Market Access with CSE: Your Guide to Italy’s Pharmaceutical Economic Evaluation Body

The Scientific and Economic Committee for Medicines (CSE) operates within the Italian Medicines Agency (AIFA) and plays a crucial role in the HTA and economic evaluation and price negotiation of medicinal products in Italy. Established to provide technical and consultative support, the CSE ensures that medicines authorized in Italy meet rigorous standards of quality, safety, efficacy, and cost-effectiveness. Engaging with the CSE is essential for stakeholders aiming to navigate market access in the Italian pharmaceutical landscape.

aifa.gov.it

Core Functions of the CSE

The CSE’s primary responsibilities include:

•     Evaluation of Medicinal Products: Assessing new medicines for marketing authorization to ensure they meet established standards.
•     Price Negotiation and Reimbursement: Conducting negotiations to determine the pricing and reimbursement status of medicines within Italy’s National Health Service.
•     Technical-Scientific Consultancy: Providing expert advice to AIFA on matters related to drug evaluation and economic considerations.

Leadership and Key Contacts

As of January 2025, the CSE is chaired by Lara Nicoletta Angela Gitto, appointed by the Minister of Health. The committee comprises ten members, including the Technical-Scientific Director of AIFA and the President of the Istituto Superiore di Sanità, or their delegate, as ex officio members. Other members are appointed by the Minister of Health, the Minister of Economy and Finance, and the Permanent Conference for Relations between the State, the Regions, and the Autonomous Provinces of Trento and Bolzano.

aifa.gov.it

Contact Details for the CSE

Website: https://www.aifa.gov.it/en/commissione-scientifica-economica

Postal Address:

Agenzia Italiana del Farmaco (AIFA)

Via del Tritone, 181

00187 Rome, Italy

Telephone: +39 06 5978401

Challenges in Working with the CSE

Engaging with the CSE involves:

•     Understanding Evaluation and Negotiation Processes: Familiarity with the CSE’s procedures for drug assessment and price negotiation is crucial for successful market access.
•     Timely and Accurate Submissions: Ensuring that all necessary documentation is complete and submitted promptly to facilitate evaluation and negotiation processes.
•     Stakeholder Collaboration: Working effectively with various healthcare stakeholders in Italy to align with the CSE’s guidelines and standards.

Successful collaboration with the CSE can lead to efficient market entry and favorable reimbursement outcomes in Italy.

Opportunities / Solutions with Justin Stindt Consultants

Justin Stindt’s CSE expertise ensures:

•     Expert Consultant CSE Submissions: Creating high-quality submissions for marketing authorizations and reimbursement applications.
•     Market Access CSE Strategies: Developing strategies that align with the CSE’s regulatory framework to optimize market access.
•     Specialist CSE Processes: Providing insights into the CSE’s procedures to enhance compliance and expedite approvals.

Justin Stindt Consultants specializes in helping clients navigate the CSE’s regulatory environment to achieve successful market access in Italy.