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About
Kyowa Kirin Cares

Kyowa Kirin Cares

Kyowa Kirin Cares is a program that offers comprehensive support to your patients who have been prescribed CRYSVITA. From access and reimbursement assistance to ongoing support during treatment, Kyowa Kirin Cares is here to help every step of the way.

Kyowa Kirin Cares offers access support for eligible patients prescribed CRYSVITA (burosumab-twza)

A Kyowa Kirin Cares Case Manager can help your patients navigate their access options.

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Commercial insurance* Patients with commercial insurance 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.
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Government insurance† Patients insured through government programs, such as Medicare, Medicaid, or TRICARE, may connect with a dedicated Case Manager to walk through available financial options.
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No insurance Patients with no insurance may be eligible to receive CRYSVITA for free through the Patient Assistance Program. Review the Terms and Conditions for more information.

Feel confident in the coverage for CRYSVITA

94%
of CRYSVITA prior
authorizations are granted
on the first submission
$0 Co-Pay Assistance Program
Co-Pay
Assistance Program

Eligible patients may pay as little as $0.2*

95% of eligible commercially insured patients enrolled in the Kyowa Kirin Cares Co-Pay Assistance Program paid $0 for CRYSVITA®. Financial assistance may be available for your patients through Kyowa Kirin Cares.

The information provided on this page is intended for informational purposes, and should not be considered a guarantee of treatment or coverage. Restrictions apply. For additional information about eligibility, please see the below Program Terms & Conditions.

A Kyowa Kirin Cares representative can help navigate documentation required for insurance coverage. Contact Kyowa Kirin Cares by calling 833-KK-CARES (833-552-2737) Monday through Friday, 8 AM to 8 PM (ET).

*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.

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 833-KK-CARES (833-552-2737).

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 eligibility 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. You are not eligible for the Program if your employer, insurance plan, payor, or a third party administrator participates in an alternative funding program and requires you to apply to the Program as a condition of, requirement for, or prerequisite to coverage of relevant Kyowa Kirin products, or if your employer, insurance plan, payor, or a third party administrator otherwise denies, restricts, eliminates, delays, alters, or withholds any insurance benefits or coverage contingent upon application to, or approval or denial of eligibility for a manufacturer patient support program like the Kyowa Kirin Program. You are ineligible for assistance when an alternative funding plan obtains CRYSVITA® through a non U.S. based distributor or outside the approved in-network distribution channels.
  • 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 eligibility 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).

§Data on File, January 2025. Data on File, May 2024.

Kyowa Kirin Cares offers support for patients prescribed CRYSVITA

Connect your patients with ongoing support

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A Case Manager can help you and your patients NAVIGATE treatment:

  • Assist with logistical information regarding access, reimbursement, and financial options
  • Explain how to work with specialty pharmacies
  • Support patients throughout their treatment journeys
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A Clinical Educator can help EDUCATE your patients about disease and treatment:

  • Help answer questions about XLH and CRYSVITA
  • Provide tips, tools, and resources to help your patients stay on track
  • Connect with your patients along their treatment journey

The information provided by the Case Manager or Clinical Educator to your patients is for informational purposes only and does not constitute medical advice. It is not intended to replace a discussion between you and your patients. All decisions regarding patient care must be made by a patient’s healthcare provider considering the unique characteristics of each patient.

Enroll your patients prescribed CRYSVITA today

Follow these steps:

  1. Download the Kyowa Kirin Cares enrollment form for CRYSVITA, fill it out in its entirety, and email it to patientsupport@kyowakirincares.com or fax it to 833-552-3299
  2. Upon receiving the completed enrollment form, Kyowa Kirin Cares will begin the benefits investigation (BI) process for the patient
  3. Once completed, you will be informed of the status of the BI. If CRYSVITA is covered by the patient’s insurance, you will receive a summary of the BI. If a prior authorization or exception is required, a Case Manager will call to inform you of next steps

If you have any questions, call us at 833-KK-CARES (833-552-2737) Monday through Friday, 8 AM to 8 PM (ET).

The information provided on this page is intended for informational purposes and should not be considered a guarantee of treatment or coverage.

VISIT KYOWA KIRIN CARES FOR MORE INFORMATION

Help your patients with XLH begin their treatment journey with CRYSVITA

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Set up time with a representative to talk more about CRYSVITA.

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Indication

CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.


Indication

CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.

Important Safety Information

CONTRAINDICATIONS

CRYSVITA is contraindicated:

  • In concomitant use with oral phosphate and/or active vitamin D analogs (e.g., calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia.
  • When serum phosphorus is within or above the normal range for age.
  • In patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism.

WARNINGS AND PRECAUTIONS

Hypersensitivity

  • Hypersensitivity reactions (e.g., rash, urticaria) have been reported in patients with CRYSVITA. Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment.

Hyperphosphatemia and Risk of Nephrocalcinosis

  • Increases in serum phosphorus to above the upper limit of normal may be associated with an increased risk of nephrocalcinosis. For patients already taking CRYSVITA, dose interruption and/or dose reduction may be required based on a patient’s serum phosphorus levels.

Hypercalcemia

  • Increases in serum calcium have been reported in patients treated with CRYSVITA. Patients with risk factors such as pre-existing hyperparathyroidism, prolonged immobilization, dehydration, hypervitaminosis D, or renal impairment, are at higher risk of hypercalcemia. Monitor these patients for serum calcium and parathyroid hormone levels before and during CRYSVITA treatment for moderate to severe hypercalcemia. In patients with moderate to severe hypercalcemia, CRYSVITA should not be administered until hypercalcemia is adequately managed.

Injection Site Reactions

  • Administration of CRYSVITA may result in local injection site reactions. Discontinue CRYSVITA if severe injection site reactions occur and administer appropriate medical treatment.

ADVERSE REACTIONS

Pediatric Patients

  • Adverse reactions reported in 10% or more of CRYSVITA-treated pediatric XLH patients across three studies are: pyrexia (55%, 44%, and 62%), injection site reaction (52%, 67%, and 23%), cough (52%), vomiting (41%, 48%, and 46%), pain in extremity (38%, 46%, and 23%), headache (34% and 73%), tooth abscess (34%, 15%, and 23%), dental caries (31%), diarrhea (24%), vitamin D decreased (24%, 37%, and 15%), toothache (23% and 15%), constipation (17%), myalgia (17%), rash (14% and 27%), dizziness (15%), and nausea (10%).

Adult Patients

  • Adverse reactions reported in more than 5% of CRYSVITA-treated adult XLH patients and in at least 2 patients more than placebo in one study are: back pain (15%), headache (13%), tooth infection (13%), restless legs syndrome (12%), vitamin D decreased (12%), dizziness (10%), constipation (9%), muscle spasms (7%), and blood phosphorus increased (6%).
  • Spinal stenosis is prevalent in adults with XLH, and spinal cord compression has been reported. It is unknown if CRYSVITA therapy exacerbates spinal stenosis or spinal cord compression.

USE IN SPECIFIC POPULATIONS

  • There are no available data on CRYSVITA use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Serum phosphorus levels should be monitored throughout pregnancy. Report pregnancies to the Kyowa Kirin, Inc. Adverse Event reporting line at 1-844-768-3544.
  • There is no information regarding the presence of CRYSVITA in human milk or the effects of CRYSVITA on milk production or the breastfed infant. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CRYSVITA and any potential adverse effects on the breastfed infant from CRYSVITA or from the underlying maternal condition.

PATIENT COUNSELING INFORMATION

  • Advise patients not to use any oral phosphate and/or active vitamin D analog products.
  • Instruct patients to contact their physician if hypersensitivity reactions, injection site reactions, and restless legs syndrome induction or worsening of symptoms occur.

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.

For important risk and use information, please see the full Prescribing Information for CRYSVITA.

Indication

CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.

Important Safety Information

CONTRAINDICATIONS

CRYSVITA is contraindicated:

  • In concomitant use with oral phosphate and/or active vitamin D analogs (e.g., calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia.
  • When serum phosphorus is within or above the normal range for age.
  • In patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism.

WARNINGS AND PRECAUTIONS

Hypersensitivity

  • Hypersensitivity reactions (e.g., rash, urticaria) have been reported in patients with CRYSVITA. Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment.

Hyperphosphatemia and Risk of Nephrocalcinosis

  • Increases in serum phosphorus to above the upper limit of normal may be associated with an increased risk of nephrocalcinosis. For patients already taking CRYSVITA, dose interruption and/or dose reduction may be required based on a patient’s serum phosphorus levels.

Hypercalcemia

  • Increases in serum calcium have been reported in patients treated with CRYSVITA. Patients with risk factors such as pre-existing hyperparathyroidism, prolonged immobilization, dehydration, hypervitaminosis D, or renal impairment, are at higher risk of hypercalcemia. Monitor these patients for serum calcium and parathyroid hormone levels before and during CRYSVITA treatment for moderate to severe hypercalcemia. In patients with moderate to severe hypercalcemia, CRYSVITA should not be administered until hypercalcemia is adequately managed.

Injection Site Reactions

  • Administration of CRYSVITA may result in local injection site reactions. Discontinue CRYSVITA if severe injection site reactions occur and administer appropriate medical treatment.

ADVERSE REACTIONS

Pediatric Patients

  • Adverse reactions reported in 10% or more of CRYSVITA-treated pediatric XLH patients across three studies are: pyrexia (55%, 44%, and 62%), injection site reaction (52%, 67%, and 23%), cough (52%), vomiting (41%, 48%, and 46%), pain in extremity (38%, 46%, and 23%), headache (34% and 73%), tooth abscess (34%, 15%, and 23%), dental caries (31%), diarrhea (24%), vitamin D decreased (24%, 37%, and 15%), toothache (23% and 15%), constipation (17%), myalgia (17%), rash (14% and 27%), dizziness (15%), and nausea (10%).

Adult Patients

  • Adverse reactions reported in more than 5% of CRYSVITA-treated adult XLH patients and in at least 2 patients more than placebo in one study are: back pain (15%), headache (13%), tooth infection (13%), restless legs syndrome (12%), vitamin D decreased (12%), dizziness (10%), constipation (9%), muscle spasms (7%), and blood phosphorus increased (6%).
  • Spinal stenosis is prevalent in adults with XLH, and spinal cord compression has been reported. It is unknown if CRYSVITA therapy exacerbates spinal stenosis or spinal cord compression.

USE IN SPECIFIC POPULATIONS

  • There are no available data on CRYSVITA use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Serum phosphorus levels should be monitored throughout pregnancy. Report pregnancies to the Kyowa Kirin, Inc. Adverse Event reporting line at 1-844-768-3544.
  • There is no information regarding the presence of CRYSVITA in human milk or the effects of CRYSVITA on milk production or the breastfed infant. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CRYSVITA and any potential adverse effects on the breastfed infant from CRYSVITA or from the underlying maternal condition.

PATIENT COUNSELING INFORMATION

  • Advise patients not to use any oral phosphate and/or active vitamin D analog products.
  • Instruct patients to contact their physician if hypersensitivity reactions, injection site reactions, and restless legs syndrome induction or worsening of symptoms occur.

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.

For important risk and use information, please see the full Prescribing Information for CRYSVITA.

References:

  • 1. Data on file. PA Approvals. Kyowa Kirin, Inc.; 2025. 2. Data on file. Kyowa Kirin Cares Copay Utilization. Kyowa Kirin, Inc.; 2024.

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COMM-US-CRY-0779 June 2026

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