Dispensing of Lyrica / Pregabalin
Published on: 22nd September 2015 | Updated on: 15th March 2022
Guidance from 17th July 2017 onward
NHS England have now released new guidance in regards to the prescribing and dispensing of pregabalin. Pharmacy teams should note that when dispensing pregabalin for the treatment of any condition, they should dispense in accordance with their normal practice.
This is due to the second patent for Lyrica expiring.
Guidance between 6th March 2015 and 16th July 2017
Pharmacy teams may be aware of the recent High Court judgement regarding Pfizer’s patent claim for Lyrica. The judgment, which may be subject to appeal, has not affected the situation for pharmacists and GPs – NHS England requires pharmacists to refer generic prescriptions back to the prescriber, if they are aware it is for neuropathic pain, and it requires prescribers to prescribe the brand for neuropathic pain.
Pharmacists can dispense prescriptions written for pregabalin, unless they have reason to believe that the prescription is for the treatment of neuropathic pain.
At present, the generic pregabalin is listed in Part VIIIA of the tariff as a Category C line with reimbursement currently based on the brand Lyrica. The prices in the Drug Tariff are set each month by the Department of Health, and Community Pharmacy England will be consulted before any change.
Community Pharmacy England will stress the importance of providing timely, clear and unequivocal guidance to pharmacists and GPs as and when the situation changes to NHS England and the Department of Health.
Support for pharmacy teams
Community Pharmacy England has received a number of queries about what pharmacy teams should do if and when they are presented with generic prescriptions for pregabalin. This is a complex area of patent law. Community Pharmacy England is unable to give legal advice, but the below FAQs may help contractors on this matter.
Following an earlier High Court ruling, NHS England issued prescribing guidance on pregabalin aimed at CCGs, GPs and community pharmacies. NHS England Schedule 1: The Pregabalin Guidance and associated FAQs.
Community Pharmacy England has created a template letter that can be given to GPs if presented with a prescription for generic pregabalin issued for the treatment of neuropathic pain: Community Pharmacy England template letter
Q. I have been presented with a prescription for generic pregabalin specifically for the patented indication; what should I do?
A. If the medicines is being provided for the patented indication, the pharmacy should advise the prescriber (see template letter).
Q.Is there any requirement in the terms of service to make inquiries of the patient (or GP) about the medical condition being treated?
Q. Is there any further information that could help pharmacies when dispensing?
A. Advice will be issued when it is available but, as above, Community Pharmacy England cannot offer legal advice and this is a specialised area in patent law.
Q. The price payable for generic pregabalin is currently based on the price of the brand. Is this likely to change now there are generics in the market?
A. The prices in the Drug Tariff are set each month by the Department of Health, and Community Pharmacy England will be consulted before any change.
Q. Does the Judgment not mean that the patent is invalid and we can dispense generics?
A. The Judgment was issued in September 2015, but it is likely that this will be appealed. NHS England, which gave guidance to GPs and pharmacists on the order of the High Court, will keep the situation under review and will provide further guidance when appropriate.