French president Emmanuel Macron announced a two-year trial that will allow pharmaceutical products that receive an ‘Amélioration du Service Médical Rendu’ (ASMR) rating of IV or better to get reimbursement [...]
Pan-European HTA will enter into force in January 2022 and finally become active in 2025. This comes almost four years after the European Commission’s original proposal, and at a time where urgency for European HTA processes is growing [...]
The National Institute for Health and Care Excellence (NICE) will mark the start of 2022 by implementing changes to health technology assessments (HTAs), demonstrating adaptability of regulatory bodies as medical technologies continue to evolve. The final HTA changes aim to provide earlier and more equitable access to treatments as well as display increased flexibility in the evaluation of new health technologies [...]
There has been a trend in manufacturers opting to bypass the NICE appraisal process and have struck deals with NHS England directly to support market access for their novel therapies.
Executive Summary In March 2020, the FDA amended its classification of add-on insulin products, changing the approval pathway from that of a chemical drug follow-on to a biosimilar and more closely aligning with the EMA’s longstanding biosimilar insulin approval…
Written by Caspar Kengeter and Manon Ricard
Executive Summary The Medical Fund Bill would increase drug spending up to 4% of the total healthcare spending in Poland The reimbursement applications can be reviewed as quickly as 180 days, reducing the typical time-to-market of two – three years…