Prospective GErman CV High Risk PatIents DYSlipidemia Treatment Indication Registry (PERI-DYS)
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The treatment of patients at high cardiovascular (HR) or very high cardiovascular (VHR) risk faces the limitations specified above: First, effect size of the formerly available therapies does frequently not suffice to achieve the treatment goal. Second, starting LDL-C level is too high to get at goal. Third, even by administering combination treatment the required LDL-C level cannot be achieved. Fourth, some patients may get no statin treatment at all or only a sub-optimal dose due to adherence problems caused by side effects and other tolerability issues.
Since end of 2015 two PCSK9i MABs (Repatha® and Praluent®) are approved in Germany as a further treatment option once the stipulated LDL-C treatment goal cannot be achieved. In parallel to the utility assessment of the two compounds according to the AMNOG law a ‘prescription restriction’ regulation was drafted for Repatha® 24 in February 2016 as well as for Praluent® 25 in May 2016 regulating that the two compounds are only to be used in a health - economically cost efficient manner. It is defining a narrowed patient population (within the CV VHR patient population) and a specific board-certified specialist group who will be entitled to prescribe this compound class. One key criterion to define this patient group is lack of LDL-C treatment target fulfillment despite maximally tolerated lipid lowering therapy (LLT) and hence qualification for LDL-C apheresis as per criteria established by the G-BA.26 Further, documented evidence of disease progression and a time span of documentation that current LLT options failed to get to treatment goal are required before PCSK9i’s can be prescribed.
Despite these regulations there is still physicians’ discretion left whom to treat with PCSK9i and whom not to treat with these. Furthermore there will be likely variability in detailed patient profiles, prior treatments applied, distance to LLT targets as well as how progressed the CV disease will be once a patient will be considered for PCSK9i. In addition this may vary among certain specialist groups or even within those. The availability of lipid apheresis in Germany, the need of intravenous access, patients’ willingness to undergo it or rare medical conditions that abrogate the conduct of an extracorporal procedure may add up to this variability.