Reason for request

Re-assessment of the Actual Benefit and the Improvement in Actual Benefit, initiated by the Transparency Committee (pursuant to Article R-163-21 of the French Social Security Code).

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Clinical Benefit

Low

The actual benefit of RASILEZ is low.

Insufficient

Given the results from the ALTITUDE study, the actual benefit of aliskiren in hypertensive patients treated with a combination already containing a renin-angiotensin system inhibitor (ACEI or ARB II), which included diabetic patients or those with renal impairment, is inadequate to justify its reimbursement through National Insurance.

 


Clinical Added Value

no clinical added value

RASILEZ does not provide an improvement in actual benefit (IAB V) in the management of arterial hypertension in patients not controlled despite using the five categories of antihypertensives (diuretics, ACEIs, ARB IIs, calcium inhibitors and beta-blockers - used alone or in combination with each other) and not treated with another RAAS inhibitor (ACEI or ARB II).


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