Similar to other buy and bill products, EVENITY™ is purchased through authorized wholesalers and can be administered in your office.
You can also schedule patients to receive EVENITY™ from an external healthcare facility, also known as an alternate site of care. To learn more about alternate sites of care, contact your Amgen representative.
*Based on data from AARP Public Policy Institute, 2009 Fact Sheet, and The Kaiser Family Foundation, analysis of Centers for Medicare and Medicaid Services 2016 Medicare Current Beneficiary Survey.
† Based on claims data set of postmenopausal osteoporosis patients on another osteoporosis therapy with or without fracture or other osteoporosis without fracture from 1/2018 to 12/2018.
‡ Approximately 92% of Medicare FFS patients paying $0 have supplemental plans.
§ Medicare patients with supplemental coverage (eg, Medigap) may require additional monthly premiums.
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.
*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.
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 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.
Amgen Assist® can refer patients, as a courtesy, 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.
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™
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.
References: 1. Data on file, Amgen. 2019. 2. Umans B, Nonnemaker KL. The Medicare beneficiary population. AARP Public Policy Institute. Fact sheet 149, January 2009. 3. Cubanski J, Damico A, Neuman T, Jacobson G. Sources of supplemental coverage among Medicare beneficiaries in 2016. The Kaiser Family Foundation. Data note, November 2018. 4. Medicare.gov. 2019. Medicare costs at a glance. https://www.medicare.gov/your-medicare-costs/medicare-costs-at-a-glance. Accessed February 12, 2019. 5. Medicare.gov. What’s Medicare Supplement Insurance (Medigap)? https://www.medicare.gov/index.php/supplements-other-insurance/whats-medicare-supplement-insurance-medigap. Accessed February 12, 2019.