Contractors struggling to source pregabalin at list price since restrictions placed by NHS England limiting the use of generic pregabalin were lifted have been told by the Pharmaceutical Services Negotiating Committee (PSNC) to “exert maximum pressure on wholesalers” to drive down its price.
In a letter to community pharmacies dated 21 June 2017, NHS England said previous dispensing guidance on pregabalin, which instructed pharmacists to return all prescriptions for generic pregablin for pain to the prescriber, was being withdrawn.
It informed pharmacists that from 17 July 2017 “when dispensing pregabalin for the treatment of any condition, you should dispense in accordance with your normal practice”.
Mike Dent, director of pharmacy funding at PSNC said pregabalin met all the criteria for inclusion in Category M (where the Department of Health calculates the reimbursement price of readily available generic drugs based on information submitted by manufacturers), so it was moved from 1 August 2017, following the patent expiry on 17 July 2017.
But some contractors claim they are now being forced by wholesalers to pay several times more than the drug tariff price for each pack of pregabalin.
Dent said: “The DH sets Category M prices at levels above the prices notified by manufacturers,” he explained. “But when the Category M reimbursement price for a particular product is reduced, it may take time, and sustained pressure from pharmacies, for wholesale prices to respond.
“During this period, it is essential that contractors exert maximum pressure on wholesalers. There have been a number of examples where manufacturers’ prices were below the Drug Tariff price but a product could not be obtained at the Drug Tariff price from a number of wholesalers.”
“We are aware that sometimes Category M medicines are difficult to obtain at the reimbursement set in the Drug Tariff and apply for price concessions as needed.”
The issue arose after a long-running patent dispute by Pfizer against generic drug manufacturers Actavis and Mylan over its product Lyrica. NHS England issued guidance on 2 March 2015 stating that any prescription for generic pregabalin for pain should be returned to the prescriber.
Pfizer developed Lyrica for the treatment of generalised anxiety disorder (GAD) and epilepsy but the patent for this indication expired in 2013. When Pfizer discovered that pregabalin could relieve pain, it took out a second medical use patent for Lyrica to cover this use, which expired in July 2017. When the first patent expired, Actavis and Mylan launched generic versions of the drug to treat GAD and epilepsy and the long-running court battle ensued.