Is Italy a favourable market for Orphan Drugs? The latest OSSFOR Booklet paints a promising picture for the Italian landscape

By Andrea Bernardini, Analyst & Akshay Kumar, Partner Email: abernardini@partners4access.com akumar@partners4access.com On the 12th of February the Orphan Drugs Observatory and the Italian Society of Hospital Pharmacy  and Pharmaceutical Services for Healthcare (OSSFOR) have produced the 5th Report on orphan drugs receiving Innovative Status by AIFA in Italy. Although AIFA’s algorithm for assigning innovation status…

Will AIFA’s net price disclosure requirement be a game-changer for Orphan Drug access?

By Akshay Kumar, Partner & Andrea Bernardini, Analyst Email: akumar@partners4access.com abernardini@partners4access.com In the latest guidelines for Pricing and Reimbursement (P&R) dossier submissions, Italian Medicines Agency (AIFA) requires manufacturers to self-report prices, including the percentage discounts and/or Management Entry Agreements (MEAs) agreed with other EU countries and the UK. If these are confidential agreements, AIFA in…

Evolution of payment models for cell and gene therapies in Italy

By Joanna Fernandes, Associate Consultant Email: jfernandes@partners4access.com Cell and gene therapies (CGTs) are considered one-time transformative treatments, positioned as having life-long benefits. These new therapies are challenging the traditional business model, with health technology assessment (HTA) and reimbursement processes having been established around chronic therapies. This has led to one of the biggest hurdles currently…