Pregabalin patent dispute could have cost the NHS up to £54m
Exclusive The NHS potentially could have saved tens of millions on its pregabalin prescribing bill if it had been paying the price of the cheapest available generic version of the drug, and not that for Pfizer’s ‘Lyrica’ drug.
An analysis of official NHS prescribing data conducted by Pulse and the research division of its publisher, Cogora, estimates that the £182m spent on pregabalin between February and September 2015 could potentially have been reduced by almost 30%.
GPs are currently being forced to prescribe the branded version of pregabalin for neuropathic pain due to the presence of a ‘second medical patent’ held by Pfizer, which covers this indication. Pulse has found that, as a result of this second patent, the NHS has had to reimburse pharmacists at a net ingredient cost of £1.15 per capsule – the cost of Lyrica – despite cheaper alternatives being available at 81p per capsule.
This potentially cost the NHS £54m last year, despite a High Court ruling this year that found that the neuropathic pain aspect of the second patent was not valid. Pfizer is appealing that decision.
Pulse has also discovered that the NHS is still paying the Lyrica price of £1.15 even for generic pregabalin prescriptions that are not for neuropathic pain, where the patent does not apply.
Even if it had paid the lower generic price only for the 30% of prescriptions that are not for neuropathic pain, it still would have saved £16m.
GP leaders have said that if accurate the figures are ‘truly shocking’ at a time of austerity in the health service. But Pfizer told Pulse that the company disagrees ‘with the way in which the data has been interpreted’.
The company maintains that it is necessary for pharmaceutical companies to defend their patents to fund the costs of research and development and that it is not seeking to prevent the use of generic pregabalin for generalised anxiety disorder or epilepsy.
Pfizer’s main patent for Lyrica in the UK had expired in July 2014, but it still held a ‘second medical use’ patent for the drug when it is prescribed for the indication of neuropathic pain.
An interim legal judgment in favour of Pfizer in March 2015 forced GPs to switch thousands of patients’ prescriptions for generic pregabalin to Lyrica. This continues despite a second High Court ruling in September 2015 that Pfizer’s ‘second patent’ claim covering neuropathic pain was invalid.
The legal position is still to be finally decided as the drug company is appealing the September 2015 ruling.
Neuropathic pain accounts for the majority of pregabalin prescriptions – around 70% – but Pulse has also learnt that the second Pfizer patent has meant that even for other indications generic pregabalin is being reimbursed by the NHS at the higher Lyrica price, despite alternatives being made available from January 2015.
The Department of Health told Pulse that, for all indications, it was not able to change the drug tariff in order to reimburse at a lower price because of the presence of the second patent, which determines how much pharmacists should receive.
Experts said that, were it not for the second patent, costs would have fallen. Warwick Smith, director general of the British Generic Manufacturers Association (BGMA) said: ‘We would ordinarily expect a product such as pregablin to move from Category C to Category M of the Drug Tariff quite quickly’.
Dr Andrew Green, a GP in east Yorkshire and chair of the GPC’s prescribing subcommittee, said: ‘These figures are truly shocking at a time when financial pressures in the NHS are placing such limitations on the care that patients receive.’
But a Pfizer spokesperson said: ‘Pfizer disagrees with the way in which the Health and Social Care Information Centre data has been interpreted. The savings calculated are based on a theoretical assumption which does not reflect the reality of the reimbursement of generic prescriptions.’
The spokesperson added that under the current reimbursement system for drugs in the NHS there is a cap on the amount spent on branded medicines.
If the NHS spend on branded medicines exceeds that cap then the pharmaceutical industry will return the difference between what is spent and the cap.
She added: ‘Pfizer maintains its strong belief in the validity, and importance, of the second medical use patent for the use of Lyrica in pain.
‘Pfizer is not seeking to prevent the use of generic pregabalin to treat generalised anxiety disorder or epilepsy, which are not patent protected.’
NHS pregabilin spend 2015