CurrentAnthemPolicy CC-0081

Crysvita (burosumab-twza) — Clinical coverage criteria for X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO)

Clinical coverage criteria and utilization management for Crysvita (burosumab-twza) for treatment of X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO); defines initial and continuation approval requirements, dosing, quantity limits, and contraindications.

Policy Summary

PayerAnthem

PolicyClinical/Medical Policy — Coverage Criteria

Policy CodePolicy CC-0081

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization; initial approvals are for 6 months and continuation approvals for 1 year with quantity limits and documentation of diagnosis and clinical response required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization

1 yrcontinuation

J0584HCPCS

360 mg/28dTIO override qty

≥6 mo / ≥2 yrmin ages

Coverage Criteria for Crysvita (burosumab-twza)

Policy Summary

PayerAnthem

PolicyClinical/Medical Policy — Coverage Criteria

Policy CodePolicy CC-0081

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization; initial approvals are for 6 months and continuation approvals for 1 year with quantity limits and documentation of diagnosis and clinical response required.

SourceLink

On This Page

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Initial therapy — X-linked hypophosphatemia (XLH)

Covered when ALL of the following are met:

XLH initial criteria: 1. Indication: treatment of X-linked hypophosphatemia (XLH).

2. Diagnosis confirmation by genetic testing (individual or directly related family member) OR FGF-23 > 30 pg/mL.

3. Reduced tubular resorption of phosphate corrected for glomerular filtration rate (TmP/GFR).

4. If age ≥18 years, presence of clinical signs and symptoms of XLH (e.g., bone pain, fractures, limited mobility).

5. Serum phosphate below the reference range for age.

Continuation therapy — X-linked hypophosphatemia (XLH)

Covered when ALL of the following are met:

XLH continuation criteria: 1. Documentation that the individual achieved and sustained a clinically significant improvement in serum phosphate level.

2. Documentation that the individual achieved and sustained clinically significant improvement of clinical signs and symptoms of XLH.

Initial therapy — Tumor-induced osteomalacia (TIO)

Covered when ALL of the following are met:

TIO initial criteria: 1. Diagnosis of tumor-induced osteomalacia (TIO).

2. Tumor(s) cannot be curatively resected or localized.

3. Diagnosis supported by FGF-23 ≥ 100 pg/mL AND reduced tubular resorption of phosphate corrected for glomerular filtration rate (TmP/GFR).

4. Serum phosphate below the reference range for age.

Operational note: Tumor localization and resection should be attempted when feasible because resection is curative; medical therapy is intended for cases where tumors cannot be localized or resected.

Continuation therapy — Tumor-induced osteomalacia (TIO)

Covered when ALL of the following are met:

TIO continuation criteria: 1. Documentation that the individual achieved and sustained a clinically significant improvement in serum phosphate level.

2. Documentation that the individual achieved and sustained clinically significant improvement of clinical signs and symptoms of osteomalacia.

Crysvita (burosumab-twza) is not approved for use in combination with oral phosphate supplementation or active vitamin D analogs (for example, calcitriol). Requests that indicate concomitant use with these agents will be excluded from coverage.

Crysvita is contraindicated in individuals with severe renal impairment or end stage renal disease; such requests are not approved. Additionally, requests that do not meet the specified coverage criteria or that are submitted for indications other than X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia (TIO) will not be approved.

Billing and Diagnosis Codes

HCPCSHCPCS

J0584	Injection, burosumab-twza 1 mg [Crysvita]
J0584	Injection, burosumab-twza 1 mg [Crysvita]

ICD-10 DiagnosisICD-10

E83.30	Disorder of phosphorus metabolism, unspecified
E83.31	Familial hypophosphatemia
E83.39	Other disorders of phosphorus metabolism
M83.8	Other adult osteomalacia
M83.9	Adult osteomalacia, unspecified

FGF-23 threshold — TIO

FGF-23 threshold (TIO)FGF-23 ≥ 100 pg/mL is required to support a diagnosis of tumor-induced osteomalacia for coverage.

Supporting documentationDiagnosis must also include reduced TmP/GFR and serum phosphate below the age reference range.

Tumor status requirementTumor(s) cannot be curatively resected or localized — medical management indicated when resection/localization not possible.

FGF-23 threshold — XLH

FGF-23 threshold (XLH)FGF-23 > 30 pg/mL may be used to confirm a diagnosis of X-linked hypophosphatemia for coverage consideration.

Alternative diagnosis confirmationGenetic testing in the individual or a directly related family member is an alternative to elevated FGF-23.

Additional biochemical requirementReduced TmP/GFR and serum phosphate below the age reference range are required in addition to diagnostic confirmation.

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Crysvita (burosumab-twza). Initial approvals are limited to 6 months; continuation approvals are for 1 year. Quantity limits apply by concentration, with specified overrides for tumor-induced osteomalacia.

Prior authorization required
Initial approval: 6 months
Continuation approval: 1 year
Quantity limits by vial strength with TIO override

Step Therapy

Step Therapy / Concomitant Therapy

No step therapy is specified for initiation of Crysvita. Crysvita must not be used in combination with oral phosphate supplements or active vitamin D analogs (eg, calcitriol).

No step therapy required prior to Crysvita
Do not combine Crysvita with oral phosphate or active vitamin D analogs (e.g., calcitriol) — combination use will not be approved

Documentation Required

Required Clinical Documentation

Provide clinical documentation to support the prior authorization request, including diagnostic confirmation and objective laboratory or imaging data demonstrating disease and response.

Diagnosis confirmation for XLH (genetic testing in the individual or a directly related family member) or elevated FGF-23 as specified
For XLH: reduced TmP/GFR (tubular maximum reabsorption of phosphate corrected for GFR)
Serum phosphate below the age-specific reference range (baseline and for continuation: documentation of improvement and sustained clinically significant increase)
For adults with XLH: documentation of clinical signs/symptoms (eg, bone pain, fractures, limited mobility)
For TIO: documentation that tumor(s) cannot be curatively resected or localized, FGF-23 ≥ 100 pg/mL, and reduced TmP/GFR
Objective evidence of clinical improvement for continuation requests (sustained improvement in serum phosphate and clinical signs/symptoms)

Denial Risk

Triggers for Denial

Authorization may be denied for use outside the approved criteria, for prohibited combinations, or when required documentation is missing or does not demonstrate diagnosis or clinical response.

Requests that do not meet diagnostic criteria (eg, no genetic testing, no elevated FGF-23, or no reduced TmP/GFR) may be denied
Requests without serum phosphate below the age-specific reference range will not meet criteria
Use in combination with oral phosphate supplements or active vitamin D analogs (eg, calcitriol) will not be approved
Individuals with severe renal impairment or end-stage renal disease are not eligible
Requests for indications other than XLH or TIO (or lacking supporting documentation) may be denied
Insufficient evidence of clinical improvement for continuation (no documented sustained increase in serum phosphate or no sustained clinical benefit) may result in denial
Quantity requests exceeding limits without an approved override (except the specified TIO override) may be denied

Background and Clinical Context

X-linked hypophosphatemia (XLH) is a hereditary disorder characterized by excess fibroblast growth factor-23 (FGF‑23) activity leading to renal phosphate wasting, resulting in rickets in children and osteomalacia and bone pain in adults. Tumor‑induced osteomalacia (TIO) is an acquired paraneoplastic syndrome in which FGF‑23–secreting tumors cause similar renal phosphate wasting; when tumors cannot be localized or curatively resected, medical therapy is used.

Crysvita (burosumab‑twza) is a monoclonal antibody that targets and neutralizes FGF‑23. By blocking FGF‑23 activity, Crysvita restores renal phosphate reabsorption and increases serum phosphate, addressing the underlying pathophysiology of both XLH and FGF‑23–mediated TIO and thereby improving biochemical abnormalities and clinical manifestations of phosphate wasting.

OpenPayer

Crysvita (burosumab-twza) — Clinical coverage criteria for X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO)

Coverage Criteria for Crysvita (burosumab-twza)

Billing and Diagnosis Codes

Prior Authorization, Documentation, and Prescriber Requirements

Background and Clinical Context

Key Definitions