MINI-HTA TRENDS FOR MEDICAL DEVICES IN THE NORDICS

Author(s)

Grundstrom JP, Friberg S, Medin EHeron Evidence Development AB, Stockholm, Sweden

OBJECTIVES: A mini-Health Technology Assessment (mini-HTA) is a defined tool in the form of a checklist designed to quickly advise evidence-based decision-making for funding when medical devices are introduced or adapted. The purpose of this study was to describe the existing structures and trends for mini-HTAs in the Nordic countries. METHODS: A structured web-based search was performed to identify and compile information from national, regional and local authorities and agencies. The mini-HTA systems were assessed by comparing the different structures across the Nordic countries. RESULTS: Denmark has the most structured process, which has been developed and refined since the early 1990s and is today compulsory in some settings. The mini-HTA format is a national standardised checklist of 3-5 pages based partly of a limited systematic review and concerning the prerequisites for and consequences of the medical device covering four perspectives: device, patient, organisation and economics. Non-compliance with these four perspectives may lead to rejection of the medical device for funding. Four regional HTA units in Sweden have implemented, and other regions are developing, standardised processes for mini-HTAs with a structure resembling the Danish format. The Finnish Managed Uptake of Medical Methods (MUFF) group affirms the benefits of implementing a structured mini-HTA process. Until a Finnish format is in place it has been proposed to use the Danish format for evaluating medical devices. In Norway, experiences from reviews of other mini-HTA systems are being used to establish a national process for assessing new medical devices. CONCLUSIONS: Countries in the Nordics have seen advantages of using mini-HTAs when time and resources are insufficient to execute a comprehensive HTA. Mini-HTAs have important criteria and have facilitated a more standardised and quick uptake process of medical devices in the Nordics and have given the industry new market access possibilities.

Conference/Value in Health Info

2011-05, ISPOR 2011, Baltimore, MD, USA

Value in Health, Vol. 14, No. 3 (May 2011)

Code

PMD39

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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