METHODS FOR EVALUATION OF MEDICAL DEVICES

Purpose: Evaluation of medical devices faces different challenges to that of the pharmaceutical drugs i.e., the approaches for cost-effectiveness modelling of pharmaceutical drugs are not suitable for evaluation of devices. For example, the value of a device goes beyond the health benefits (i.e QALYs) to the patient as it might include other aspects such as increased efficiency, patient dignity, etc. Similarly, traditional cost modelling techniques are not suitable for evaluation of devices. The costs are not evenly spread across time and depend on implementation strategies (i.e. parameters such as volume, scale, etc) and there is a need for a modelling framework that can output time profile of costs by stakeholder. Furthermore, the cost-effectiveness depends on the service setting (i.e. parameters such as volume and scale of deployment). 

Method: This presentation describes the lessons learnt while evlauating the cost-effectivess of diagnostic tests and devices. The details of the different projects are as follows a) Finanical modelling of telemonitoring for HF and COPD, b) Cost effectiveness of Cardiac Magnetic Resonance imaging for ischaemic cardiomyopathy, c) Cost-effectiveness of Telemonitoring technologies for congestive heart failure

Result: A brief description of the context that makes HTA of medical devices of interest and characteristics of the devices that make them different from pharmaceutical drugs is detailed. An overview of current approaches of evaluating devices at different HTA bodies such as NICE, MSAC, HAS, CVZ etc is then provided. A taxonomy to represent the value of medical devices along with methods for incorporating patients' preferences with examples of specific case studies. Finally, a financial modelling framework for evaluating devices that provides time profile of costs by stakeholder .

Conclusion: Cost-effectiveness evaluation of medical devices is quite different to that of pharmaceutical drugs. An overview of current methods for evaluation of devices and the issues involved are described along with a tentative  framework proposal for cost-effectiveness modelling of devices