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ANALYSIS THIS MONTH


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 last autumn 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 the lower generic price had


been paid for just the 30% of scripts that are not for neuropathic pain, the NHS would still have saved £16m.


Interpretation 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 disagreed ‘with the way in which the data have 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 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 last March 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 learned 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 available since January 2015.


Expert view


The Department of Health told Pulse that, for all indications, it was not able to change the drug tariff that determines how much pharmacists should receive in order to reimburse at a lower price because of the presence of the second patent, . Experts said that, were it not for the second patent, costs would have fallen. Warwick Smith, director general of the British Generic Manufacturers


28 February 2016 Pulse


These figures are shocking at a time when


financial


pressures are limiting care Dr Andrew Green


NHS spend on pregabalin £182m £54m £16m


Actual spend by the NHS, having paid the Lyrica price of £1.15 per capsule dispensed


Association 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


Savings if all pregabalin was dispensed and reimbursed at price of lowest available generic


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 have 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 that can be spent on branded medicines.


Savings if only pregabalin used for neuropathic pain was dispensed and reimbursed at Lyrica price


Source: Health and Social Care Information Centre, GP practice prescribing presentation-level data from February to end of September 2015. NB: Net ingredient cost (NIC) refers to the cost of the drug before discounts and does not include any dispensing costs or fees. It does not include any adjustment for income obtained where a prescription charge is paid at the time the prescription is dispensed or where the patient has purchased a prepayment certificate.


If the NHS spend on branded medicines exceeds that cap then the pharmaceutical industry will return the excess.


The spokesperson 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.’


Time to slash psychoactive drug prescribing? pulsetoday.co.uk/ psychoactive


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