Market Access in Italy

What does “Access” mean?

Nowadays, the concept of “access” is comprehensive and needs to be declined in its multiple meanings. In particular, we can consider three different definitions of “access”.

1. Access to treatment means the provision of hospitals, institutions, and organizations to ensure and facilitate patient’s Access to treatment;

    

2. Accessibility means the provision of specific services and information needed for patients to get Access to the treatment (ex. home care delivery in Covid-19 pandemic, other patient support programs, and particular logistics and pathways to foster linkage to care);

    

3. Market access provides evidence to assess a new drug’s health outcomes and economic and organizational impact to obtain the most appropriate reimbursement price for the most appropriate population.

In other terms, market access is the complex of activities that bring a company’s product to a specific market after having obtained marketing authorization.

What is essential to understand is that if a company wants to be successful in market access in a market like the European one, the market access strategy has to be strongly evidence-based. To be successful in a market like Italy’s (and not only this one), your evidence-based market access strategy has to link all the concepts we mentioned.

Market access, in another sense, is an opportunity for companies and payors. Suppose you genuinely address and produce all evidence necessary to show the impact of a new drug or medical device on health outcomes, expenditures (both from NHS and hospital perspective), and organizations (mainly in hospital and regional perspective). It helps all the stakeholders understand appropriate pricing and reimbursement schemes for the most appropriate patient populations and with the most suitable delivery regimen.

Companies can support the healthcare system in improving Access by providing evidence of “new treatment opportunities” or improving efficacy, safety, and administration route of existing therapies. Moreover, it can help the system fostering Access to care for patients, i.e., providing:

• Patient Support Programs (PSP) to improve homecare delivery
• distance monitoring
• or generate new data

The most transparent and high evaluation standard is practical to support HTA bodies and payors to assess the new treatment options’ impact.

The activity of market access of a company by encouraging Access and Accessibility becomes an assurance of its success.

The Italian NHS and pharmaceuticals

The Italian National Health Service, a Beveridge model-based system established in 1978, manages Access and Accessibility in Italy through Public and Private hospitals, accredited (funded) by the NHS. This system represents a complex model that evaluates approval in each of the 21 Regions and nationally. 

AIFA, the Italian Medicine Agency, represents the public Institution responsible for approving and listing into the National pharmaceutical formulary new drugs, giving a general price and bargaining scheme of reimbursement with the Company.

After that, the 21 Regional Authorities, which independently manage the budget for territorial pharmaceutical expenditure, assess regional Access by including the drug in a regional prontuary. Then, following the rules issued by the Regions, the medication is dispensed in Hospitals, through hospital pharmacies, and Territorial Pharmacies.

So the Italian drug market is organized on two levels:

• National Access: AIFA is in charge for the approval, which follows an evaluation from different Committee such as CTS (Commissione Tecnico Scientifica), CPR (Comitato Prezzi e Rimborso), CDA (Consiglio di Amministrazione AIFA). After that, there is the Publication into the GU – Official Bulletin.
• Regional Access: Since 2007, each Italian Region has developed its Regional Hospital Therapeutic Handbook (PTOR – PTR), and every Italian Region has specific requirements for Access to regional hospitals and pharmacies.

Reasons why you need a detailed market access strategy in Italy 

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. 

The Italian market is a highly regulated reality and represents an excellent opportunity for pharmaceutical and Medtech companies worldwide. The most appropriate Market Access strategies are based on evidence supporting health systems fostering Access to treatments and Accessibility. HOW? By exploiting the new criterion of “Added Therapeutic Value,” which, based on evidence, shows the new drug’s 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 of primary importance in the evaluation of new medicinal products. Moreover, by promoting Patient Support Programs or Awareness initiatives that allow the unmet needs to emerge.