Earlier this year, the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) adopted new guidelines relating to the pricing and reimbursement (P&R) process in Italy. The new guidelines feature a shift away from economic modelling in favour of a focus on clinical benefit, as well as new dossier requirements and negotiation procedures. In this blog we provide an overview of the latest trends and recent changes to the P&R process. We also provide some insight on what this means for companies looking to launch in Italy.
Following the Ministerial Decree on 1 August 2019 (published in the Italian Official Journal no. 185 of 24 July 2020), AIFA has adopted new guidelines relating to the P&R process. The most important change is the new emphasis on the ‘added therapeutic value’ of the product compared to existing treatments, representing a shift away from the focus on cost-effectiveness. This indicates a willingness to cater for innovative, higher-cost treatments in the pipeline, a challenge faced in all markets.
New approaches for high-cost treatments are already established in practice. AIFA has led the way in implementing innovative payment agreements for advanced therapy medicinal products (ATMPs). Two major challenges for ATMPs are the high, one-off costs and associated high levels of uncertainty. ATMPs tend to be reimbursed in Italy through managed entry agreements and outcomes-based payment agreements whereby payments are made in instalments based on the collection of individual patient data. For instance, an innovative payment model for Zolgensma was introduced earlier this year, with an agreement to spread payments over four years. The contract combines an obligatory discount on the ex-factory price with conditional outcomes-based payments at milestones occurring 12, 24, 36 and 48 months post-treatment.
The P&R process itself remains untouched by the new guidelines. The P&R timelines can be highly variable but usually take around 9–12 months. In fact, for orphan drugs the average length of the P&R process exceeded official timelines at 386 days. The P&R process requires companies to engage with AIFA and is as follows:
1. Once the company has submitted a dossier, the Scientific Technical Committee (Comitato Tecnico Scientifico, CTS) decides whether the product is innovative and which class the product belongs to: Class A (general use); Class H (hospital use); Class C (not eligible for reimbursement).
2. The Pricing and Reimbursement Committee (Comitato Prezzi e Rimborso, CPR) reviews the dossiers of Class A and H products and conducts pricing negotiations with the company.
3. Final approval is given by the AIFA Board of Directors and the decision is eventually published in the Official Journal (Gazzeta Ufficiale).
4. The Regional Health Services (Servizio Sanitario Regionale, SSR) and Local Health Authorities (Azienda Sanitaria Locale, ASLs) may add the product to its regional formularies, except for innovative medicines which are automatically included.
Changes have also been observed in relation to routes for early access, with a push away from the Law 648/96 programme and towards the AIFA 5% National Fund programme. Law 648/96 is a cohort programme that provides reimbursement for the product, funded by the National Health Service (Servizio Sanitario Nazionale, SSN). AIFA 5% National Fund (Law 326/2003) is a named patient programme that provides reimbursement for the product, funded by AIFA. This means that medicines accepted for use under Law 648/96 can be made available to all eligible patients, whereas AIFA must approve a physician’s application to provide access for each individual patient for medicines covered by the 5% National Fund.
Before the new guidelines came into effect, companies could set a price freely for products covered by Law 648/96. Now companies must submit a dossier and enter into a price negotiation with AIFA. Furthermore, MAP’s Italian partner, Regulatory Pharma Net, estimates that only around 20% of applications for Law 648/96 are successful, suspecting that AIFA are pushing companies towards the AIFA 5% Fund instead.
It should be noted the new guidelines now grant AIFA the power to initiate renegotiations for medicines that have a significant impact on National Health Service spending, that have never been subject to negotiations and/or that are not reimbursement (class C) due to failure to reach an agreement in previous negotiations.
The new guidelines also introduce extra dossier requirements to support P&R applications. For instance, companies must now provide the prices of the product in other EU member states and the UK, including the existence of any negotiated discounts/confidential agreements, information on any public contributions received for R&D and information on the tools used to identify patients eligible for treatment and/or the level of care envisaged for administering the product.
Some of these changes may spark concern for some pharmaceutical companies. The end of free pricing in Law 648/96 could lead to reduced prices before marketing authorisation, with a potential downward pressure on price further down the line. The push away from Law 648/96 towards the named patient 5% National Fund programme signals some hesitation on AIFA’s part in relation to early access.
Moreover, the requirement to declare the existence of any confidential discounts in other countries will ring alarm bells. Although this could have negative consequences for pricing in Italy, the good news is that it is highly unlikely that companies will be required to disclose confidential information that might have an impact in other markets too.
Whilst these changes signal AIFA’s intention to bring down pharmaceutical prices, the new focus on clinical benefit and shift away from cost-effectiveness will be welcome news for companies with innovative, higher cost treatments that have a significant impact on patient outcomes.
We have recently refreshed MAP Online Italy, providing new and updated insights. We continually monitor developments in the Italian market access landscape. Please contact our Member Support team with any questions you have, including if you would like to book a navigational tour.
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