The updated regulations are effective immediately upon their publication in Italy’s Official Journal.
The new 2024 Italian AIFA Commission, known as the Scientific and Economic Committee (CSE), was officially established on March 26, 2024. This new commission merges the functions and responsibilities of the former Scientific-Technical Committee (CTS) and the Pricing and Reimbursement Committee (CPR) into a single entity.
The Italian Medicines Agency (AIFA) has released new regulations governing the organization and functions of the Scientific and Economic Committee (CSE).
The restructuring aims to streamline AIFA’s processes, reduce costs, and improve the efficiency of health technology assessments (HTA) and drug evaluations.
Key Changes and Objectives
The newly published document outlines the composition and appointment procedures of the CSE members, building upon the foundations set by the previous Technical-Scientific Advisory Committee (CTS) and the Pricing and Reimbursement Committee (CPR). The CSE operates independently, making crucial decisions on technical-scientific and health levels, and providing vital technical-scientific consultancy to various institutional bodies. One primary responsibility of the CSE under the new regulations is to support AIFA by proposing draft negotiation agreements that indicate classification for reimbursement, supply regime, price, and further conditions for admission to reimbursement.
Binding Opinions and Responsibilities
The committee provides several binding opinions, including:
- Defining the Supply Regime: Specifies how the product is dispensed and prescribed, and if it is restricted to certain specialist physicians or settings.
- Establishing the Place in Therapy: Evaluates the added therapeutic value of a medicine for NHS reimbursement eligibility.
- Classifying Innovative Drugs: Aligns with Article 1, paragraph 402 of Law No. 232 of December 11, 2016, to classify innovative drugs.
- Allocating Innovativeness Requirements: Determines access to reimbursability with resources from the innovation fund.
Procedural Rights for Applicants
Applicants now have the right to request a single hearing of up to 30 minutes and present a maximum of two counter-arguments following a committee refusal decision.
Principles and Role of the CSE
The restructuring aims to improve access to innovative medicines while ensuring safe and appropriate use. The CSE’s role is to guarantee access to essential medicines, foster a pricing policy that rewards therapeutic value, and align with European regulatory bodies. The principles of the CSE include:
- Guaranteeing Access to Essential Medicines: The CSE aims to provide universal and homogeneous access to innovative, orphan, and essential medicines for treating serious, acute, and chronic diseases.
- Ensuring Safety and Appropriate Use: The committee seeks to ensure that medicines are used safely and appropriately.
- Implementing a Value-Based Pricing Policy: Adopting a pricing policy that rewards therapeutic innovations based on predetermined scientific criteria.
- Alignment with European Guidelines: Considering guidance from the European Medicines Agency (EMA) and other European health technology assessment agencies in its evaluations.
CSE Membership
The new CSE, chaired by Lara Nicoletta Angela Gitto, includes the following members:
- Ex Officio Members:
- Pierluigi Russo, Technical and Scientific Director of AIFA
- Rocco Bellantone, President of the Istituto Superiore di Sanità
- Appointed Members:
- Lara Nicoletta Angela Gitto, Chair, designated by the Minister of Health
- Giancarlo Agnelli, cardiologist, appointed by the Minister of Health
- Walter Marrocco, general practitioner, appointed by the Minister of Health
- Vincenzo Danilo Lozupone, pharmacist, appointed by the Minister of Health
- Ida Fortino, head of the Pharmaceutical Service of the Lombardy Region, appointed by the Minister of Economy and Finance
- Elisa Sangiorgi, manager of the Drug and Medical Devices area of Emilia-Romagna, appointed by the State-Regions Conference
- Giuseppe Toffoli, director of Experimental and Clinical Pharmacology at the Aviano Oncological Center, appointed by the State-Regions Conference
- Giovanna Scroccaro, head of the Pharmaceutical Service of the Veneto Region, appointed by the State-Regions Conference
Meeting Frequency and Recent Activity
The CSE convenes monthly (and as needed) to address emerging healthcare and pharmaceutical developments. During the first meeting from April 22nd to 24th, a backlog of 130 HTA and pricing procedures was identified. Due to time constraints, an extraordinary meeting on May 6th and 7th, followed by a regular four-day meeting from May 14th to 17th, reduced this backlog to 57 procedures. This indicates the new CSE is rapidly addressing the accumulated workload.
Several clients of our consulting firm, Justin Stindt Consultants, have received feedback from the CSE, while others await further updates. Our team is adept at assisting pharma and biotech companies with AIFA hearings and counter-arguments, ensuring they navigate these procedures effectively.
Our Expertise
At Justin Stindt Consultants, we excel in Global Pricing & Reimbursement, offering in-depth strategic advice on pricing and reimbursement pathways, analogue research & price benchmarking, and international reference pricing. Our comprehensive approach ensures that pharmaceutical and biotech companies can navigate complex global markets efficiently and effectively.
Our services extend to Health Technology Appraisal (HTA) scientific advice, where we provide expert guidance to optimize the evaluation process, ensuring that products meet the stringent requirements of HTA bodies. We also facilitate payer advisory boards, creating platforms for meaningful dialogue between manufacturers and payers, helping to align product value propositions with payer expectations.
Additionally, we offer comprehensive market access training, equipping your teams with the necessary skills and knowledge to succeed in the dynamic healthcare landscape. Our training programs are tailored to address specific market challenges, providing practical insights and strategies.
Justin Stindt Consultants is a seasoned agency experienced in handling AIFA dossiers, hearings, supporting pharma and biotech companies with effective strategies for such hearings and counter-arguments. Our proven track record in this area underscores our ability to successfully navigate regulatory environments and secure favorable outcomes for our clients.
Stay Updated
We are closely monitoring the developments of the Italian CSE and will keep our clients informed of the latest changes. For more detailed insights and updates, visit our blog regularly.
Why Choose Us?
- Proven Expertise: With years of experience in global pricing and reimbursement, our team offers unparalleled expertise and strategic insights.
- Tailored Solutions: We understand that each client and market is unique, and we provide customized solutions that address specific needs and challenges.
- Comprehensive Support: From initial strategic advice to implementation and beyond, we offer end-to-end support to ensure your success.
- Regulatory Mastery: Our deep understanding of regulations, requirements and processes, including extensive experience with AIFA, positions us to effectively advocate for your products.
Partner with Justin Stindt Consultants to leverage our expertise and achieve your market access goals with confidence.
