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PROCORALAN

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Opinions on drugs - Posted on May 21 2013

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”.

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Clinical Benefit

Substantial

The actual benefit of these proprietary medicinal products is substantial.


Clinical Added Value

minor

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).


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