New indication reimbursed for anti-PCSK9 Praluent
France __ The Sanofi laboratory introduced on August 30 that the anti-PCSK9 alirocumab (Praluent®) was now reimbursed within the occasion of a contraindication (CI) or confirmed intolerance to statins and/or ezetimibe.
in grownup sufferers with atherosclerotic heart problems established by a historical past of ACS*, insufficiently managed (LDL-c ≥ 0.7 g/L),
in grownup sufferers with heterozygous familial hypercholesterolemia, at very excessive cardiovascular threat, insufficiently managed and requiring therapy with LDL-apheresis, together with optimized lipid-lowering therapy or alone in case of IC or confirmed intolerance to each statins and ezetimibe.
Initially reserved for sufferers with familial hypercholesterolemia or statin-resistant hypercholesterolemia, the 2 anti-PCSK9 medication at the moment obtainable in France had obtained, in 2020, an extension of their reimbursable therapeutic indications (ITR) together with an optimized lipid-lowering therapy in sufferers adults with atherosclerotic heart problems established by a current historical past of ACS (secondary prevention), uncontrolled (LDL-c ≥ 0.7 g/L) regardless of optimized lipid-lowering therapy comprising at the least one statin on the most tolerated dose.
In return for this extension of indication, medical insurance has submitted the prescription and renewal of those pricey remedies to its prior settlement.
Certainly, anti-PCSK9 are thought-about distinctive medication in France due to their excessive value. And, since December 15, 2021, the reimbursement by medical insurance of the anti-PCSK9 medication, alirocumab and evolocumab, (Repatha ®, Amgen) is topic to the prior settlement of the medical insurance service. This request for prior settlement (DAP) is critical for every prescription, initiation or renewal. Nevertheless, it’s usually tough to acquire this settlement.
Whereas this new indication is not going to resolve the case of prescription requests for sufferers with established atherosclerotic heart problems apart from a current historical past of ACS or who should not have related hypercholesterolemia, it ought to make it potential to simply receive a settlement for sufferers illiberal to statins, in whom statins are contraindicated or not receiving optimized therapy with at the least one statin on the most tolerated dose.
Notice that since April 29, 2022, docs specializing in vascular medication or neurology may implement these remedies. The preliminary annual prescription of those medication was beforehand reserved for specialists in cardiology, endocrinology-diabetology-nutrition or inside medication.
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