Exclusive: GPs face restrictions on their use of the first alternative to warfarin to be approved on the NHS in 50 years, after PCTs and clinical commissioning groups began frantically drawing up prescribing policies to soften the financial impact.
NICE last week gave the green light for GPs to use dabigatran in patients with atrial fibrillation and one additional risk factor for stroke, after evidence it could reduce risk by up to 40% compared with warfarin. But GP commissioners are warning its use as an alternative to warfarin could push up the overall primary care drug budget by as much as 20%, and cost some areas £10m in the new financial year.
CCGs plan emergency measures to limit the impact on the 2012/13 budget, with some to allow GPs only to prescribe the drug to high-risk patients not suitable for warfarin.
The restrictions could turn dabigatran prescribing into a new battleground between CCGs and practices. They could also put CCGs at risk of legal action, particularly with the Government set to insist all drugs recommended in NICE appraisals are included in local formularies within 90 days.
NICE published a final version of its appraisal of dabigatran approving use of the drug after rejecting an appeal by NHS managers, who had argued it would bust drug budgets.
NHS Salford predicted the recommendation would have ‘one of the largest impacts on the NHS to date', but NICE argued it would prove cost-effective in the long term.
Professor Carole Longson, director of the NICE health technology evaluation centre, said: ‘Because dabigatran does not require frequent blood tests it represents a useful alternative for people with atrial fibrillation.'
But leaders of PCTs and CCGs are alarmed at the immediate costs – of around £1,000 extra a year per patient – and the need for wholesale service redesign.
NHS North Yorkshire and York said it faced a £4m financial risk from use of dabigatran, and that it would have to consider decommissioning other services to manage it.
NHS Somerset estimated the prescribing costs of dabigatran would be £9.5m annually – compared with the current £1m for warfarin enhanced services – and plans to give detailed advice to local GPs restricting the drug only to patients at highest risk.
Dr Donal Hynes, PEC chair at NHS Somerset and vice chair of the NHS Alliance, said dabigatran would be a ‘huge cost pressure' and that he planned to restrict GP use to patients who were housebound or had unstable INR levels.
Minutes of the Carlisle locality board warned ‘there is an issue of affordability', and said guidance would be issued to GPs. Dr Peter Weaving, chair of the group and joint chair of Cumbria Clinical Senate, said he hoped local GPs would use the drug only ‘very cautiously': ‘Use of dabigatran as a replacement for warfarin could add 20% to primary care prescribing costs.'
How dabigatran could add to costs
Annual prescribing costs estimated by NHS Somerset (compared with £1m for warfarin services)
Annual cost per patient estimated in Carlisle
Cost per quality-adjusted life year estimated in NICE appraisal
Price per pack assumed in NICE appraisal