AIFA's Restructuring: Exploring the Changes and Uncertainties of the New CSE Commission
The New CSE: Principles and Role
The Italian Medicines Agency (AIFA) has restructured its evaluation process by merging the Technical-Scientific Advisory Commission (CTS) and the Pricing and Reimbursement Committee (CPR) into a single entity, known as the Commissione Scientifica ed Economica del farmaco (CSE). This consolidation is guided by a set of principles aimed at improving access to innovative medicines while ensuring safe and appropriate use. The CSE's role is to guarantee access to innovative and 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 medicines, orphan medicines, and other essential drugs for the treatment of serious, acute, and chronic diseases.
• Ensuring safety and appropriate use: The CSE seeks to ensure that medicines are used in a safe and appropriate manner.
• Implementing a pricing policy focused on therapeutic value: The CSE adopts a pricing policy that rewards therapeutic innovations, based on predetermined scientific criteria.
• Alignment with European guidelines: The CSE considers guidance from the European Medicines Agency (EMA) and other European health technology assessment agencies in its evaluations.
In terms of function, the CSE performs the tasks previously handled by the CTS and CPR, adopting its own technical-scientific and health-related determinations. Additionally, it provides technical and advisory support to AIFA for negotiating prices of medicines reimbursed by the National Health Service (SSN).
Questions on Innovativeness and HTA Assessments
With the restructuring into the CSE, questions arise about how the commission will assess "innovativeness" differently. As innovativeness is a key factor in drug evaluations and health technology assessments, it can affect a drug's reimbursement, pricing, and overall market access. The ability to demonstrate innovative qualities could lead to quicker reimbursement decisions and potentially higher pricing, benefiting companies with groundbreaking therapies. The real question is how the CSE's approach to assessing innovativeness will impact the speed and efficiency of these processes, and whether new criteria will affect market dynamics.
Streamlining AIFA: Fewer Committee Members, New Structures
AIFA's goal in creating the CSE is to streamline AIFA’s processes and thus reduce the costs of health technology assessments. Although the restructuring involves a reduction in the number of committee members, to maintain the quality of evaluations AIFA has taken measures to support the CSE by identifying individual experts with proven national and international technical and scientific expertise. Additionally, advisory sub-committees will be set up to support evaluations, offering non-binding advice to guide the CSE's decisions.
Acceptance of European-Wide HTA Initiative
A notable aspect of the new Regulation establishing the CSE is its acknowledgment of the Joint Clinical Assessment (JCA), part of the European-wide health technology assessment initiative. This official reference to the JCA in relation to the commission signifies that AIFA is open to utilizing and engaging with this broader European framework. The CSE's engagement with the JCA indicates a commitment to aligning Italy's drug assessment processes with European standards, which could lead to greater consistency and harmonization across the region.
Faster Timelines for Faster Reimbursement Decisions
One of the key benefits of the new CSE structure is the potential for shorter timelines in the evaluation and reimbursement process. Previously, clinical and pricing evaluations were carried out in separate, sequential stages, with multiple rounds of negotiations. The new Regulation imposes limits on the number of counter-proposals allowed during pricing negotiations, with only two counter-proposals permitted before the commission issues its final opinion. Furthermore, companies must respond to pricing and economic feedback within 15 days of receiving a "notice of refusal." These changes are expected to result in a shorter assessment period, benefiting patients in Italy by enabling quicker access to necessary medicines.
However, while patients may benefit from these streamlined processes, pharmaceutical companies could face challenges. The limitation on counter-proposals could make complex pricing negotiations more difficult, potentially leading to fewer approvals for specific medicines and a narrower range of available therapies.
Conclusion
While the restructuring of AIFA's committees into the new Commissione Scientifica ed Economica del farmaco (CSE) introduces some distinct changes, such as streamlined processes and reduced running costs, it is still unclear how the commission's day-to-day functioning will differ from that of the previous structure. Key questions remain about how "innovativeness" will be assessed, how complex pricing negotiations will be handled, and whether the tighter timelines will impact patient access to essential medicines.
The outcome of the upcoming committee meeting (April 22nd to 24th) will be critical in providing more clarity on these matters. Additionally, the industry and stakeholders will need to monitor further meetings over the next few months to understand how the CSE's new structure influences the speed and quality of health technology assessments in Italy. These initial developments will be essential in determining whether the CSE achieves its goals of improving access to innovative medicines while maintaining a robust and efficient regulatory process.
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Written by Lucas Moore
Decisive Dialogue 29th April 2024
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