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…

Comparing cost-effectiveness outcomes of cell and gene therapies across HTA organisations

By Chloe Sheppard, Senior Analyst & Max Rex, Consultant Email: csheppard@partners4access.com mrex@partners4access.com Cost-effectiveness analyses, as part of Health Technology Assessments (HTAs) for new therapies, appear to be growing in importance across Europe. These analyses are already required in many markets within and outside of Europe for HTAs, including Canada, England, and the Netherlands. In future,…

France’s new 10-year cancer strategy and its implications on the rare disease space

By Erfan Akbraian, Analyst Email: eakbraian@partners4access.com On World Cancer Day, 4th February 2021, President Emmanuel Macron announced France’s 10-year Cancer plan1. His predecessors have rolled out these strategies before, but they have been mid-term 5-year strategies. France has taken on board previous cancer plan insights and built an ambitious holistic 10-year strategy now. The plan…

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…

India’s new draft national policy for rare disease and the road to accessing gene therapies

By Ciaran Cassidy, Snr Analyst Email: ccassidy@partners4access.com With one of the fastest-growing economies and the second largest population in the world India is a market of increasing interest to the biopharmaceutical industry.1,2 However, the potential for access to innovative rare disease therapies, such as gene therapies, is not particularly well supported by the central government…