CurrentUnitedHealthcarePolicy CSOH2025D0071.C

Crysvita (burosumab) — Ohio medical policy (XLH and TIO)

Clinical coverage criteria for UnitedHealthcare Ohio members for burosumab (Crysvita) to treat X-linked hypophosphatemia (XLH) in patients ≥6 months and FGF23-related hypophosphatemia in tumor‑induced osteomalacia (TIO) in patients ≥2 years, including initial and continuation authorization rules.

Policy Summary

PayerUnitedHealthcare

PolicyCrysvita (burosumab) — Ohio medical policy (XLH and TIO)

Policy CodePolicy CSOH2025D0071.C

Change TypeRoutine review — no change

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis, age, diagnostic confirmation, prior therapy status, fasting serum phosphorus below age normal, specialist prescribing or consultation, and dosing per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥6 mominimum age (XLH)

≥2 yrsminimum age (TIO)

≤12 moinitial auth

Ohiostate

J0584HCPCS

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Coverage criteria for burosumab (Crysvita)

Initial therapy — X-linked hypophosphatemia (XLH)

Covered when ALL of the following are met for initial therapy:

Diagnosis of XLH: Diagnosis of X‑linked hypophosphatemia (XLH) confirmed by one of the following: genetic testing demonstrating a PHEX mutation in the patient or a first‑degree relative; OR elevated serum FGF23 > 30 pg/mL; OR all of the following biochemical findings: serum phosphate < 3.0 mg/dL (0.97 mmol/L) AND serum creatinine below the age‑adjusted upper limit of normal (ULN) AND serum 25(OH)D ≥ 16 ng/mLsee text

From Coverage Rationale (XLH initial)

Age and prescriber: Patient is age 6 months or greater; prescribed by, or in consultation with, an endocrinologist or metabolic bone specialistage >= 6 months

Per FDA indication and policy

Prior conventional therapy requirement: When specified elsewhere in policy, history of failure, contraindication, or intolerance to vitamin D analog therapy in combination with an oral phosphate agent is required (see policy for details)N/A

Policy references conventional therapy requirement

Laboratory and dosing: Fasting serum phosphorus is below normal for age; dosing consistent with United States FDA approved labeling; initial authorization will be for no more than 12 monthssee text

From Coverage Rationale and Instructions for Use

Continuation (re-authorization) — XLH

Covered when ALL of the following are met for continuation of therapy:

Previous burosumab exposure: Patient has previously received treatment with burosumabN/A

Required

Prescriber: Prescribed by, or in consultation with, an endocrinologist or specialist experienced in the treatment of metabolic bone disordersN/A

Required

Clinical response: Patient has experienced a positive clinical response to burosumab (examples include: enhanced height velocity, improvement in skeletal deformities, reduction of fractures, reduction of generalized bone pain)N/A

Initial therapy — FGF23-related hypophosphatemia in tumor‑induced osteomalacia (TIO)

Covered when ALL of the following are met for initial therapy in TIO:

Diagnosis of FGF23‑related hypophosphatemia in tumor‑induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumorsN/A

From Coverage Rationale (TIO initial)

Resection status: Disease cannot be curatively resected or localizedN/A

Required condition per policy and FDA indication

Age and prescriber: Patient is age 2 years or greater; prescribed by, or in consultation with, an oncologist, an endocrinologist, or a specialist experienced in the treatment of metabolic bone disordersage >= 2 years

Per FDA indication and policy

Continuation (re-authorization) — TIO

Covered when ALL of the following are met for continuation of therapy in TIO:

Previous burosumab exposure: Patient has previously received treatment with burosumabN/A

Required

Prescriber: Prescribed by, or in consultation with, an oncologist, an endocrinologist, or a specialist experienced in the treatment of metabolic bone disordersN/A

Required

The U.S. Food and Drug Administration (FDA) approval of Crysvita (burosumab) is provided for informational purposes only. FDA approval alone is not a basis for coverage. Coverage under this policy is limited to the clinical indications, patient ages, and criteria described herein and remains subject to applicable federal, state, and contractual requirements that may further restrict benefits.

A routine policy review was completed on 07/01/2025. No changes to the coverage guidelines resulted from that review; the prior policy version was archived. Any future revisions will be documented in the policy history.

Coding and diagnostic criteria

Applicable HCPCSHCPCS

J0584

Injection, burosumab-twza, 1 mg.

Referenced diagnosis codesICD-10

E83.31	Familial hypophosphatemia
M83.8	Other adult osteomalacia

Serum phosphate (XLH biochemical criterion)

Serum phosphate< 3.0 mg/dL (0.97 mmol/L)

ContextBiochemical finding used to support XLH diagnosis when genetic testing or elevated FGF23 is not available

Associated labs requiredMust be accompanied by serum creatinine below age-adjusted ULN and serum 25(OH)D ≥ 16 ng/mL per XLH criteria

Elevated FGF23 (diagnostic threshold)

FGF23 threshold> 30 pg/mL

RoleDiagnostic confirmation option for XLH when genetic testing is not available

Prior authorization and documentation requirements

Prior Authorization

Prior authorization required for burosumab (J0584)

Prior authorization is required for burosumab (J0584). Requests must document the covered indication (XLH or FGF23‑related hypophosphatemia in TIO), meet the age requirement for the indication (age ≥ 6 months for XLH; age ≥ 2 years for TIO), include diagnostic confirmation as specified in the policy, and show dosing consistent with the FDA label. Initial authorizations are limited to no more than 12 months.

Applicable HCPCS: J0584 (Injection, burosumab‑twza, 1 mg).
XLH minimum age: patient is age 6 months or greater.
TIO minimum age: patient is age 2 years or greater.
Initial authorization duration: no more than 12 months.
Dosing must be in accordance with United States FDA approved labeling.

Step Therapy

Prior conventional therapy required when specified

The policy requires a history of failure, contraindication, or intolerance to vitamin D analog therapy in combination with an oral phosphate agent for certain situations: specifically for TIO initial therapy and as required in some XLH continuation/authorization rules.

Background

X-linked hypophosphatemia (XLH) is a heritable disorder of renal phosphate transport characterized by excess fibroblast growth factor 23 (FGF23), renal phosphate wasting, and resulting hypophosphatemia that impairs bone mineralization and causes rickets in children and osteomalacia in adults. Conventional management has included oral phosphate supplementation combined with active vitamin D analogs.

Burosumab (Crysvita) is a monoclonal antibody that binds FGF23 and can normalize serum phosphate. The FDA indication covers treatment of XLH in patients aged 6 months and older, with use appropriate when diagnostic confirmation is present (for example, PHEX mutation, elevated FGF23 > 30 pg/mL, or characteristic biochemical profile) and when laboratory and clinical criteria in this policy are met.

Tumor-induced osteomalacia (TIO) is an acquired, typically paraneoplastic, cause of FGF23-related hypophosphatemia due to phosphaturic mesenchymal tumors; burosumab is indicated when the tumor cannot be curatively resected or localized and for patients aged 2 years and older per FDA labeling.

Definitions

XLH (X-linked hypophosphatemia)

DefinitionHeritable disorder of renal phosphate transport associated with elevated FGF23 leading to hypophosphatemia and rickets/osteomalacia

Diagnostic criteriaConfirmed by PHEX gene mutation in patient or first-degree relative, or elevated FGF23 > 30 pg/mL, or characteristic biochemical profile (e.g., serum phosphate < 3.0 mg/dL with normal SCr and 25(OH)D ≥16 ng/mL)

Age indication for burosumabFDA indication: patients 6 months of age and older

Treatment considerationsConventional therapy: oral phosphate plus active vitamin D metabolites; burosumab indicated when criteria met

TIO (Tumor-induced osteomalacia)

DefinitionRare acquired paraneoplastic syndrome caused by phosphaturic mesenchymal tumors secreting FGF23, leading to FGF23-related hypophosphatemia

Policy Summary

PayerUnitedHealthcare

PolicyCrysvita (burosumab) — Ohio medical policy (XLH and TIO)

Policy CodePolicy CSOH2025D0071.C

Change TypeRoutine review — no change

Effective DateJul 1, 2025

Next Review Date

SourceLink

On This Page

Clinical benefit required

Dosing and duration: Dosing is in accordance with United States FDA approved labeling; reauthorization will be for no more than 12 monthsN/A

From Instructions for Use

Prior therapy: History of failure, contraindication, or intolerance to vitamin D analog therapy (e.g., calcitriol, paricalcitol, doxercalciferol) in combination with an oral phosphate agent (e.g., K‑Phos®, K‑Phos Neutra®)N/A

Required prior therapy

Laboratory and dosing: Fasting serum phosphorus is below the normal range for age; dosing is in accordance with United States FDA approved labeling; initial authorization will be for no more than 12 monthssee text

From Coverage Rationale and Instructions for Use

Clinical benefit required

Dosing and duration: Dosing is in accordance with United States FDA approved labeling; reauthorization will be for no more than 12 monthsN/A

From Coverage Rationale

TIO relevanceElevated circulating FGF23 is characteristic of FGF23-related hypophosphatemia in TIO

Examples of vitamin D analogs: calcitriol, paricalcitol, doxercalciferol.
Examples of oral phosphate agents: K‑Phos®, K‑Phos Neutra®.

Documentation Required

Required clinical documentation for prior authorization

Include supporting clinical documentation with the prior authorization to confirm diagnosis, age, laboratory evidence, prior therapy status, prescriber specialty or consultation, and dosing per FDA labeling.

Diagnostic confirmation: genetic testing confirming a PHEX mutation in the patient or first‑degree relative, OR elevated serum FGF23 > 30 pg/mL, OR biochemical findings (serum phosphate < 3.0 mg/dL; serum creatinine below age‑adjusted ULN; serum 25(OH)D ≥ 16 ng/mL).
Fasting serum phosphorus below the normal range for age (biochemical requirement).
Documentation of prior failure, contraindication, or intolerance to vitamin D analog plus oral phosphate when required.
Prescribed by or in consultation with an endocrinologist, oncologist, or specialist experienced in metabolic bone disorders as appropriate to the indication.
Dosing consistent with United States FDA approved labeling.

Denial Risk

State medical necessity evaluation may apply

Requests for burosumab may be evaluated for medical necessity under Ohio Administrative Code 5160‑1‑01 when services are described as unproven or when coverage or quantity limits apply.

Policy note: FDA approval alone is not a basis for coverage; federal/state/contractual requirements govern coverage determinations.

Surgical considerationIndication applies when tumor cannot be curatively resected or localized

Age indication for burosumabFDA indication: patients 2 years of age and older

Prior therapy requirementHistory of failure, contraindication, or intolerance to vitamin D analog plus oral phosphate is required for initial burosumab in TIO per policy