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International Network of Agencies for Health Technology Assessment

Guidelines International Network - (GIN)

Red de Evaluación de Tecnologías Sanitarias de las Américas

Member of:

Health Technology Assessment International- HTAi


HTA and CPGs as tools to inform

decision-making (macro & micro)

Héctor Castro MD, MSc, PhD

CEO


» Decision-making in health and health care

» IETS advancing HTA into reimbursement decisions

» IETS advancing CPGs to improve quality of health care

» The adaptation of what is deemed as good HTA practice

» The advantages of technical independence

» Challenges, perspectives and future initiatives

OUTLINE


“Decision-making in health care is a complex process taking

place along a continuum that moves from evidence generation

to deliberation and communication of the decision made

(Goetghebeur et al, 2008)”

Decision-making in health and health care


» HTA is only part of process; examines implications of the diffusion and

use of a medical technology in healthcare.

» Aimed at better informing decision-makers.

» Key principles for robust operation of HTA: Transparency, robust and

appropriate methods for combining costs and benefits, explicit

characterization of uncertainty and active engagement with stakeholders

(Drummond et al, 2008 and Chalkidou et al, 2009):

» Current level of application of these principles, uniformly poor in Latin

America (Pichon- Riviere et al, 2010)…although changing!

HTA processes and institutions


A consistent trend to implement or use HTA for resource allocation decision- making in HICs & MICs

From mid 1980´s onwards:

Commonly processes and institutions are rigorous, independent and involve relevant stakeholders

A global trend to use HTA


The use of evidence and levels of decision-making:

• Macro- Government (MoHSP, INS, regulatory agencies):

– Comparative analysis of safety, efficacy, effectiveness and cost-effectiveness, value based

pricing, infectious diseases modelling, public policies.

• Meso- Health insurers, Hospitals and other providers:

– CPGs, protocols, health care pathways, quality standards and outcomes, self-

regulation of professionals.

• Micro- Health care professionals, carers and patients:

– Safety, efficacy, effectiveness, CPGs, self- care.

7

Decision-making in health and health care


The notion of priority setting as a process or a sub- system

Identify and select

possible candidates

for evaluation

Technical assessment using robust methods and

evidence summary

Budget impact analysis

Appraisal

Deliberation

process and

recommend

ations

Monitoring

and

Evaluation

Marketing

authorization

Decision Making

Source: Adapted from IDB, Colombia priority setting of public expenditure project, 2011 Adapted H, Castro 2013.

STEWARDSHIP OF PRIORITY SETTING POLICY

I N F O R M A T I O N S Y S T E M


Identify and select possible candidates for

evaluation

Technical appraisal

using robust methods and

evidence summary

Budget

impact

analysis

Deliberation process on

evidence and recommenda

tions

Monitoring and

Evaluation

Marketing

authorization

Decision

Making

IETS

NICE

IQWiG

MoHSP

G-BA

Colombia

England

Germany

MHRA EMA

INVIMA INS

BfArM EMA

MoHSP

The notion of priority setting as a process or a sub- system


» 1993 HSR, statutory health insurance.

» Explicit BP, inequitable list for POS- C & S.

» POS covers nearly 96% of the country´s population

(MoHSP, 2012). THE 6.5- 7.4% GDP

» Many performance indicators have improved after HSR

(WHO and PAHO and Escobar, 2005).

» List of healthcare benefits established in 1994, not

regularly updated.

» BP challenged by patients with exceptional requests and

judiciary claims. Forced to cover services not initially

budgeted for.

47 Million inhabitants. UMIC- GDP pc (ppp)

USD $10,110. Source WB 2012

The current context of the Colombian health system


» In 2008 the CC mandated the government to equalise and

update POS content ASAP

» Health system´s financial crisis

» Government appointed in late 2010, taken steps to control

costs and strengthen institutional capacity.

» Dec 2011 POS was updated by CRES. Raised criticism

insufficient use of evidence, weakness of methods and lack

of transparency. July 2012 POS equalisation.

» To produce information to set priorities for health (care) in a

systematic fashion the Health Technology Assessment

Institute- IETS created in Sep 2012.

» Dec 2012 CRES disbanded

Late 2009 a COL $2 Billion deficit total

budget for health announced by the

former President

The current context of the Colombian health system


Heuristic approach

» Agenda setting towards HTA

» Policy formulation for HTA

» Policy implementation for HTA

» Follow up

Setting up IETS- incremental steps


Problem stream Policy stream Politics stream

Policy window of

opportunity 2

2004 inflationary costs and raising exceptions, government starts

considering HTA processes

2008 Constitutional court´s mandate to

amend structural factors

2008 National methods guidelines

Early 2009 crisis within the health system

threatening sustainability

Mid 2009 increased interest in NICE methods and processes, government´s

official request for technical advice

Late 2009 controversial law of social

emergency by former president

Policy window of

opportunity 1

2007 Decision making body

created not an HTA agency

2011 HTA agency (IETS)

enacted by law

Late 2010 New

government

2010 2011 2007 2006 2004 2005 2009 2008

Early 2010 law of social emergency

declared unenforceable

Source: Based on Kingdon model- 1984 by Castro HE, 2013 work in progress

Agenda setting- the policy context in Colombia

2012

2012 Decision making body

abolished lack of legitimacy

2013 POS content

updated using HTA by IETS

2013

2012 HTA agency (IETS)

starts operations


1. Non-profit, joint participation and private character, with its own patrimony. Founding

partners: MoHSP, INS, INVIMA; Colciencias, ASCOFAME… National Association of Scientific

Societies- ACSC

2. IETS aims to promote HTA at the national level, and contribute to the development of

best healthcare practices by supporting public health policies formulation with evidence

based information.

3. IETS balances in- house activities with out- sourced assessment centers

4. Governance structure to be led by a an independent board

5. Senior staff appointed by public tender based on technical profiles.

IETS

IETS advancing HTA into reimbursement decisions


Budget Impact

Monitoring

and

Evaluation

Explicit or

implicit plan

Decision

making

Source IDB adapted, Colombia priority setting of public expenditure project, 2011.

Pilot Nov 2012, 6 criteria for ordinary topic selection: severity, size of population, public health interest, cost, civil society´s request, attention to vulnerable population. Engagement with academics, scientific societies and patients. Extraordinary pathway under construction


Marketing

authorization

Identify and select candidates for

evaluation

Topic selection

robust methods and evidence

summary

Assessment

Appraisal

Deliberation



exclusiones

Budget Impact

Monitoring

and

Evaluation

Explicit or

implicit plan

Decision

making

Marketing

authorization


evaluation

Topic selection


summary

Assessment

Appraisal

Deliberation


Feb 2013 onwards, PICO questions refined with clinicians and patients, declaration of vested interest, 51 comparative analysis of safety and effectiveness, 34 extractions of evidence from updated CPGs and 42 BIA… moving towards cost- effectiveness, policy briefs bearing in mind MCDA request from the MoHSP



exclusiones

Budget Impact

Monitoring

and

Evaluation

Explicit or

implicit plan

Decision

making

Marketing

authorization


evaluation

Topic selection


summary

Assessment

Appraisal

Deliberation


HTA IS MORE THAN JUST METHODS


El proceso de priorizar y decidir aplica para listas de inclusiones o exclusiones

Former CRES work 2012 and IETS Aug 2013, pilot tested 15 MCDA criteria (13 EVIDEM y 2 local) for resource allocation decision- making, 4 technologies tested. Focus group with 7 stakeholders. Qualitative EVIDEM tested vs. narrative HTA summary + BIA vs. ICER

Budget Impact

Monitoring

and

Evaluation

Explicit or

implicit plan

Decision

making

Marketing

authorization


evaluation

Topic selection


summary

Assessment

Appraisal

Deliberation



exclusiones


Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options Institute of Medicine, 2011

What are Clinical Practice Guidelines (CPG)?


Previous attempts Res. 412/2000 and HIV CPG 2006

CPG Manual 2008-2009 Harvard, FSB and NI…GAI (Integral

healthcare guidelines)

2009, 24 GAI commissioned by colciencias and MoH&SP

24 GAIs published in 2013

2013 Manual update…CPGs…IETS promotes implementation

2014…16 new CPGs on their way IETS endorses quality

Clinical Practice Guidelines (CPG) in Colombia


PRIORITY SETTING

CALL FOR PROPOSALS

DEVELOPMENT SUPERVISION DISSEMINATION IMPLEMENTATION

Responsible: • Ministry of

Health • National

Institute of Health

Support: • IETS


Science and Technology (Colciencias)

Support:

• Ministry of Health

• IETS

Responsible: • Developers/aca

demia


Health

(Content supervision)

• Ministry of

Science and Technology (Colciencias)

(Administrative supervision)

• IETS (Technical supervision)


Health Support: • IETS

Responsible: • Ministry of Health Support: • IETS

Development of CPGs in Colombia


• Develops strong, scientifically valid, and consistent methods for CPG development

• Supports Colciencias and the MSPS in the selection of CPG developers

• Provides technical supervision to developers throughout the CPG development

process

• Peer reviews CPG draft documents

• Supports the MSPS in the CPG implementation process

What is the role of IETS in the development of CPGs?


The adaptation of what is deemed as good HTA practice

Identify and select

possible candidates

for evaluation

Budget impact analysis

Appraisal

Deliberation

process and

recommend

ations

Monitoring

and

Evaluation

Marketing

authorization

Decision Making

Source: Adapted from IDB, Colombia priority setting of public expenditure project, 2011 Adapted H, Castro 2013.

STEWARDSHIP OF PRIORITY SETTING POLICY

I N F O R M A T I O N S Y S T E M

Technical assessment using robust methods

and evidence summary

HTA


The adaptation of what is deemed as good HTA practice

exclusiones

Budget Impact

Monitoring

and

Evaluation

Explicit or

implicit plan

Decision

making

Marketing

authorization


evaluation

Topic selection


summary

Assessment

Appraisal

Deliberation


…BUT HTA ALSO NEEDS ROBUST METHODS http://www.iets.org.co/manuales

Methods manuals of safety, effectiveness and diagnostic test assessment, economic-

evaluation (reference case), BIA, stakeholder engagement, CPGs


Board of Directors

CEO

Deputy- director HTA Deputy- director CPGs

Deputy- director operations

Deputy- director communications

Deputy- director dissemination and

transfer

Deputy- director stakeholder engagement

General Assembly Fiscal Auditor Structure

Advisory committee

The advantages of technical independence


Actividades de participación

Pilot to set up a priority setting

committee

Meeting with representatives form

professional bodies

Meeting with patients, people´s

advocates, and civil society Talks and meetings with the

pharmaceutical and devices producers

The advantages of technical

independence

IET

S lia

ises w

ith d

iffere

nt

stakeh

old

ers

IET

S is a

n in

sider w

ithin

the d

ecisio

n-m

ak

ing

pro

cess le

d b

y th

e

Mo

HS

P


Reach fair and

sustainable universal

coverage

Total health expenditure

Population who is covered ? (breadth)

Direct costs: what proportion of costs are

covered? (height)

Extend to non-covered

Reduce cost sharing and fees

Include other services

Gasto publico en salud

Fuente: The World Health Report (OMS, 2008), modified by HE, Castro 2014

Challenges, perspectives and future initiatives


The concept of “drivers” has emerged

for the future development and use of

HTA in Colombia

Availability &

quality of data

PositiveImpact

NegativeImpact

DRIVER

• Potential impact• Directionality• Level of impact

HTA Development

Stakeholder´spressure

Policy/Politicssupport

Local capacity

Implementationstrategy

Cultural aspects

Financialsupport

Globalisation Health systemcontext

Usefulnessperception

HTA use

Could evolve in time

Interconnectedness


Source Castro HE, 2013. Assessing the feasibility to conduct and use HTA in Colombia- WiP .

Overcome barriers


» Support the use of HTA to inform public health and social policies in Colombia

» Support local/regional capacity building for HTA

» Design and implement successful strategies of knowledge transfer

» Promote the use of dynamic modelling for infectious diseases

» Advance the use of HTA within the region (Costa Rica, Peru, Ecuador, Mexico)


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