STAKEHOLDER INVOLVEMENT IN HEALTH TECHNOLOGY ASSESSMENT (HTA) OF NOVEL MEDICAL DEVICES

Author(s)

Hidefjall PKTH Royal School of Technology, Huddinge, Huddinge, Sweden

HTA for medical devices follows the path of drugs in many countries. There are however substantial differences that should be considered when evaluating medical devices. Drummond (2009) describes six important differences. Medical devices: 1) are often diagnostic therefore requiring to consider their related therapeutic effects; 2) have faster product cycles often making trial results outdated; 3) performance depend on users’ skills and complementary investments in training and equipment; 4) innovation may cause a shift from one in-patient setting (operating room) to another (cathlab) or to an out-patient setting with substantial cost-effects; 5) are manufacturer specific, making it difficult to draw conclusions about product class effects; 6) innovation may be difficult to protect with patents thus encouraging imitation with resulting falling prices. In addition to issues 1-6, regulatory approval of a device does not require the same level of evidence as for drugs. Despite initial poor evidence, decisions on health care resource-use based on cost-utility (QALY) need to be made throughout the product lifecycle. This can be achieved by involving stakeholders in regular, timely data exchange for model updating, considering issues 1-6 above. As medical devices directly affect several stakeholders, their respective treatment costs from accounting systems can be used (4). As product registries are continuously updated the improving performance due to new devices and user learning is reflected (2-3). According to regulatory requirements manufacturers must evaluate their product performance and notify competent authorities of adverse events. Such data should update cost-utility evaluations relating to manufacturer specific patient morbidity (5). Furthermore as outcomes data are increasingly captured by devices directly or apps and electronically transferred to electronic health records, the burden on manufacturers to administrate registries may be lessened (2). As medical devices are regularly procured in tenders, their product prices should be used (6). In turn HTA outcomes should inform tenders.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PHP196

Topic

Health Policy & Regulatory

Disease

Multiple Diseases

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