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ACCESS STEPS FOR CRYSVITA

You prescribed CRYSVITA® (burosumab-twza) for your patients.
Now what?

Enroll your patient today! Kyowa Kirin Cares can help your patient from prescription to treatment with an overview of insurance coverage, financial assistance options, and shipment coordination.

Step 1: Enrollment

Download the enrollment form, fill it out with your patient’s information, sign it, and email it to patientsupport@kyowakirincares.com or fax it to 833-552-3299.

A document

Provide complete and accurate information to reduce additional follow-up and potential treatment delay.

Two speech bubbles

Set expectations with your patient.

 
  • Patient consent is needed to proceed with Kyowa Kirin Cares access services and financial assistance options for those who qualify
  • Let your patient know that they will be assigned a dedicated Case Manager and to expect a call from Kyowa Kirin Cares 833-KK-CARES (833-552-2737)
  • Use the Patient Next Steps guide to help your patient understand the process and the role they play

Step 2: Authorization

Upon receiving the completed enrollment form, Kyowa Kirin Cares will begin the benefits investigation (BI) process for the patient, then inform you of the results.

For information on prior authorization (PA) or exception requirements, visit https://www.kyowakirincares.com/crysvita-healthcare-providers/#crysvita-resources to learn more and to access medical necessity and appeal letters.

Show description

A flow diagram that shows 2 pathways for the benefits investigation results for the patient. In the first pathway, CRYSVITA® (burosumab-twza) is covered without prior authorization (PA) and you receive an overview of the benefits investigation. In the second pathway, PA or exception is required for CRYSVITA and a Patient Services Representative will call you to inform you of next steps.

A person with a book

A dedicated Case Manager will call the patient to review insurance coverage. They will inform the patient of the financial assistance options available to them.

Step 3: Procurement

A Field Reimbursement Manager (FRM) will work with you to coordinate a procurement option based on your patient’s BI results. CRYSVITA can be procured by an authorized Specialty Distributor or from a select group of Specialty Pharmacies, and ordering requirements may differ based on the patient’s coverage.

Questions? Ask a representative or call Kyowa Kirin Cares at 833-KK-CARES (833-552-2737) Monday through Friday, 8 AM to 8 PM (ET).

Prior authorization and medical documentation for CRYSVITA

Understanding prior authorization

Documents and other criteria are commonly required by health plans to cover CRYSVITA. A dedicated FRM will contact you with your patient’s plan-specific drug requirements.

A document

Provide all documentation required by the patient’s health plan to prevent delays and denials.

 
  • Health plans may require documentation of past and current disease management interventions, such as use of supplement therapy or growth hormone, or orthopedic/dental surgery
A calendar date with a star in the middlecalendar icon

Schedule testing:

 
  • Your patient’s health plan may have specific testing requirements
  • A dedicated FRM can help you determine plan-specific criteria
  • Timely submission of test results will facilitate the PA process
Two speech bubbles

Monitor communications with the patient’s health plan and answer any additional requests or questions promptly.

A doctor and another person looking at a tablet together

Actor portrayal

Ready to start your patients on CRYSVITA?

Take the first step by filling out the enrollment form.

Indication

CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for 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.


Indication

CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for 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 who undergo treatment of the underlying tumor should have dosing interrupted and adjusted to prevent hyperphosphatemia.

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

Adult Patients

  • 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.

References:

  • 1. American Academy of Professional Coders. ICD-10-CM 2023. Salt Lake City, UT: American Academy of Professional Coders; 2022. 2. American Medical Association. CPT 2023 Professional Edition. Chicago, IL: American Medical Association; 2022. 3. Cigna. Burosumab. Coverage Policy Number IP0285. Effective December 1, 2023. 4. CRYSVITA (burosumab-twza). US Prescribing Information. Kyowa Kirin, Inc.; April 2026.
Indication

CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for 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 who undergo treatment of the underlying tumor should have dosing interrupted and adjusted to prevent hyperphosphatemia.

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

Adult Patients

  • 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.

References:

  • 1. American Academy of Professional Coders. ICD-10-CM 2023. Salt Lake City, UT: American Academy of Professional Coders; 2022. 2. American Medical Association. CPT 2023 Professional Edition. Chicago, IL: American Medical Association; 2022. 3. Cigna. Burosumab. Coverage Policy Number IP0285. Effective December 1, 2023. 4. CRYSVITA (burosumab-twza). US Prescribing Information. Kyowa Kirin, Inc.; April 2026.

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COMM-US-CRY-1000 June 2026