OREANDA-NEWS. Amgen (NASDAQ: AMGN) today announced that CVS Health will provide preferred access to Repatha® (evolocumab) through its CVS/caremark commercial formularies.

"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 U.S. Food and Drug Administration 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.1 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.2 In patients with HoFH, Repatha reduced LDL-C by approximately 30 percent compared with placebo.1 

Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood.3,4 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.2,5 Familial hypercholesterolemia is caused by genetic mutations that lead to high levels of LDL-C at an early age.6 It is estimated that one million people in the U.S. have FH (heterozygous and homozygous forms), yet less than one percent are diagnosed.7

Amgen is committed to providing personalized support services for patients and providers in the U.S. through its RepathaReadyTM program. RepathaReady is a comprehensive suite of services to help patients and providers, including one or more months of free Repatha through the Repatha Patient Start Program while insurance coverage is pending; the Repatha $5 co-pay card for eligible commercial patients; insurance coverage support; and injection training for patients. Amgen also provides patient assistance for its medicines marketed in the U.S. in a variety of ways, including free medicines through The Safety Net Foundation for qualifying individuals with no or limited drug coverage.

About Repatha® (evolocumab)
Repatha® (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).8 Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.1

Important Safety Information About Repatha
Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha. Hypersensitivity reactions (e.g. rash, urticaria) have been reported in patients treated with Repatha, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until signs and symptoms resolve.

The most common adverse reactions (>5% of Repatha-treated patients and more common than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. 

In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2% of Repatha-treated patients and 1% of placebo-treated patients. The most common adverse reaction that led to Repatha treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for Repatha and placebo, respectively).

Adverse reactions from a pool of the 52-week trial and seven 12-week trials, included:

Local injection site reactions that occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. The proportions of patients who discontinued treatment due to local injection site reactions in Repatha-treated patients and placebo-treated patients were 0.1% and 0%, respectively. 

Allergic reactions occurred in 5.1% and 4.7% of Repatha-treated and placebo-treated patients, respectively. The most common allergic reactions were rash (1.0% versus 0.5% for Repatha and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

Neurocognitive events were reported in less than or equal to 0.2% in Repatha-treated and placebo-treated patients.

In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1988 patients treated with Repatha had at least one LDL?C value < 25 mg/dL. Changes to background lipid-altering therapy were not made in response to low LDL-C values, and Repatha dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very low levels of LDL-C induced by Repatha are unknown.

Musculoskeletal adverse reactions were reported in 14.3% of Repatha-treated patients and 12.8% of placebo-treated patients. The most common adverse reactions that occurred at a rate greater than placebo were back pain (3.2% versus 2.9% for Repatha and placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).

In 49 patients with homozygous familial hypercholesterolemia studied in a 12-week, double-blind, randomized, placebo-controlled trial, 33 patients received 420 mg of Repatha subcutaneously once monthly. The adverse reactions that occurred in at least 2 (6.1%) Repatha-treated patients and more frequently than in placebo-treated patients, included upper respiratory tract infection (9.1% versus 6.3%), influenza (9.1% versus 0%), gastroenteritis (6.1% versus 0%), and nasopharyngitis (6.1% versus 0%).

About Amgen Cardiovascular
Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses, Amgen is dedicated to addressing important scientific questions to advance care and improve the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide.9Amgen's research into cardiovascular disease, and potential treatment options, is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of today's important unmet patient needs, such as high cholesterol and heart failure.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.