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GET HELP WITH ACCESS OPTIONS
Kyowa Kirin Cares can provide assistance navigating access options for CRYSVITA®(burosumab-twza).
Commercial insurance
If you have commercial insurance, you may be eligible to receive co-pay assistance for CRYSVITA through the Kyowa Kirin Cares Co-Pay Assistance Program. Please review the full terms and conditions* for more information.
Government insurance
If you have government insurance, such as Medicare, Medicaid, or TRICARE, a dedicated case manager will be able to walk you through available financial options.a
No insurance
If you do not have insurance, you may be eligible to receive CRYSVITA for free through the Patient Assistance Program. Review the terms and conditions to learn if you qualify.
- a Select government-insured patients who are experiencing financial and/or medical hardship may be eligible to receive assistance through a Kyowa Kirin Cares Patient Assistance Program. Restrictions and other eligibility criteria may apply. For more information, call us at 1-833-KK-CARES (833-552-2737).
*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:
- You must be a United States resident (including the United States territories) and reside in the US or its territories.
- You are being treated in an outpatient setting and have a valid prescription from a licensed U.S. healthcare professional.
- You are not receiving treatment in, or do not reside in, a clinic, hospital, nursing home, correctional facility, or a court-appointed program or facility.
- Your prescriber must certify in the submitted application that the requested product is prescribed for the Food and Drug Administration (FDA) approved indication.
- You 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: You 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 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 annual household income must meet the Program financial criteria.
- You 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 you have no income, you will be required to provide a signed, notarized letter, stating the need for assistance.
- You and your prescriber 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 you to use any specific health care provider, and you are 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 you have a change in insurance status or income, you 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 you 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 prescribing healthcare provider free of charge, so long as you have a legally valid prescription for the requested product and remain eligible for the Program during the entire enrollment period.
If you have any questions regarding the Program, your eligibility, or if you wish to discontinue your 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).
Call 833-KK-CARES (833-552-2737)
Monday through Friday, 8 AM to 8 PM (ET)
RECEIVE PERSONALIZED AND ONGOING SUPPORT
Kyowa Kirin Cares is committed to supporting you throughout your journey with CRYSVITA.
Work closely with your Kyowa Kirin Cares Case Manager and healthcare provider to ensure you are receiving the support you need throughout your journey with CRYSVITA.
Please note that your doctor can provide you with information on what to expect regarding treatment with CRYSVITA. If you have any clinical or medical questions, please ask your doctor.
FIND IMPORTANT FORMS AND RESOURCES
Access Kyowa Kirin Cares forms as well as useful CRYSVITA information and resources.
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Support brochure
Download this Kyowa Kirin Cares brochure and use it as a quick reference for program offerings.
Doctor discussion guide
Use this resource to guide conversations about CRYSVITA with your healthcare provider
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About CRYSVITA
Visit the CRYSVITA website to learn more about how CRYSVITA works, and details around the CRYSVITA injection schedule.
What is CRYSVITA® (burosumab-twza)?
CRYSVITA is a prescription medicine used to treat:
- Adults and children 6 months of age and older with X-linked hypophosphatemia (XLH).
- Adults and children 2 years of age and older with fibroblast growth factor 23 (FGF23)–related hypophosphatemia in tumor-induced osteomalacia (TIO) when the tumor cannot be located or removed.
Important Safety Information
You should not take CRYSVITA if:
- You take an oral phosphate supplement and/or a specific form of vitamin D supplement (such as calcitriol, paricalcitol, doxercalciferol, calcifediol).
- Your phosphorus levels from a blood sample are within or above the normal range for age.
- You have kidney problems.
What is the most important information you should know about CRYSVITA?
- Some patients developed allergic reactions (e.g., rash and hives) while taking CRYSVITA. Your doctor will monitor you for symptoms of an allergic reaction while you are taking CRYSVITA. Your treatment may need to be discontinued for serious allergic reactions.
- High levels of phosphorus in the blood have been reported in some patients taking CRYSVITA. This may be related to a risk of high calcium levels in the kidneys. Your doctor will collect blood samples to monitor your levels. If you are already taking CRYSVITA, dose interruption and/or dose reduction may be required based on your serum phosphorus levels.
- High levels of calcium in the blood have been reported in patients taking CRYSVITA. The risk is greater in patients with pre-existing hyperparathyroidism (overactive parathyroid glands), for those who are unable to move for extended periods of time, become dehydrated, have high vitamin D levels, or have kidney issues. If you are at greater risk, your doctor will monitor your blood calcium and parathyroid hormone levels before you start and while taking CRYSVITA. If you develop high levels of blood calcium, your doctor may need to stop your treatment until it is adequately managed.
- Administration of CRYSVITA may result in reactions at the injection site, such as hives, reddening of the skin, rash, swelling, bruising, pain, severe itching of the skin, and collection of blood outside of a blood vessel (i.e., hematoma). Call your doctor if you develop an injection site reaction. CRYSVITA may be discontinued if severe injection site reactions occur.
- If you are taking CRYSVITA for TIO, your doctor will have you stop your CRYSVITA treatment temporarily if you are undergoing treatment for your tumor (e.g., surgical removal of the tumor or radiation therapy).
What are the possible side effects of CRYSVITA?
- Adverse reactions that were seen in children with XLH are:
- Fever
- Injection site reaction
- Cough
- Vomiting
- Pain in arms and legs
- Headache
- Tooth abscess
- Dental cavities
- Diarrhea
- Decreased vitamin D levels
- Toothache
- Constipation
- Muscle pain
- Rash
- Dizziness
- Nausea
- Adverse reactions that were seen in adults with XLH are:
- Back pain
- Headache
- Tooth infection
- Restless legs syndrome
- Decreased vitamin D levels
- Dizziness
- Constipation
- Muscle spasms
- Phosphorus levels increased in the blood
- Narrowing of the spaces within the spine is common in adults with XLH, and pressure on the spinal cord has been reported in adults taking CRYSVITA. It is not known if taking CRYSVITA worsens the narrowing of the spaces within the spine or the pressure on the spinal cord.
- Adverse reactions that were seen in adults with TIO are:
- Tooth abscess
- Muscle spasms
- Dizziness
- Constipation
- Injection site reaction
- Rash
- Headache
Before taking CRYSVITA, tell your doctor about all of your medications (including supplements) and medical conditions, including if you:
- Are taking oral phosphate and/or active vitamin D (such as calcitriol, paricalcitol, doxercalciferol, calcifediol).
- Are pregnant, think you may be pregnant, or plan to become pregnant. There is not enough experience to know if CRYSVITA may harm your unborn baby. Report pregnancies to the Kyowa Kirin, Inc. Adverse Event reporting line at 1-844-768-3544.
- Are breastfeeding or plan to breastfeed. There is not enough experience to know if CRYSVITA passes into your breast milk. Talk with your doctor about the best way to feed your baby while you receive CRYSVITA.
While taking CRYSVITA, tell your doctor if you experience:
- An allergic reaction such as rash or hives
- A rash, swelling, bruising, or other reaction at the injection site
- New or worsening restless legs syndrome
These are not all the possible side effects of CRYSVITA. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Kyowa Kirin, Inc. at 1-844-768-3544.