Exploring Early Reimbursement Opportunities in Italy: Law 648/1996 and AIFA 5% Fund for Pharmaceutical Manufacturers
In Italy, there are 2 invaluable opportunities for manufacturers to secure early access.
Law 648/1996: A Pathway to Early Reimbursement for Medicines in Italy Before Marketing Authorization
Law 648/1996 presents an opportunity to secure reimbursement by the National Health Service (SSN) before marketing authorization. Reimbursement through this list is granted for a cohort of patients. Medicines included in the 648 list are closely monitored by the Regions and AIFA (Italian Medicines Agency) through registers from the prescriber structure.
Inclusion within the 648 list is based on specific requirements. Medicines may qualify for early reimbursement when there is an unmet need for which there is no valid therapeutic alternative available, including innovative medicines authorized in other countries but not yet in Italy, or those undergoing clinical trials with at least phase II results available. Alternatively, drugs may be considered for reimbursement when there is a valid therapeutic alternative, and they are intended for a therapeutic indication other than the authorized one, aligned with research conducted within the national and international medical-scientific community.
Under this law, pharma and biotech manufacturers have to negotiate the price of not commercialized drugs with AIFA. One of the advantages of Law 648 is that there are no time limitations for staying on the list; medicinal products remain listed as long as the requirements that led to their inclusion persist.
Unlocking Early Access for Orphan Drugs in Italy: The Role of AIFA’s 5% Fund in Supporting Rare Disease Treatments
Additionally, Italy’s AIFA 5% Fund, established by Law 326/2003, provides another avenue for early access to orphan drugs for rare diseases. The Fund is formed by 50% of the contribution that pharmaceutical companies pay annually to AIFA, corresponding to 5% of the annual expenses allocated to promotional activities for doctors. Access to the AIFA National Fund is granted on a nominal basis for each patient, offering a unique opportunity for manufacturers seeking early reimbursement for their orphan drugs.
Our agency has been selected by many pharma and biotech companies as service provider of choice to write the Italian early access applications. Our company leverages Italian native speakers with extensive experience both in the industry and consulting agencies and a successful track record of early access dossiers leading to early access in Italy.
Navigating Early Access Programmes with Our Consulting Agency: Expert Insights and Strategies
Justin Stindt Consultants is your agency with the right experts who understand the critical significance of these early access programs in Italy and the potential they hold for your innovative medicines. With our consulting firm’s in-depth expertise and experience in navigating Italy’s market access landscape, we can guide you through the application process, ensuring compliance with all requirements and maximizing your chances for successful inclusion in the 648 list or access to the AIFA 5% Fund.
In addition to the reimbursed programmes, there is also the opportunity to provide products via compassionate use.
Do not miss out on the chance to accelerate patient access to your life-changing treatments in Italy. Contact our team of specialists today to explore how our tailored services can help you navigate the complexities and harness the full potential of early access opportunities in Italy. Together, we can make a difference in improving healthcare outcomes for patients in need.
If you are looking for more than a vendor to support your Italian early access programme applications, select a service provider that will go the extra mile to enable endorsement and early access for your innovative medicines. More than just a supplier, Justin Stindt Consultants can be your trusted consulting partner and provide full-service support including engagement with the authorities and price negotiations.
Meet one of our Early Access Programmes Italy experts
Get in touch with our expert
CLIENT TESTIMONIALS
