Reason for request
Inclusion on the list of medicines refundable by National Health Insurance (B/56 only) and approved for hospital use (B/56 and B/100) in the extension of indication: “Treatment of chronic heart failure: Ivabradine is indicated in the treatment of 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”.
The actual benefit of these proprietary medicinal products is substantial.
Clinical Added Value
Taking into account the results of the SHIFT study, PROCORALAN offers a minor
improvement in actual benefit (IAB IV) in the therapeutic strategy and only in patients with stable class II to III heart failure with systolic dysfunction, sinus rhythm and a heart rate ≥ 77 bpm in whom beta-blockers are contraindicated or poorly tolerated.
|no clinical added value
In other patients, PROCORALAN does not offer any improvement in actual benefit (IAB V).