITEC)
Uruguay Fondo Nacional de Recursos
2 Medical Devices24 Medicines
1 Other technology
Centro Nacional de Excelencia Tecnológica en Salud (CENETEC) 5 Medical Devices
6 + 26 Medical Devices6 + 63 Medicines
1 Medical Devices3 Medicines
Method
|
STAGE 1. Countries and health technologies selection
LAC Canada, Brazil, Colombia, Mexico and Uruguay
CEE United Kingdom, Sweden, Scotland, France, Austria & Germany
Web searches of the technologies evaluated in the past 10 years
A. Technology selection
Comprehensive listing
“experienced” and “emerging” HTA countries
“experienced” HTA countries
First selection
First list of technologies Final decision
Selection of comparator (experienced HTA setting)
B. Country selection
Selection of emerging HTA setting (case studies)
Canada & UK (NICE & CADTH): Medicine & Medical DeviceJCVI: Vaccine
One vaccine
One medicine
One medical device
Invitation by email to key informants identified 7 EUNetHTA countries 8 Non EUNetHTA countries
First country selection Brazil & Colombia (LAC)
Polonia & Albania (CEE)
Incorporated: Estonia (CEE)
Case Studies on decision-making informed by HTA
Method
|
Case Studies on decision-making informed by HTA
Indication COUNTRY / REGION
Europe Latin America UK FR SE AT GE SC CA BR CO UY MX
Medicines
RANIBIZUMAB Macular degeneration ● ● ● ●
BEVACIZUMAB Macular degeneration ● ●
INFLIXIMAB Rheumatoid arthritis ● ● ● ● ●
INFLIXIMAB Psoriatic arthritis ● ● ● TRASTUZUMAB Breast cancer ● ● ● ● ● ● ● ● VACCINE VPH
Cervical cancer ● ● ● ● ● ● ● ● ●
Medical devices
DRUG ELUTING STENTS
Coronary arteries diseases ● ● ● ● ● ● ● ● ●
IMPLANTABLE CARDIAC DEFIBRILATOR
Heart failure/ sudden cardiac death / arrhythmias
● ● ●
UK: United Kingdom; FR: France; SE: Sweden; AT: Austria; GE: Germany; SC: Scotland; CA: Canada; BR: Brazil; CO: Colombia; UY: Uruguay; MX: México
Method
|
STAGE 1. Countries and health technologies selection
LAC Canada, Brazil, Colombia, Mexico and Uruguay
CEE United Kingdom, Sweden, Scotland, France, Austria & Germany
Web searches of the technologies evaluated in the past 10 years
A. Technology selection
Comprehensive listing
“experienced” and “emerging” HTA countries
“experienced” HTA countries
First selection
First list of technologies Final decision
Selection of comparator (experienced HTA setting)
B. Country selection
Selection of emerging HTA setting (case studies)
Canada & UK (NICE & CADTH): Medicine & Medical DeviceJCVI: Vaccine
One vaccine
One medicine
One medical device
Invitation by email to key informants identified 7 EUNetHTA countries 8 Non EUNetHTA countries
First country selection Brazil & Colombia (LAC)
Polonia & Albania (CEE)
Incorporated: Estonia (CEE)
Case Studies on decision-making informed by HTA
Method
|
Structure and main questions Survey Items Corresponding to the principle of Drummond
Medicine Vaccine Medical device
1. Introduction General information about the assessment and final recommendation 1-3 1-3 1-2
Independent assessment; participation of experts 4-5 4-5 3-4 (2) HTA should be an unbiased and transparent exercise.
Publicity of the assessment and recommendations 6-7 6-7 5-6 (2) HTA should be an unbiased and transparent exercise.
- Link between scientific assessment and the appraisal decision - Transparent approach for weighing various considerations 8 8 7
(15) The link between health technology assessment and decision-making processes needs to be transparent and clearly defined.
- Institutions involved in the priority setting - Selection criteria for the technology - Evolutionary stage of the technology
9-11 9-11 8-10 (4) A clear system for setting priorities for HTA should exist.
Level of participation in the HTA process and type of stakeholder 12-13 12-13 11-12 (10) Those conducting HTAs should actively engage
all key stakeholder groups.
2. Structure and methods - The report include a scoping or background document - Detail of the information included 14-15 14-15 13-14 (1) The goal and scope of the HTA should be
explicit and relevant to its use.
Description of the decision problem 16-17 16 15 (3) HTA should include all relevant technologies.
- Clinical evidence used for the HTA report - Limitations found the review of the literature - Clinical endpoints included in the assessment
18-19 17-18 16-17 (6) HTA should consider a wide range of evidence and outcomes.
- Costs, benefits, and harms - Economic model and a systematic review of clinical evidence 20-22 19-21 18-20 (5) HTA should incorporate appropriate methods
for assessing costs and benefits.
- Types of costs considered in the HTA report - Costs in added years of life and endpoints 23-25 22-24 21-23 (7) A full societal perspective may be considered
when undertaking HTAs.
- The model uncertainties - Sensitivity analysis - Key deficiencies (or data limitations) - Key future research - Methods guidance for transferability issues
26-31 25-30 24-29
(8) HTAs should explicitly characterize uncertainty surrounding estimates. (9) HTAs should consider and address issues of generalizability and transferability.
The HTA organization monitor the impact of its recommendations 32 31 30 (12) The implementation of HTA findings needs to
be monitored.
3.Use of HTA in Decision Making Main source of information in which decisions were based on (reports and evidence) 33-34 32-33 31-32
- To make the decision rely on the conclusions of the assessment (Additional factors) - Threshold used to determine the cost-effectiveness - Planning to repeat or update the assessment in regular intervals - Communications plan
35-39 34-38 33-37 (13) HTA should be timely. (14) HTA findings need to be communicated appropriately to different decision makers.
Method
|
•Medicine •Medical Device
•Vaccine
1 Product •2 LAC •3 CEE
Emerging Setting
•Canada •UK
Mature Setting
• Trastuzumab • Drug Eluting
Stent • Human
Papillomavirus Vaccine
1 Product
•Colombia & Brazil
•Poland, Albania & Estonia
Emerging Setting
•CADTH, INESSS, NACI/CIC
•NICE&JCVI
Mature Setting
Case Studies on decision-making informed by HTA
|
POLAND AOTM
Positive: An Immunization Program has been established in Poland. The vaccination is mandatory but not refunded by Minister of Health
Local governments may cover par t or total spending of their citizens on HPV immunization and they do it under local heal th programs
Restrictions & Comments
CANADA NACI & CIC
Positive: HPV vaccine (HPV2 or HPV4) is recommended for females between 9 and 26 years of age and for those between 14 and 26 years of age who have had previous Pap abnormalities, including cervical cancer and AGW
HPV vaccination may be admin istered to females over 26 years of age and is not recommended in females <9 years of age. It́ s expected to be implemented on a voluntary rather to a llow for parental and rel igious differences
Country Institution Recommendation
ENGLAND JCVI Positive: HPV vaccine into the routine national immunisation schedule
HPV vaccination programme was restricted to girls aged 12 to 13 years and targeted g irls up to age 18 and a time-limited ‘catch up vaccination of girls aged 13 to 17 years
BRAZIL CONITECPositive: HPV vaccine is administered through a national HPV immunization program.
Only on girls, age group 9-13 years o ld. With a gradual implementation of vaccine schedule: in 2014, female adolescents aged 11-13 years old, in 2015, will be adolescents aged 9-11 years o ld, and in 2016 girls aged 9 years o ld.
COLOMBIA CRESPositive: the HPV vaccine is part of a national immunization program for women from 9 years o ld and older
Main Results – Case Studies HPV vaccine
CEE Countries: England: (Joint Committee on Vaccination and Immunisation JCVI); P: Poland (AOTM) LAC Countries: Canada (NACI&CIC) B: Brazil (CONITEC); C: Colombia (CRES) *NACI: National Advisory Committee of Immunization (CANADA) CIC: The Canadian Immunization Committee (CANADA)
|
Key principle: HTA should actively engage on key stakeholder groups
CEE Countries: UK: United Kingdom (NICE&JCVI); A: Albania (University Hospital) ; P: Poland (AOTM); ES: Estonia (EHIF) LAC Countries: CA: Canada (CCOHTA); Q: Quebec (INESSS); B: Brazil (CONITEC); C: Colombia (IETS);
Main Results – Case Studies
UK A P B C UK ES Q B C UK P CA B C
Patients groups
Clinical specialists
Technology manufacturers
Civil society
DES HPV vaccineTrastuzumabIn the Priority setting
UK A P B C UK ES Q B C UK P CA B C
Patients groups
Clinical specialists
Technology manufacturers
Civil society
Trastuzumab DES HPV vaccineIn the submission or review of evidence
*INESSS process is very different now (the process reported is from 2004). Patients, clinical specialists and civil are taking part in all of the mentioned stages
|
Key principle: HTA should actively engage on key stakeholder groups
Main Results – Case Studies
UK A P B C UK ES Q B C UK P CA B C
Patients groups
Clinical specialists
Technology manufacturers
Civil society
Trastuzumab DES HPV vaccineIn the Appraisal
CEE Countries: UK: United Kingdom (NICE&JCVI); A: Albania (University Hospital) ; P: Poland (AOTM); ES: Estonia (EHIF) LAC Countries: CA: Canada (CCOHTA); Q: Quebec (INESSS); B: Brazil (CONITEC); C: Colombia (IETS);
*INESSS process is very different now (the process reported is from 2004). Patients, clinical specialists and civil are taking part in all of the mentioned stages
UK A P B C UK ES Q B C UK P CA B C
Patients groups
Clinical specialists
Technology manufacturers
Civil society
Trastuzumab DES HPV vaccineIn the Final Decision
|
Conclusions
Positive trends were identified among the reviewed countries regarding: scope, priorities, methodology, process and the impact of HTA.
The lack of transparency, as the HTA reports were not public, associated with the language barriers were the main difficulties to make a more complete case studies analysis of the use of HTA in CEE countries.
Despite the differences in the institutional contexts, the results showed in these case studies exercise are one of the bases for start preparing the toolbox. The toolbox will outline best practice, including recommendations, and providing advice for emerging countries in the use of HTA.
|
Task 6.3. HTA Toolbox. Objective
To Develop adaptable toolbox for emerging countries to improve decision-making processes, outlining best practices, concrete examples and innovative approaches:
– Based on the current situation and the emerging changes captured in the mapping and lessons learned from case studies, this toolbox is developed with a set of recommendations for effectively implementing HTA in the priority setting process.
– Added value • Offer examples • Provide best practices developed by CEE & LAC countries • Its purpose is to serve as a support to other countries willing to
implement HTA as a tool to decision making.
|
HTA Toolbox
HTA & HEALTHCARE
SYSTEM
• PRIORITY SETTING IN HEALTH SERVICE - Definition of Health Service
- Definition of Universal Health Coverage - Defining population needs - Types of Priority Settings - Essential medicines List - Strategic Fund - Vaccination Program Strategies - Health Benefit Plan (health insurance schemes/ tax-funded systems) - Disinvestment/ Delisting Decisions - Concrete examples
• HTA - Purposes
- Fields of application - Role of HTA in the Decision Making Process
• EXAMPLES OF THE USE OF HTA IN THE DECISION MAKING PROCESS
|
BUILDING THE HTA FUNCTION Examples of HTA bodies/Organizations
Types of HTA bodies/organizations and their responsibilities
Advantages of HTA-networking
HTA Toolbox
|
BUILDING THE HTA FUNCTION
HTA Toolbox
• SOCIAL VALUES AND PERSPECTIVES OF DIFFERENT SOCIAL ACTORS IN DECISION MAKING
* Ethics in the decision process * Tools to include equity perspective - The Equity-Oriented Toolkit - INATHA’s ethics working group experience - the EuneHTA ethical analysis model - morally questions to assess HT * Participation of different social actors in the decision process * Transferability * Methods for ethical analysis * Examples of HT covered after ethical analysis
|
Types of HTA - Advantages/ disadvantages - Fields of application (national, regional, hospital)
Guidelines based on HTA - Where can HTA/EE Guidelines be found: - in the America’s Region - in the CEE Region
Transnational HTA - Opportunities - Problems with transferability of HTA reports - Best Practices to address the transferability of HTA - Role of EUneHTA - Role of RedETSA - Role of INAHTA
HTA PRODUCTS
HTA Toolbox
|
* Structure and content of a report * Scope * Efficacy, effectiveness, safety - Definition - Recommendations - Tools :
• Clinical endpoints • Composite endpoints • Surrogate endpoints • Safety • Health-related quality of life • Criteria for the choice of the most appropriate
comparator(s) • Internal validity • Applicability of evidence in the context of a
relative effectiveness assessment
* Systematic Review of clinical evidence - Definition - Recommendations - Best Practices examples - Tools: - for systematic reviews - for metanalisis/ Direct and indirec comparison
• ELEMENTS TO CONSIDER IN A REPORT OF HTA
HTA PRODUCTS HTA PRODUCTS
HTA Toolbox
|
* Economic Evaluation of HT & BIA - Definition - Key issues in EE - Roles of modeling in HTA - Cost-effectiveness thresholds - Recommendations - Best Practices examples - examples of EE in decision-making - methodological guidelines - Tools: - For developing cost effectiveness analysis - For modeling - For adapting cost effectiveness analysis - To estimate the budgetary impact
• ELEMENTS TO CONSIDER IN A REPORT OF HTA
HTA PRODUCTS HTA PRODUCTS
HTA Toolbox
|
HTA Toolbox
Beyond HTA: using MCDA to facilitate decision-making and priority setting
Figure 2. An overview of Multi-criteria decision analysis.
Source: Angelis & Kanavos 2015 (14).
|
Task 6.3 The Toolbox
• CLINICAL PRACTICE GUIDELINES BASED ON HTA * Methodological aspects for the development of guides Adaptation of guidelines - Definition - Tools and checklists - Examples - Repositories Disinvestment / Reinvestment & Countries examples Monitoring and evaluation
V. IMPLEMENTATION OF THE DECISIONS
|
Lessons Learnt (I)
Different/broad interpretation about what is HTA when asking is in the country they are performing HTA
– An affirmative answer goes from a “simple” HTA (literature review looking for evidence, for example) to a more complete HTA (Literature review + Cost effectiveness studies + BIA +…)
|
Lessons Learnt (II)
Difficult to gathering information about the HTA and the decision making process in some countries
– Not clear steps of the process (sometimes is informal) – Lack of HTA regulatory framework
|
Lessons Learnt (III)
Lack of transparency for getting the HTA reports (it is not only a problem of the language)
– NICE website as example of transparency
|
Lessons Learnt (IV)
“Overall capacity is still limited” but with differences within the countries.
Capacity to perform HTA
N (%) yes 15 (55.6%) No 9 (33.3%) Missed data 3 (11,1%)
55.6% of the respondents affirmed that their countries have the capacity to perform HTA regularly and systematically.
|
Lessons Learnt (V)
Most of the HTAs are made for medicines, so
what about other health technologies?
| Source: A comparative analysis of the role and impact of Health Technology Assessment: 2013. Charles River Associates
|
Way Forward (I)
To make aware/advice to the payers that HTA is a important tool to make a efficient use of the health technologies (opportunity cost)
|
Way Forward (II)
To improve the exhange of information between HTA bodies/institutions in order to avoid overlapping / contradiction in the HTA technical reports
but “Transferability should be assessed carefully” (Gulacsi 2014)
|
Way Forward (III)
Need of a public guidelines of the HTA process that helps everyone to know the “rules”. Arbitrarity in the decision making is not a good reference.
|
Way Forward (IV)
HTA as a tool for disinvestment – Re-evalution of medicines when there is new evidence
(MEA) – Evaluation of old medicines that are actually reimbursed and
that were not under a HTA process
Recommended