PT  - JOURNAL ARTICLE
AU  - Richard Croker
AU  - Darren Smyth
AU  - Alex J Walker
AU  - Ben Goldacre
TI  - The clinician impact and financial cost to the NHS of litigation over pregabalin: an economic impact analysis
AID  - 10.1101/266403
DP  - 2018 Jan 01
TA  - bioRxiv
PG  - 266403
4099  - http://biorxiv.org/content/early/2018/02/16/266403.short
4100  - http://biorxiv.org/content/early/2018/02/16/266403.full
AB  - Objectives There has been significant litigation regarding pregabalin, focusing on the second-use medical patent for neuropathic pain. This caused NHS England to take the unprecedented step of instructing all GPs to prescribe the brand (Lyrica) for pain. Pfizer’s patent for use of pregabalin in neuropathic pain was itself found to be invalid in 2015; this ruling has been subject to ongoing appeals, with a Supreme Court appeal hearing in February 2018. If this appeal is unsuccessful, the NHS may be able to reclaim excess prescribing costs. We set out to describe the variation in prescribing of pregabalin and branded Lyrica across the country and over time; to determine the impact of the NHS England instruction to GPs; and to model the additional costs to the NHS attributable to various legal judgments.Setting English primary careParticipants English general practicesPrimary and secondary outcome measures We described the variation in prescribing of branded Lyrica across the country before and after the NHS England instruction, by practice and by Clinical Commissioning Group (CCG). We used pricing data to model excess prescribing costs.Results The proportion of pregabalin prescribed as Lyrica increased from 0.3% in the six months prior to the NHS England instruction (September 2014-February 2015) to 25.7% in the six months following (April - September 2015). Although 70% of pregabalin is estimated to be for neuropathic pain, only 11.6% of practices prescribed 70% of pregabalin as Lyrica. Among practices the median proportion for Lyrica was 8.8% (IQR 1.1-41.9%); among CCGs it was 21.2% (IQR 13.5-31.7%). If Lyrica had come off patent in September 2015, and Pfizer had not appealed, we estimate that the NHS would have spent approximately £502m less on pregabalin to July 2017.Conclusion NHS 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 the final appeal on the patent is unsuccessful the NHS can seek reimbursement of their excess costs which we estimate at £502m.Strengths and weaknesses of the studyWe were able to measure the prescribing of pregabalin across all prescribing in England, eliminating bias.We were able to measure the impact of the NHS England’s instruction to GPs, which had a clear start and end date.Using the available data, and assumptions on generic prices which occurred following the end of the patent, we were able to confidently predict the excess costs to the NHS.The prescribing dataset does not include indication, and therefore we were not able to measure which patients had been changed to Lyrica from generic pregabalin.