The clinician impact and financial cost to the NHS of litigation over pregabalin: a cohort study in English primary care

Abstract

ObjectivesFollowing litigation over pregabalin’s second-use medical patent for neuropathic pain, National Health Service (NHS) England was required by the court to instruct general practitioners (GPs) to prescribe the branded form (Lyrica) for pain. Pfizer’s patent was found invalid in 2015, a ruling subject to ongoing appeals. If the Supreme Court appeal in February 2018, whose judgement is awaited, is unsuccessful, the NHS can seek to reclaim excess prescribing costs. We set out to describe the variation in prescribing of pregabalin as branded Lyrica, geographically and over time; to determine how clinicians responded to the NHS England instruction to GPs; and to model excess costs to the NHS attributable to the legal judgements.SettingEnglish primary care.ParticipantsEnglish general practices.Primary and secondary outcome measuresVariation in prescribing of branded Lyrica across the country before and after the NHS England instruction, by practice and by Clinical Commissioning Group; excess prescribing costs.ResultsThe proportion of pregabalin prescribed as Lyrica increased from 0.3% over 6 months before the NHS England instruction (September 2014 to February 2015) to 25.7% afterwards (April to September 2015). Although 70% of pregabalin is estimated to be for pain, including neuropathic pain, only 11.6% of practices prescribed Lyrica at this level; the median proportion prescribed as Lyrica was 8.8% (IQR 1.1%–41.9%). If pregabalin had come entirely off patent in September 2015, and Pfizer had not appealed, we estimate the NHS would have spent £502 million less on pregabalin to July 2017.ConclusionNHS England instructions to GPs regarding branded prescription of pregabalin were widely ignored and have created much debate around clinical independence in prescribing. Protecting revenue from ‘skinny labels’ will pose a challenge. If Pfizer’s final appeal on the patent is unsuccessful, the NHS can seek reimbursement of excess pregabalin prescribing costs, potentially £502 million.

Lost cost savings to the NHS in England due to the delayed entry of multiple generic low-dose transdermal buprenorphine: a case scenario analysis

“…The lost savings from the delayed entry of generic LDTB patches is much less than savings lost from the prolongation of the patent of Lyrica, which has been estimated to be approximately £500 million due to the longer duration of litigation and greater utilisation of pregabalin in comparison with LDTB patches 29. Our study and the work done by Croker et al support the estimate that a more cost effective policy could save the NHS over £1 billion per year 31 43…”

“…Interestingly, a similar situation has been reported with pregabalin during a period of patent litigation between 2015 and 2017, in which the generic pregabalin did not result in cost savings to the NHS, despite gaining more than half of the market. This is due to the reimbursement price for this generic being similar to the brand Lyrica 3132 suggested that the generic pregabalin was priced in this way, because the UK Department of Health did not wish to recategorise pregabalin as generic while the originator brand Lyrica second patent (pain patent) was still being asserted by Pfizer 32.…”

Pregabalin: what the patent litigation means for doctors and drug companies

“…In our accompanying paper in BMJ Open we present data showing that overall GPs did not comply with NHS England’s instructions 8. About 70% of pregabalin prescriptions are estimated to be for pain, but during the period of litigation only 11% of practices prescribed Lyrica at this level, and no CCGs did so.…”

“…If Pfizer had not appealed the loss of the second medical use patent for pain in 2015, then pregabalin would instead have become generic at that time and the price drop observed in August 2017 would have occurred in October 2015. We estimate that the delay in the price drop resulted in total excess costs to the NHS of £502m,8 representing a substantial proportion of the entire NHS primary care prescribing spend (roughly £9bn in England for 2017) 10. If the Supreme Court upholds the decision that Pfizer’s pain patent is invalid, NHS England should be able to recoup some excess prescribing costs from Pfizer.…”

PrAna: An R package to calculate and visualize England NHS primary care prescribing data

“…Information on prescribing quantity of different APIs in a particular year and a year-long trend of an API are interesting for various applications including community health monitoring [23,[34][35][36], environmental monitoring [37,38], policy interventions [39], and environmental and water quality management [21,40,41]. This tool can facilitate research in these aspects and in the identi cation of most prescribed API in particular region or in a practice and able to identify the variation across the prescription of API over a period or region or practice.…”