MTRAC, the Midlands Therapeutics Review & Advisory Committee, has issued its latest Commissioning Guidance report, covering dabigatran etexilate (Pradaxa®) for stroke prevention in patients with atrial fibrillation (AF).
The Committee concludes that dabigatran is suitable for prescribing in primary care as a second-line treatment. In view of the considerable financial implications, it should however only be prescribed for the following patients:
• Those with co-morbidities who are adherent to warfarin monitoring and lifestyle requirements but need frequent co-prescribed medicines that interact with warfarin and affect the patient’s time in INR therapeutic range
• Those who are adherent to monitoring and lifestyle requirements but whose time in therapeutic range remains unacceptable despite attempts to optimise treatment with warfarin
The report briefly summarises the clinical trial data for dabigatran for this indication, concluding that there is relatively strong evidence of efficacy. The considerable cost impact and concerns about monitoring adherence to treatment and long-term safety gave dabigatran a low place in therapy.