Exclusive Drugs giant Pfizer has called for changes to GP software to ensure only branded pregabalin is prescribed for neuropathic pain, as its legal action involving NHS England and generic manufacturers continues.
In documents submitted to the High Court – and seen by Pulse – Pfizer calls for ‘high severity’ computer warnings that GPs are unable to disable and further guidance to be issued to pharmacists and hospitals to ensure that its patent for the drug Lyrica is respected by prescribers.
The court hearing is the latest in a series of court hearings as the drugs manufacturer seeks to defend its ‘second patent’ on the branded version of pregabalin.
An interim High Court ruling in March ordered NHS England and its equivalent bodies to write to NHS prescribers advising they must specify ‘Lyrica’ when issuing new prescriptions for neuropathic pain.
But it provoked an angry backlash from GPs who warned the guidance undermined the fundamental principle that GPs were free to prescribe according to their clinical judgment and was unfunded work.
The legal case – the first of its kind in the UK – has wide implications, with experts watching closely to see if other drug companies will launch ‘second patent’ bids for existing off-patent drugs in the UK.
In legal documents submitted to the High Court this month, Pfizer argues that current measures have only had a ‘limited effect’.
The document says: ‘The NHS guidance has been welcomed, the unfortunate truth is that it is not fully effective.’
It adds: ‘A top 20 nationwide pharmacy chain has informed [the claimant] that, based on the Patient Care Records maintained in their branches, prescriptions for Lyrica by brand had gone up to about 21% by 21 April and to about 28% by 28 May 2015.
‘These data demonstrate that the NHS guidance, and equivalent in Wales and NI, is only now beginning to have some limited effect on prescribers.’
In the annex to its evidence, it calls for measures to ensure GP software providers: ‘Implement any software warning that Lyrica should be prescribed for the treatment of pain as a “high severity” warning; require that such warnings are applied in all GP practices; and require that such warnings are not switched off or otherwise rendered ineffective by GP practices.’
However, in response the Department of Health said the evidence ‘shows that since the NHS England and other guidance has been issued brand prescribing has risen steadily from practically nothing to approximately 30%’.
The DH added that ‘given the time it takes for guidance to filter through, for doctors to adopt it and for repeat prescriptions to be changed from generic to branded, the rapid rise in brand prescribing for pain suggests that the guidance will routinely be followed as and when doctors are alerted to it’.
Generic pregabalin manufacturer Actavis’s submission stated that the current situation of NHS England-issued guidance suffices.
Its statement says: ‘There is a simple fix as the Court has observed previously, and as Pfizer has agreed: the guidance to prescribers to prescribe for the patented indication by brand. Further, the secretary of state for health agrees, viewing this as “clearly the best and most appropriate, if not the only, way in which the competing interests … can be fairly balanced”. And yet, despite this guidance having been issued, Pfizer has pressed on with this litigation.’
The GPC has advised practices they should follow the NHS prescribing guidance to avoid any litigation and repeated interruptions from pharmacists wanting to check the indication before dispensing the drug.