Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future

Introduction: The manufacturer of pregabalin has a second use patent covering prescribing for neuropathic pain - its principal indication. The manufacturer has threatened legal action in the UK if generic pregabalin rather than Lyrica is prescribed for this indication. No problems exist for practitioners who prescribe pregabalin for epilepsy or generalized anxiety disorder. This has serious implications for health authorities. In Germany, however, historically generics can be legally prescribed for any approved indication once one indication loses its patent. Aim: To establish the current situation with pregabalin among health authorities principally from European countries. Methods: Personnel from 33 regional and national health authorities mainly from Europe, and nine from universities across Europe working as advisers to health authorities or with insight into their activities, were surveyed regarding four specific questions via email to shed light on the current situation with Lyrica and pregabalin in their country. The information collated from each country was subsequently checked for accuracy with each co-author by email and face-to-face contact, and collated into five tables. Results: The scenarios ranged from extending the patent life of Lyrica, e.g. France, endorsing the prescribing of Lyrica for neuropathic pain at the same price as the generic drug, e.g. Catalonia and South Korea, and current prescribing of pregabalin for all indications, e.g. Germany and Serbia. Little activity has taken place in European countries in which generic pregabalin is not yet reimbursed. Conclusion: The availability of generic pregabalin has prompted a number of different activities to be undertaken among the 33 countries and regions surveyed. The situation in Serbia and the historic situation in Germany provide examples of ways to maximize savings once a product loses its patent for at least one indication.