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…

Patient Centricity in HTA: Fact or Fable?

By Erfan Akbraian, Analyst Email: eakbraian@partners4access.com In recent years there have been discussions to shift to a multi-stakeholder approach and increase early communication amongst key stakeholders to ensure appropriate access of advanced therapy medicinal products (ATMPs). With an increasing number of ATMPs for orphan diseases in the pipeline, there is a need for health technology…

Will the latest changes of the Bulgarian pricing and reimbursement policy have finally an impact?

By Akshay Kumar, Partner & Andrea Bernardini, Analyst Email: akumar@partners4access.com abernardini@partners4access.com Bulgaria introduced multiple reforms to their healthcare system since 2011. This included the introduction of health technology assessments in 2015. However, evidence has shown that these reforms have had so far little impact on improving effectiveness of care, patient access to treatments or cost containment.  …

France’s New ATU Process: Why only truly innovative therapies should now apply

By Nicola Allen, Associate Director & Andrea Bernardini, Analyst Email: nallen@partners4access.com or abernardini@partners4access.com The French Authorisation for Temporary Use (ATU) was originally established in 1994 [1] to enable pharmaceutical companies to sell certain medicinal products prior to marketing authorisation and reimbursement negotiations. The original ATU program has since evolved into six different pathways with overlapping…

4 key trends changing the access landscape through to 2025

By Jens Leutloff, Senior Consultant Email: jleutloff@partners4access.com Partners4Access  asked payer experts from France, Germany, Italy, Spain, and the Nordics what the key trends are for market access by 2025. Besides the financial challenge posed by high-cost innovative therapies, they will also influence how other drugs will be looked at. An increasing number of innovative therapies…

Under the microscope: Orphan Drug incentives in Europe

By Chloe Sheppard, Analyst Email: csheppard@partners4access.com The European Commission is imminently expected to publish a report evaluating the pros and cons of the EU Orphan and Paediatric Legislation introduced 20 years ago. The regulation has so far had success towards its primary goal to incentivise the development of orphan medicinal products (OMPs) for patients living…

Deadline day approaches for Israel’s market entry hopefuls

By Erfan Akbraian, Analyst Email: eakbraian@partners4access.com Majority of orphan drug manufacturers do not currently view Israel as an early launch opportunity. However, universal reimbursed access to high quality healthcare which is at par with Western European countries, combined with the expansion of the prenatal and new-born screening programmes[1] that have considerably improved diagnosis rates is…