By Counterforce Health Team in Crysvita (burosumab) —

Blue Cross Blue Shield California Crysvita (Burosumab) Coverage: Prior Authorization Requirements and Appeal Process

Answer Box: Getting Crysvita Covered by Blue Cross Blue Shield California

To get Crysvita (burosumab) approved by Blue Cross Blue Shield California, you need: (1) documented XLH or TIO diagnosis with biochemical confirmation, (2) specialist prescription from endocrinologist or nephrologist, and (3) prior authorization through their specialty pharmacy network. For XLH, adults need evidence of osteomalacia symptoms; for TIO, tumor must be unresectable. Start today: Contact your specialist to initiate the Blue Shield California prior authorization process and arrange specialty pharmacy dispensing.

Table of Contents

  1. Blue Shield California Policy Overview
  2. Indication Requirements for Crysvita Coverage
  3. Step Therapy and Medical Exceptions
  4. Quantity Limits and Dosing Frequency
  5. Required Diagnostics and Lab Values
  6. Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Documentation
  9. Common Denial Reasons and Solutions
  10. California Appeals Process
  11. Costs and Patient Support Options
  12. FAQ

Policy Overview

Blue Shield of California covers Crysvita (burosumab) under their specialty drug benefit with strict prior authorization requirements. The medication requires clinical review before approval and must be dispensed through designated specialty pharmacies.

Plan Types and Coverage:

  • HMO plans: Prior authorization required through primary care referral to specialist
  • PPO plans: Direct specialist access, but PA still mandatory
  • Medi-Cal managed care: Additional state-specific requirements may apply

According to Blue Shield California's medical policy, Crysvita is covered for two FDA-approved indications with specific clinical criteria that must be met.

Indication Requirements for Crysvita Coverage

X-linked Hypophosphatemia (XLH)

Adults (≥18 years):

  • Must be prescribed by endocrinologist or specialist in metabolic bone disorders
  • History of osteomalacia-related symptoms or complications required
  • Maximum dose: 90 mg subcutaneously every 4 weeks

Pediatric patients (<18 years):

  • Weight-based dosing up to 90 mg every 2 weeks
  • Growth monitoring and rickets documentation required

Tumor-Induced Osteomalacia (TIO)

All ages:

  • Signs or symptoms of TIO documented
  • Evidence that tumor cannot be curatively resected
  • Prior trial of oral phosphate and calcitriol unless contraindicated
  • Maximum dose: 180 mg every 2 weeks
Note: Both conditions require biochemical confirmation of hypophosphatemia with evidence of renal phosphate wasting.

Step Therapy and Medical Exceptions

For TIO patients, Blue Shield California requires documentation of:

  1. Failed conventional therapy with oral phosphate supplements and active vitamin D (calcitriol)
  2. Contraindications to standard therapy (documented intolerance or medical reasons)
  3. Inadequate response to conventional treatment after appropriate trial period

Medical Exception Pathways:

  • Severe hypophosphatemia with fractures
  • Documented intolerance to oral phosphate (GI side effects)
  • Contraindications to active vitamin D therapy
  • Tumor location preventing surgical resection

Quantity Limits and Dosing Frequency

Blue Shield California enforces strict quantity limits based on FDA-approved dosing:

XLH Limits:

  • Adults: 90 mg every 28 days (4 weeks)
  • Pediatric: 90 mg every 14 days (2 weeks)

TIO Limits:

  • All ages: 180 mg every 14 days (2 weeks)

Dosing Adjustments:

  • Cannot be made more frequently than every 4 weeks
  • Requires documented serum phosphorus monitoring
  • Weight-based calculations must be provided for pediatric patients

Required Diagnostics and Lab Values

Essential Laboratory Tests:

Test Requirement Timing
Fasting serum phosphorus Below age-specific normal range Within 30 days
FGF23 level Elevated or inappropriately normal If available
Alkaline phosphatase Elevated (especially pediatric) Within 30 days
TmP/GFR or TRP Below normal (renal phosphate wasting) Within 30 days
Creatinine clearance ≥30 mL/min Within 30 days

For XLH Diagnosis:

  • Genetic testing for PHEX mutation (when no family history)
  • Exclusion of vitamin D deficiency
  • Documentation of rickets/osteomalacia symptoms

For TIO Diagnosis:

  • Imaging studies (FDG-PET/CT, MRI, or CT) showing unresectable tumor
  • FGF23 level >100 pg/mL preferred

Specialty Pharmacy Requirements

Crysvita must be dispensed through Blue Shield California's contracted specialty pharmacy network. Retail pharmacies cannot dispense this medication.

Specialty Pharmacy Process:

  1. Prior authorization approval obtained
  2. Prescription sent to designated specialty pharmacy
  3. Patient enrollment and coordination of care
  4. Home delivery or clinic shipment arranged
  5. Ongoing monitoring and refill coordination

Storage and Handling:

  • Requires refrigeration (2-8°C)
  • Single-use vials with specific administration requirements
  • Healthcare provider administration or patient/caregiver training needed

Evidence to Support Medical Necessity

Clinical Guidelines to Reference:

  • FDA prescribing information for approved indications
  • Pediatric Endocrine Society guidelines for XLH management
  • International consensus statements on TIO diagnosis and treatment

Key Evidence Points:

  • Documented failure of conventional phosphate/vitamin D therapy
  • Biochemical markers consistent with FGF23-mediated hypophosphatemia
  • Clinical symptoms impacting quality of life or bone health
  • Specialist assessment of treatment necessity

Sample Medical Necessity Documentation

Template for XLH (Adult): "Patient is a [age]-year-old with genetically confirmed X-linked hypophosphatemia (PHEX mutation documented) presenting with persistent hypophosphatemia (serum phosphorus [value] mg/dL, normal [range]), elevated alkaline phosphatase ([value] U/L), and clinical evidence of osteomalacia including [specific symptoms]. TmP/GFR is reduced at [value], confirming renal phosphate wasting. Patient has experienced [complications] that significantly impact functional status. Conventional therapy with oral phosphate and calcitriol is contraindicated due to [reason] or has failed to normalize phosphorus levels after [duration] trial. Crysvita 1 mg/kg (rounded to [dose] mg) every 4 weeks is medically necessary to address the underlying FGF23 excess and prevent further bone complications."

Common Denial Reasons and Solutions

Denial Reason Solution
Insufficient diagnostic documentation Submit complete lab panel with TmP/GFR calculation and specialist interpretation
Missing genetic confirmation for XLH Provide PHEX genetic testing results or detailed family history documentation
Inadequate prior therapy documentation Document specific oral phosphate/calcitriol trials with doses, duration, and outcomes
Quantity limit exceeded Verify weight-based dosing calculations and provide clinical justification
Non-specialist prescriber Transfer prescription to endocrinologist or nephrologist

California Appeals Process

If Blue Shield California denies your Crysvita prior authorization, California offers robust appeal rights through the Department of Managed Health Care (DMHC).

Internal Appeal Process:

  1. File grievance within 180 days of denial
  2. Timeline: Plan must respond within 30 days (72 hours for urgent)
  3. Documentation: Include all medical records, lab results, and specialist letters

Independent Medical Review (IMR):

How to File IMR:

  • Call DMHC Help Center: (888) 466-2219
  • Online application at healthhelp.ca.gov
  • Must file within 6 months of final internal denial
From our advocates: "We've seen TIO cases initially denied for 'experimental' designation get approved at IMR when comprehensive FGF23 data and tumor imaging were submitted together with FDA labeling excerpts. The key was demonstrating that surgical resection wasn't feasible and conventional therapy had failed."

Costs and Patient Support Options

Manufacturer Support:

  • Ultragenyx Patient Connect program
  • Copay assistance for eligible commercially insured patients
  • Free drug program for uninsured patients meeting income criteria

Financial Assistance:

  • National Organization for Rare Disorders (NORD) grants
  • HealthWell Foundation specialty drug assistance
  • State pharmaceutical assistance programs

Estimated Costs:

  • Annual treatment costs typically range $50,000-$300,000+ depending on dose
  • Specialty pharmacy copays vary by plan tier and deductible status

FAQ

How long does Blue Shield California prior authorization take? Standard PA decisions are made within 14 business days. Urgent requests are processed within 72 hours when clinical urgency is documented.

What if Crysvita is non-formulary on my plan? Request a formulary exception with medical necessity documentation. California law requires coverage consideration for medically necessary non-formulary drugs.

Can I request an expedited appeal? Yes, if delay in treatment could seriously jeopardize your health. Document the urgency with your specialist's clinical assessment.

Does step therapy apply if I've tried phosphate therapy outside California? Previous therapy trials from other states are generally accepted if properly documented in medical records.

What happens if my appeal is denied at IMR? IMR decisions are binding on the health plan. If approved, Blue Shield must authorize coverage. There are limited grounds for further legal challenge.

Counterforce Health helps patients navigate complex prior authorization and appeal processes for specialty medications like Crysvita. Our platform analyzes denial letters and creates targeted, evidence-backed appeals that align with payer-specific requirements. By pulling the right clinical evidence and weaving it into compelling medical necessity arguments, we help turn insurance denials into approvals. Visit www.counterforcehealth.org to learn how we can support your coverage journey.

When facing a Blue Shield California denial for Crysvita, having the right documentation and understanding the specific clinical criteria can make the difference between approval and prolonged delays. Counterforce Health's approach focuses on creating comprehensive appeals that address each payer's unique requirements while building strong medical necessity cases.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For assistance with insurance appeals in California, contact the DMHC Help Center at (888) 466-2219.

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