GPs have been issued the first guidance on the use of new oral anticoagulants in primary care and warned they will face intense patient pressure, as well as significant service redesign, when the drugs become available as alternatives to warfarin.
A raft of new oral anticoagulants is set to be approved for prescription in the UK over the coming year for the prevention of stroke in patients with atrial fibrillation, which will heap more pressure on overstretched PCT prescribing budgets.
The UK Clinical Pharmacy Association has issued a position statement on the use of the new, in preparation for the forthcoming licensing of dabigatran, manufactured by Boehringer Ingelheim, and rivaroxaban, manufactured by Bayer.
The UKCPA warned ‘the introduction of these new agents will require significant pathway redesign and realignment of anticoagulant services in order to offset the additional cost associated with these drugs.’
The position statement, it says, ‘will assist decision makers in defining the appropriate use of new oral anticoagulants for stroke prevention in atrial fibrillation until national guidance is published and long-term service redesign can be implemented.’
NICE is currently finalising a final technology appraisal, due to be published in December band will announce in the next month whether to launch a full-scale review of its clinical guidance on atrial fibrillation, published in 2006.
The UKCPA guidance warns GPs should be prepared to ‘manage patient expectations in terms of access to these agents, as wide media coverage is anticipated at launch.’
It came as a randomised controlled trial of over 14,000 patients published in the New England Journal of Medicine found the 20mg dose of rivaroxaban was non-inferior to warfarin and reduced the rate of a composite primary endpoint of ischaemic or haemorrhagic stroke and systemic embolism by 21% compared to warfarin, to 1.7% per year compared to 2.2% per year in the warfarin group.
In an intention to treat analysis the primary endpoint occurred in 2.1% of patients per year in the rivaroxaban group compared with 2.4% of patients per year in the warfarin group, a significant difference showing non-inferiority, but did not prove superiority.
The rate of clinically relevant bleeding was higher in the rivaroxaban group, at 14.9% per year, than the 14.5% per year seen in the warfarin group but this difference was not statistically significant and the researchers argued ‘bleeding that proved fatal or involved a critical anatomical site occurred less frequently in the rivaroxaban group.’
Study leader Dr Manesh Patel, a cardiologist at Duke University medical center in North Carolina, conclude: ‘The efficacy of rivaroxabn, as compared with warfarin was as favourable in centers with the best INR control as in those with poorer control.’