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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

NHS pregabilin spend 2015

 

Readers' comments (21)

  • So what?

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  • Blahdy, blahdy, blah. It's not our money, it is the Goevernment's. The same Government that abuses and exploits GP's.

    Are you prepared to bargain, argue etc with patients?
    What would that mean for you other than complaints for which you receive no support and which are driving up our indemnity fees?

    Drug costs are not our problem. Prescribe away folks!
    OR
    If you want a really definitive solution - Ditch the contract comrades!

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  • Why generic prescribing?
    Pharma companies invest billions in drug research that our government is not prepared to. More exploitation, from a government that invests nothing, but expects everything.
    Collusion with generic prescribing inhibits future drug development. You are a doctor. Is that what you want?
    Do not let the politicians coerce you into destroying research and degrading healthcare.

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  • 1:37 - this is not 'The Government's money' - this is money allocated to the NHS which could be paying for something else.
    1.58 - drug companies make huge profits - they have patents to protect their rights and once these are over, other companies can step in and make these drugs at nearer to cost price. If we simply pay top branded prices, there will be no money for anything else.

    It is up to us as GPs to make sure we do not waste resources so that our patients can benefit the most from the resources the NHS can offer. To waste money by not caring seems completely alien to me. I will prescribe drugs that are expensive if these will help my patients but will always try to choose the most cost effective treatments. Isn't that part of our job?

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  • I'm with the first 3 comments. No one cares about our work load, our costs, our (forever falling) income, our (forever increased) expenses. I couldn't care less about saving money that costs me or the patient nothing, but is benefiting the patient I'm prescribing it to. Show someone cares about GP's and I'll reconsider. Until then, its about the patient only, if they want a referral they get it, if they want branded they get it. End of story

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  • Vested interests of Hospital Consultants with the drug companies has much to blame here! Audit/probe them ...along with the CEO's ...and the Politicians....the trail continues right to the top!
    ...as long as the NHS suffers, all is good!

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  • 9.24 - but it is costing you and the patient money - where do you think the money comes from? I agree that we have a ridiculous workload and money is not being put where it should be, but surely wasting money only makes this worse?

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  • It is not necessarily a waste of money to prescribe trade names. If investors in drug companies do not see a decent return, where will the money come from to develop new drugs? Our government does not wish to invest in anything medical, let alone new drugs. Its tight fisted approach which forces drug companies to provide drugs to the NHS at a lower rate, is also causing drug shortages in the UK as pharmacists buy them at low NHS prices and then sell them on in other countries at a profit.
    We/our government has a something for nothing attitude and with our relatively small population we cannot successfully bully a global market. And when patients cannot get their meds it is the GP who has to spend time changing treatment regimes and reissuing prescriptions. The same GP that is expected to spend their (block contracted –so who cares how long it takes?) time making generic switches and arguing with patients over it.
    Please do not attack me over this pharmacists. I know it is not all of you. Reports suggest it is around 11%.

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  • Lyrica = we can all send a message. Prescribe away folks.

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  • If all pregabalin prescriptions are being paid to pharmacists at the rate for Lyrica, are pharmacists making a windfall if they can - legitimately - dispense generically?
    What happens in the reverse situation: prescribed generically but - for whatever reason - dispensed by trade name?(I remember having to change the prescription on occassion) or where the branded product is cheaper than the generic?

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