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3 March 2015Big Pharma

NHS ordered to provide guidance on Lyrica use

The English High Court has ordered the country’s National Health Service (NHS) to issue guidance to medical professionals so that they prescribe Pfizer’s branded product Lyrica (pregabalin)—not the generic version—for neuropathic pain.

Justice Arnold granted the order on Thursday (February 26) following a dispute between Pfizer’s subsidiary Warner-Lambert and pharmaceutical company Actavis. It will come into effect from 16.00 local time today (March 3).

Warner had a patent granted for its Lyrica (pregabalin) drug, covering the treatment of epilepsy, generalised anxiety disorder (GAD) and neuropathic pain.

After this patent expired in 2013, Warner obtained a second medical use European patent that covered the use of pregabalin for treating neuropathic pain.

Actavis makes a generic version of Lyrica, called Lecaent, which it markets to treat epilepsy and GAD. However, as many prescriptions do not specifically detail Lyrica's patented indication (to treat neuropathic pain), Actavis’s generic version has at times been dispensed instead.

Warner’s request for an interim injunction requiring Actavis to take steps to ensure this did not happen was refused on January 21 by Justice Arnold, who said there was “no serious issue”.

He said the solution was to try to ensure that doctors prescribe the branded drug rather than the generic for the patented indication, though he accepted that neither company was in a position to make this happen.

“It depends ultimately on the prescribers,” he said.

Arnold had said it was a matter for the NHS to decide whether to issue guidance stating that pharmacists must dispense the brand name drug for the patented indication and the generic for non-patented indications—and urged it to “consider doing so as a matter of urgency”.

On February 20, after arguing that the NHS was unwilling to issue guidance on prescribing Lyrica, Warner applied for a court order forcing it to do so.

Arnold’s February 26 order stated that from today at 16.00 the NHS must ensure guidance is published to all clinical commissioning groups (CCGs) in England and the NHS Business Services Authority.

Arnold suggested the following wording is used: “If treating neuropathic pain, prescribe Lyrica (brand) due to patent protection. For all other indications, prescribe generically.”

An NHS spokesperson said: “The NHS is committed to ensuring the best outcome for every patient. The primary objective for this unique case has been to ensure that practitioners are aware of new guidance when dispensing certain pain medication. Information will be provided to CCGs outlining this advice.”

A Pfizer spokesperson told LSIPR in a statement: “Pfizer is aware this is a relatively unusual legal situation that has led to some confusion among prescribers and pharmacists. It is for this reason that we have been actively seeking to provide this essential guidance for prescribers and pharmacists by engaging with a broad range of stakeholders over the past six months, including the Department of Health, commissioning bodies, pharmacy associations, as well as the NHS England and other NHS devolved bodies.”

It added: “Pfizer believes this High Court order will provide much-needed clarity for prescribers and pharmacists and, importantly, help protect pharmacists from unwittingly infringing the pain patent.”

The patent at issue is due to expire in July 2017.

The spokesperson continued: “Pfizer takes no issue with the supply of generic pregabalin products for use in the treatment of epilepsy or GAD.”

Actavis did not respond to a request for comment.

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