“Ensuring access to Repatha for appropriate patients is among Amgen’s highest priorities, and we are delighted that CVS Health has granted Repatha a preferred position on their commercial formularies,” said Anthony C. Hooper, Executive Vice President of Global Commercial Operations at Amgen. “Value-based partnerships are a key area of focus for Amgen, and Repatha gave us a great opportunity to offer value-based contracts that address payers’ concerns by linking the net price of Repatha to expected LDL cholesterol reductions and anticipated appropriate patient utilization. This is an important milestone for patients, and we will continue to engage constructively with other payers to enable patients to have access to Repatha.”
Repatha, approved by the FDA on Aug. 27, is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C); and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. The effect of Repatha on cardiovascular morbidity and mortality has not been determined.
In Phase 3 trials, adding Repatha to background lipid-lowering therapy that included statins resulted in intensive reductions in LDL-C levels with favorable effects on other lipid parameters. In patients with clinical ASCVD or HeFH, Repatha reduced LDL-C by approximately 54 to 77 percent compared with placebo. In a pivotal Phase 3 trial, 90 percent of clinical ASCVD patients who received Repatha in addition to maximum doses of statins achieved a LDL-C level less than 70 mg/dL. In patients with HoFH, Repatha reduced LDL-C by approximately 30 percent compared with placebo.
Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood. In the U.S., there are approximately 11 million people with ASCVD and/or familial hypercholesterolemia (FH), who have uncontrolled levels of LDL-C over 70 mg/dL, despite treatment with statins or other cholesterol-lowering therapies. Familial hypercholesterolemia is caused by genetic mutations that lead to high levels of LDL-C at an early age. It is estimated that one million people in the U.S. have FH (heterozygous and homozygous forms), yet less than one percent are diagnosed.