Burosumab (Crysvita)

Policy ID: I-198-006

Section: Injections

Effective Date: January 01, 2019

Revised Date: July 12, 2022

Revision Effective Date: September 01, 2022

Last Reviewed: July 26, 2023

Applies To: Commercial Only

Description

Burosumab-twza (Crysvita®) is a human immunoglobulin G subclass 1 (IgG1), fibroblast growth factor 23 (FGF23) blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH). Burosumab-twza (Crysvita) is also indicated for the treatment of tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors.

XLH is caused by excess FGF23 which suppresses renal tubular phosphate reabsorption and the renal production of 1,25 dihydroxy vitamin D.

X-linked hypophosphatemia has also been referred to as X-linked hypophosphatemic rickets, Hypophosphatemic rickets, X-linked dominant hypophosphatemic rickets (XLHR), X-linked rickets (XLR), Vitamin D-resistant rickets, X-linked Vitamin D-resistant rickets (VDRR), Hypophosphatemic vitamin D-resistant rickets (HPDR), Phosphate diabetes, and Familial hypophosphatemic rickets.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Burosumab (Crysvita) is considered medically necessary in adult and pediatric individuals six (6) months of age or older who meet ALL of the following:

Diagnosis of XLH, verified by pathogenic mutation in PHEX; and
Oral phosphate and active vitamin D analogs have been discontinued and will remain discontinued at least seven (7) days before and during ongoing treatment with burosumab (Crysvita); and
Documentation of fasting serum phosphorus concentration below the reference range for age; and
At least ONE of the following:
- Documentation of low tubular resorption of phosphate corrected for glomerular filtration rate (TmP/GFR) based on age; or
- Documentation of any of the following signs and symptoms of XLH including but not limited to growth retardation, bone fractures, musculoskeletal pain, dental abscesses, x-ray imaging showing deformities, or Thacher Rickets Severity Score (RSS), etc.

Continuation of therapy with burosumab (Crysvita) after twelve months may be considered medically necessary for the treatment of an individual with documented diagnosis of XLH when the following criteria are met:

Diagnosis of XLH; and
Documentation of improved fasting serum phosphorus concentration in relation to age (doses should be held if serum phosphorus is above 5 mg/dL); and
Documentation of improved TmP/GFR level if previously reported; and
Documentation of improved signs and symptoms of XLH such as a lower score on the Thacher Rickets Severity Score (RSS).

The use of burosumab (Crysvita) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Code

J0584

Burosumab (Crysvita) is considered medically necessary in adult and pediatric individuals two (2) years of age or older who meet ALL of the following:

Diagnosis of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized; and
Oral phosphate and active vitamin D analogs have been discontinued and will remain discontinued at least seven (7) days before and during ongoing treatment with burosumab (Crysvita); and
Documentation of fasting serum phosphorus concentration below the reference range for age prior to initiation of treatment.

Continuation of therapy with burosumab (Crysvita) after twelve months may be considered medically necessary for the treatment of an individual with documented diagnosis of TIO when the following criteria are met:

Diagnosis of TIO; and
Documentation of improved fasting serum phosphorus concentration in relation to age (doses should be held if serum phosphorus is above 5 mg/dL); and
Documentation of improved TmP/GFR level if previously reported; and
Documentation of improved signs and symptoms of TIO.

Procedure Code

J0584

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

E83.31

M83.8

Professional Statements and Societal Positions Guidelines

Not Applicable

Rationale

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-14-2019 Adopted policy

Internal Medical Policy Committee 1-22-2020 Annual Review, no clinical content change

Internal Medical Policy Committee 11-19-2020

Added tumor-induced osteomalacia (TIO) indication

Internal Medical Policy Committee 11-23-2021 Annual Review, no clinical content change

Internal Medical Policy Committee 7-21-2022

Updated diagnosis codes, and
Updated the experimental/investigational statement

Internal Medical Policy Committee 7-26-2023 Annual Review, no clinical content change

Link

References

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-198-005

Section: Injections

Effective Date: January 01, 2019

Revised Date: July 12, 2022

Revision Effective Date: September 01, 2022

Last Reviewed: July 21, 2022

Archived Date: January 03, 2021

Applies To: Commercial Only

Description

XLH is caused by excess FGF23 which suppresses renal tubular phosphate reabsorption and the renal production of 1,25 dihydroxy vitamin D.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Burosumab (Crysvita) is considered medically necessary in adult and pediatric individuals six (6) months of age or older who meet ALL of the following:

Diagnosis of XLH, verified by pathogenic mutation in PHEX; and
Oral phosphate and active vitamin D analogs have been discontinued and will remain discontinued at least seven (7) days before and during ongoing treatment with burosumab (Crysvita); and
Documentation of fasting serum phosphorus concentration below the reference range for age; and
At least ONE of the following:
- Documentation of low tubular resorption of phosphate corrected for glomerular filtration rate (TmP/GFR) based on age; or
- Documentation of any of the following signs and symptoms of XLH including but not limited to growth retardation, bone fractures, musculoskeletal pain, dental abscesses, x-ray imaging showing deformities, or Thacher Rickets Severity Score (RSS), etc.

Diagnosis of XLH; and
Documentation of improved fasting serum phosphorus concentration in relation to age (doses should be held if serum phosphorus is above 5 mg/dL); and
Documentation of improved TmP/GFR level if previously reported; and
Documentation of improved signs and symptoms of XLH such as a lower score on the Thacher Rickets Severity Score (RSS).

Procedure Codes

J0584

Burosumab (Crysvita) is considered medically necessary in adult and pediatric individuals two (2) years of age or older who meet ALL of the following:

Diagnosis of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized; and
Oral phosphate and active vitamin D analogs have been discontinued and will remain discontinued at least seven (7) days before and during ongoing treatment with burosumab (Crysvita); and
Documentation of fasting serum phosphorus concentration below the reference range for age prior to initiation of treatment.

Diagnosis of TIO; and
Documentation of improved fasting serum phosphorus concentration in relation to age (doses should be held if serum phosphorus is above 5 mg/dL); and
Documentation of improved TmP/GFR level if previously reported; and
Documentation of improved signs and symptoms of TIO.

Procedure Codes

J0584

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

E83.31

M83.8

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-14-2019 Adopted policy

Internal Medical Policy Committee 1-22-2020 Annual Review, no clinical content change

Internal Medical Policy Committee 11-19-2020 Added tumor-induced osteomalacia (TIO) indication

Internal Medical Policy Committee 11-23-2021 Annual Review, no clinical content change

Internal Medical Policy Committee 7-21-2022 Updated diagnosis codes and the experimental/investigational statement

Links

References (PDF)

Disclaimer

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