The NHS could have saved millions last year if an ongoing patent case had not restricted the use of generic pregabalin, a new analysis claims.

Between February and September 2015 the NHS spent an estimated £182 million on pregabalin, but an analysis by Pulse claims that this could potentially have been reduced by almost 30 percent (£54 million) if the health service had been able to use generic alternatives.

GPs currently have to prescribe Pfizer’s branded version of the drug, Lyrica, for this indication due to a complex, ongoing legal case.

Pfizer’s original patent for pregabalin as a treatment for epilepsy expired in 2014, paving the way for companies like Actavis to launch cheaper generic formulations. However, Pfizer secured a second-use patent protecting pregabalin as a treatment for pain until July 2017, and it has argued that that the generics would inevitably be used for this indication and infringe on its patent. 

In September last year the High Court ruled that Pfizer’s patent protection is invalid and not infringed by Actavis’ drug, but Pfizer is appealing the judgement.

The Department of Health has said that because of the second-use patent, it cannot change the drug tariff for any indication, meaning that the NHS has had to pay the brand price for the drug across the board.

In our Review of 2015 in the January issue of PharmaTimes, Dr Berkeley Phillips, UK medical director for Pfizer, called for a national system to help manage second-medical-use patents.

“As science evolves, patients are increasingly benefiting from research into existing medicines, but to fuel such intensive work, second medical use patents must be respected. A system that fails to provide a mechanism for the implementation of the rights conferred by second medical use patents is one that is failing to keep pace with the evolution of R&D.

“Put simply, we need a system that encourages innovation, while ensuring doctors and pharmacists can continue to focus on delivering the very best patient care.

“This need has been recognised broadly, including the British Generic Medicines Association and the Association of the British Pharmaceutical Industry, and, as we look to 2016, our hope is that a growing consensus on this issue will be the catalyst for constructive debate and bring the clarity and reassurance we all so badly need.”