Burosumab (Crysvita) (Medicaid Expansion)

Policy ID: ME-I-198-004-02

Section: Injections

Effective Date: January 01, 2022

Revised Date: November 28, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 15, 2023

Applies To: Medicaid Expansion 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.

The use of burosumab (Crysvita) may be considered medically necessary when ALL of the following criteria are met:

Documentation to confirm the diagnosis must be submitted, as evidenced by the following:
- Genetic testing confirming phosphate regulating gene with homology to endopeptidases on the X chromosome (PHEX-gene) mutation; and
- Increased (FGF23) level based on laboratory reference range with unresectable phosphaturic mesenchymal tumor; and
Burosumab (Crysvita) must be prescribed by, or in consult with, nephrologist, endocrinologist, geneticist, or specialist experienced in the treatment of metabolic bone disorders; and
Documentation must be submitted confirming the individual is experiencing the following:
- Phosphate manifestations (must have one):
  - Fasting serum phosphate is below provided age adjusted reference range; or
  - Low tubular resorption of phosphate corrected for glomerular filtration rate (TmP/GFR) based on age; and
- Bone manifestations (must have one):
  - Epiphyseal plate has not fused; or
  - Bone fractures; or
  - Planned orthopedic surgical procedure.

Initial Authorization: 12 months (one-time six (6)-month approval for adult with planned orthopedic surgical procedure)

Reauthorization Criteria

Continuation of therapy with burosumab (Crysvita) may be considered medically necessary when the following is met:

Documentation must be submitted demonstrating that the member has demonstrated a disease stability or beneficial response to therapy from baseline as shown by one or more of the following:
- Normalization of phosphate levels as defined by laboratory
- Decrease in serum alkaline phosphatase activity
- Improvement of renal phosphate wasting
- Normalization of growth velocity
- Reduction or healing of fractures
- Improvement of Thacher Rickets Severity Score (TRSS).

The use of burosumab (Crysvita) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

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 11-23-2021 Adopted Medicaid Expansion specific policy effective 1-1-2022

Internal Medical Policy Committee 11-29-2022 - Effective January 1, 2023

Updated initial criteria, and
Updated reauthorization criteria, and
Updated diagnosis codes, and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 Annual Review-no changes in criteria

Links

References (PDF)

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: ME-I-198-004-01

Section: Injections

Effective Date: January 01, 2022

Last Reviewed: November 23, 2021

Archived Date: December 31, 2022

Applies To: Medicaid Expansion 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.

The use of burosumab (Crysvita) may be considered medically necessary when ALL of the following criteria are met:

The individual must have diagnosis of X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia confirmed by the following:
- Genetic testing confirming phosphate regulating gene with homology to endopeptidases on the X chromosome (PHEX-gene) mutation; and
- Increased (FGF23) level based on laboratory reference range with unresectable phosphaturic mesenchymal tumor; and
The prescriber must be, or in consult with a nephrologist, endocrinologist, geneticist, or specialist experienced in the treatment of metabolic bone disorders; and
Documentation must be submitted confirming the individual is experiencing the following:
- Phosphate manifestations (must have one):
  - Fasting serum phosphate is below provided age adjusted reference range; or
  - Low tubular resorption of phosphate corrected for glomerular filtration rate (TmP/GFR) based on age; and
- Bone manifestations (must have one):
  - Epiphyseal plate has not fused; or
  - Bone fractures; or
  - Planned orthopedic surgical procedure.

Initial Authorization: 12 months (one-time 6-month approval for adult with planned orthopedic surgical procedure)

Reauthorization Criteria

Continuation of therapy with burosumab (Crysvita) may be considered medically necessary when the following is met:

The prescriber has provided documentation that the individual has demonstrated a disease stability or beneficial response to therapy from baseline as shown by one or more of the following:
- Normalization of phosphate levels as defined by laboratory
- Decrease in serum alkaline phosphatase activity
- Improvement of renal phosphate wasting
- Normalization of growth velocity
- Reduction or healing of fractures
- Improvement of Thacher Rickets Severity Score (TRSS).

Continuation Authorization: 12 months

The use of burosumab (Crysvita) is considered experimental/investigational and, therefore, non-covered for all other indications. Scientific literature does not support its use for other indications.

Procedure Codes

J0584

Diagnosis Codes

E83.30

E83.31

E83.39

M83.8

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021 Adopted Medicaid Expansion specific policy effective 1-1-2022

Links

References (PDF)

Disclaimer

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Medical Policies Quick Search

Burosumab (Crysvita) (Medicaid Expansion)

Description

Criteria

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer