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HEALTH TECHNOLOGY

ASSESSMENT AS A TOOL FOR

DECISION MAKING AT CENTRAL

AND LOCAL LEVELS

Medical devices at local levels

Nicolas Martelli - PharmD, PhD

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Conflict of interest

Nothing to disclose

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Self assessment questions1. Is hospital-based HTA useful for all types of medical devices?

A. Yes

B. No

2. Mini-HTA can be defined as a decision support tool using achecklist/form designed for a short and rapid assessment.

A. True

B. False

3. Is it possible to combine different models of hospital-based HTA?A. Yes

B. No

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Learning objectives

• Identify the specificities of medical devices and their

consequences on decision making at local level

• Categorize the existing models of hospital-based

health technology assessment

• Apply a model of hospital-based health technology

assessment adapted to your resources

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The real life

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I want it and I want it

now!

YOU

Specificities of medical devices

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Medical

device

Diversity

EffectivenessOrganisational

impact

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Diversity

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Effectiveness

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• Device classes

• Class I = self-certification

• Class IIa, IIb and III = notified body

• Class III and implantable devices

• Clinical investigations shall be performed unless it is duly

justified to rely on existing clinical data

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Effectiveness

• Level of evidence in clinical studies by CE

marking classification

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Boudard, A., Martelli, N., Prognon, P., & Pineau, J. (2013). Clinical studies of innovative medical devices: what level of evidence for hospital‐based health technology assessment?. Journal of

evaluation in clinical practice, 19(4), 697-702.

Organisational impact

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Single use flexible

intubation scope

Reusable flexible

intubation scope

VS

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Hospital-based HTA (HB-HTA)

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Why hospitals do not always use reports

from national HTA agencies ?

Timing ScopeFew reports

on medical

devices

Hospital-based HTA (HB-HTA)

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HTA

METHODOLOGY

LOCAL DATA HB-HTA

REPORT

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Models of hospital HTA

Ambassador

modelMini-HTA

Internal

committeeHTA unit

Individual

Group

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Models of hospital HTA

Ambassador

modelMini-HTA

Internal

committeeHTA unit

Clinical practice Decision-making

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Models of hospital HTA

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Mini-HTA

Internalcommittee

HTA unit

Resources

Complexity

Mini-HTA

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TECHNOLOGY PATIENT ORGANIZATION ECONOMY

~ 25-30

questions

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Mini-HTA

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Clinical effects?

Quality of evidence?

Patients’ experience of

the technology?

Organizational impacts

inside/outside the

hospital department?Additional or

saved costs?

Recommended by HTA

agencies?

Mini-HTA• Introduction to mini-HTA a management and

decision support tool for the hospital service 2005• The Danish Centre for Evaluation and Health Technology

Assessment

• http://www.sst.dk/~/media/47C62A769EBC4E80A153F986C5348F55.ashx

• The AdHopHTA handbook 2015 – mini-HTAtemplate:• http://www.adhophta.eu/handbook

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Internal committee

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Multidisciplinarity

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2

3

Internal committee

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Medical staff

Nursing staff

Hospital pharmacist

Biomedical engineers

Supply management

TE

AM

Martelli, N., Lelong, A. S., Prognon, P., & Pineau, J. (2013). Hospital-based health technology assessment for innovative medical devices in university hospitals and the role of hospital pharmacists:

learning from international experience. International journal of technology assessment in health care, 29(02), 185-191.

Communication

Planning

Project leader

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HTA unit

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McGregor, M., & Brophy, J. M. (2005). End-user involvement in health technology assessment (HTA) development: a way to increase impact. International Journal of Technology Assessment in

Health Care, 21(02), 263-267

HTA unit

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HTA unit

Hospital

management

Pharmacy

Care units

Biomedical

engineering

Research

Device

companiesHealth

authorities

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HTA unit

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Physicians

Health economists

Hospital pharmacists

Biomedical engineers

Statisticians

TE

AM

HTA unit

• The AdHopHTA handbook 2015 – mini-HTAtemplate:• http://www.adhophta.eu/handbook

• Catananti, C., Cicchetti, A., & Marchetti, M.(2012). Hospital-based health technologyassessment: The experience of Agostino GemelliUniversity Hospital’s HTA Unit. Italian Journal ofPublic Health, 2(2).

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Example: Leadless pacemaker

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1 2 3

Example: Leadless pacemaker

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1

Nicolas

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3 months

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Local HTA - central HTA: how can we

collaborate better?

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Halmesmäki, E., Pasternack, I., & Roine, R. (2016). Hospital-based health technology assessment (HTA) in Finland: a case study on collaboration between hospitals and the national HTA unit.

Health Research Policy and Systems, 14(1), 25.

Local HTA Central HTA

Identifying new HTs

Monitoring local impacts

HTA methodology

Literature search

Self assessment questions

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1. Is hospital-based HTA useful for all types of medical devices?

NO

2. Mini-HTA can be defined as a decision support tool using a

checklist/form designed for a short and rapid assessment.

TRUE

3. Is it possible to combine different models of hospital-based

HTA?

YES

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Take home messages1. Hospital pharmacists can have a key role in

Hb-HTA.

2. No universal HB-HTA model. So make yourown!

3. Adopt a multidisciplinary approach as muchas possible!

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Thank you for your

attention!Dr Nicolas Martelli

Hôpital Européen Georges Pompidou 20, rue Leblanc 75015 Paris : +33 1 56 09 25 75

@ : nicolas.martelli@aphp.fr

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References• Vestergaard, M., Ehlers, L., Kidholm, K., Holt, P., Bonnevie, B., & Jensen, M. (2005). Introduction to mini-

HTA–a management and decision support tool for the hospital service. Danish National Board of Health-Center for Evaluation and HTA.

• Sampietro-Colom, L., Lach, K., Cicchetti, A., Kidholm, K., Pasternak, I., & Fure, B. (2015). The AdhopHTAhandbook: a handbook of hospital-based Health Technology Assessment (HB-HTA); Public deliverable; TheAdHopHTA Project (FP7/2007-13 grant agreement No. 305018).

• Gagnon M-P, Abdeljelil AB, Desmartis M, et al. Opportunities to promote efficiency in hospital decision-making through the use of health technology assessment. CHSRF series of reports on cost drivers andhealth system efficiency: paper 7. Ottawa: Canadian Health Services Research Foundation; 2011.

• Catananti, C., Cicchetti, A., & Marchetti, M. (2012). Hospital-based health technology assessment: Theexperience of Agostino Gemelli University Hospital’s HTA Unit. Italian Journal of Public Health, 2(2).

• McGregor, M., & Brophy, J. M. (2005). End-user involvement in health technology assessment (HTA)development: a way to increase impact. International Journal of Technology Assessment in Health Care,21(02), 263-267.

• Martelli, N., Puc, C., Szwarcensztein, K., Beuscart, R., Coulonjou, H., Degrassat-Théas, A., ... & Lechat, P.(2017). Hospital-based health technology assessment in France: a focus on medical devices. Thérapie2017.

• Halmesmäki, E., Pasternack, I., & Roine, R. (2016). Hospital-based health technology assessment (HTA) inFinland: a case study on collaboration between hospitals and the national HTA unit. Health Research Policyand Systems, 14(1), 25.

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