HTA: key learnings and proposals to involve patients in HTA...Nov 26, 2018 · From HTA bodies Very...

HTA: key learnings and proposals to involve

patients in HTA

Maria Jose Vicente Edo

Health Science Institute of Aragon (IACS)

Zaragoza-Spain

Athens, 21st November 2018

I do not have any financial or other

interest with any pharmaceutical

industry or other private companies.

➢ Great Innovation and technologies

- Not available to everyone

- Access differences to first line treatments

➢ To help payers spend a fixed budget

allocation wisely

➢ Medicines already introduced in the market

have little value.

LEGITIMACY

Patients know how to

live with the

condition as

patient/carer/family

LEGITIMACY


live with the

condition as


IDENTIFY AND

PRIORITIZE

Selection of HTA topics

(identifying and prioritizing

HTA questions).

LEGITIMACY


live with the

condition as


IDENTIFY AND

PRIORITIZE



HTA questions).

FAIRNESS

Patients has the right

to contribute to HTA

process as other

stakeholders

LEGITIMACY


live with the

condition as


IDENTIFY AND

PRIORITIZE



HTA questions).FAIRNESS



process as other

stakeholders

RELEVANCE

How the condition is

clinically managed:

disease burden,

diagnosis , treatment,

pathways of care.

LEGITIMACY


live with the

condition as


IDENTIFY AND

PRIORITIZE






process as other

stakeholders

RELEVANCE


clinically managed:

disease burden,


pathways of care.

OUTCOMES

Identify what kinds of

outcomes matter, what

kinds of processes might

help to improve these

outcomes, and ensure its

inclusion in HTA process

LEGITIMACY


live with the

condition as


IDENTIFY AND

PRIORITIZE






process as other

stakeholders

RELEVANCE


clinically managed:

disease burden,


pathways of care.

OUTCOMES






inclusion in HTA processEQUITY

Identify unmet needs

LEGITIMACY


live with the

condition as


IDENTIFY AND

PRIORITIZE






process as other

stakeholders

RELEVANCE


clinically managed:

disease burden,


pathways of care.

OUTCOMES








COUNTERBALANCE

The value judgments and

preferences brought by other

stakeholders.

LEGITIMACY


live with the

condition as


IDENTIFY AND

PRIORITIZE






process as other

stakeholders

RELEVANCE


clinically managed:

disease burden,


pathways of care.

OUTCOMES








COUNTERBALANCE



stakeholders. TRANSPARENCY

LEGITIMACY


live with the

condition as


IDENTIFY AND

PRIORITIZE






process as other

stakeholders

RELEVANCE


clinically managed:

disease burden,


pathways of care.

OUTCOMES








COUNTERBALANCE




SOCIAL IMPLICATIONS

Social, Societal implications of

the health condition and its

treatment

LEGITIMACY


live with the

condition as


IDENTIFY AND

PRIORITIZE






process as other

stakeholders

RELEVANCE


clinically managed:

disease burden,


pathways of care.

OUTCOMES








COUNTERBALANCE




SOCIAL IMPLICATIONS



treatment

EVIDENCE

The right time to improve

evidence

LEGITIMACY


live with the

condition as


IDENTIFY AND

PRIORITIZE






process as other

stakeholders

RELEVANCE


clinically managed:

disease burden,


pathways of care.

OUTCOMES








COUNTERBALANCE




SOCIAL IMPLICATIONS



treatment

EVIDENCE

The right time to improve

evidence

ADVERSE EFFECTS

triggered by the Treatment

Patients’ perspective are

essential in the advice

to HTA process

Focus on organisational and

procedural aspects of the

HTA process and delivery of

HTA results to inform

decision-making

https://ec.europa.eu/health/sites/health/files/technology_assessment/docs/2018_mapping_npc

_en.pdf (May 2017)

https://ec.europa.eu/health/sites/health/files/technology_assessment/docs/2018_mapping_npc_en.pdf

• EU countries and Norway have anHTA system informing decision -making at national level.

25

• Organizations (all public bodies)are identified as the HTA bodieshaving a clearly defined role in theHTA process to inform decision-making at the national level.

56

• EU countries have a singularnational body whose main roleincludes development of HTArecommendations.

15

Representativeness

(patients profile and

capabilities)

Conflicts of interest

“ Ok, now that we all agree, let´s all discuss why this

does not work.”

“True” involvement?

From decision-makers

▪ Policy, legal (governance requirements) and regulatory

framework about how to engage patients in HTA and in

decision-making process

▪ Finding an interlocutor within the decision-making

body/institution

▪ System to allocate resources based on:

- Common values (necessary, equitable, accessible,

affordable…etc)

- Achieving optimal individual needs

- Optimize population impact

- Sustainability model

From HTA bodies

▪ Communication in a clear and accessible manner with regular

feedback to inform patients about outcomes/changes

▪ Promote transparency in any decision-making process

▪ Capacity building:

- Training programs and methods on HTA and regulatory

process to patients (e.g. EBM, HTA methodology, decision

making processes…etc)

* vulnerable population needs and requirements

* Clear and understandable formats (i.e potential

impairments, literacy levels, cultural, cultural

backgrounds, other factors as age, disease…etc)

From HTA bodies

▪ Very good knowledge about the condition of the disease

▪ Competences needed in patient involvement practices

▪ A unique point of contact to whom patients can reach out to

when needed.

▪ Easy to read HTA summaries in HTA reports that can be

understood by patients/patients’ organizations/ informal

carers

From Patients

▪ Translate collective needs not my own needs

▪ Demonstrate independence by diversifying the organization's

financial support and having a transparent framework for

cooperating with industry

▪ Help to the sustainability of the health systems understanding

the decision making-process

▪ Compromise with the HTA process (defined methods and

strict timelines that must be adhered to)

▪ "Professionalization" of patient’s associations

[1 http://www.eu-patient.eu/globalassets/projects/hta/hta-epf-final-report2013.pdf (2013)]

http://www.eu-patient.eu/globalassets/projects/hta/hta-epf-final-report2013.pdf

http://www.eu-patient.eu/globalassets/projects/hta/hta-epf-final-report2013.pdf

HTA bodies, patients,

decision-makers and pharmaceutical industry

▪ Build a common framework which include tools, guidance

about how to engage patients in HTA

▪ Resources (i.e adequate infrastructures, financial

compensation, human resources…etc)

▪ Easy access to key reports/guides/protocols on HTA process

▪ Clear and understandable key documentation (e.g informed

consent, confidentiality docs, protocols, reports etc)

Success isn’t easy

▪ HTA bodies as “helpers” to the

sustainability of health systems

▪ Legal framework and public policies that

encourage participation

▪ Willingness to involve patients

▪ Use of participatory approaches

▪ PI must be imbedded in organizational

culture

▪ Transparency (regular feedback)

▪ Resources

▪ PI since the very beginning of all HTA

process

[email protected]

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