Article
Author(s):
Murdo Gordon, Executive Vice President, Global Commercial Operations for Amgen is responsible for ensuring Amgen’s innovative medicines reach patients around the world.
Although the world is focused on the COVID-19 pandemic, heart disease remains one of the most important public health issues of our time and we can’t lose sight of the significant impact it continues to have on our society. To put this in context: a heart attack strikes every 40 seconds in the U.S., which is almost 800,000 heart attacks every year.[1] Of those, 25% are recurrent heart attacks in people who have already suffered at least one earlier in life.[1] For this reason, Amgen is committed to continued research and development in this field because we need more innovation, not less, to help these patients.
This past summer marked the fifth anniversary of regulatory approval for Repatha® (evolocumab)— Amgen’s innovative cholesterol-lowering medicine. Repatha® is also proven to reduce the risk of another heart attack for patients with established cardiovascular disease.
It took our scientists more than a decade to research, develop and make Repatha® available to patients. But in today’s healthcare environment, medical innovation is not enough. Affordability is a necessity—especially for people who need a medicine like Repatha® to reduce the risk of another life-changing heart attack.
That’s why Amgen reduced the list price of Repatha® by 60% and worked with insurance companies and pharmacy benefit managers to reduce access barriers over the past year. We’re pleased to report that we’ve made significant progress for patients. It’s about time!
Today, more than 80%* of prescriptions for Repatha® patients have an affordable co-pay of less than $50 per month.[2] And eligible commercial patients could pay as little as $5 per month with the Repatha® Copay Card†. Further, many access barriers have been addressed, and now, eight out of 10 patients‡ have formulary coverage for Repatha®.[3]
We’re committed to keeping Repatha® affordable and reducing barriers to access for everyone who needs Repatha®, and we are not going to stop. You can count on us because every heart counts.
Important Safety Information
Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.
Allergic Reactions: Hypersensitivity reactions (e.g. angioedema, 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 in Primary Hyperlipidemia (including HeFH): The most common adverse reactions (>5% of patients treated with Repatha® and occurring more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
From a pool of the 52‐week trial and seven 12‐week trials: Local injection site reactions 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.
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%).
Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and occurring more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).
Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new‐onset diabetes mellitus during the trial was 8.1% in patients assigned to Repatha® compared with 7.7% in those assigned to placebo.
Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.
Indications
Prevention of Cardiovascular Events: In adults with established cardiovascular disease, Repatha® is indicated to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
Primary Hyperlipidemia (including Heterozygous Familial Hypercholesterolemia): Repatha® is indicated as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C).
Please see full Prescribing Information.
For more information on how to access Repatha®, please visit www.RepathaHCP.com/affordable.
*Based on IQVIA claims data from 01/2020 to 08/2020 using Commercial, Medicare, and Medicaid claims.
†Eligibility requirements for the Repatha® Copay Card: Open to patients with commercial prescription insurance and who are not enrolled in any government-funded program that pays for prescription drugs. This program is not open to uninsured patients or patients enrolled in any federal-, state-, or government-funded healthcare program such as Medicare, Medicare Advantage, Medicare Part D, the Retiree Drug Subsidy Program, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD) or TRICARE®, or where prohibited by law. Cash Discount Cards and other noninsurance plans are not valid as primary insurance coverage under this offer. Other restrictions, including annual copay maximum limits may apply. This offer is subject to change or discontinuation without notice. Please visit Repatha.com for full terms and conditions.
‡Based on MMIT data as of 09/2020 for Commercial, Medicare, and Medicaid lives.
[1] Benjamin, EJ, et al. Circulation. 2019; 139: e56-e528.
[2] Data on File, Amgen; [1]; 2020.
[3] Data on File, Amgen; [2]; 2020.