INDICATIONS

Repatha® is indicated:

  • In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization... READ MORE
  • Resources for Patient Access and Support

    Materials for Your Office

    • Getting Patients Started on Repatha®

      Specialist Consultation Referral Form

      This form collects the information required to refer patients for consultation with a specialist in the initiation of Repatha® therapy for insurance and coverage purposes.

      Helping Patients Start and Stay on Repatha®

      A reference for you and your office staff to help patients start and stay on Repatha®, including where to find tools, resources, prior authorization information, example ICD-10 codes as well as Co-Pay card information.*

      *Subject to eligible criteria and program maximums. Visit www.repatha.com/copay for full terms and conditions.

    • Patient Education

      Repatha® Patient Onboarding Brochure

      This resource is for patients who are just starting to take Repatha®. It includes information on how to fill their Repatha® prescription, what to expect from Repatha®, and information about the injection.

      Repatha® SureClick Overview
      Resource for Patients

      This resource can be shared with your patients after you have trained them on how to inject. It includes a copy of the Instructions for Use, key injection steps, and resources to get the patient started with at-home injection.

    • CODING RESOURCES

      Example ICD-10 Coding Booklet*

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

      FDA National Drug Code
      Directory

      Medicare Example ICD-10 Coding

      AMA guidance
      on telemedicine coding

      Medicare telemedicine
      healthcare provider fact sheet

      *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.

    • ACCESS AND REIMBURSEMENT RESOURCES

      Repatha® 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.

      Repatha® Sample Appeals Letter

      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.

      Physician Patient Documentation Checklist

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

      Repatha® Coverage & Affordability Brochure

      This brochure provides an overview of information related to improved access and affordability of Repatha® over the years.

    Information for Patients

    • REPATHA® ONBOARDING

      Repatha® Patient Onboarding

      This resource is for patients who are just starting to take Repatha®. It includes information on how to fill their Repatha® prescription, what to expect from Repatha®, and information about the injection.

      Repatha® Patient Brochure

      A resource designed to help patients learn more about treatment with Repatha®.

    • Repatha® Financial SUPPORT RESOURCES

      Repatha® Co-Pay Card for eligible commercial patients

      This informational guide to the Repatha®
      Co-Pay Card includes program details, eligibility criteria, and how to get started.

    • INJECTION SUPPORT RESOURCES

      Every-2-Week Repatha® SureClick® Autoinjector

      Watch a video on how to inject with the Repatha® SureClick® Device (140 mg/mL single-dose prefilled autoinjector).

      Repatha® SureClick®
      Instructions for Use

      Repatha® SureClick Overview
      Resource for Patients

      This patient resource may help with getting started and answering questions about the SureClick® Autoinjector.

      Once-a-Month Repatha®
      Pushtronex® System

      Watch a video on how to inject with the Repatha® Pushtronex® Device (420 mg/3.5 mL single-dose on-body infusor with prefilled cartridge).

      Repatha® Pushtronex® Instructions
      for Use

      Repatha® Prefilled Syringe
      Instructions for Use

      Quick Reference Guide for
      Injection

    NRx, new prescription; PCSK9, proprotein convertase subtilisin/kexin type 9; PCSK9i proprotein convertase subtilisin/kexin type 9 inhibitor.

    Important Safety Information

    Contraindications: 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:

    • In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
    • 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.