Pfizer has reaffirmed its decision to prevent the generic version of Lyrica being prescribed for pain.
Retaining the patent for pain treatment until June 2017 had not been intended to cause confusion or add to pharmacists’ workload, the manufacturer said in an open letter to pharmacists and other clinicians sent to C+D today (June 10).
Numark raised concerns in February that pharmacists who ran out of Lyrica would face a “temptation” to dispense the generic alternative pregabalin - which can be used to treat epilepsy - for pain-related prescriptions, and Pfizer said it hoped its letter would bring “further clarity and reassurances” for the sector.
“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 said in the letter.
The “much needed” guidance issued by NHS England to clinical commissioning groups (CCGs) in February had clarified that all clinical decisions to treat pain with pregabalin should result in a prescription for Lyrica, despite its general patent expiring in July 2014, the medical directors said.
Using EPS to enforce restrictions
Pfizer had been working with software providers over the past year to see if the electronic prescription system (EPS) could be used to enforce the prescribing restrictions, they said.
Lyrica had originally been developed to treat epilepsy and its benefits as a pain treatment had only been discovered “as a result of our investment in this additional research programme”, the medical directors explained. “It is for this discovery that Pfizer was granted the patent protecting its use for pain,” they added.
Although the generic version could still be prescribed for epilepsy and generalised anxiety disorder, its use as a pain treatment was prohibited until June 2017 “subject to ongoing legal proceedings with generics companies”, Pfizer stressed.
Almost 5 million Lyrica products and only 600 generic pregabalin products were dispensed in the community in 2014, according to data from the Health and Social Care Information Centre (HSCIC).However, HSCIC was unable to specific which conditions the products were prescribed for.
View the full letter here.