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Pregabalin prescribing restrictions finally end next month

Pharmacists will be able to dispense generic pregabalin "in accordance with normal practice" from July 17*, NHS England has announced.

Pfizer’s general patent for Lyrica – of which pregabalin is the active ingredient – expired in 2014, but Pfizer retained the product’s patent for the treatment of pain until 2017. Despite a long-running legal battle (see below), this branded product has remained the only pregabalin-based product licensed for treating all types pain, as well as anxiety and epilepsy.

In a letter from NHS England – seen by C+D – director of primary care commissioning David Geddes told clinical commissioning groups on Wednesday (June 21) that previous guidance, advising dispensers to supply branded Lyrica for pain "as far as reasonably possible", has been withdrawn and replaced.

From July 17, “when dispensing pregabalin for the treatment of any condition, you should dispense in accordance with normal practice”, Mr Geddes said in this week's letter.

He added that any amendments made to electronic prescription systems to ensure practitioners followed the previous guidance should now be "reversed".

The pregabalin story so far...

July 2014 – The patent confusion starts

The general patent for Lyrica expires, but Pfizer retains the product’s patent for the treatment of pain until July 2017. The Pharmaceutical Services Negotiating Committee explains that until this happens, Lyrica – Pfizer’s branded product – will remain the only pregabalin-based product licensed for treating pain, as well as epilepsy and generalised anxiety disorder.

February 2015 – Numark raises concerns

Independent support group Numark raises concerns that pharmacists who run out of Lyrica may be “tempted” to disobey the patent restrictions and dispense generic pregabalin instead. Pfizer reassures pharmacists that it does not think this will be an issue because it constantly manages stock supplies.

March 2015 – NHS produces guidance on pain medication

Pharmacy Voice chief executive Rob Darracott says NHS guidance on pregabalin – which advises that dispensers should supply Lyrica for pain “as far as reasonably possible” – reduces the risk of pharmacists falling foul of Pfizer’s existing patent. Mr Darracott points out that the guidance will ensure pharmacists are not “unfairly placed in a difficult position” of having to decide whether to follow a prescription to treat pain with a generic version.

June 2015 – Pfizer defends its patent

In an open letter to pharmacists and other healthcare professionals, Pfizer highlights that it holds pregabalin’s patent to treat pain until 2017. “We wish we had been able to explain this patent situation earlier and better. This is new territory for all of us and there was no system or policy in place to deal with it,” the manufacturer’s UK medical directors Berkeley Phillips and Seema Patel write.

September 2015 – High Court rules Pfizer “went too far”, but confusion remains

The High Court appears to rule that pharmacists can supply generic pregabalin to treat pain, and labels some of Pfizer’s attempts to enforce its patent as amounting to “threats”. But patent lawyer Jonathan Radcliffe – partner at Charles Russell Speechlys – tells C+D that it is “still unclear” whether pharmacists can dispense pregabalin in this way.

October 2016 – Court of Appeal backs High Court decision

The Court of Appeal upholds the High Court's decision that Pfizer's patent for pregabalin was “invalid”. But Pfizer highlights that the patent for treating certain types of pain – including “acute herpetic, post-herpetic and causalgia pain” – still stands. It vows to continue the legal battle and take the decision to the UK's Supreme Court.


*AMENDMENT: The first line of this article has been amended from 'Pharmacists will be able to dispense generic pregabalin for "any condition"', to '"in accordance with normal practice"'

How often do you dispense pregabalin products for pain?

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