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Amgen Commitment to Improve Patient Access to Repatha® (evolocumab)

Cardiovascular disease remains a leading health issue in the U.S., with 790,000 heart attacks and 795,000 strokes annually.1 Repatha, an innovative medicine approved by the FDA to prevent heart attacks and strokes in patients with established cardiovascular disease, can help lessen this burden. Doctors prescribing Repatha often face time-consuming challenges from insurers and pharmacy benefit managers before their patients are approved to receive this therapy.  Such delays put these patients at additional risk for heart attacks and strokes.

At the recent American Heart Association’s “Value in Healthcare Summit” held on March 5th in Washington, D.C., various stakeholders agreed to act on behalf of patients with cardiovascular disease.  Over the last several weeks, Amgen has offered payers meaningful reductions in price for those who significantly improve access, and we look forward to hearing from them soon.  It is critical that high-risk patients gain improved access to Repatha.

Amgen continues to offer personalized support services for insured patients and providers in the U.S. through its RepathaReady® program, which is a comprehensive suite of services to help patients and providers, including a Repatha $5 co-pay card for eligible commercial patients. In addition, the Amgen Safety Net Foundation also provides Repatha at no cost to qualifying uninsured patients and Commercial and government patients with no drug coverage. Amgen also offers payers innovative contracts, including one that offers a refund of the cost of Repatha for all of their eligible patients who have a heart attack or stroke.

“With its proven ability to prevent heart attacks and strokes, Repatha offers hope for one of the greatest public health challenges facing society. However, seven out of ten Americans with cardiovascular disease who are prescribed Repatha find their prescriptions rejected by their pharmacy benefit manager or insurer,” said Robert A. Bradway, chairman and chief executive officer. “We won’t stand by when every forty seconds an American has a heart attack or stroke, some of which might well be prevented by Repatha.  We are partnering with health plans and pharmacy benefit managers to provide improved access to and affordability for Repatha.”

Based on 2016 rejection and event rates, the data suggest that if all appropriate patients were prescribed PCSK9 inhibitors, over 110,000 acute cardiovascular events would occur in patients inappropriately rejected.2

“Physicians now have the results of three large cardiovascular outcomes studies of varying designs performed with three different PCSK9 inhibitors. These studies together clearly establish that lowering LDL cholesterol by the PCSK9 mechanism meaningfully reduces cardiovascular risk and the benefit grows over time,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The science also clearly indicates that “lower is better” with respect to the relationship between LDL lowering and cardiovascular risk. Repatha provides extremely potent LDL lowering efficacy and is therefore of high clinical and economic value.”

Repatha is a groundbreaking medicine proven to dramatically lower “bad cholesterol” or low-density lipoprotein (LDL). Elevated “bad cholesterol” or LDL-C is one of the most important modifiable risk factors for heart attack and stroke prevention. Repatha is for high-risk patients who suffer from a combination of high LDL and cardiovascular disease, and who continue to struggle with lowering their LDL despite statin therapy. In December, the U.S. Food and Drug Administration (FDA) approved Repatha as the only PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease.

U.S. Repatha Indication

Repatha is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor antibody indicated:

  • to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.
  • as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary  hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) to reduce low-density lipoprotein cholesterol (LDL-C).
  • as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDLC.

The safety and effectiveness of Repatha have not been established in pediatric patients with HoFH who are younger than 13 years old or in pediatric patients with primary hyperlipidemia or HeFH.

Important U.S. Safety Information

Contraindication: Repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha.

Allergic reactions: 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.

Adverse reactions: The most common adverse reactions (>5 percent of Repatha-treated patients and occurring more frequently than placebo) in controlled trials involving patients with primary hyperlipidemia, including HeFH, 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 percent of Repatha-treated patients and 1 percent 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 percent versus 0 percent for Repatha and placebo, respectively).

Adverse reactions from a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2 percent and 3.0 percent 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 percent and 0 percent, respectively.

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

The safety profile of Repatha in the cardiovascular outcomes trial was generally consistent with the safety profile in the 12- and 52-week controlled trials involving patients with primary hyperlipidemia, including HeFH. Serious adverse events occurred in 24.8 percent and 24.7 percent of Repatha-treated and placebo-treated patients, respectively. Adverse events led to discontinuation of study treatment in 4.4 percent of patients assigned to Repatha and 4.2 percent assigned to placebo. Common adverse reactions (>5 percent of patients treated with Repatha and occurring more frequently than placebo) included diabetes mellitus (8.8 percent Repatha, 8.2 percent placebo), nasopharyngitis (7.8 percent Repatha, 7.4 percent placebo) and upper respiratory tract infection (5.1 percent Repatha, 4.8 percent placebo). Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1 percent in patients assigned to Repatha compared with 7.7 percent in those assigned to placebo.

Homozygous Familial Hypercholesterolemia (HoFH): 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 percent) Repatha-treated patients and more frequently than in placebo-treated patients, included upper respiratory tract infection (9.1 percent versus 6.3 percent), influenza (9.1 percent versus 0 percent), gastroenteritis (6.1 percent versus 0 percent), and nasopharyngitis (6.1 percent versus 0 percent).

Immunogenicity: Repatha is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with Repatha

Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436) or 844-REPATHA (844-737-2842) regarding Repatha® availability or find more information, including full Prescribing Information, at www.amgen.com and www.Repatha.com.

References

  1. Benjamin, E.J., et al. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation 135, e146-e603 (2017).
  2. Baum, SJ, et al. Cardiovascular Risk in Patients Denied Access to Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Therapy. Poster session presented at the American College of Cardiology 2018 Scientific Sessions.