GPs could soon be given the green light to switch patients on Lyrica back to the generic version pregabalin, after pharma giant Pfizer failed to have a patent ruling overturned.
Pfizer is planning to appeal the decision again but in the meantime it says NHS England can lift some restrictions on generic pregabalin, which last year forced GPs to switch thousands of repeat prescriptions to the brand name Lyrica.
NHS England said it will ‘consider’ the decision but warned that GPs should continue prescribing only branded Lyrica for neuropathic pain for the time being, as laid out in prescribing guidance issued last March.
But the GPC said it hoped the ruling and Pfizer’s position should see GPs start prescribing pregabalin freely again.
NHS England was told to issue the guidance to GPs last March by a High Court judge, who ruled the NHS should take action to prevent any potential infringement of a ‘second medical use’ patent Pfizer claimed it held for use of the drug for neuropathic pain.
Generic versions of the drug were already available in the UK because the original patent covering pregabalin use for epilepsy had expired, but Pfizer argued most of the drug is prescribed for neuropathic pain.
The move sparked outrage amongst GPs who warned it impinged on their prescribing independence and involved significant extra workload for already overburdened practices.
And in September the High Court ruled Pfizer’s second patent claims – covering pain and neuropathic pain – were invalid, raising the prospect that all the work had been completely unnecessarily.
Pfizer last week had an appeal against that decision thrown out and said that, although it intends to appeal again, it will now seek to get the prescribing guidance revised.
But because the Court of Appeal upheld Pfizer’s exclusive rights to market the drug for some other more limited pain indications – such as acute and post-herpetic neuralgia – GPs could still find themselves forced to prescribe by the brand name Lyrica for any patients who are taking the drug for one of these specific conditions.
A spokesperson for Pfizer said: ‘Pfizer is disappointed with the decision issued by the Court of Appeal in London on 13th October 2016 and will seek to appeal the decision. The Court of Appeal affirmed the High Court’s decision finding that the patent covering Lyrica (pregabalin) for pain is not infringed by Actavis and also finding patent claims directed generally to pain and neuropathic pain invalid.
‘However, the Court of Appeal affirmed the High Court’s decision in upholding as valid Pfizer’s patent claims directed to certain types of pain, including acute herpetic pain, postherpetic pain and causalgia pain.’
They added: ‘Following the Court of Appeal’s judgment, and pending the outcome of its appeal to the Supreme Court, Pfizer will now seek to have the NHS England Pregabalin Guidance on prescribing and dispensing by brand name, Lyrica, limited to prescribing and dispensing for the types of pain in those patent claims upheld as valid by the Court of Appeal.’
An NHS England spokesperson said: ‘NHS England is considering the judgement handed down and is awaiting the final court order. We will consider what steps, if any, are appropriate at that stage. The Pregabalin guidance remains in place until new guidance is issued.’
Dr Andrew Green, chair of the GPC clinical and prescribing subcommittee, said he was ‘delighted it would appear that GPs can now prescribe in a cost effective manner’.
He said: ‘I would hope that NHS England will not sit on its hands but issue rapid guidance empowering GPs to prescribe generically wherever possible, as every day that passes results in more money being lost to the NHS.
‘Considering how quickly area teams bear down on individual practices who prescribe by brand, sometimes for very good reasons, it would be hypocritical of them not to be robust and prompt in their actions now.’
Dr Green noted that the majority of affected prescriptions were ‘for more general neuropathic reasons, so most will be able to be switched’.
How the Lyrica saga unfolded
NHS England was told to issue prescribing guidance to GPs last March by a High Court judge, who ruled the NHS should take action to prevent any potential infringement of a ‘second medical use’ patent Pfizer claimed it held for use of the drug for neuropathic pain.
Generic versions of the drug were already available in the UK because the original patent covering pregabalin use for epilepsy had expired, but Pfizer argued most of the drug is prescribed for neuropathic pain.
The move sparked outrage amongst GPs who warned it impinged on their prescribing independence and involved significant extra workload for already overburdened practices. One CCG billed NHS England for all the work it carried out getting all its’ practices’ patients switched over.
The controversy led LMCs to call for an end to such ‘second use’ patent protection in the NHS, after Pulse highlighted that other ‘re-purposed’ medicines in the pipeline could cause further such disputes to arise.
But Pfizer even called for stronger action on GPs to enforce the prescribing guidance, and offered to reimburse practices for the work involved in switching prescriptions, to help speed up the process, after it claimed most prescriptions were still being done by generic name.
However, in September the High Court ruled Pfizer’s second patent claims – covering pain and neuropathic pain – were invalid, raising the prospect that all the work had been completely unnecessarily.
A Pulse analysis found that the dispute may have cost the NHS tens of millions in pounds by keeping the price of the drug artificially high.
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