To gain access to the Italian market, a pharmaceutical company must be prepared to give payers a money-back guarantee. These “risk-sharing” agreements between central and regional payers and manufacturers are becoming more common in Italy, forcing companies to prove the value proposition of their products, or risk not getting paid. That is why companies must collect outcomes and value-added data early and throughout the development of a compound, through clinical trials and non-clinical studies.

Italy’s Payer Stakeholders

Italian citizens receive free, universal health care, and the Italian Medicine Agency (AIFA, or Agenzia Italiana del Farmaco) manages pharmaceutical marketing authorisation, pricing, and reimbursement approvals. AIFA’s two committees negotiate with companies to determine the value of a new therapy. The Technical Scientific Committee classifies new drugs into one of three reimbursement categories:

    • Class H for hospital use only
    • Class A to be dispensed through pharmacies directly to patients – essential drugs and drugs prescribed for chronic diseases, paid by the National Health System
    • Class C to be dispensed through pharmacies directly to patients – drugs not included in Class A and OTC drugs, paid by citizens

The Prices and Reimbursement Committee uses a strict health technology assessment (HTA) to arrive at a price. Manufacturers must be prepared to show how a new product delivers value to a specific population and to the Italian health care system. As of late, patient centricity is also influencing market access, and companies often collaborate with patient advocacy groups to collect data and insights that can represent an added value to dialogue with healthcare systems.

Regional Authorities Act Independently

AIFA approval does not automatically make a new drug accessible to all patients in Italy. The country’s 21 Regional Authorities each control their own costs and thus manage access to new drugs. Sometimes, a treatment is offered at clinics in one region, but not in another. A manufacturer may need to make a case for its product with all 21 of them.

Manufacturers should prioritise regions in Italy for launch purposes, considering the local economy, the incidence of disease in the region and how many specialty clinics it has, for example. With offices throughout Italy and relationships with key stakeholders, GLOBALHealthPR can help you prioritise regions and navigate the variables to tell an optimal value story.


Important Points to Keep in Mind

The Italian government aims to keep health care costs in check via risk-sharing agreements with pharma companies and by forcing manufacturers to align pricing with cheaper alternatives and with prices negotiated in nearby countries.

Through risk-sharing or “innovative pricing” arrangements, the Italian Medicine Agency and regional bodies agree to cover innovative new drugs on the condition that they prove to benefit patients and cut costs. Data on responding patients and non-responders are perhaps most critical for manufacturers, so you can negotiate a risk-sharing agreement with payers with confidence. If you are reimbursed only for those patients who actually respond to the treatment, you want to be certain you can identify them.

The Italian Medicine Agency maintains a database that collects data on patients treated with new medicines during the risk-sharing period, to assess the safety and effectiveness of the treatment. This technology is a significant investment in infrastructure, and Italian stakeholders including payers, physicians and pharma companies have access to it.

Reference Pricing is Common

Payers in Italy use “reference pricing” to contain pharmaceutical costs, creating a competitive situation that forces manufacturers to price their products the same as cheaper alternatives. This “therapeutic reference price” is the maximum the Italian National Healthcare Service will pay for a drug.

Through “international reference pricing,” prices in Italy are compared to those in the rest of the region for the same product. The transparent nature of pharmaceutical pricing in the EU means all the other countries know if you gave somebody else a good deal! So, in launching a new product, as in life, timing is everything.

GLOBALHealthPR can help you develop and communicate a global launch sequence strategy to maximise the price for your new product among interdependent markets such as the EU.

Implications for Industry

A market access strategy for Italy requires an understanding of the international implications as well as the variables unique to each of the country’s 21 regions. Risk-sharing is the new norm. Telling your value story early and often will smooth the pathway for access and maximum reimbursement for your product. The GLOBALHealthPR team has years of experience in Italy and EU markets. Working with your team and key stakeholders, we can help you build a compelling launch communications and marketing plan to create optimal conditions for brand success in this important European market.

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