Crysvita (burosumab-twza) (Subcutaneous) coverage criteria
Customize your policy alerts
Sign up for eocco Policy M-0362 alerts
Get alerted when Policy M-0362 changes without checking for updates manually.
Monitor payer policy activity
Defines prior authorization, dosing, eligibility, monitoring, and renewal criteria for Crysvita (burosumab-twza) for X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO) for members covered by eocco.
No material clinical or coverage changes in this revision.
Coverage Criteria
Universal and initial approval criteria
Covered when ALL of the following are met
Phosphorus levels should be obtained fasting 12 hours or more; lab values (GFR, phosphorus, TmP/GFR) should be obtained within 28 days of administration
XLH-specific initial criteria
AND for XLH patients, ALL of the following
Adults require documentation of inadequate response to oral phosphate and active vitamin D analogs
TIO-specific initial criteria
AND for TIO patients, ALL of the following
Tumor must be non-resectable or non-localizable
Renewal criteria
Renewal may be granted when ALL of the following are met
Prior authorization renewals per policy may require continued documentation of labs and clinical improvement
Severe renal impairment is an exclusion for burosumab therapy. Specifically, members with a glomerular filtration rate (GFR) of 30 mL/min do not meet coverage criteria and therapy is not permitted for these individuals.
Medicare coverage rules may apply to some members. Where applicable, providers must comply with Medicare National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) and any Local Coverage Articles (LCAs). The CMS coverage database (https://www.cms.gov/medicare-coveragedatabase/search.aspx) may be used to identify relevant NCDs/LCDs; additional indications may be applied at the health plan’s discretion.
Burosumab must not be used concomitantly with oral phosphate supplements or active vitamin D analogs. The policy requires that therapy will not be used concomitantly with oral phosphate and/or active vitamin D analogs as a condition of coverage.
Coding and Billing
| J0584 | Injection, burosumab-twza, 1 mg |
| 42747-0102-xx | Crysvita 10 mg/mL single-dose vial |
| 42747-0203-xx | Crysvita 20 mg/mL single-dose vial |
| 42747-0304-xx | Crysvita 30 mg/mL single-dose vial |
| E83.31 | Familial hypophosphatemia |
| E83.39 | Other disorders of phosphorus metabolism |
| M83.8 | Other adult osteomalacia |
| No codes listed |
| No codes listed |
Provider Actions and Prior Authorization
Prior authorization required; initial 6 months, renewals every 12 months
Prior authorization is required for Crysvita; initial approval is valid for 6 months (180 days) and renewals may be granted every 12 months (365 days). Authorization will only be provided when the member meets the universal criteria and the indication‑specific criteria for XLH or TIO (including age limits, diagnostic confirmation, and laboratory evidence of hypophosphatemia).
- Initial PA validity: 6 months (180 days).
- Renewal interval: every 12 months (365 days).
- Approval requires meeting universal criteria plus XLH- or TIO-specific criteria (age, diagnostic confirmation, labs).
PA applied per NQTL checklist; include covered diagnosis code
Prior authorization is applied consistent with the NQTL checklist; coverage consideration requires submission of a covered diagnosis code from Appendix 1 with the PA request.
- NQTL checklist factors indicate PA is considered for this indication and cost.
- Include one of the Appendix 1 ICD‑10 diagnosis codes with the authorization request (see Appendix 1).
Step requirement — adults with XLH must document prior therapy failure
For adult members with XLH, the request must document an inadequate clinical response to prior therapy with oral phosphate and active vitamin D analogs before approval will be granted.
- Adults with XLH must have failed or had an inadequate response to oral phosphate plus active vitamin D analog therapy prior to initiation.
No action specified
No provider action content specified for this inventory placeholder.
Required clinical documentation: fasting phosphorus, TmP/GFR, diagnostic labs
Submit baseline fasting serum phosphorus obtained after a 12‑hour fast and within 28 days of planned administration, documentation of reduced TmP/GFR, and other relevant labs (FGF23 or PHEX testing as appropriate); monitoring labs per dosing guidance should also be provided.
- Fasting serum phosphorus (≥12 hours fasting) obtained within 28 days demonstrating current hypophosphatemia (below lab lower limit).
- TmP/GFR showing reduced tubular phosphate reabsorption corrected for GFR.
- Diagnostic confirmation labs (FGF23 or PHEX mutation) as indicated by diagnosis.
- Baseline and planned monitoring labs per dosing/administration guidance (serum phosphorus monitoring schedule).
Required diagnosis coding — use Appendix 1 ICD‑10 codes
Document the member's diagnosis using one of the covered ICD‑10 codes listed in Appendix 1 (E83.31, E83.39, M83.8) when submitting the prior authorization request.
- Covered diagnosis codes (Appendix 1): E83.31, E83.39, M83.8.
Denial risk if no recent fasting phosphorus or alternate causes not excluded
Requests may be denied if there is no recent fasting serum phosphorus showing current hypophosphatemia or if alternative causes of hypophosphatemia have not been excluded; other denial considerations include severe renal impairment (GFR <30 mL/min) or use with oral phosphate/active vitamin D.
- No fasting serum phosphorus within 28 days demonstrating hypophosphatemia → denial risk.
- Failure to exclude other causes of hypophosphatemia → denial risk.
- Severe renal impairment (GFR <30 mL/min) or concomitant use with oral phosphate/active vitamin D → not eligible.
PA may be considered due to indication and drug cost (NQTL)
Prior authorization may be considered because of the drug indication and cost as reflected in the NQTL factor checklist; include NQTL considerations when submitting and reviewing PA requests.
- Appendix A notes 'Indication' and 'Cost of drug' as factors supporting consideration for PA.
Definitions and Diagnostic Confirmation
Background
Burosumab (Crysvita) is a monoclonal antibody targeting FGF23 and is indicated for treatment of X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO). This policy defines eligibility, prior authorization processes, dosing and monitoring expectations, and renewal criteria for these indications, including diagnostic confirmation (FGF23 or PHEX mutation for XLH; elevated FGF23 with non-resectable/non-localizable tumor for TIO) and laboratory monitoring requirements such as fasting serum phosphorus and TmP/GFR.
References, Appendices and Revision History
For members covered by Medicare, providers should follow Medicare guidance where applicable. Appendix 2 notes that Medicare Part B coverage rules are outlined in the Medicare Benefit Policy Manual and that NCDs/LCDs/LCAs may exist and must be followed. If Medicare Part B rules apply, ensure claims and clinical documentation align with applicable Medicare policies and jurisdictional MAC guidance.
When Medicare Part B applies, document the member’s diagnosis using one of the covered diagnosis codes referenced in Appendix 1. The policy’s Appendix 1 lists the applicable ICD-10 codes (e.g., E83.31, E83.39, M83.8) that should be used for coverage consideration and billing under Part B when relevant.
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.