INDICATIONS

Repatha® is indicated:

  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults with established cardiovascular disease.. READ MORE

    • For US healthcare professionals

    Resources for Patient Access and Support

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    STARTING PATIENTS ON REPATHA®

    Repatha® (evolocumab) Patient Onboarding Brochure

    Repatha® Patient Brochure

    This comprehensive resource helps equip your patients with information for their Repatha® treatment, including information on preparation, an LDL-C Tracker, and financial support information for patients’.

    Financial Support and Resources

    Financial & Patient Support Resources

    Learn more about how Amgen SupportPlus can help your patients access their prescribed medication.

    Email

    Send your patients a direct link to enroll in the services provided by Amgen SupportPlus

    Repatha® (evolocumab) Co-Pay Card

    Repatha® Co-Pay Card Brochure

    Your eligible commercially insured patients may pay as little $15 per month* with the Repatha® (evolocumab) Co-pay Card.

    *Eligibility criteria and program maximums apply. Please see full Terms and Conditions at Repatha.com/copaytcs.

    Repatha® (evolocumab) SureClick® Autoinjector

    SureClick® Autoinjector Support Resources

    Review the Instructions for Use and following resources:

    2

    ACCESS & REIMBURSEMENT RESOURCES

    Sample Letter of Appeal

    Sample Letter of Appeal

    This sample letter is a template that can be used to support the clinical rationale for prescribing Repatha®. This can be used during the appeals process.

    Sample Letter of Medical Necessity

    Sample Letter of Medical Necessity

    This sample letter is a template that can be used to support the clinical rationale for prescribing Repatha®, if required to accompany a prior authorization.

    Physician Patient Documentation Checklist

    Physician Patient Documentation Checklist

    This checklist can organize specific information about patients’ diagnosis and treatment history to help complete a prior authorization.

    Example ICD-10 Coding Booklet

    Example ICD-10 Coding Booklet*

    This resource provides an informational guide to example ICD-10 codes frequently applicable to appropriate patients for Repatha®.

    *Sample diagnosis codes are informational and not intended to be directive or a guarantee of reimbursement and include potential codes that would include FDA-approved indications for Repatha®. Other codes may be more appropriate given internal system guidelines, payer requirements, practice patterns, and the services rendered. It is the duty of the provider to understand individual patient considerations and use their own judgment and clinical decision making when determining a particular patient’s diagnosis and treatment.

    3

    Additional Resources*

    *Sample diagnosis codes are informational and not intended to be directive or a guarantee of reimbursement and include potential codes that would include FDA-approved indications for Repatha®. Other codes may be more appropriate given internal system guidelines, payer requirements, practice patterns, and the services rendered. It is the duty of the provider to understand individual patient considerations and use their own judgment and clinical decision making when determining a particular patient’s diagnosis and treatment.

    Disclaimer: These links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Amgen of any of the products, services, or opinions of the organization or individual. Amgen bears no responsibility for the accuracy, legality, or content of the external site or for that of subsequent links.

    Important Safety Information

    Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.

    Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity 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: The most common adverse reactions (>5% of patients treated with Repatha® and 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. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity 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 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 treated with Repatha® compared with 7.7% in patients that received placebo.

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

    Indications

    Repatha® is indicated:

    • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults with established cardiovascular disease
    • as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C

    Please see full Prescribing Information.

    Important Safety Information

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