INDICATION

EVENITY® is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Read More

The anabolic effect of EVENITY® wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY® use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an antiresorptive agent should be considered. Close
PRESCRIBING INFORMATION MEDICATION GUIDE IMPORTANT SAFETY INFORMATION INDICATION FOR PATIENTS CONNECT WITH A REP

All Medicare Part B patients have access to EVENITY® as initial therapy1,*

  • No step edit required
  • No prior authorization required
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EVENITY® is the only bone builder† dosed monthly for 12 months and is covered under the medical benefit2-5

  • Your Medicare Part B patients have coverage for EVENITY®5
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You can refer patients to an alternate site of care where they can receive EVENITY®. To learn more, contact your Amgen representative, or visit EVENITYFinder.com to search for alternate sites of care where EVENITY® can be administered to your patients.

Discussing patient cost

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A full course of EVENITY® is 12 monthly doses, and patient financial responsibility for EVENITY® is limited to the course of treatment2

  • 87% of Medicare Part B patients pay $0 for each dose of EVENITY®6,‡,§
    • —

      After a deductible is met, Medicare typically picks up 80% of office-administered products under Part B7

    • —

      Patients may obtain an additional insurance plan (eg, Medigap, commercial, TRICARE) to pick up the remaining 20%8

    • —

      Data do not include medical benefit out-of-pocket (OOP) costs related to office visits or administration of EVENITY®. Additional insurance may require additional monthly premiums.7 Individual OOP costs will vary

  • Amgen Assist® can help you verify your patient's OOP costs
  • *

    All Medical Lives associated with Coverage Restriction for EVENITY® in DRG Coverage data snapshot as of April 2021 are included in this analysis.

  • †

    Compared to FORTEO® (teriparatide injection) and TYMLOS® (abaloparatide). Registered trademarks are the property of their respective owners.

  • ‡

    Amgen Assist® insurance verification data for October 2020 to March 2021 was analyzed to determine the OOP Distribution. Only EVENITY® prospective patients are included in the analysis.

  • §

    The co-pay may depend on coverage of additional insurance plan.

Get answers and support to help your patients get started on EVENITY®

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Amgen Assist® can help you verify your patients’ benefits

Contact Amgen Assist® at 1-866-AMG-ASST (1-866-264-2778) for assistance with insurance verifications.

Financial resources are available for eligible patients with any coverage type

FOR ELIGIBLE COMMERCIALLY INSURED PATIENTS

Lower out-of-pocket costs with the EVENITY® Co-Pay Program

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Eligible patients pay as little as$25per dose of EVENITY®

  • Pay as little as $25 for each dose of EVENITY® up to an annual Maximum Program Benefit per calendar year**
  • Can be applied to deductible, co-insurance, and/or co-pay for EVENITY®, but not costs associated with office visit or the administration of EVENITY®
  • No income eligibility requirement
  • Please see the EVENITY® Co-Pay Program terms and conditions below

**Other restrictions apply. Visit EVENITYSupport.com or call 1-800-761-1558 for more information about this program, including the Maximum Program Benefit and full Terms and Conditions.

Help patients enroll online at EVENITYSupport.com or by phone at 1-800-761-1558

EVENITYSUPPORT.COM TERMS AND CONDITIONS

Additionally, if patients become aware that their health plan or pharmacy benefit manager does not allow the use of manufacturer co-pay support as part of their health plan design, patients agree to comply with their obligations, if any, to disclose their use of the card to their insurers.

EVENITY® CO-PAY CARD TERMS AND CONDITIONS

SUMMARY OF TERMS AND CONDITIONS

It is important that every patient read and understand the full EVENITY® Co-Pay Card Terms and Conditions. The following summary is not a substitute for reviewing the Terms and Conditions in their entirety.

As further described below, in general:

The EVENITY® Co-Pay Card is open to patients with commercial insurance, regardless of financial need. The program is not valid for patients whose EVENITY prescription is paid for in whole or in part by Medicare, Medicaid, or any other federal or state healthcare program. It is not valid for cash paying patients or where prohibited by law.

The EVENITY® Co-Pay Card may help lower your EVENITY out-of-pocket medication costs. Out-of-pocket costs include co-payment, co-insurance, and deductible out-of-pocket costs. The EVENITY Co-Pay Card does not cover any other costs related to office visits or administration of EVENITY. The EVENITY Co-Pay Card provides support up to the Maximum Program Benefit or Patient Total Program Benefit. If a patient’s commercial insurance plan imposes different or additional requirements on patients who receive EVENITY Co-Pay Card benefits, Amgen has the right to reduce or eliminate those benefits. Whether you are eligible to receive the Maximum Program Benefit or Patient Total Program Benefit is determined by the type of plan coverage you have. Please ask your EVENITY Support Representative to help you understand eligibility for the EVENITY Co-Pay Card, whether your particular insurance coverage is likely to result in your reaching the Maximum Program Benefit or your Patient Total Program Benefit amount by calling 1-800-761-1558.

EVENITY® patients pay as little as $25 for each dose, and Amgen will pay the remaining eligible out-of-pocket costs on behalf of the patient until the Amgen payments have reached either the Maximum Program Benefit or the Patient Total Program Benefit. Patients are responsible for all amounts that exceed this limit.

Ongoing activation of the EVENITY® Co-Pay Card is contingent on the submission of the required Explanation of Benefits (EOB) form by the healthcare provider’s office within 180 days of the use of the EVENITY Co-Pay Card.

See EVENITYSupport.com for full Terms and Conditions.

FOR COMMERCIAL, MEDICARE, OR GOVERNMENT PROGRAM COVERAGE
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Referrals to Independent Co-pay Foundations

Amgen Assist® can refer patients, as a courtesy, to independent co-pay foundations.††

Contact Amgen Assist® at 1-866-AMG-ASST (1-866-264-2778) for more information about referrals to independent co-pay foundations.

††Provided through independent charitable patient assistance programs; program eligibility is based on the charity's criteria. Amgen has no control over independent, third-party programs and provides referrals as a courtesy only.

UNINSURED OR UNDERINSURED
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Referrals to Amgen Safety Net Foundation

Amgen Safety Net Foundation (ASNF) is an independent, nonprofit patient assistance program that provides EVENITY® at no cost to qualifying patients who have a financial need and who are uninsured or have insurance that excludes EVENITY®

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IMPORTANT SAFETY INFORMATION

POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH
EVENITY® may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY® should be discontinued.

In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY® compared to those treated with alendronate.

Contraindications: EVENITY® is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY®. EVENITY® is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria.

Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in EVENITY®-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY®.

Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITY®. Correct hypocalcemia prior to initiating EVENITY®. Monitor patients for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Adequately supplement patients with calcium and vitamin D while on EVENITY®.

Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving EVENITY®. A routine oral exam should be performed by the prescriber prior to initiation of EVENITY®. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ. Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy.

For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. In these patients, dental surgery to treat ONJ may exacerbate the condition. Discontinuation of EVENITY® should be considered based on benefit-risk assessment.

Atypical Femoral Fractures: Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving EVENITY®. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated.

During EVENITY® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of EVENITY® therapy should be considered based on benefit-risk assessment.

Adverse Reactions: The most common adverse reactions (≥ 5%) reported with EVENITY® were arthralgia and headache.

EVENITY® is a humanized monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

Please see EVENITY® full Prescribing Information, including Medication Guide.

IMPORTANT SAFETY INFORMATION

POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH
EVENITY® may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY® should be discontinued.

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References: 1. Data on file, Amgen; [1]; 2021. 2. EVENITY® (romosozumab-aqqg) prescribing information, Amgen. 3. FORTEO® (teriparatide injection) prescribing information, Eli Lilly and Company. 4. TYMLOS® (abaloparatide) prescribing information, Radius Health, Inc. 5. Data on file, Amgen; [2]; 2021. 6. Data on file, Amgen; [3]; 2021. 7. Medicare.gov website. Medicare costs at a glance. https://www.medicare.gov/your-medicare-costs/medicare-costs-at-aglance. Accessed September 9, 2021. 8. Medicare.gov website. What’s Medicare Supplement (Medigap)? https://www.medicare.gov/supplements-otherinsurance/whats-medicare-supplement-insurance-Medigap. Accessed September 9, 2021.