Health care will see immediate access to new drugs upon marketing authorization, with an algorithm to set an initial launch price that adjusts based on outcomes, as the primary goal of Robert Nisticò, the newly appointed President of the Italian Medicines Agency (AIFA). Nisticò emphasizes the importance of appropriately rewarding innovation and streamlining the decision-making process for drug access.
Nisticò identifies recognizing and rewarding truly innovative drugs—those considered breakthroughs by the FDA, offering significant added value over existing therapeutic alternatives—as a central challenge. He highlights the critical role of the new Scientific and Economic Commission (CSE) at AIFA, which combines multidisciplinary expertise to evaluate such innovations.
Health Care Innovation: AIFA and Industry Collaborate to Prioritize Drug Approvals and Enhance Communication
Following discussions with industry associations Farmindustria and Egualia, two technical working groups will be established. These groups aim to develop tools to prioritize the approval of drugs that can enhance the quality of care and expand therapeutic options. A dedicated online platform will be launched to facilitate direct communication between pharmaceutical companies and AIFA regarding cases submitted to the CSE. Nisticò mentions that AIFA is considering incentives and the implementation of evaluations as outlined in the HTA Regulation to expedite the dossier evaluation process in Italy.
Addressing the current 2-3 year wait for access to innovative drugs in Italy, Nisticò proposes a flexible access system to ensure patients receive therapies immediately after authorization. This system would involve continuous monitoring of the risk-benefit profile and ensure sustainability for the National Health System. Nisticò envisions immediate access to medicines and the ability to negotiate with the industry without delaying patient access to innovative therapies.
AIFA is exploring new access models that allow early access and reimbursement for all new active ingredients or advanced therapies immediately after their central approval. This approach would involve setting an initial price based on an algorithm developed by AIFA, using specific predetermined variables. Eligible patients would benefit from the therapy without delay, and the negotiation process would not affect the drug’s availability. After negotiations, any necessary price adjustments would be made based on the difference between the applied price and the negotiated price.
Health Care Reforms: Uncertainty Surrounds AIFA’s Autonomy, but Commitment to Immediate Drug Access Marks Major Shift in Italy
It remains uncertain how much autonomy AIFA has to implement such reforms independently and to what extent the government will support these proposed changes. However, the aspiration to provide immediate access to innovative drugs while ensuring affordability and sustainability reflects a significant shift in Italy’s healthcare approach.
The vision outlined by Robert Nisticò, President of AIFA, represents a transformative approach to drug access in Italy. His emphasis on rewarding true innovation, streamlining access, and ensuring immediate availability of new therapies aims to address longstanding delays in patient access to cutting-edge treatments. By utilizing an algorithm to set initial prices and allowing for post-approval adjustments based on real-world outcomes, Nisticò proposes a flexible and efficient system that balances patient needs with the sustainability of the National Health System.
Immediate Access: Patients gain access to new drugs immediately after marketing authorization, without the typical 2-3 year wait.
Algorithm-Based Pricing: An initial launch price is set using an algorithm developed by AIFA, which can be adjusted based on treatment outcomes.
Continuous Monitoring: Ensures the risk-benefit profile of new drugs is continuously assessed, maintaining patient safety and system sustainability.
Collaboration and Communication: Enhanced collaboration with industry through technical working groups and a dedicated online platform for streamlined communication.
Innovation Rewarded: Emphasis on recognizing and rewarding truly innovative drugs, with the support of AIFA’s new Scientific and Economic Commission.
The success of these reforms will depend on the collaboration between AIFA, the pharmaceutical industry, and government support. If implemented effectively, this approach could significantly improve the accessibility and quality of healthcare in Italy, ensuring that patients receive timely and effective treatments.
Resource: This report is inspired by the article written by Neil Grubert, dated June 9, 2024.
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