- There are currently two PCSK9 inhibitors, Amgen's Repatha (evolocumab) and Sanofi/Regeneron's Praluent (alirocumab), in final stages of development for treatment of hypercholesterolemia.
- Prime Therapeutics, a PBM, is warning that this new class of drugs could cost the healthcare system up to $23.3 billion per year.
- This class of drugs has generated excitement because of clinical trial results showing that they lower "bad" LDL cholesterol by about 60%.
Though the figure seems high up front, the mathematics behind Prime's modeling make sense. PCSK9 inhibitors are being considered for approval for treatment of familial hypercholesterolemia (which only affects about 200,000 Americans), as well as individuals with hypercholesterolemia who are statin intolerant and individuals with refractory hypercholesterolemia. Combined, this represents about 2.3 million Americans.
Prime Therapeutics analysts based their model on an annual price of between $7,000 to $12,000 per year. The analysts warn that much of that cost could be borne by Medicare Part D.
Now that they have issued a warning, Prime's remedy is to make good use of a series of utilization-management strategies, including prior authorizations, quantity limits, and care management.
FDA staff recommended approval of Praluent on Tuesday. A vote on Amgen's competing product is expected Wednesday.