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ICER Comfirms Vascepa Benefit
The Institute for Clinical and Economical Review (ICER) is a "Boston-based independent nonprofit organization that seeks to improve healthcare value by providing comprehensive clinical and cost-effectiveness analyses of treatments, tests, and procedures" (Source: AHDB).
Their independent reviews are becoming more & more influential since its inception in 2005.
ICER recently released their review of Vascepa for the population of patients studied in Amarin's (AMRN) REDUCE-IT.
ICER Grading System
ICER graded Vascepa with a B+ citing "moderate certainty of a small or substantial net health benefit, with high certainty of at least a small net health benefit". With this grade, ICER considers the effectiveness, safety, long-term benefits/risks, and cost of the drug.
A B+ rating is a high mark, but would likely be improved if the mineral oil concerns would be laid to rest and their was other conclusive evidence of pure EPA procuring similar benefits.
Safety & Efficacy
Vascepa is well-tolerated, which is key for a drug that is going to be utilized in broad indications, but it does come with some issues:
The significant increases in heart arrhythmia are not entirely unexpected of icosapent ethyl (Vascepa).
Bleeding episodes is probably representative of Vascepa's antithrombotic properties (this property is also a reason why Vascepa is effective). This side effect is not unique for historically great drugs that provide net benefits (see aspirin, plavix). Furthermore, Vascepa-treated patients were without any fatal bleeding events.
ICER did raise concerns over the impact of the use of mineral oil as placebo:
Biomarker changes observed in the trial raise the possibility that the mineral oil used was not biologically inert, however; patients in the placebo arm experienced a threefold-higher percentage increase in LDL-C at year one (10.2% vs. 3.1% for icosapent ethyl, p<0.001 for between-group difference) and a substantial increase in the inflammation marker hsCRP at year two (32.9% vs. -13.9%, p<0.001), adding to documented concerns regarding the mineral oil’s potential interference with statin absorption.9 As described above, the manufacturer conducted a post-hoc analysis, which stratified patients with and without on-trial increases in LDL-C in the placebo arm. The results of this analysis suggested a consistent risk reduction with icosapent ethyl irrespective of whether LDL-C increased in the placebo arm. However, it is difficult to interpret analyses of effects utilizing on-treatment response subgroups, and so residual concerns remain about a potentially biologically active “placebo” and the possibility that the true effect of icosapent ethyl may be attenuated from that observed in the REDUCE-IT trial. To the best of our knowledge, similar analyses have not been performed in relation to changes in hsCRP from baseline.
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Disclosure: I am/we are long AMRN.