What Does The EU Regulation On HTA Mean For Medtech And When Will It Apply?

Several updates have come in recent weeks on the European Commission’s planned new Regulation on HTA, including a list of stakeholder members and updated rolling timeline. Medtech Insight explains how and when this legislation will affect the medtech sector.

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Health technology assessment (HTA) processes for drugs and medical devices are currently the sole responsibility of individual member states, but the new EU HTA Regulation will set a legal framework for joint, EU-level assessment processes and common methodologies.

What Is HTA?

Health technology assessment is a means of evaluating a medical product for its clinical and cost-effectiveness, taking into consideration clinical evidence, a comparison to existing therapies/devices and many other socio-economic and ethical factors.

It is crucial to note that the HTA Regulation will focus solely on comparing the clinical evidence available for new products to that of similar existing therapies at an EU-level. How these reports are interpreted for reimbursement decisions will be up to individual member states.

Assessments carried out under the HTA Regulation also will not dictate how member states allocate their national health budgets or decide which products to reimburse.