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Market Access in Italy

Do you want to launch a new drug in Italy without costly delays successfully? Do you need to fulfil Italian medicine agency (AIFA) requirements and the Italian regional therapeutic commissions? ISHEO is your ideal partner to navigate the complex arena of market access in Italy

Advancing your goals

In terms of $ PPP, Italian Pharmaceutical Sales’ value ranked 3rd in 2017 and 4th in 2018 among OECD countries. Considering the lack of few countries in the OECD dataset, we can indeed state that Italy is among the 5 OECD countries in terms of the value of pharmaceutical sales in 2017 and 2018 in PPP. Although the Italian market is a highly regulated environmen, it represents an excellent opportunity for pharmaceutical and Medtech companies worldwide.

 

The most successful Market Access strategies in Italy are based on evidence and exploit the criterion “Added Therapeutic Value,” which means the new drug shows significant clinical benefit compared to therapeutic alternatives, if available. This parameter is a crucial part of the new Price and Reimbursement Dossier, recently reformulated and introduced by AIFA with the central objective of making the therapeutic value evaluation of new medicinal products. Moreover, it’s pivotal to organize patient support programs or awareness initiatives that uncover unmet needs and pave the way for successful market entry.

Need for a detailed strategy

The Italian Medicine Agency (AIFA) approves new interventions for entry into the Italian Pharmaceutical formulary after assessment by Commissione Tecnico Scientifica (CTS) and Comitato Prezzi e Rimborso (CPR). Market Authorization will be published in the Gazzetta Ufficiale (GU).

To enter Italian Regions, you must also submit to the individual Regions for inclusion in their regional formulary. Since 2007 each Region has developed its own procedures and the requirements are constantly changing.

ISHEO continuously monitors the evolution of regulatory provisions and regional requirements and can provide full support to ensure pharmaceutical companies successfully meet them.

italian region market access

Market Access Strategies

We assist you in developing clear strategies for pricing, reimbursement, and market access that ensure access to all patients, are sustainable, and generate a fair profit.

We provide a wide range of services to complete your Market Access Strategy throughout the EU.

National & Regional Liaison

We act as your link between you and the authorities to ensure clear, effective communication and optimize the returns from your interactions.

With our inhouse local and regional staff, we can be your feet on the ground throughout Italy.

The Italian Reimbursement landscape

 

The Italian health system – established in 1978 and is a Beveridge Model-based system in which the NHS manages access and accessibility through public and private hospitals.

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The Italian Medicine Agency (AIFA) approves new interventions for entry into the Italian Pharmaceutical formulary after assessment by Commissione Tecnico Scientifica (CTS) and Comitato Prezzi e Rimborso (CPR).

To enter Italian Regions, you must submit to the individual Regions for inclusion in their regional formulary. Since 2007 each Region has developed its specific regional procedures; the requirements are constantly changing.

Hospitals deliver therapies through their hospital pharmacies,  following provision ruled  by the Regions

Webinar – Learn about Market Access Strategies in Italy

“Explore the Italian market with Isheo. “

Start a conversation

Please feel free to contact us. We are always glad to offer you our support, discuss how to generate new evidence and disseminate results of modern-day advances in medical science. Leave us a request and we will turn back to you with a tailored strategy, a plan of activities, and a mindset to help you advance your goals.

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