Introduction to the new EU Health Technology Assessment (HTA) and Spanish HTA regulation

New medicinal products and medical devices typically undergo a centralized approval process to assess their safety and effectiveness on a EU level. However, in order to enter the Spanish market and receive approval for reimbursement, an additional step must be completed: the Health Technology Assessment (HTA).

HTA is a comparative evaluation of a new medicinal product’s value relative to the current standard of care. It typically includes both a clinical and an economic assessment. Simplified, if the new product offers greater clinical and/or economic benefits over the previous standard of care, it may qualify for better pricing.

Depending on the product type and the indication, the clinical HTA is conducted either at the EU level or at the Spanish national level. The economic assessment and overall appraisal of any new medicinal product are handled at the national level in Spain.

In this talk, we will provide an introduction to HTA and explain the EU HTA process as well as the Spanish national processes.

Objective: Attendees will gain a basic understanding of HTA, including the EU HTA and Spanish national HTA processes.

Aimed at Biotech and pharma companies, as well as individuals interested in working within Health Technology Assessment (HTA) departments. Suitable for those seeking a general understanding of HTA regulations.

Speakers

Dr Eva-Maria

Senior HTA manager and medical writer at AMS. She consults pharmaceutical companies in developing a comprehensive HTA strategy for Germany and EU HTA. As a lead of the AMS international HTA network she is well versed in the European HTA requirements, including Spain.

Mrs. Beatriz Águeda Gómez

Senior Regional Regulatory Manager/ PM with more than 10 years of experience in clinical trials, clinical investigations with medical devices, non-interventional studies and HTA expert for Spain.

AMS is a full service CRO, with extensive experience in HTA services.

AMS  since 1997 is a competent partner to the pharmaceutical and healthcare industry. As an experienced full service CRO (Contract Research Organization), AMS  offers 360° customer support in Clinical Trials for phase I – IV as well as for NIS (Non Interventional Trials), HTA, and pricing. Our services include Project Management, Monitoring, Data Entry, Data Management, Biostatistics, Pharmacovigilance/Clinical Safety and Medical Writing as well as Quality Management, and Public Health Economics.

We are pioneers in German HTA of pharmaceuticals since the Act on the Reform of the Market for Medicinal Products (AMNOG) came into effect in Germany in 2011. Through our wide experience, we are a strong European partner in the fields of Market Access and HTA. Our customers are world-leading international pharmaceutical as well as biotech companies.