The first of two cholesterol-lowering PCSK9 inhibitors (proprotein convertase subtilisin/kexin type 9) is expected to be approved by the US Food and Drug Administration as early as this week.
However, just this week the first such PCSK9 inhibitor, US biotech major Amgen’s (Nasdaq: AMGN) Repatha (evolocumab), was approved by the European Commission (The Pharma Letter July 21). Repatha is expecting imminent US approval, as is Regeneron (Nasdaq: REGN) and Sanofi’s (Euronext: SAN) Praluent (alirocumab), which is likely to be the first.
To guide its utilization management approach of these new drugs, US pharmacy benefits manager Prime Therapeutics analyzed its claims data and confirmed current statin treatments were not being used or adhered to as guidelines recommend. Adherence to statins is a long-standing national problem which is well studied and documented. Not surprisingly, Prime's analysis validates there is a significant opportunity to optimize statin use even for members who may be eligible for PCSK9s.
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