HTA and decision-making in the Region of the Americas

Alexandre Lemgruber

Advance HTA – Final Conference

London November 2015

Balancing efficiency and equity through an HTA

approach in the Region of the Americas

• In September 2012, in the Pan American Sanitary

Conference, the Ministries of Health of all Member States in the Region of the Americas adopted the Resolution CSP 28.R9 on HTA and decision making

• The Resolution was the first one on HTA to be approved by Member States

• Progress Report on the implementation of the Resolution was presented to the Directing Council on September 2015.

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• The Resolution urges Member States to:

Resolution CSP28.R9

Encourage the establishment of decision-making processes based on HTA

Promote efforts to strengthen institutional frameworks for the incorporation of health technologies

Promote the production and dissemination of HTA results among decision-makers

Strengthen national, sub-regional and regional networks to promote exchange among institutions and countries

Actively participate in RedETSA (Regional HTA Network)

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Key elements The proposal was presented in the policy document on HTA and decision making, with the following elements:

1. Integration of HTA into public policies on health

technologies

2. Establishment of an institutional framework for HTA-based decision

making

3. Human Resources Development

4. Dissemination of information

5. Rational use of health technologies

6. Promotion of network collaboration

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4

Integrated approach in support of decision

making: from the concept to the practice

• Workshop with Caribbean countries (Trinidad and Tobago, August 2015): Roadmap for implementing the integrated approach; sub regional HTA commission established

• Paraguay is in the process of creating a Department of HTA and Rational Use of Health Technologies - the first in the Region to integrate both issues

• Integrated course on HTA and Rational Use is under development

for the PAHO Virtual Campus.

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Chile: National HTA Commission, with

13 members (2012) HTA Department at MoH (6

members) HTA unit in Regulatory Authority

– ISP (2011) New Law establishing HTA as

mandatory for decision making for high cost medicines

HTA at National Level Argentina: HTA Coordination Unit –

UCEETS (2009), with 14 institutions

HTA unit in Regulatory Authority - ANMAT (2012)

IECS: WHO CC

Colombia: HTA institute (IETS); creation

approved by a Federal Law in 2011; operation initiated in 2012

Uruguay: HTA Division in the Ministry of

Health (2009) EE to support coverage

decisions for high cost drugs

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Mexico: Evaluations are required by the National commission that defines the

benefit package (2011). HTA unit at the National Center for Health Technologies-CENETEC

(2004), WHO/PAHO CC

HTA at National level (2)

Brazil: HTA Units in the MoH and in the Regulatory Agency – ANVISA (2003) Pricing decisions (as part of the marketing authorization) based on

HTA (2004) National Policy on Health Technologies (2009) Federal law and the strengthening of a national commission

(CONITEC) to regulate the incorporation of new health technologies in the Public Health System (2011): 13 members from MoH, civil society, local and state governments, physicians association and the expansion of a national network (REBRATS) with more than 75 institutions

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Chile

Mexico

Cuba

Costa Rica

Brazil

Argentina

Uruguay

Paraguay Bolivia

Peru

Ecuador Colombia

Canada

El Salvador

• Launched 2011 • PAHO as Secretariat • 28 members • 14 countries

RedETSA

www.redetsa.org

Meetings and collaboration with other HTA networks

June 2011

1st meeting: Rio de Janeiro: official launch

April 2012

2nd meeting: Lima Definition of priorities and work plan, with the participation of EUnetHTA, IDB, World Bank Institute

June2012

Workshop to discuss collaboration with EUnetHTA, HTAsiaLink and INAHTA, Bilbao

Dec 2012

3rd meeting: Bogota To discuss the implementation of the Resolution

Sep 2013

Nov 2014

Jun 2014

Jun 2013

4th meeting, Brasilia: Interaction between regulation and HTA; social values in decision-making; economic evaluations and their importance for decision making; HTA in hospitals; CPG

5th meeting: WDC HTA, Prioritization and Universal Health Coverage

Workshop to discuss collaboration with EUnetHTA, HTAsiaLink and INAHTA, Seoul

6th meeting: Mexico Organized with CENETEC forum Mapping results presentation, and new projects.

Jun 2015

Participation in Euroscan Meeting, Oslo

Sep 2015 7th meeting: Chile

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Advance HTA Workshops

MEXICO • November 2014 • 59 participants • 14 countries*

*Argentina, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, Paraguay, Peru, Trinidad & Tobago, Uruguay and Mexico

CHILE • September 2015 • 70 participants • 13 countries** **Argentina, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, Ecuador, Mexico, Paraguay, Peru, Uruguay and USA

Mapping of HTA situation in the Region Partnerhip Advance HTA Project and RedETSA

Two components:

• Institutional capacity to perform HTA (tool developed

by RedETSA)

• HTA and Decision-making (tool developed as part of

the Advance HTA project)

Surveys sent to: Ministries of health; HTA institutions; other

health and academic institutions

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HTA in Emerging Settings – Work Package of the Project ADVANCE HTA (funded by European Commission): PAHO, Escuela Andaluza de Salud Pública, London School of Economics and National Institute for Health and Care Excellence-NICE

o Mapping of existing HTA capacity and decision making

processes in Central and Eastern Europe and Central American and Caribbean countries.

o Case studies on decision-making informed by HTA, with a view to producing recommendations for strengthening and implementing HTA as a decision-making tool (LAC: Brazil and Colombia)

o Toolbox on best practices and recommendations on HTA implementation

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• Argentina • Brazil • Bolivia • Canada • Chile • Colombia • Costa Rica • Cuba • Ecuador • El Salvador • México • Paraguay • Peru • Uruguay

• Bahamas • Barbados • Belize • Bermuda • Dominican

Republic • Guatemala • Guyana • Haiti • Honduras • Jamaica • Nicaragua • Panama • St. Lucia • St. Maarten • Suriname • Trinidad & Tobago • Venezuela

Mapping of HTA situation in the Region

31 countries mapped 89% response rate 147 responses were received 11 countries have HTA units,

commissions, or institutes. 86 institutions carry out some

type of HTA-related activity

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Country Formal HTA Body Performs HTA

Bahamas No No

Barbados No ✔

Belize No ✔

Bermuda No ✔

Costa Rica No ✔

Dominica* No No

Dominican Republic No ✔

El Salvador No ✔

Guatemala No ✔

Guyana No No

Haiti No ✔

Honduras No ✔

Jamaica No ✔

Nicaragua No ✔

Panama No ✔

St. Lucia No ✔

St. Maarten No ✔

Suriname No ✔

Trinidad and Tobago No ✔

Venezuela Yes ✔

Countries Formal HTA Body Performs HTA

Argentina Yes ✔

Bolivia No ✔

Brazil Yes ✔

Canada Yes ✔

Chile Yes ✔

Colombia Yes ✔

Costa Rica No ✔

Cuba No ✔

Ecuador No ✔

El Salvador No ✔

Mexico Yes ✔

Paraguay No ✔

Peru Yes ✔

Uruguay Yes ✔

14 *information from literature review

HTA Capacity Mapping

Surveys are sent to Focal Points (FP) of RedETSA

•N = 25 •Answers: 100%

FP identify institutions with potential capacity to perform HTA in the country

•118 identified institutions

Surveys sent to the identified institutions

•51 answered surveys

76 answers

51

25

86 institutions with capacity to perform HTA

73%

21%

6%

Yes

No

Don't know

Institutions that undertake HTA related activities

0

5

10

15

20

25

30

N=118

22%

16%

16%

13%

12%

11%

8%

1%

1%

0% 5% 10% 15% 20% 25%

Lack of qualified HR

Lack of $

Lack of incorporation of the HTA as a tool for decision making

Lack of institutional political decision

Lack of access to data bases

Lack of support staff

Lack of physical infrastructure

None

Lack of Technical Cooperation Agreements with InternationalOrganizations of HTA

Main barriers for HTA implementation

7%

50% 14%

18%

7% 4%

Always Most of the time

Sometimes Rarely

No, decision making is not based on HTA Did not answer

12%

24%

4% 16%

24%

20%

Advance HTA Countries RedETSA

Is Decision Making informed by HTA?

18

25%

21% 39%

11%

3% RedETSA

There is legislation establishing that HTA reports must be considered in the decision-making process(mandatory)There is legislation establishing that HTA reports should be considered to support coverage decisions(recommendation)There is no specific legislation at the present time stating that coverage decisions should be informedby HTA reports, but HTA reports are used to support policy making.There is no link and the decisions are not informed by HTA

Did not answer

16% 4%

24% 36%

20%

Advance HTA Countries

Is HTA explicitly linked to Decision Making?

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Mapping results: Advance HTA countries

Are there methodological guidelines for the conduct of HTA?

30

70

Yes

No

Are decisions based on HTA conclusion?

56.25

37.5

6.25

Yes

No

Rarely

Is there a publicly financed benefits package?

58.82

41.17 Yes

No

Is the benefits package informed by HTA findings?

33.33

66.66

Yes

No

Implementation of HTA

Advance HTA Project Countries Is an economic evaluation required for the decision-making process?

Are there explicit thresholds for cost-effectiveness?

Are there methodological guidelines for economic evaluations?

0

20

40

60

80

Yes No

0

20

40

60

80

Yes No

0

20

40

60

80

100

Yes No

Implementation of HTA

Advance HTA Project Countries Are there monitoring mechanisms for assessing the uptake of technology recommendations?

How are clinical guidelines disseminated to users and the public health system?

Is there a national strategy for the rational use of medicines or other health technologies?

Is there a national commission or institution responsible for this strategy?

0 20 40 60 80

Yes

No

Unsure

0 20 40 60 80

Email

Website

Other

0 10 20 30 40 50

Yes

No

Unsure

0 10 20 30 40 50 60

Yes

No

Unsure

Are HTA reports from other countries taken into account for decision-making?

NICE, CADTH, INESSS, CENETEC, FDA, ANVISA, PBAC

HTA Toolbox

• Objective: to develop adaptable toolbox targeted to emerging settings to improve decision-making processes, outlining best practices, concrete examples and innovative approaches: o Based on the current situation and the emerging changes

captured in the mapping and lessons learned from case studies, the toolbox was developed with a set of recommendations for effectively implementing HTA in the priority setting process.

o Added value • Provide examples • Provide best practices observed in CEE & LAC countries • Its purpose is to serve as a support to other countries

willing to implement HTA to improve decision making.

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HTA Toolbox

• Four main topics:

I. Building the HTA Function II. HTA Products III. HTA & Healthcare Systems IV. Implementation of the decisions

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WP6: most important findings (LAC)

• Lack of HTA capacity, specially in Central American and Caribbean countries

• Lack of guidelines/ standard procedures for HTA • No explicit links between HTA and decision-

making • Lack of qualified human recourses and

organizational issues are the main barriers for the use of HTA

• There is no mechanisms in place to monitor the implementations of the decisions

Other RedETSA Activities - Community of Practice

- Webinar Program

- Professional Exchange Program • One-week visits to other institutions in the Network

o Visit to CONITEC on first week of December

• Participants from Argentina, Colombia, Costa Rica, El Salvador, Paraguay and Uruguay

o INESSS, IETS, IECS

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RedETSA Community of Practice

Virtual Library: • 152 documents • 67 HTA reports

Discussion Forum for members • addressing subjects

of interest • consultations on

specific technologies

Member Directory • direct contact • consultations on

specific technologies

Agenda • Meetings • Webinars • Events

News: • Published by

members or by Secretary

Launch of the new phase: Nov 15

• New search engine on library

• New programming technology

• Flexible data population tools

• New friendlier interface

RedETSA website

• www.redetsa.org • English, Spanish and Portuguese • Information of RedETSA members, news, events, contacts • HTA reports, documents, articles and webinars • Directory of HTA institutions in Americas

RedETSA Webinar program

• Monthly webinars • Topics proposed by RedETSA

members • Started in July 2015 • “Instruments for measuring quality

of life” was the first topic • All webinars available on

www.redetsa.org

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Training activities

Course in Spanish: 252 applications

Introduction to Health Technology Assessment and Economic Evaluation

• PAHO Virtual Campus of Public Health • Introduction to Health Technology Assessment. • In partnership with the Institute of Clinical Effectiveness and Health Policy, from Argentina

Spanish version: -352 applications -47 participants chosen through a very careful selection process -Participants from 20 countries: Argentina, Bolivia , Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Dominican Republic, Uruguay and Venezuela.

MAIN TOPICS:

• Introduction to Health Technology Assessment.

• Introduction to Economic Evaluations

• Cost-minimization, cost-effectiveness and cost-utility studies.

• Principles for making and implementing HTA and EE

• Results interpretation • HTA and EE on decision

making

Training activities 2015: • 6 participants in the Master Program on HTA and EE virtual courses

offered by the Institute of Clinical Effectiveness and Health Policy (IECS)

2016: • Virtual course on HTA and Rational Use at the Virtual Campus • 6 participants in the IECS e-learning Master Program • 15 participants on the HTA virtual course offered by RedARETS

(HTA Argentinian Network)

Challenges for the Region

• Even though some countries have made important progresses on HTA, building capacity and strengthening institutions, in most of the countries there is still no explicit links between HTA and decision-making

• It is important to develop tools for measuring the impact of HTA for the health systems

• The increasing number of judicial claims related to the incorporation of health technologies (“judicialization”) cause a distortion in the decision-making process, and represent a threat for the sustainability of health systems in the Region

• Lack of implementation: dissemination of the toolbox will help to address this gap

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