GET YOUR PATIENTS STARTED WITH SUPPORT

*Kyowa Kirin Cares Co-Pay Assistance Program Terms and Conditions

Patients who are enrolled in any federal or state healthcare program, including, without limitation, Medicaid, Managed Medicaid, Medicare, Medicare Advantage, Medigap, CHAMPVA, TriCare, Veterans Affairs (VA), or Department of Defense (DoD), or any state or patient assistance program are not eligible for Kyowa Kirin Cares Co-Pay Assistance Program. The Kyowa Kirin Cares Co-Pay Assistance Program for CRYSVITA helps commercially insured individuals who are residents of the United States (including the United States territories) and who are prescribed CRYSVITA for a use approved by the Food and Drug Administration (FDA) pay for their eligible out-of-pocket costs and cost-sharing for CRYSVITA and the associated cost-sharing for drug administration, up to a specified maximum benefit per calendar year. To learn the maximum benefit of financial assistance available to you under the Kyowa Kirin Cares Co-Pay Assistance Program, call Kyowa Kirin Cares at 833-KK-CARES (833-552-2737). Either the patient, or the patient's legal guardian or representative, must personally enroll in the Kyowa Kirin Cares Co-Pay Assistance Program. Health insurance plans, pharmacy benefit managers, employers, payors, or any of their representatives or agents are prohibited from enrolling patients or assisting patients with enrolling in the Kyowa Kirin Cares Co-Pay Assistance Program.

Note that individuals residing in Massachusetts or Rhode Island (or elsewhere as prohibited by law) may not be eligible for financial assistance related to the administration/injection of CRYSVITA. In order to be eligible for the Program, individuals must provide a signed authorization compliant with the Health Insurance Portability and Accountability Act of 1996 and the regulations thereunder (collectively “HIPAA”). The Program does not cover the costs of physician office visits or evaluations, blood work or other testing, or transportation or other related services. Individuals may not seek reimbursement from any health savings, flexible savings, or other healthcare reimbursement account for any amounts received from the Co-Pay Assistance Program. Claims accrued 90 days prior to enrollment in Kyowa Kirin Cares will not be eligible for Co-Pay Assistance. The Program is NOT insurance. Void if copied, transferred, purchased, altered, or traded, and where prohibited and restricted by law. For additional terms and conditions, call Kyowa Kirin Cares at 833-KK-CARES (833-552-2737).

The above set of Terms and Conditions are subject to change at any time without prior notification. Kyowa Kirin reserves the right to make eligibility determinations, to set parameters for its Programs, to monitor participation, and to change, modify, or discontinue its Programs at any time without notice.

*Kyowa Kirin Cares Patient Assistance Program Terms and Conditions

The Kyowa Kirin Cares Patient Assistance Program (the “Program”) provides eligible patients with free Kyowa Kirin product from the date of approval into the Program through the end of the calendar year. Program eligibilty is determined on a case-by-case basis, and patients must meet all of the following eligibility criteria to be considered for the Program:

• Your patient must be a United States resident (including the United States territories) and reside in the US or its territories.
• Your patient is being treated in an outpatient setting and have a valid prescription from a licensed U.S. healthcare professional.
• Your patient is not receiving treatment in, or does not reside in, a clinic, hospital, nursing home, correctional facility, or a court-appointed program or facility.
• You must certify in the submitted application that the requested product is prescribed for the Food and Drug Administration (FDA) approved indication.
• Your patient must have no health or prescription drug coverage, or insurance coverage of any kind for CRYSVITA® (burosumab-twza), or you have been denied CRYSVITA® (burosumab-twza) coverage and have exhausted available appeals. Please note: Your patient will not be eligible for Kyowa Kirin Cares PAP if your employer, insurance plan, payor, or a third party administrator participates in an alternative funding program and requires you to apply to Kyowa Kirin Cares PAP Program as a condition of, requirement for, or prerequisite to coverage of relevant Kyowa Kirin products, or if your patient’s insurance plan, employer, third party administrator, or payor otherwise denies, restricts, eliminates, delays, alters, or withholds any insurance benefits or coverage contingent upon application to, or denial of eligibility for a manufacturer patient support program like Kyowa Kirin Cares PAP.
• Your patient’s annual household income must meet the Program financial criteria.
• Your patient will be asked to submit documentation to validate levels of income (e.g., federal tax returns; IRS forms such as W-2 or 1099; Social Security statement; pay stubs, etc.).
• If your patient has no income, your patient will be required to provide a signed, notarized letter, stating the need for assistance.
• You and your patient may not bill, charge, seek credit for or otherwise submit any claim for reimbursement to any third-party payer for product provided through the Program.
• Participation in the PAP does not obligate your patient to use any specific health care provider, and your patient is free to change providers at any time.
• No product provided through the Program may be sold, traded, or returned for credit.
• The Program has the right to verify your eligibility, including the right to audit any information provided on the Program application form.
• If your patient has a change in insurance status or income, your patient must notify the Program immediately and acknowledge you may be deemed no longer eligible for the Program.
• The Program benefits, rules, and product availability are subject to change at any time without prior notification. Kyowa Kirin reserves the right to make eligibility determinations, to set Program parameters, to monitor participation, and to change, modify, or discontinue the Program at any time without notice.

The Program is NOT insurance, it is a “free goods” program which provides free Kyowa Kirin product only to qualifying enrollees.

A complete Program application that is signed by both the applicant and the prescribing healthcare provider is required for consideration for Program eligiblity and enrollment. Approved patients will receive the requested Kyowa Kirin product free of charge from the date of Program approval through the end of the calendar year, after which time your patient must re-apply for continued assistance.

Program applications that reference or list an individual associated with, acting on behalf of, or a representative of, the applicant’s insurance company or payor as an alternate contact will be subject to additional review and will be denied. Also, Program applications that are completed or submitted at the direction of the applicant’s employer, insurance company or payor, or representative, or acting on behalf of the insurance company or payor, will be denied.

If enrolled in the Program, the requested Kyowa Kirin product will be shipped to you or your patient free of charge, so long as your patient has a legally valid prescription for the requested product and remain eligible for the Program during the entire enrollment period.

If your patient has any questions regarding the Program, your patient’s eligibility, or if your patient wishes to discontinue participation, please contact us at 833-KK-CARES Monday through Friday, 8AM to 8PM, Eastern Time (ET).

Restrictions and other eligibility criteria may apply. For more information, call us at 1-833-KK-CARES (833-552-2737).