Italy shakes up early access programmes
By Richard Wang, Senior Analyst & Andrea Bernardini, Senior Analyst Email: [email protected] [email protected] On 10th of November, the Italian Medicines Agency AIFA announced that it
Is Spain becoming a cost-effectiveness market for biopharma?
By Ciaran Cassidy, Snr Analyst Email: [email protected] On the 25th of July, the AEMPS of Spain published the first Therapeutic Positioning Report (Informe de Posicionamiento
FDA stokes controversy with Alzheimer’s drug approval – what will it mean?
By Max Rex, Consultant Email: [email protected] On Monday 7th June, the FDA approved aducanumab, the first new treatment for Alzheimer’s in 18 years. Aducanumab, manufactured
NICE’s 5 year strategy looks towards a dynamic future
By Jayne Watson, Senior Analyst Email: [email protected] In April, the National Institute for Health and Care Excellence (NICE) launched its 5 year strategy, outlining their
What will happen to free pricing and Orphan Drugs in Germany after the election?
By Jens Leutloff, Senior Consultant Email [email protected] The discussion of cost containment measures in the German healthcare system does not seem to stop, and could
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: [email protected] [email protected] On the 12th of February the Orphan Drugs Observatory and the Italian Society of
Comparing cost-effectiveness outcomes of cell and gene therapies across HTA organisations
By Chloe Sheppard, Senior Analyst & Max Rex, Consultant Email: [email protected] [email protected] Cost-effectiveness analyses, as part of Health Technology Assessments (HTAs) for new therapies, appear
France’s new 10-year cancer strategy and its implications on the rare disease space
By Erfan Akbraian, Analyst Email: [email protected] On World Cancer Day, 4th February 2021, President Emmanuel Macron announced France’s 10-year Cancer plan1. His predecessors have rolled
Will AIFA’s net price disclosure requirement be a game-changer for Orphan Drug access?
By Akshay Kumar, Partner & Andrea Bernardini, Analyst Email: [email protected] [email protected] In the latest guidelines for Pricing and Reimbursement (P&R) dossier submissions, Italian Medicines Agency