GET YOUR PATIENTS STARTED WITH SUPPORT
Enroll your patients who have been prescribed CRYSVITA® (burosumab-twza).
Enrollment form
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ACCESS OPTIONS FOR PATIENTS
Kyowa Kirin Cares can provide assistance navigating access options for CRYSVITA® (burosumab-twza).
To get started:
- Download the Kyowa Kirin Cares CRYSVITA enrollment form, fill it out and fax it to 833-552-3299
- Upon receiving the completed enrollment form, Kyowa Kirin Cares will begin the benefits investigation (BI) process for the patient
- Within two business days, 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)
Through Kyowa Kirin Cares, access options are available for eligible patients
A Kyowa Kirin Cares Case Manager can help your patients navigate their access options.
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.
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.a
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.
Field Reimbursement Managers (FRMs) can help navigate documentation required for insurance coverage. Contact Kyowa Kirin Cares by calling 833-KK-CARES (833-552-2737).
- 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 provides eligible patients with free Kyowa Kirin product from the date of approval into the Kyowa Kirin Cares Patient Assistance Program through the end of the calendar year. Your patient may be eligible for the Kyowa Kirin Cares Patient Assistance Program if:
- Your patient is a United States resident (including the United States territories) and reside in the United States or its territories;
- Your patient is being treated in an outpatient setting and has a valid prescription for a Kyowa Kirin product (for an FDA approved indication) from a licensed U.S. healthcare professional;
- Your patient has limited or no insurance coverage for CRYSVITA under their medical or pharmacy benefit insurance;
- Your patient has demonstrate certain income limits and/or qualifying financial requirements; and
- Patients with commercial insurance plans supporting with or requiring them to apply to Kyowa Kirin Cares as a condition of, requirement for, or prerequisite to, coverage of relevant Kyowa Kirin products—commonly known as alternative funding programs—are not eligible for 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).
Call 833-KK-CARES (833-552-2737)
Monday through Friday, 8 AM to 8 PM (ET)
CONNECT YOUR PATIENTS WITH ONGOING SUPPORT
Kyowa Kirin Cares provides your patients with ongoing support throughout their journeys with CRYSVITA.
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
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
Enroll your patients who have been prescribed CRYSVITA into Kyowa Kirin Cares. Or your patients can enroll themselves by using the ENROLLMENT FORM button at the top of the Patients and Care Partners page.
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.
FIND IMPORTANT FORMS AND RESOURCES
Access Kyowa Kirin Cares forms as well as useful CRYSVITA information and resources.
Enrollment
Download the Kyowa Kirin Cares prescription and enrollment form to enroll your patients.
Support brochure
Download this Kyowa Kirin Cares brochure and use it as a quick reference for program offerings.
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About CRYSVITA
Visit the CRYSVITA website to learn about efficacy, safety, dosing, and more.
Medical necessity letter
Download and use this template letter of medical necessity for appropriate patient cases.
Appeal letter
Download and use this template letter of appeal for your patients who have been denied coverage.
Prior authorization checklist
Download this resource about common criteria and documentation that may be required for a prior authorization.
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.1
- The treatment of FGF23-related hypophosphatemia in tumor induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years 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.
- Patients with TIO who undergo treatment of the underlying tumor should have dosing interrupted and adjusted to prevent hyperphosphatemia.
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%).
- Postmarketing experience reported in CRYSVITA-treated pediatric XLH patients: blood phosphorus increased.
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.
- Adverse reactions reported in more than 10% of CRYSVITA-treated adult TIO patients in two studies are: tooth abscess (19%), muscle spasms (19%), dizziness (15%), constipation (15%), injection site reaction (15%), rash (15%), and headache (11%).
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