| Sumario: | Ivabradine (Lancora) is a heart-rate regulating drug for the management of heart failure (HF) that acts by selectively inhibiting the If current in the sinus node. Ivabradine is indicated for the treatment of stable chronic HF with reduced left ventricular ejection fraction (LVEF) d 35% in adult patients with New York Heart Association (NYHA) functional class II or III HF who are in sinus rhythm with a resting heart rate e 77 beats per minute (bpm). Ivabradine is intended to be used in combination with standard chronic HF treatments. The recommended starting dosage of ivabradine is 5 mg twice daily. After two weeks of treatment, the dose may be adjusted as required; if a patient's resting heart rate is persistently at or above 60 bpm, then the dose should be increased to 7.5 mg twice daily. Ivabradine is available as 0.85 mg and 7.5 mg tablets, at the marketed price of 0.85 per 5 mg tablet and 1.56 per 7.5 mg tablet, for a daily cost of 1.70 to 3.11. The manufacturer submitted a cost-utility analysis of ivabradine as an add-on therapy to standard of care (SOC) compared with SOC alone, which includes an angiotensin-converting enzyme inhibitor (ACEI) (or an angiotensin receptor blocker [ARB] if the ACEI is not tolerated), a beta-blocker, and/or a mineralocorticoid receptor antagonist. The submitted model was based on a Markov model previously submitted to the National Institute for Health and Care Excellence (NICE) in the UK, in 2012. The Markov cohort model has two health states -- "alive" and "dead" -- and follows patients with HF through the progression of the disease using monthly cycles run over a lifetime time horizon (approximately 30 years). The model considered NYHA classes and hospitalization events within the "alive" health state. The modelling approach was based on predictive equations for outcomes developed using data from the full population of the Systolic Heart Failure Treatment with the If inhibitor Ivabradine Trial (SHIfT) (heart rate e 70 bpm, NYHA class II to IV patients), though this was a broader population than the one indicated for treatment (heart rate e 77 bpm, NYHA class II or III). The manufacturer noted that the broader (full trial) population was used to develop predictive functions to avoid breaking randomization and avoid reducing the predictive power of the risk equations from a smaller sample size. Adjusted predictive risk equations were used to model transitions between NYHA classes, cardiovascular (CV) mortality and hospitalization, while adjusted trial-derived EuroQol 5-Dimensions questionnaire (EQ-5D) data were used to estimate utility values. The model was set to allow assessment of different populations based on the SHIfT study, including the base case population for which ivabradine is indicated (heart rate e 77 bpm, NYHA class II or III). In the manufacturer's base case probabilistic analysis, the incremental cost-utility ratio (ICUR) for ivabradine plus SOC was 7,969 per quality-adjusted life-year (QALY) compared with SOC alone.
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