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

All Medicare Part B patients are covered* for EVENITY® with no prior authorization required1,†

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EVENITY® is fulfilled through the traditional buy and bill pathway

  • Similar to other buy and bill products, EVENITY® can be administered in your office and is covered under Medicare Part B
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You can also schedule patients to receive EVENITY® from an external healthcare facility, also known as an alternate site of care. To learn more, contact your Amgen representative.

EVENITYFinder.com allows you to search for alternate sites of care where EVENITY® can be administered to your patients.

Discussing patient cost

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The majority of EVENITY® (romosozumab-aqqg) patients have a Medicare Part B plan2,‡

  • 81% of Medicare Part B patients have supplemental insurance, meaning they will likely pay $0 per dose of EVENITY®3,§
  • Patients may have additional medical benefit OOP costs related to office visits or administration of EVENITY®. Individual OOP costs will vary
  • After a deductible is met, Medicare typically picks up 80% of office-administered products under Part B4
  • Patients may obtain a supplemental insurance (eg, Medigap) plan to pick up some of the additional 20%5,**

Consult with Amgen Assist® or your payer to verify actual patient out-of-pocket cost

  • Medicare patients with supplemental coverage (eg, Medigap) may require additional monthly premiums

*Covered per the label indication.

†Based on DRG coverage data as of 02/2020.

‡Based on a study population of 12,954 prospective EVENITY® patients, who have gone through Amgen Assist® insurance verification data for 3/2019 to 02/2020 (Medicare FFS - 8,344; Medicare Advantage - 2,075; Private Commercial - 2,352; and Other - 183).

§Based on Amgen Assist® insurance verification data. Only EVENITY® prospective patients, who have opted for Amgen hub services and identified through insurance verification information, are included in the analysis. Data is for 09/2019 to 02/2020.

**Patient should be enrolled in Medicare Part A and Part B. Medicare patients with supplemental coverage (eg, Medigap) may require additional monthly premiums5

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

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Sign up for benefit verification support through Amgen Assist®

With Amgen Assist®, you have tools to help you find out if your patient's EVENITY® prescription is covered. Start the process by registering with Amgen Assist® or initiating a request online.

REGISTER YOUR OFFICE
INITIATE ONLINE REQUEST
INSURANCE VERIFICATION REQUEST FORM

Financial informational resources or support is available through Amgen Assist® for eligible patients with any coverage type

COMMERCIAL INSURANCE COVERAGE

The EVENITY® Co-pay Card can help patients with commercial insurance pay $25 or less per dose*,†

  • Pay $25 or less per dose of EVENITY® therapy, up to a maximum benefit of $8,000 per patient, 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
  • Registered offices can assist patients with a 4-step EVENITY® Co-pay Card enrollment process
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*See Patient Eligibility Requirements and Coverage Limits for full eligibility details; other restrictions may apply.

†This program does not provide support for any physician-related services associated with administration of EVENITY® (romosozumab-aqqg).

The EVENITY® Co-pay Program Prepaid MasterCard® is issued by Comerica Bank pursuant to license by MasterCard International Incorporated. No cash or ATM access. MasterCard is a registered trademark of MasterCard International Incorporated. This card can be used only to cover co-payment for eligible prescriptions covered under the program at participating merchant locations where Debit MasterCard is accepted.

To check your patient's eligibility and to activate the EVENITY® Co-pay Card, call 1-800-761-1558 or visit EVENITYsupport.com

VERIFY ELIGIBILITY

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 insurer.

ELIGIBILITY REQUIREMENTS FOR THE EVENITY® CO-PAY PROGRAM

Eligibility requirements for the EVENITY® Co-pay Program

Eligibility Criteria: Open to patients with an EVENITY® (romosozumab-aqqg) prescription and commercial insurance for EVENITY®. Patients may not seek reimbursement for value received from the EVENITY® Co-pay Program from any third-party payers, including a flexible spending account or healthcare savings account. This program is not open to uninsured patients or 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 the EVENITY® Co-pay Program at 1-800-761-1558 (9:00 am-8:00 pm ET, Monday-Friday) to stop participation. Restrictions may apply. Amgen reserves the right to revise or terminate this program, in whole or in part, without any notice at any time. This is not health insurance. Program invalid where otherwise prohibited by law.

Program Details: The EVENITY® Co-pay Program provides financial support for eligible commercially insured patients. The program does not provide support for supplies, procedures, or any physician-related services associated with EVENITY®. For eligible patients, the program covers the amount of OOP cost for EVENITY® that exceeds $25 for each dose, up to a maximum benefit of $8,000 per patient, per calendar year. Patient is responsible for costs above this amount. Patient card is reset every January 1. Patients need to re-verify their eligibility on a yearly basis.

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.*

LEARN MORE

*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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READ FULL DETAILS

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; [2]; 2020. 2. Data on file, Amgen; [3]; 2020. 3. Data on file, Amgen; [4]; 2020. 4. Medicare.gov. 2020. Medicare costs at a glance. https://www.medicare.gov/your-medicare-costs/medicare-costs-at-a-glance. Accessed October 12, 2020. 5. Medicare.gov. What's Medicare Supplement Insurance (Medigap)? https://www.medicare.gov/index.php/supplements-other-insurance/whats-medicare-supplement-insurance-medigap. Accessed October 12, 2020.