Is Spain becoming a cost-effectiveness market for biopharma?

By Ciaran Cassidy, Snr Analyst Email: ccassidy@partners4access.com On the 25th of July, the AEMPS of Spain published the first Therapeutic Positioning Report (Informe de Posicionamiento Terapéutico, IPT) including both a clinical and a cost-effectiveness assessment.1 The Coordination Group of the National Health System (NHS) Drug Evaluation Network (REvalMED) evaluated Pfizer’s Talzenna® (talazoparib) as monotherapy for…

NICE’s 5 year strategy looks towards a dynamic future

By Jayne Watson, Senior Analyst Email: jwatson@partners4access.com In April, the National Institute for Health and Care Excellence (NICE) launched its 5 year strategy, outlining their key priorities between now and 20261. The launch of the strategy comes at an interesting time when government and healthcare authorities globally are considering their priorities. The UK is in…

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,…

Innovative access agreements for ATMPs in Europe

Why embrace them? By Chloe Sheppard, Erfan Akbraian, Andrea Bernardini & Richard Wang Advanced Therapy Medicinal Products (ATMPs) have significant potential to transform the lives of patients by delivering remarkable, durable improvements in clinical outcomes, in addition to providing long-term cost-savings to healthcare budgets. Manufacturers often face challenges with securing reimbursement and access for high-cost…

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…