Confidence in Coverage, Cost, and Support on the Path to Repatha® Access

Getting Started with Repatha®

Your Amgen Team
is Here to Help

For support & resources, call
your Repatha® representative or
1-844-REPATHA.

1. Gather clinical documentation

  • Diagnosis details (chart notes)

  • Recent lipid panel including LDL with dates, usually within 30 days

  • History of other lipid-lowering therapy (chart notes)

2. Submit prior authorization (PA)

  • Follow the same process you normally follow for PAs

  • Payers typically require PA form and supporting clinical documentation

  • You can access PA requirements and forms at RepathaCoverage.com

  • If you need help getting started, specialty pharmacies in the Repatha® network can help

3. Contact us for support

  • The plan may request additional information for approval. Call your Repatha® representative and we can help

NEXT:Coverage

Repatha® is the #1 prescribed PCSK9 inhibitor and is covered by most insurance plans1,2,*,†

91%

of adults are covered

for Repatha®
in the US2,†

~44,000

patients have

received
Repatha®1,‡

*Based on IMS (TRx) data for the period of September 11, 2015 to June 2, 2017.

Repatha® is on the formulary of the plans of 91% of adults with prescription drug coverage. Based on reported coverage as of March, 2017. Source: Managed Markets Insights & Technology.

Based on IMS (NBRx) data for the period of September 11, 2015 to June 2, 2017. These data include only dispensed scripts.

NEXT:Cost

Amgen is Committed to Helping Patients Access Their Medicines

Commercial Commercial Commercial
National Medicare Part D National Medicare Part D National Medicare Part D

For patient assistance, call 1-844-REPATHA

*Eligibility Criteria―Open to patients with a Repatha® prescription who have commercial insurance. Patients may not seek reimbursement for value received from the Repatha® Copay Card from any third-party payers, including a flexible spending account or a healthcare savings account. This program is not open to patients receiving prescription reimbursement under any federal, state or government-funded healthcare program, such as Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD) or TRICARE® or where prohibited by law. If at any time patients begin receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patients will no longer be able to use this card and you must call 1-844-REPATHA to stop participation. Restrictions may apply. Offer subject to change or discontinuation without notice.

LIS = low-income subsidy.

NEXT:Clinical Documentation

Your Amgen team can help through the payer approval process

Repatha® requires a prior authorization (PA) and is typically filled through a specialty pharmacy

Diagnosis Details (Chart Notes)

  • For patients with primary hyperlipidemia and clinical ASCVD or FH: primary & secondary ICD-10 codes

  • For patients with FH: diagnostic criteria used (eg, Simon Broome, Dutch Lipid Clinical Network)

Recent Lipid Panel Including LDL Labs with Dates

  • Typically in the last 30 days; if the patient has tried Repatha®, remember to include PRE- and POST-Repatha® LDL levels

History of Other Lipid-Lowering Treatment (Chart Notes)

  • Chart notes (EMR) indicating current treatment, history of statins and other lipid-lowering drugs (maximum dosage and dates/duration for each treatment)

Review Repatha®
Documentation Pocket Guide

for documentation checklists and
additional details.

Download

Specific plan requirements may vary: additional clinical information and documentation may be required.

NEXT:Support

Amgen is here to help your patients start and stay on Repatha®

Insurance Support

Your Amgen team offers resources for insurance support, including:

Prior Authorization
(PA) process

In-office support from the
Repatha® Access Specialists

You can also call 1-844-REPATHA
to speak with a live counselor

Patient & Prescription Reminders

  • Once approved, don’t forget to send the prescription to the specialty pharmacy, which may be mandated by the patient’s payer

  • Remind your commercially insured patients that they pay no more than $5 per month with the Repatha® Copay Card*–patients must visit Repatha.com or call 1‑844‑REPATHA to activate their card

  • Inform your patients to expect a call from the pharmacy so they can coordinate payment, financial assistance, and delivery

  • Schedule follow-up to check lab results and patient progress

Rely on RepathaReady® to help your patients get on the path with Repatha®

Call 1-844-REPATHA for patient support, including:

  • Patient support & injection training from RepathaReady® nurses

  • Repatha® copay enrollment

  • Medication reminders

  • Emails and resources to help patients start and stay on therapy

  • Free needle disposal kits mailed to your patient’s door

*Eligibility Criteria―Open to patients with a Repatha® prescription who have commercial insurance. Patients may not seek reimbursement for value received from the Repatha® Copay Card from any third-party payers, including a flexible spending account or a healthcare savings account. This program is not open to patients receiving prescription reimbursement under any federal, state or government-funded healthcare program, such as Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD) or TRICARE® or where prohibited by law. If at any time patients begin receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patients will no longer be able to use this card and you must call 1-844-REPATHA to stop participation. Restrictions may apply. Offer subject to change or discontinuation without notice.

NEXT:Getting Started

See Next

References: 1. Data on file, Amgen; 2017. 2. Data on file, Amgen; 2017. 3. Centers for Medicare and Medicaid Services. Announcement of Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. April 2016.
https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2017.pdf. Accessed May 17, 2017. 4. Kaiser Family Foundation. The Medicare Part D Prescription Drug Benefit. September 2016. http://files.kff.org/attachment/Fact-Sheet-The-Medicare-Part-D-Prescription-Drug-Benefit. Accessed May 3, 2017.

IMPORTANT SAFETY INFORMATION

See More

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 in Primary Hyperlipidemia, including HeFH: The most common adverse reactions (> 5% of Repatha®-treated patients and occurring more frequently than placebo) in clinical trials in 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% 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).

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. 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%).

Adverse reactions in the Cardiovascular Outcomes trial: The safety profile of Repatha® in this trial was generally consistent with the safety profile described above in the 12- and 52-week controlled trials involving patients with primary hyperlipidemia (including HeFH). Serious adverse events occurred in 24.8% and 24.7% of Repatha®-treated and placebo-treated patients, respectively. Adverse events led to discontinuation of study treatment in 4.4% of patients assigned to Repatha® and 4.2% assigned to placebo. Common adverse reactions (>5% of patients treated with Repatha® and occurring more frequently than placebo) included 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 a potential for immunogenicity with Repatha®.

Please see full Prescribing Information.

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