Doctors are warned not to prescribe generic pregabalin for pain control

Doctors have been warned against prescribing generic pregabalin for pain control and instead told to prescribe Lyrica (Pfizer, New York) by brand. Failing to do so may leave them open to litigation, both the BMA and NHS England have warned.

The patent for Lyrica that expired in July 2014 only related to its use for epilepsy and generalised anxiety disorder. The manufacturer, Warner-Lambert (a subsidiary of Pfizer), still holds a “second medical use” patent for the use of pregabalin in the treatment of peripheral and central neuropathic pain, which expires in July 2017. A second medical use patent is one that relates to a new medical use for a known compound.

So despite being the same as the branded version, generic versions of pregabalin have been approved for use only in epilepsy and generalised anxiety disorder. Pfizer is in dispute with a number of generic drug suppliers and has indicated that it will contest any challenges to the patent for pain.

Earlier this year Pfizer sent a letter to pharmacists and hospital administrators stating that pharmacists and others in the supply chain may infringe the patent, even potentially unwittingly, if they supply generic pregabalin for the pain indication and that this would be an unlawful act.

After a High Court ruling on 2 March the NHS was told it must not promote generic pregabalin for pain. As a result NHS England issued guidance to GPs and pharmacists saying that “so far as reasonably possible” pregabalin should only be prescribed for the treatment of neuropathic pain under the brand name Lyrica. Pharmacists have been told to confirm the indications for generic prescriptions of pregabalin. If the indication is for neuropathic pain then pharmacists have been told to return the prescription for amendment to Lyrica.

NHS England has also told clinical commissioning groups to ensure that any electronic prescription system is amended to include a notice or advice box saying, “If treating neuropathic pain, prescribe Lyrica due to patent protection. For all other indications, prescribe generically.”

The BMA’s General Practitioners Committee has advised GPs to prescribe Lyrica by brand when used for pain control for the time being. Andrew Green, chair of the BMA’s GP clinical and prescribing subcommittee, said, “The BMA was made aware of attempts by Pfizer to enforce use of their brand when pregabalin is prescribed for long term pain, even though the brand is much more expensive and no more effective than the generic version. Accordingly, we issued pragmatic guidance designed to protect doctors from personal legal challenge as well as from being distracted from patient care by pharmacists anxious about the intended use of a generic prescription.” He added, “There would be considerable savings for the NHS if generic pregabalin was available for long term pain relief.”

A spokesperson for Pfizer said in a statement, “Pfizer does not wish to take legal action against any individuals or organisations in relation to this matter. We recognise this is a relatively unusual situation and have therefore been engaging with stakeholders across the NHS for over six months to ensure essential guidance is available. We are confident that the central guidance and FAQs recently issued by NHS England will provide much needed clarity and also help to protect pharmacists from unwittingly infringing the patent.”

The spokesperson said that the current situation was unprecedented. But they added that second medical use patents are likely to become increasingly common and so similar situations could occur more frequently in the future. “We hope the work we have been doing with stakeholders across the NHS will help provide clarity around the Lyrica (pregabalin) pain patent specifically but, more importantly, also help ensure the right policy, infrastructure, and guidance is in place to support and protect future medical innovation.”