2 The technology

2 The technology

2.1 Ivabradine (Procoralan, Servier Laboratories) is a heart-rate-lowering agent that selectively and specifically inhibits the cardiac pacemaker If current, which controls the spontaneous diastolic depolarisation in the sinus node that regulates the heart rate. Ivabradine is 'indicated in chronic heart failure NYHA class II to IV with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated'. Ivabradine is administered orally at a recommended starting dose of 5 mg twice daily. This dose may be increased after 2 weeks of treatment to 7.5 mg twice daily if the resting heart rate is above 60 bpm, or decreased to 2.5 mg (half of the 5 mg tablet) twice daily if the resting heart rate is below 50 bpm. For full details of dosage see the summary of product characteristics.

2.2 The summary of product characteristics lists the following adverse reactions for ivabradine: luminous phenomena (phosphenes), bradycardia, atrioventricular first degree, ventricular extrasystoles, blurred vision, headache, dizziness and uncontrolled blood pressure. For full details of adverse reactions and contraindications, see the summary of product characteristics.

2.3 Ivabradine is available in 5 mg and 7.5 mg tablets at a net price of £40.17 per 56-tablet pack (excluding VAT; 'British national formulary' [BNF] edition 63). The manufacturer's submission quoted an average monthly cost of £42.10 (excluding VAT) based on the proportion of patients using 2.5 mg (7%) and either 5 mg or 7.5 mg (93%) in the SHIFT study (see section 3.1). Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)