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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAmeriHealth Caritas Burosumab Coverage | OpenPayer
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    ModifiedAmeriHealth Caritas VIP CarePolicy MA08.099b

    Burosumab-twza (Crysvita) Coverage Criteria

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    Medical-benefit (Medicare Part B) coverage and medical necessity for burosumab-twza in eligible individuals with X-linked hypophosphatemia or tumor-induced osteomalacia, subject to applicable benefit limitations and clinical criteria.

    Policy Summary
    PayerAmeriHealth Caritas VIP Care
    PolicyBurosumab-twza (Crysvita) Coverage Criteria
    Policy CodePolicy MA08.099b
    Change TypeModified
    Effective DateMarch 15, 2021
    Next Review DateN/A
    Key ActionDocument the applicable XLH or TIO diagnosis, supporting evidence, serum FGF23 level, clinical features, phosphorus level, and renal function.
    SourceLink
    POLICY UPDATE CHANGES

    Added coverage criteria for tumor-induced osteomalacia (TIO) in consideration of revised FDA labeling.

    Changed the minimum age for initial and continuation therapy for X-linked hypophosphatemia to 6 months.

    Deleted HCPCS code J3590 from the policy.

    6 months+Minimum age for XLH
    2 years+Minimum age for TIO
    >30 pg/mLRequired FGF23
    <30 mL/min

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    GFR exclusion threshold
    Part BBenefit
    Not coveredOther uses

    Coverage Criteria

    Initial Therapy

    Covered when all applicable criteria are met:

    ALL of the following

    • ONE of the following indications

      • Individual is at least 6 months of age with X-linked hypophosphatemia (XLH).>= 6 months of age
      • Individual is at least 2 years of age with tumor-induced osteomalacia (TIO) associated with a phosphaturic mesenchymal tumor (PMT) that cannot be curatively resected or localized.>= 2 years of age

    • ALL of the following clinical criteria

      • Diagnosis of XLH or TIO associated with PMT is supported by appropriate documentation: for XLH, a documented PHEX pathogenic (disease-causing) mutation in the individual or a directly related family member with appropriate X-linked inheritance; or for TIO, documented evidence of TIO associated with a PMT.
      • Serum fibroblast growth factor 23 (FGF23) level is greater than 30 pg/mL.> 30 pg/mL
      • Classic clinical features of the disease are documented, such as rickets, growth abnormalities including short stature or lower-extremity bowing, bone pain, or bone fractures.
      • Fasting serum phosphorus is below the normal range for age.
      • Individual does not have renal impairment or end-stage renal disease, defined as a glomerular filtration rate less than 30 mL/min.>= 30 mL/min
      • Individual has discontinued, or is willing to discontinue, oral phosphate and active vitamin D analogs within 1 week before treatment initiation.Within 1 week before initiation

    Continuation Therapy

    Covered during continuation therapy when all applicable criteria are met:

    ALL of the following

    • ONE of the following indications

      • Individual is at least 6 months of age with XLH.>= 6 months of age
      • Individual is at least 2 years of age with TIO associated with a PMT that cannot be curatively resected or localized.>= 2 years of age
    • Serum phosphate has normalized during therapy and hyperphosphatemia is absent.

    • Documented clinical improvement appropriate to the individual’s age

    Experimental/Investigational Uses

    Uses are experimental/investigational and not covered unless the indication qualifies as an accepted off-label use under the Company medical policy on off-label coverage for prescription drugs and biologics.

    Experimental/investigational use

    • The use of burosumab-twza (Crysvita®) is not an indication meeting the medically necessary criteria for initial or continuation therapy in this policy.
    • The indication is not supported as an accepted off-label use under the Company medical policy on off-label coverage for prescription drugs and biologics.

    Uses of burosumab-twza (Crysvita®) that do not meet the covered medically necessary indications and criteria are excluded from coverage. An otherwise excluded indication may be covered only when it is supported as an accepted off-label use under the Company medical policy on off-label coverage for prescription drugs and biologics.

    Subject to the applicable Evidence of Coverage, burosumab-twza (Crysvita®) is covered under the medical benefits of the Company's Medicare Advantage products when the medical necessity criteria in this medical policy are met.

    There is no Medicare coverage determination addressing this drug; therefore, the Company policy is applicable.

    For Medicare Advantage members, certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy addresses only instances when burosumab-twza (Crysvita®) is covered under a member's medical benefit (Part B benefit). It does not address instances when burosumab-twza (Crysvita®) is covered under a member's pharmacy benefit (Part D benefit).

    Burosumab-twza (Crysvita®) should be interrupted if the individual's phosphorus level exceeds the upper limit of normal, because hyperphosphatemia may increase the risk of nephrocalcinosis. Dose adjustment or interruption of therapy may be required based on phosphorus levels.

    Phosphorus levels and other safety concerns should be monitored during therapy, including any previous serious hypersensitivity reaction to burosumab-twza (Crysvita®).

    Initial Therapy Criteria

    Initial Therapy Criteria

    Initial therapy is covered when the applicable indication and all required criteria are met.

    Initial therapy

    • Covered indication

      • XLH: The individual is at least 6 months of age and has XLH supported by a documented PHEX pathogenic, disease-causing mutation in the individual or in a directly related family member with appropriate X-linked inheritance.Age at least 6 months
      • TIO: The individual is at least 2 years of age and has TIO associated with a phosphaturic mesenchymal tumor that cannot be curatively resected or localized, supported by documented evidence of TIO associated with the tumor.Age at least 2 years

    Continuation Criteria

    Continuation Therapy Criteria

    Continuation therapy is covered when all of the following are met.

    Continuation criteria

    • Documented clinical improvement: For adult individuals, improvement may include improvement in bone pain, enhanced mobility, or radiographic evidence of improvement in osteomalacia or fracture healing. For pediatric individuals, improvement may include enhanced height velocity, improvement in lower-extremity bowing and associated abnormalities, improved walking ability, or radiographic evidence of improvement in rickets, osteomalacia, or epiphyseal healing.

      Document at least one applicable clinical improvement based on the individual's age.

    Coding and Clinical Thresholds

    CPT Procedure Code Number(s)CPT
    N/AN/A
    ICD-10 Diagnosis Code Number(s)ICD-10
    E55.0Rickets, active
    E83.31Familial hypophosphatemia
    M83.8Other adult osteomalacia
    HCPCS Level II Code Number(s)HCPCS
    J0584Injection, burosumab-twza 1 mg
    Revenue Code Number(s)Revenue
    N/AN/A
    Serum FGF23
    TestSerum fibroblast growth factor 23 (FGF23)
    Required level> 30 pg/mL
    Applies toInitial evaluation for XLH or TIO associated with a phosphaturic mesenchymal tumor
    Fasting Serum Phosphorus
    TestFasting serum phosphorus
    Required resultBelow the normal range for age

    Documentation and Provider Actions

    Documentation Required

    Medical Records and Supporting Reports

    Submit complete medical-necessity documentation supporting burosumab-twza treatment. The record may include professional provider, hospital, nursing home, home health, therapy, and laboratory or other test reports; all requested documentation must be available for Company review or audit.

    • Provide records and supporting reports from all relevant care settings and services.
    • Failure to produce requested information may result in denial of the drug.
    Documentation Required

    Initial-Therapy Clinical Documentation

    For initial therapy, document the qualifying diagnosis and clinical, laboratory, renal-function, and prior-therapy requirements before treatment begins.

    • Age and indication: individual is at least 6 months old with XLH, or at least 2 years old with TIO associated with a phosphaturic mesenchymal tumor (PMT) that cannot be curatively resected or localized.
    • Diagnosis and disease evidence: for XLH, a documented PHEX pathogenic mutation in the individual or a directly related family member with appropriate X-linked inheritance; for TIO, documented TIO associated with PMT; and serum FGF23 > 30 pg/mL.

    Clinical Background

    These disorders may present with rickets, growth abnormalities, bone pain, fractures, skeletal deformities, muscle weakness, and gait disturbance. In TIO, medical treatment may be needed when the phosphaturic mesenchymal tumor cannot be localized or curatively resected.

    Definitions

    XLH
    Full termX-linked hypophosphatemia
    Genetic associationAssociated with a mutation in the PHEX gene sequence
    Disease mechanismExcessive FGF23 activity causes phosphate wasting and low serum phosphorus
    TIO
    Full termTumor-induced osteomalacia
    SyndromeAn FGF23-related hypophosphatemic syndrome causing phosphate wasting and chronic hypophosphatemia
    Tumor associationAssociated with phosphaturic mesenchymal tumors that secrete excessive FGF23
    Policy Summary
    PayerAmeriHealth Caritas VIP Care
    PolicyBurosumab-twza (Crysvita) Coverage Criteria
    Policy CodePolicy MA08.099b
    Change TypeModified
    Effective DateMarch 15, 2021
    Next Review DateN/A
    Key ActionDocument the applicable XLH or TIO diagnosis, supporting evidence, serum FGF23 level, clinical features, phosphorus level, and renal function.
    SourceLink
    On This Page
    Coverage CriteriaInitial Therapy CriteriaContinuation CriteriaCoding and Clinical ThresholdsDocumentation and Provider ActionsClinical BackgroundDefinitions
    Adult individual: documented improvement in bone pain, enhanced mobility, or radiographic evidence of improvement in osteomalacia or fracture healing.
  1. Pediatric individual: documented enhanced height velocity, improvement in lower-extremity bowing or associated abnormalities, improved walking ability, or radiographic evidence of improvement in rickets, osteomalacia, or epiphyseal healing.
    2. Required clinical and laboratory criteria: Serum FGF23 is greater than 30 pg/mL; classic clinical features of disease are documented; fasting serum phosphorus is below the normal range for age; the individual does not have renal impairment or end-stage renal disease defined as a glomerular filtration rate less than 30 mL/min; and the individual has discontinued or is willing to discontinue oral phosphate and active vitamin D analogs within one week before treatment initiation.FGF23 >30 pg/mL; fasting serum phosphorus below the age-specific normal range; glomerular filtration rate must not be <30 mL/min

    Classic clinical features may include rickets, short stature, lower-extremity bowing, bone pain, or bone fractures.

    Purpose
    Supports the diagnosis of XLH or TIO associated with a phosphaturic mesenchymal tumor
    Glomerular Filtration Rate
    MeasureGlomerular filtration rate (GFR)
    Exclusion thresholdRenal impairment or end stage renal disease defined as GFR < 30 mL/min
    Coverage requirementThe individual must not have a GFR below 30 mL/min
    Age-Specific Normal Serum Phosphorus: 0–11 Months
    Age range0–11 months
    Normal serum phosphorus4.8–8.2 mg/dL
    Measurement unitMilligrams of phosphorus per deciliter of blood (mg/dL)
    Age-Specific Normal Serum Phosphorus: 1–3 Years
    Age range1–3 years
    Normal serum phosphorus3.8–6.5 mg/dL
    Measurement unitMilligrams of phosphorus per deciliter of blood (mg/dL)
    Age-Specific Normal Serum Phosphorus: 4–6 Years
    Age range4–6 years
    Normal serum phosphorus4.1–5.4 mg/dL
    Measurement unitMilligrams of phosphorus per deciliter of blood (mg/dL)
    Age-Specific Normal Serum Phosphorus: 7–11 Years
    Age range7–11 years
    Normal serum phosphorus3.7–5.6 mg/dL
    Measurement unitMilligrams of phosphorus per deciliter of blood (mg/dL)
    Age-Specific Normal Serum Phosphorus: 12–13 Years
    Age range12–13 years
    Normal serum phosphorus3.3–5.4 mg/dL
    Measurement unitMilligrams of phosphorus per deciliter of blood (mg/dL)
    Age-Specific Normal Serum Phosphorus: 14–15 Years
    Age range14–15 years
    Normal serum phosphorus2.9–5.4 mg/dL
    Measurement unitMilligrams of phosphorus per deciliter of blood (mg/dL)
    Age-Specific Normal Serum Phosphorus: 16–20 Years
    Age range16–20 years
    Normal serum phosphorus2.7–4.7 mg/dL
    Measurement unitMilligrams of phosphorus per deciliter of blood (mg/dL)
    Age-Specific Normal Serum Phosphorus: 21 Years and Older
    Age range21 years and older
    Normal serum phosphorus2.5–4.5 mg/dL
    Measurement unitMilligrams of phosphorus per deciliter of blood (mg/dL)
    Fasting Serum Phosphorus Target for TIO
    ConditionTumor-induced osteomalacia (TIO)
    Fasting serum phosphorus target2.5 to 4.0 mg/dL
    Treatment contextWeight-based burosumab-twza dosing was titrated to achieve this target
    Serum Phosphorus Outcome for TIO
    Outcome measureSerum phosphorus level above the lower limit of normal (LLN)
    Week 24 result69% of treated individuals achieved a mean serum phosphorus level above the LLN
    Study population13 adults with confirmed TIO
  2. Clinical manifestations: documented classic features such as rickets, growth abnormalities including short stature or lower-extremity bowing, bone pain, or bone fractures.
  3. Laboratory and renal status: fasting serum phosphorus below the normal range for age, with no renal impairment or end-stage renal disease defined as GFR < 30 mL/min.
  4. Prior therapy: the individual has discontinued or is willing to discontinue oral phosphate and active vitamin D analogs within one week before treatment initiation.
    5. Documentation Required

    Continuation Response Documentation

    For continuation therapy, document that treatment has normalized serum phosphate without hyperphosphatemia and has produced clinically meaningful improvement.

    • For adults, document improvement such as reduced bone pain, enhanced mobility, or radiographic improvement in osteomalacia or fracture healing.
    • For pediatric individuals, document improvement such as increased height velocity, reduced lower-extremity bowing or associated abnormalities, improved walking ability, or radiographic improvement in rickets, osteomalacia, or epiphyseal healing.

    Unsupported block type: prior_auth_

    Denial Risk

    Noncovered or Unrecognized Indication

    All other uses of burosumab-twza are experimental/investigational and not covered unless the indication is supported as an accepted off-label use under the Company's medical policy for off-label coverage of prescription drugs and biologics.

    • Verify that the requested indication is XLH or qualifying TIO, or follow the applicable off-label coverage pathway.
    Denial Risk

    Missing Documentation

    Provide all requested medical-necessity records and supporting reports. The Company may review or audit services regardless of provider participation status, and missing records may result in denial of the drug.

    • Make records available upon request, including provider, facility, therapy, home health, laboratory, and other relevant reports.
    Denial Risk

    Initial Criteria Not Met

    Initial therapy may be denied when the applicable age, diagnosis, clinical, laboratory, renal-function, or prior-therapy requirements are not met or cannot be supported in the medical record.

    • Individual is younger than 6 months for XLH or younger than 2 years for qualifying TIO, or the indication does not meet the applicable XLH or TIO/PMT requirements.
    • Required PHEX or TIO evidence, FGF23 level > 30 pg/mL, or classic clinical manifestations are absent or undocumented.
    • Fasting serum phosphorus is not below the normal range for age.
    • GFR is < 30 mL/min or the individual has renal impairment or end-stage renal disease.
    • Oral phosphate and active vitamin D analogs have not been discontinued, and the individual is not willing to discontinue them within one week before initiation.
    Denial Risk

    Continuation Criteria Not Met

    Continuation therapy may be denied when serum phosphate has not normalized, hyperphosphatemia is present, or clinical improvement is not documented.

    • No documented normalization of serum phosphate during therapy or evidence of hyperphosphatemia.
    • No documented adult improvement in pain, mobility, or radiographic osteomalacia or fracture healing.
    • No documented pediatric improvement in height velocity, lower-extremity bowing or associated abnormalities, walking ability, or radiographic rickets, osteomalacia, or epiphyseal healing.
    PMT
    Full termPhosphaturic mesenchymal tumors
    Typical characteristicsSmall and slow-growing tumors that can occur in soft tissue or bone
    Relationship to FGF23Secrete excess FGF23, causing phosphate wasting and chronic hypophosphatemia
    FGF23
    Full termFibroblast growth factor 23
    Physiologic roleRegulates renal phosphate excretion and vitamin D production by the kidney
    Excess activityReduces serum phosphorus and vitamin D, causing phosphate wasting and hypophosphatemia