Questionable Guidelines Promoting Lyrica For Neuropathy

Today's post from pulsetoday.co.uk (see link below) is an alarming example of how forces beyond the patient's understanding can promote and push for a particular drug to be prescribed when there are serious arguments for that to be a big mistake. Pfizer's patent on Lyrica (pregabalin) has recently expired, which means that if it's suitable for you, generic (and thus cheaper) pregabalin should be being prescribed as a matter of course and of course sound financial management. However, it seems that in the UK, the National Health Service is pressuring doctors to only prescribe the named version (Lyrica) and not the cheaper generic version. There are two huge problems for both diabetics and people with HIV-related neuropathy here. Two years ago and under pressure from the American FDA, Pfizer withdrew their own recommendation for Lyrica as a treatment for these forms of neuropathy a) because it was proved to be ineffective and b) because the side effects were causing all kinds of law suits. So you have to ask yourself why a national health authority such as the NHS is bringing so much pressure on doctors to prescribe the named drug for neuropathy as a whole and therefore including diabetes and HIV-related neuropathy. The advice here if you have diabetes or HIV and neuropathy, is to take heed of Pfizer's own negative advice and the FDA's warnings and have a serious discussion with your doctor if they wish to prescribe Lyrica for your problems. There is something evidently not right with what is described in this article and it may not be in your (the patient's) interest - you don't have to be subject to pharmaceutical market forces -  there are plenty of alternatives!
More articles on this subject can be found by using the search facility to the right of this blog.

GPs told to carry out review of patients taking pregablin 'as soon as possible'
6 March 2015 | By Caroline Price

CCGs will issue guidance to GPs instructing them to carry out an urgent review of patients taking pregabalin following a High Court ruling.

The guidance – which NHS England said CCGs must send out to all GP practices by today – advises practices they should review all patients on long-term prescriptions of pregabalin for neuropathic pain and make sure any on a generic version of the drug are switched to the branded form Lyrica.

In addition, NHS England said GPs should from now on make sure to stipulate Lyrica on any new prescriptions of pregabalin they write for patients being given the drug for pain.

GPs are free to continue prescribing generic versions of the drug for other conditions.

The move comes after a recent High Court ruling that the NHS should stop promoting generic pregabalin for neuropathic pain.

The guidance states: ‘When prescribing pregabalin for the treatment of neuropathic pain to patients you should (so far as reasonably possible): prescribe by reference to the brand name Lyrica and write the prescription with only the brand name “Lyrica” and not the generic name pregabalin or any other generic brand.

‘When prescribing pregabalin for the treatment of anything other than pain, you should continue to prescribe by reference to the generic name pregabalin.’

And in a ‘frequently asked questions’ document accompanying the advice, NHS England explains that for new patients the guidance should be implemented ‘immediately’ and ‘when reasonably possible’ for repeat prescriptions.

But leading GPs criticised NHS England’s response, arguing it was not GPs’ role to take action and that practices were too overloaded to take on the work.

Dr Andrew Mimnagh, NHS Sefton CCG lead on urgent care, said it was up to dispensing pharmacists to resolve the issue.

Dr Mimnagh told Pulse: ‘Asking me to change a prescription for non-clinical reasons is not part of my professional duty of care or contractual obligation – I am not a contracted dispensor.

‘It is my belief NHS England are using GPs as the no-cost errand boy to sort their problem out, without regard for the intolerable workload pressures decimating the profession.’

An NHS England spokesperson told Pulse: ‘The NHS is committed to ensuring the best outcome for every patient. The primary objective for this unique case has been to ensure that practitioners are aware of new guidance when dispensing certain pain medication. Information will be provided to CCGs outlining this advice.’

The basic patent for Lyrica and regulatory data protection has expired. However, Pfizer has a second medical use patent (new therapeutic use) protecting the use of pregabalin in pain until July 2017.

Drugs company Pfizer holds the patent on pregabilin for use in neuropathic pain.

Pfizer said in a statement: ‘Pfizer is aware this is a relatively unusual exclusivity situation that has led to some confusion among prescribers and pharmacists. This is a legal matter not a clinical one. It is for this reason that we have been actively seeking to provide this essential guidance for prescribers and pharmacists by engaging with a broad range of stakeholders over the past six months, including the Department of Health, commissioning bodies, pharmacy associations as well as NHSE and other NHS devolved bodies.’

It continued: ‘In line with the measures sought by Pfizer to help prevent infringement of the pain patent, NHSE issued guidance on 27 February 2015 for prescribers via Clinical Commissioning Groups (CCGs) and pharmacists via NHS Business Services Authority (BSA) that directs the prescription and dispensing of Lyrica®, by brand name only, when pregabalin is used for the treatment of neuropathic pain. The NHSE guidance issued on Friday 27 February requests that the CCGs and NHS BSA distribute the notice on or before Friday 6 March 2015.’

The statement added: ‘The patent at issue, EP (UK) 0934061, expires in July 2017. A full hearing on the infringement and validity of the patent is scheduled to begin on 29 June 2015. Pfizer takes no issue with the supply of generic pregabalin products for use in the treatment of epilepsy or generalised anxiety disorder.’

http://www.pulsetoday.co.uk/clinical/prescribing/gps-told-to-carry-out-review-of-patients-taking-pregablin-as-soon-as-possible/20009393.article#.VPqtXC4tH7A