XXIII NATIONAL CONFERENCE - National Healthcare Systems and universal

coverage: are they still feasible?

Lessons learned and challenges ahead after 70 years of the British NHS and 40 years of the
Italian NHS

Naples, 27-28 September 2018

MCDA for Medical Devices

evaluation in Lombardy Region
Valentina
Click to edit Master subtitle style Beretta, University of Pavia
Michele Tringali, DG Welfare, Lombardy Region; ASST G.O.M. Niguarda
Cristina Mazzali, DG Welfare, Lombardy Region; ASST G.O.M. Niguarda
Greta Puleo, DG Welfare, Lombardy Region; ASST G.O.M. Niguarda
Mauro Caruggi, DG Welfare, Lombardy Region; ASST Valle Olona
 INTRODUCTION
•
The technological trend in healthcare asks for a systematic analysis of the apparent innovativeness of healthcare
technologies and related health benefits and costs in order to sustain an equitable access opportunity to patients. For
this purpose, many jurisdictions have implemented policies aims at rationalizing healthcare resources while improving
the efficacy and efficiency of care (Catananti, Cicchetti and Marchetti, 2005).
•
Health Technology Assessment (HTA) emerged as “a multidisciplinary process that summarises information about the
medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent,
unbiased, robust manner […] to inform the formulation of safe and effective health policies that are patient focused and
seek to achieve best value” (EUnetHTA).
•
However, many decisions in healthcare are still based on non transparent decisions (Glassman et al., 2012). Given the
incoherent and unstructured decision process, it is not clear how different criteria, processes and practices influenced
the final decision (Baltussen and Niessen, 2006).
•
This study aims at describing the HTA framework implemented by Regione Lombardia (RL) to inform decision making
processes in Lombardy healthcare.

Beretta et al., MCDA for Medical Devices evaluation in Lombardy Region, Naples, 27-28 September 2018 2
 LITERATURE REVIEW

Accountability for reasonableness

(Daniels and Sabin, 1997):

- Substantial condition: Relevance of the argumentations;

-
Procedural conditions: Public evidence; Possibility of revision;
Coherence and rigour in the application.

Beretta et al., MCDA for Medical Devices evaluation in Lombardy Region, Naples, 27-28 September 2018 3
 RL MCDA FRAMEWORK
QUANTITATIVE CRITERIA QUALITATIVE CRITERIA
Dimension Criterium Dimension Criterium
D1 – Health problem C01– Disease severity D7 – Ethical aspects C15 – Equitable opportunities for access and use
relevance C02 – Size of affected population D8 – Social aspects C16 – Pressures and difficulties of stakeholders
D2 – Technology C03 – Type of preventive benefit D9 – Legal aspects C17 – Mandate and scope of NHS
solution relevance C04 – Type of therapeutic benefit
C05 – Quality of evidence
The listed dimensions and criteria,
D3 - Safety C06 – Comparative safety / tolerability
and their application procedures,
C07 – Efficacy and effectiveness advantages
are aimed to satisfy the most important requirements
C08 – Patient reported outcomes advantages for the use of MCDA
D4 - Effectiveness C09 – Unmet needs (Belton and Stewart, 2002):
C10 – Clinical practice guidelines and regulatory state
D5 – Financial C11 – Direct financial impact on health care budget •
Completeness;
aspects C12 – Cost consequences on other medical costs
C13 – Cost consequences on non-medical costs •
Non-redundancy;
D6 – Organizational C14 – System capacity and requisites
aspects for appropriate use
•
Mutual independence;
•
Operability.

Beretta et al., MCDA for Medical Devices evaluation in Lombardy Region, Naples, 27-28 September 2018 4
Reflective Multiple Criteria Analysis
RL FRAMEWORK

Beretta et al., MCDA for Medical Devices evaluation in Lombardy Region, Naples, 27-28 September 2018 5
 CONCLUSIONS
RL has introduced a framework aimed at giving a central role to both data and the scientific evidence, building the appraisal
upon structured multi-agency (committee’s members) reflection processes guided by multiple criteria.
The framework proposed by RL is the result of a review of the Literature. A crucial role is played by the EUnetHTA Core
Model (Lampe et al., 2009; EUnetHTA, 2011) for the definition of Dimensions for priority judgments and the Reflective MCDA
(Goetghebeur ET AL., 2017) for the definition of appraisal judments and for the overall synthesis of argumentations and
indexes.

The advantages provided by this framework are recognized in the Literature:

•
Inclusion of qualitative criteria with a direct impact on the value of the intervention (Goetghebeur and Wagner, 2017);
•
Potential distortions of argumentations and/or interpretation of scientific sources can be avoided by exploring their face
validity (Goetghebeur and Wagner, 2017) and can be minimized, when identified, through careful quality controls;
•
Capacity of clarify and support the deliberative process of the decision, by operationalizing the accountability for
reasonableness of the decision (Goetghebeur and Wagner, 2017; Baltussen et al., 2016; Jansen et al., 2016; Daniels and
Sabin 1999).

Beretta et al., MCDA for Medical Devices evaluation in Lombardy Region, Naples, 27-28 September 2018 6
THANK YOU FOR YOUR ATTENTION

Click to edit Master subtitle style

XXIII NATIONAL CONFERENCE - National Healthcare Systems and universal
coverage: are they still feasible?
Lessons learned and challenges ahead after 70 years of the British NHS and 40 years of the
Italian NHS

Naples, 27-28 September 2018