- For most patients treated with Amgen's recently approved PCSK9 inhibitor Repatha (evolocumab), dosing is 140 mg every other week. Amgen has asked the FDA to approve a once-monthly dosing option for the cholesterol-lowering medication.
- Repatha is approved for treatment of hypercholesterolemia in patients who have cardiovascular disease (CVD), as well as treatment of hereditary hypercholesterolemia, also known as heterozygous familial hypercholesterolemia (HeFH). It is also approved for homozygous familial hypercholesterolemia (HoFH), which is a rare condition.
- The only patients who can currently receive once-monthly dosing with Repatha are patients with HoFH—at a dose of 420 mg.
Regardless of whether the FDA approves the dosing expansion, Amgen has already said that the once-montly dosing option won't be available until next year.
This request is taking place in the context of a heated debate over price in which budget-conscious payers, including CVS Health Corp and Aetna, the latter of which has already imposed limitations on eligibility for both Repatha and Sanofi/Regeneron's competing Praluent (alirocumab). With costs ranging from $14,000 to $14,600 per year, the Institute for Clinical and Economic Review (ICER) has estimated that costs could hit $20 billion if only 25% of eligible patients use the drugs.
The question here is whether having a more convenient dosing option for a broader pool of patients will increase uptake among physicians and patients and provide Amgen with a competitive advantage. However, a more important question is whether a modified dosing regimen will be cheaper. That issue is still very much in flux.