OBJECTIVES: This research seeks to establish the traditional launch sequencing pattern of new drugs in Europe and to explore potential opportunities to optimise launch sequencing in the light of EU HTA regulation, which will apply from January 2025. If, within 2 years of marketing authorisation, a product is launched and continuously supplied in all EU member states, an additional 2 years of data protection can be obtained. In the case of small and medium-sized enterprises, not-for-profit entities, or companies with limited experience in the EU system, the period for launch extends to 3 years.

METHODS: This was conducted and supplemented with data from GPI-Pulse® and the Initiate Reimbursement Radar. A launch sequencing tool was employed to test opportunities to optimise the sequence based on factors including time to market, population, and price maintenance.

RESULTS: A generalised pattern of launch was established, with three waves: Wave 1 in the EU4 and UK, Wave 2 in the Nordics, Benelux, and central markets; and Wave 3 in Eastern European markets. This traditional launch sequence typically lasts for 24-36 months. Launch sequencing varied for drugs for rare and ultra-rare diseases. For drugs for ultra-rare diseases in particular, there was a disconnect in launch sequencing records due to differences between national and local funding. If pharmaceutical companies can optimise this sequence and meet the 2-year target defined by EU HTA, they can potentially achieve higher pricing and greater revenue in a shorter time.

CONCLUSIONS: This research suggests that the objective of the EU HTA regulation to improve and accelerate the availability of medicines could be fulfilled. It should be noted that the regulation does not require reimbursement to be secured, only the medicine to be made available, although this research does suggest opportunities do exist to achieve reimbursement in the 2 year time horizon.