Italy is one of the largest healthcare markets in Europe with a population of approximately 60 million people, therefore most companies make Market Access in Italy an important priority. The country has a well-established healthcare system, known as the National Health Service (Servizio Sanitario Nazionale or SSN), which provides universal coverage and access to essential healthcare services. Our agency Justin Stindt Consultants is specialized in Market Access Italy and can help you navigate Italian Market Access.
Market Access Italy – Italian market is a key priority for pharma, biotech and medtech
Italy has a relatively high healthcare spending, with the total expenditure on healthcare reaching around 8.8% of its GDP in recent years. This level of healthcare investment, coupled with a strong emphasis on research and innovation, makes Italian Market Access a key target for pharma, biotech and medtech companies. The Italian population’s demand for high-quality healthcare services, coupled with a supportive regulatory framework, creates a favorable environment for companies looking at Market Access in this vibrant healthcare market.
In Italy there are 2 Reimbursed Early Access Programs available that make it a very attractive market to enter in the early stages of new medicines as they allow for fully reimbursed usage. These early access programs are known as the Law 648/1996 and AIFA 5% Fund.
Although the Italian healthcare system is decentralized, pricing & reimbursement of products is mainly decided on the national level and published in the official journal.
Understanding AIFA’s Role in Italy: Drug Classification, Reimbursement, and Pricing & Reimbursement Dossier Requirements
In Italy, AIFA is the HTA body responsible for assessing and classifying medicines at the national level. Medicines can be classified as class H, A or C. While class A and H drugs are fully reimbursed, class C drugs are not reimbursed and manufacturers can set a free price. For reimbursed medicinal products, AIFA also negotiates the prices with pharmaceutical companies. It is fundamental to submit a P&R dossier (i.e. e-Dossier Prezzo e Rimborso) that is complete, accurate, and oriented towards AIFA’s requirements. For more information visit our Italian P&R dossier page.
AIFA, the Italian HTA body responsible for assessing and classifying drugs, has recently undergone a series of reforms. The so-called Scientific Technical Committee (CTS), in charge of evaluating and providing advisory opinion on the classification of medicinal products for reimbursement purposes, and the Price and Reimbursement Committee (CPR), in charge of negotiating for the reimbursement of medicinal products, have been merged into the Scientific and Economic Commission (CSE).
Securing Innovative Status in Italy: Unlocking Benefits and Access to Special Funds in the Pricing & Reimbursement Landscape
A medicine can gain extra benefits if it reaches the innovative status in Italy. This enables access to certain benefits such as access to the innovative drugs special funds, exemption from payback mechanisms, and immediate inclusion in the Regional Formularies. For more information about the Pricing & Reimbursement pathways in Italy, see our page on this topic on Strategic advice on Pricing & Reimbursement Italy.
Integrating Medical Devices in Italy’s NHS: The Role of National and Regional HTA in Reimbursement Decisions
Medical devices are typically directly purchased by the NHS in the context of tender offers governed by the Italian procurement law. There is a positive list of commercialized medical devices introduced by the law 266/2002, however, neither this nor the CE approval guarantees reimbursement by the SSN. Reimbursement decisions are often made on a regional and local level.
The 2014-2016 Health Pact and the Stability Laws for 2015 and 2016 outlined a new institutional model of cooperation between central and regional levels to achieve objectives of clinical effectiveness, management efficiency and sustainability of innovation.
A Cabina di regia (Control Room) was therefore established which, through collaboration between the Ministry, the national agencies (AGENAS and AIFA) and the Regions, can coordinate the Health Technology Assessment activities developed at national and local level, implementing a National Program. The Cabina di regia has the task of:
- identifying the evaluation priorities of national interest, in line with European guidelines
- promoting and coordinating coherent and non-overlapping evaluation activities
- validating methodological guidelines shared between all actors
- promoting the use and dissemination of evaluations, verifying that virtuous behavior results in investment and disinvestment policies
For each technology being evaluated (HTA report), the Cabina di regia adopts an appraisal judgment, containing preliminary recommendations for use within the National Health Service (use, non-use, use in research, conditional use). The judgment is based on scientifically validated appraisal methods and tools.
Justin Stindt Consultants is your agency to support you with Market Access in Italy
Justin Stindt Consultants is your consulting firm with experts who have extensive experience in Market Access Italy. As a service provider, our consultancy has helped many clients by engaging the AIFA and developing Pricing & Reimbursement dossiers. Our consultants also support price negotiations. For medical devices and digital health apps, our agency supports dossiers and negotiations. Many of our consulting firm’s clients have found Italy a key priority for Market Access in Europe and decided to enlist our agency as partner of choice given our experience in the Italian market.
Contact our experts today to learn how our agency can tailor our services to meet your unique needs to enable Market Access in Italy.
Market access services for pharmaceutical and biotech products in Italy
Case studies for Italy market
- Support entire Italian Market Access process
- ATU Feasibility Assessment
- HAS early dialogue meeting
