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who have been prescribed CRYSVITA® (burosumab-twza).

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ACCESS OPTIONS FOR PATIENTS

Kyowa Kirin Cares can provide assistance navigating access options for CRYSVITA.

The process is simple:

  • Download the Kyowa Kirin Cares CRYSVITA enrollment form, fill it out with your patient’s information, 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

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

Government Insurance

Patients with government or military insurance, including Medicare, Medicaid, or TRICARE may connect with a dedicated Case Manager to walk through available financial options.a

No insurance

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.b

Patient Access Liaisons (PALs) can help navigate diagnostic documentation required for insurance coverage. Contact Kyowa Kirin Cares by calling 833-KK-CARES (833-552-2737).

  1. a Select government- and military-insured patients who are experiencing financial and/or medical hardship may be eligible to receive assistance through a Patient Assistance Program. Kyowa Kirin recognizes that exceptions need to be made based on a patient's individual circumstances. If patients do not meet the coverage criteria and there are special circumstances of financial and/or medical hardship that apply to their situation, they can request that an exception be made for them.
  2. b Patients must be US residents with no active medical or pharmacy benefit insurance or no coverage for CRYSVITA under their medical or pharmacy benefit insurance and an annual gross income at or below 400% of the federal poverty level, confirmed by documented proof of income. Call Kyowa Kirin Cares at 833-KK-CARES (833-552-2737) for additional information.

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

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). Depending on your commercial insurance plan and/or provider setting assistance under the Kyowa Kirin Cares Co-Pay Assistance Program may be provided via a pre-loaded debit card that can be utilized to pay your cost-sharing obligation for CRYSVITA and its administration or through a co-pay card that adjudicates as secondary insurance or a combination of both.

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. 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).

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 partners with you to provide your patients with ongoing support throughout their journeys with CRYSVITA. A dedicated Case Manager will be available to:

Answer questions about the treatment experience

Answer general questions about CRYSVITA

Provide external resources, when applicable

Support patients throughout their treatment journey

By downloading the enrollment form and enrolling your patient in Kyowa Kirin Cares, you’re providing a resource to your patients, especially those requiring financial assistance. Your patients can also take advantage of ongoing support from a Case Manager by using the ENROLLMENT FORM button at the top of the Patients and Care Partners page.

The information provided by the Case Manager 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 patient. 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.

download

Support brochure

Download this Kyowa Kirin Cares brochure and use it as a quick reference for program offerings.

download

About CRYSVITA

Visit the CRYSVITA website to learn about efficacy, safety, dosing, and more.

Visit Site

Medical necessity

Download and use this template letter of medical necessity for appropriate patient cases.

download

Appeal letter

Download and use this template letter of appeal for your patients who have been denied coverage.

download

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

1CRYSVITA. Prescribing Information. Kyowa Kirin Inc. Princeton, NJ.