New PCSK9 cholesterol drugs could be next budget busters, says Prime

Prime's internal analysis finds PCSK9 inhibitors (proprotein convertase subtilisin/kexin type 9) could add between $0.93 and $6.71 per member per month (PMPM) to commercially insured coverage costs and up to $15.66 PMPM to Medicare coverage costs depending on which conditions the drugs are approved to treat.

Two PCSK9 inhibitors – Praluent (alirocumab from Regeneron (Nasdaq: REGN) and Sanofi (Euronext: SAN), and Repatha (evolocumab) from Amgen (Nasdaq: AMGN) – are expected to be approved by the US Food and Drug Administration this summer. Just yesterday, an FDA advisory panel voted to recommend Praluent, and Repatha is up for review today.

Unlike traditional statins, which are oral medicines and have inexpensive generic alternatives, PCSK9 inhibitors are self-injected monoclonal antibodies. These drugs act by preventing the protein PCSK9 from interfering with the liver LDL removal process, allowing more LDL cholesterol removal from the blood. A new class of cholesterol-lowering medicines aimed at helping some people improve their low density lipoprotein (LDL), or "bad" cholesterol, could quickly cost the US health system up to $23.3 billion a year, according to new research by pharmacy benefit manager Prime Therapeutics.