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…
By Max Rex, Consultant Email: mrex@partners4access.com On Monday 7th June, the FDA approved aducanumab, the first new treatment for Alzheimer’s in 18 years. Aducanumab, manufactured by Biogen, was granted accelerated approval by the FDA based on results from Phase III trials showing reduction of amyloid beta plaque in patients’ brains. Aducanumab approved in spite of…
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…
By Jens Leutloff, Senior Consultant Email jleutloff@partner4access.com The discussion of cost containment measures in the German healthcare system does not seem to stop, and could gain new momentum after Germany’s federal election in September. Once again, the idea to shorten the free pricing period in Germany was raised recently. During a virtual event celebrating 10…
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…
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,…
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…
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…
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…
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…