1. Introduction



Health Technology Assessment (HTA) is an evidence-based process that independently and objectively assesses a new or existing health technology and compares it to other technologies and/or the current standard of care to inform decision-makers 1) whether to implement the technology and 2) about the value of the technology before negotiations on pricing and reimbursement.  

HTAs are typically carried out at the national level by HTA bodies and according to a wide variety of methodologies. Please, also see the Module on HTA, principles and methodologies for more information.

HTA is very rarely conducted on Medical Devices and IVDs even though it is commonly used for medicinal products. Very often, critical or innovative medicinal products undergo an HTA to evaluate their added value, mostly because implementation of these products may be expensive. For these products, the HTA recommendation plays a predefined role at, or shortly after, the time of market authorisation. HTAs for Medical Devices are currently only performed in a limited number of European states for a limited number of devices (i.e., 1% of new devices per year) [1].

The application of HTA to Medical Devices and IVDs, in a similar manner to medicinal product, is not straightforward although the evaluation addresses the same assessment domains for both. HTA is a data driven process and many HTA bodies adhere to the hierarchy of evidence, traditionally from robust, randomised controlled trials. For many Medical Devices and IVDs, such evidence is often limited or unavailable at the time of launching the product and may not always be fit for purpose, since the period until new versions of devices are implemented can be very short. 

When HTA is used for Medical Devices and IVDs, it tends to be used for a number of different and various purposes (i.e., not only for informing a decision on pricing and reimbursement, as for medicinal products) and at different points in time of Medical Devices’ or IVDs’ life cycle.   

This course presents the basic principles of HTA, the current status of the efforts in the European Union for a harmonised and collaborative HTA process, and the methodologies that apply to both medicinal products as well as Medical Devices and IVDs. This section also covers information about patients’ essential roles in the HTA of Medical Devices and IVDs which may differ from their role in the HTA of medicinal products. 


[1] Nordic Medtech Growth 2. https://www.nordicinnovation.org/sites/default/files/inline-images/Health%20Technology%20Assessment%20%28HTA%29%20in%20the%20Nordic%20countries.pdf