CurrentUnitedHealthcarePolicy CSPA2026D0071P

Crysvita (burosumab) — Pennsylvania medical benefit drug coverage criteria for XLH and TIO

Defines UnitedHealthcare Pennsylvania-specific medical benefit drug coverage criteria for burosumab (Crysvita) for X-linked hypophosphatemia (XLH) and FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO), including initial and continuation authorization requirements for providers and patients.

Policy Summary

PayerUnitedHealthcare

PolicyCrysvita (burosumab) — Pennsylvania medical benefit drug coverage criteria for XLH and TIO

Policy CodePolicy CSPA2026D0071P

Change TypeNo material change

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization (approvals limited to ≤12 months) and include documentation supporting diagnosis, relevant labs, specialty prescriber, and evidence of clinical response for continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsminimum age for XLH coverage

2 yearsminimum age for TIO coverage

≤12 momax auth interval

J0584HCPCS listed

94%

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adult XLH trial response

Coverage Criteria for Burosumab (Crysvita)

Initial Therapy — XLH

Covered when ALL of the following are met:

XLH initial therapy: Diagnosis of X-linked hypophosphatemia (XLH), confirmed by genetic testing (e.g., PHEX mutation in the patient or a first-degree relative) OR elevated FGF23; AND biochemical findings: fasting serum phosphorus below the normal range for age; serum creatinine (SCr) below the age‑adjusted upper limit of normal (ULN); and serum 25(OH)D ≥ 16 ng/mL; AND patient age ≥ 6 months; AND prescribed by, or in consultation with, an endocrinologist or specialist experienced in the treatment of metabolic bone disorders; AND dosing in accordance with the United States Food and Drug Administration approved labeling; AND initial authorization will be for no more than 12 months.

Continuation Therapy — XLH

Covered when ALL of the following are met:

XLH continuation therapy: Patient has previously received treatment with burosumab; AND prescribed by, or in consultation with, an endocrinologist or specialist experienced in the treatment of metabolic bone disorders; AND patient has experienced a positive clinical response to burosumab (e.g., enhanced height velocity, improvement in skeletal deformities, reduction of fractures, reduction of generalized bone pain); AND dosing in accordance with the United States Food and Drug Administration approved labeling; AND reauthorization will be for no more than 12 months.

Initial Therapy — TIO

Covered when ALL of the following are met:

TIO initial therapy: Diagnosis of FGF23‑related hypophosphatemia in tumor‑induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors; AND disease cannot be curatively resected or is unlocalized; AND patient age ≥ 2 years; AND prescribed by, or in consultation with, an oncologist, endocrinologist, or specialist experienced in the treatment of metabolic bone disorders; AND fasting serum phosphorus is below the normal range for age; AND dosing in accordance with the United States Food and Drug Administration approved labeling; AND initial authorization will be for no more than 12 months.

Continuation Therapy — TIO

Covered when ALL of the following are met:

TIO continuation therapy: Patient has previously received treatment with burosumab; AND prescribed by, or in consultation with, an oncologist, endocrinologist, or specialist experienced in the treatment of metabolic bone disorders; AND patient has experienced a positive clinical response to burosumab (e.g., enhanced height velocity, improvement in skeletal deformities, reduction of fractures, reduction of generalized bone pain); AND dosing in accordance with the United States Food and Drug Administration approved labeling; AND reauthorization will be for no more than 12 months.

The codes shown in this policy are provided for billing and coding reference only. Listing a code does not imply the service is covered, nor does inclusion guarantee payment or reimbursement. Benefit coverage is determined by applicable federal, state, or contractual requirements and laws, which may mandate coverage or impose restrictions independent of this policy.

This Medical Benefit Drug Policy is informational and is intended to assist interpretation of UnitedHealthcare standard benefit plans. Policy statements must be reconciled with federal, state, or contractual plan requirements, and in the event of conflict those requirements govern. Before using this policy for a coverage decision, verify the applicable plan terms.

No additional coverage notes are provided in the available policy excerpt.

Relevant Codes and Lab Criteria

Covered HCPCSHCPCSCovered

J0584

Injection, burosumab-twza, 1 mg

Diagnosis Codes (reference)ICD-10

E83.31	Familial hypophosphatemia
M83.8	Other adult osteomalacia

inv-10: Fasting serum phosphorus — lab threshold

Fasting serum phosphorusBelow the normal range for age (must be documented as fasting)

ContextRequired for initial therapy in TIO and as a biochemical criterion for XLH initial therapy

DocumentationLaboratory report showing fasting status and age-referenced normal range must be provided

inv-11: Serum creatinine (SCr) — requirement

Serum creatinine (SCr) requirementBelow age‑adjusted upper limit of normal (ULN)

PurposePart of biochemical criteria required for XLH initial therapy

Prior Authorization, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for burosumab (Crysvita) requests. Initial and reauthorization approvals are generally limited to no more than 12 months. UnitedHealthcare may require prior authorization documentation to support medical necessity and dosing consistent with FDA‑approved labeling.

Initial and reauthorization approvals limited to ≤ 12 months
PA required for burosumab (J0584)

Note

Use of External Criteria

UnitedHealthcare may use clinical decision support tools developed by third parties (for example, InterQual®) to assist in claims and medical necessity review. These tools supplement but do not replace review of the patient’s clinical record and the plan’s benefit terms.

Third‑party clinical criteria (e.g., InterQual®) may be used to assist review

Clinical Background

X-linked hypophosphatemia (XLH) is a heritable disorder characterized by elevated fibroblast growth factor 23 (FGF23), renal phosphate wasting, hypophosphatemia, and impaired bone mineralization leading to rickets or osteomalacia. Burosumab is a monoclonal antibody that targets and neutralizes FGF23, thereby increasing renal phosphate reabsorption and normalizing serum phosphate levels to address the underlying biochemical defect in XLH.

Clinically, burosumab is used for patients with XLH (including those with PHEX mutation or elevated FGF23) to improve phosphate homeostasis and related skeletal outcomes. Treatment is managed by specialists experienced in metabolic bone disease or endocrinology, and coverage criteria require documentation of diagnosis, relevant biochemical values (for example, fasting serum phosphorus below the age‑normal range and serum 25(OH)D ≥ 16 ng/mL), appropriate patient age thresholds, and dosing consistent with FDA labeling.

Key Definitions

inv-22: XLH — definition and clinical features

DefinitionX‑linked hypophosphatemia (XLH) is a heritable disorder of renal phosphate transport characterized by PHEX gene mutation or elevated FGF23 leading to renal phosphate wasting, hypophosphatemia, and defective bone mineralization (rickets/osteomalacia).

PathophysiologyElevated circulating FGF23 causes decreased renal phosphate reabsorption and low serum phosphate; burosumab targets excess FGF23 to normalize serum phosphate.

Clinical featuresRickets/osteomalacia in children, growth impairment, skeletal deformities; in adults, bone pain, recurrent pseudofractures, stress fractures, and impaired mobility.

inv-23: TIO — definition

DefinitionTumor‑induced osteomalacia (TIO) is an acquired paraneoplastic syndrome of FGF23‑related hypophosphatemia caused by phosphaturic mesenchymal tumors that ectopically secrete FGF23.

Policy Summary

PayerUnitedHealthcare

PolicyCrysvita (burosumab) — Pennsylvania medical benefit drug coverage criteria for XLH and TIO

Policy CodePolicy CSPA2026D0071P

Change TypeNo material change

Effective DateJun 1, 2026

Next Review DateN/A

SourceLink

On This Page

DocumentationRecent serum creatinine with laboratory reference range demonstrating age‑adjusted ULN

inv-12: Serum 25(OH)D — requirement

Serum 25(OH)D threshold≥ 16 ng/mL

PurposeRequired biochemical criterion for XLH initial therapy

DocumentationRecent serum 25(OH)D level report meeting or exceeding 16 ng/mL

Note

Reference Applicable Plan and Regulatory Terms

When evaluating requests, reference the patient’s applicable federal, state, or contractual benefit plan terms. If there is a conflict between this policy and the governing plan or regulatory requirements, the federal, state, or contractual requirements control and will govern coverage decisions.

Refer to applicable federal, state, or contractual benefit plan terms — those terms govern in case of conflict

Note

Conventional (Prior) Therapy Context

Conventional therapy (oral phosphate supplementation and active vitamin D metabolites) is a longstanding treatment context for X‑linked hypophosphatemia (XLH). Prior or alternative use of conventional therapy may be relevant to clinical assessment, particularly in pediatric candidates and when documenting prior treatment history.

Conventional therapy: balanced oral phosphate + active vitamin D metabolites
Document prior or alternative use of conventional therapy when relevant to the request

Billing Rule

Verify Plan‑Specific Utilization Controls and Coding

Verify plan‑specific utilization controls (for example, step therapy, network restrictions, site‑of‑care rules, or additional benefit limits) before submitting a prior authorization request. Coverage and coding (including HCPCS J0584 and applicable diagnosis codes) remain subject to the member’s benefit plan and applicable laws.

Confirm step therapy, site‑of‑care, and network restrictions with the member’s plan
HCPCS: J0584 — Injection, burosumab-twza, 1 mg
ICD-10 example codes referenced for clinical context: E83.31 (Familial hypophosphatemia), M83.8 (Other adult osteomalacia)

Biochemical and bone mineralization abnormalities resemble genetic hypophosphatemic rickets; most patients have elevated circulating FGF23.

Treatment implicationsApplicable when tumor cannot be curatively resected or is unlocalized; burosumab is indicated for patients ≥2 years with FGF23‑related hypophosphatemia in TIO.

inv-24: TIO (supporting reference summary)

Pathology referenceMost osteomalacia‑associated mesenchymal tumors are phosphaturic mesenchymal tumors of mixed connective tissue type (Folpe et al., Am J Surg Pathol. 2004).

Clinical studiesTIO tumors ectopically express and secrete FGF23 and other phosphaturic proteins; clinical reports detail tumor localization challenges and biochemical consequences (Shane et al., J Bone Miner Res. 1997).

Implication for diagnosisSupporting literature underscores that tumors are often small, slow‑growing, and may be unlocalizable or unresectable, necessitating medical therapy for FGF23‑mediated hypophosphatemia.