Generic version of Pfizer’s Lyrica launched
pharmafile | March 25, 2015 | News story | Sales and Marketing | CCG, Lyrica, NHS, Pfizer, consilient health, pregabalin, rewisca
A UK pharma firm has launched a cut-price version of Pfizer’s Lyrica along with a bespoke supply chain to ensure prescriptions are honoured, after Pfizer issued legal letters to doctors.
Consilient Health is a manufacturer of generic and speciality pharma products and has launched Rewisca as its generic version of Lyrica (pregabalin). The drug is available to prescribe in the UK, and costs 25% less than the drug tariff price for Lyrica.
Rewisca is available for two of the three Lyrica indications: as an additional treatment for adults with partial seizures with or without secondary generalisation, and for adults with generalised anxiety disorder.
It cannot be prescribed for the third Lyrica indication however – central and neuropathic pain – as this use remains protected by a Pfizer patent until July 2017. The patent for the epilepsy and anxiety indications expired in July last year.
Pfizer has faced criticism for writing to doctors, pharmacists and CCGs in the UK warning them not to prescribe generic or alternative versions of Lyrica for neuropathic pain. The letter urges prescribers to “take necessary action to prevent patent infringement by your organisation” and indicates that the US pharma giant would be willing to contest what it deemed to be challenges to its pain patent.
“In this regard, we believe the patent may be infringed, even potentially unwittingly, by pharmacists and others in the supply chain, if they supply generic pregabalin for the pain indication… which would be an unlawful act” the letter reads.
“We also note that, by issuing guidance, your CCG is able to influence patterns of prescribing and dispensing in your area. We believe these powers must be exercised responsibly and with a view to avoiding the infringement of Pfizer’s pain patent.”
And the GP website Pulse Today notes that pharmacists have been reporting GPs to NHS England if they have prescribed generic pregabalin, “so as not to fall foul of the threats from Pfizer”.
Consilient says the situation surrounding the letter and the subsequent crackdown by NHS England, “has caused concern and some uncertainty amongst healthcare professionals regarding how generic pregabalin should be prescribed and dispensed to avoid unwitting infringement”.
The company has negotiated arrangements with two national suppliers, to ensure that Rewisca will be supplied by pharmacies that receive a Rewisca-branded prescription.
Ahmed Al-Derzi, chief executive of Consilient Health, says: “We are pleased we have been able to launch Rewisca, allowing the NHS to start making immediate savings. We fully respect the current patent protection of Lyrica for use in pain, but appreciate that the situation has created uncertainty. In response, we have invested in the development and design of the Consilient Health Scheme which helps ensure Rewisca can be prescribed and dispensed with confidence for its two indications.”
Pregabalin capsules cost over £212 million in 2013, according to Prescription Cost Analysis data for England. Consilient estimates that prescribing Rewisca within the two approved indications would save between £209.87 and £314.81 for every patient each year.
Pfizer is keen to protect its Lyrica pain patent. The company recently suffered a setback in seeking a paediatric approval in the US after a late-stage trial in adolescents failed to demonstrate significant benefits.
The company’s 2014 financial results showed it is still heavily reliant on Lyrica for sales: in the fourth quarter of 2014 it posted a 3% decline, which could have been worse but for strong performances from Lyrica and other key drugs.
Lilian Anekwe
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