By Counterforce Health Team in Krystexxa (pegloticase) —

If Krystexxa (Pegloticase) Isn't Approved by Blue Cross Blue Shield in Washington: Formulary Alternatives & Exception Paths

Answer Box: When Krystexxa Isn't Covered

If Blue Cross Blue Shield in Washington denies Krystexxa (pegloticase), you have several options: try formulary alternatives first (allopurinol, febuxostat), request a step therapy exception if previous treatments failed, or file an internal appeal within 30 days. Washington's external review process through an Independent Review Organization (IRO) can overturn denials when medical evidence supports necessity. Start by contacting your provider to document treatment failures and submit a formulary exception request through BCBS's provider portal.

Table of Contents

When Alternatives Make Sense

Blue Cross Blue Shield in Washington typically requires patients to try conventional gout therapies before approving Krystexxa (pegloticase). This approach makes clinical and financial sense for several reasons:

Cost considerations: Krystexxa costs approximately $30,000 per infusion, with annual treatment reaching $780,000, while conventional therapies cost $20-200 monthly.

Clinical appropriateness: The FDA label specifically indicates Krystexxa for chronic gout "refractory to conventional therapy," meaning standard treatments must be tried first.

Safety profile: Conventional therapies have well-established safety profiles, while Krystexxa carries risks of severe infusion reactions and requires specialized administration settings.

Alternatives make sense when:

  • You haven't tried maximum tolerated doses of first-line therapies
  • Previous treatment attempts were inadequate in duration (less than 3 months)
  • You have contraindications to Krystexxa (G6PD deficiency)
  • Your insurance requires step therapy documentation

Typical Formulary Alternatives

Blue Cross Blue Shield Washington formularies include these alternatives to Krystexxa, organized by treatment approach:

Xanthine Oxidase Inhibitors (First-Line)

  • Allopurinol: Most commonly prescribed; start 100mg daily, titrate to achieve serum uric acid <6 mg/dL
  • Febuxostat: Second-line XOI; 40-80mg daily; avoid in patients with cardiovascular disease due to FDA black box warning

Uricosuric Agents

  • Probenecid: Increases uric acid excretion; contraindicated with kidney stones or severe renal impairment
  • Lesinurad: Must be combined with XOI; not approved as monotherapy

Acute Flare Management

  • Colchicine: For acute attacks and prophylaxis during urate-lowering therapy initiation
  • NSAIDs: Indomethacin, naproxen for acute management
  • Corticosteroids: Oral or injectable for patients who can't tolerate NSAIDs or colchicine
Note: Washington state law requires insurers to provide step therapy exceptions when medically appropriate, including when previous therapies caused adverse reactions or were ineffective.

Pros and Cons Overview

Conventional Therapy Advantages

  • Lower cost: Significantly more affordable with better insurance coverage
  • Oral administration: No need for infusion center visits
  • Established safety: Decades of clinical experience
  • Monitoring requirements: Standard lab monitoring (liver function, kidney function)

Conventional Therapy Limitations

  • Slower onset: May take 6-12 months to see full benefit
  • Hypersensitivity risk: Allopurinol can cause severe skin reactions, especially in certain ethnic groups
  • Drug interactions: Allopurinol interacts with azathioprine and warfarin
  • Renal dosing: Requires adjustment in kidney disease

Krystexxa Advantages

  • Rapid uric acid reduction: Can achieve target levels within weeks
  • Tophi dissolution: Effective for visible tophi that don't respond to conventional therapy
  • Refractory cases: Only option for patients who've truly failed all alternatives

Krystexxa Limitations

  • High cost: Requires extensive prior authorization
  • Infusion reactions: Risk of anaphylaxis requires specialized monitoring
  • Limited duration: Many patients lose response over time
  • G6PD screening: Required before initiation

Exception Strategy

When conventional alternatives aren't appropriate, request a formulary exception through these steps:

Documentation Requirements

Your provider should submit:

  • Treatment history: Detailed records of allopurinol and febuxostat trials, including doses, duration (minimum 3 months each), and outcomes
  • Contraindications: Documentation of adverse reactions, allergies, or medical contraindications
  • Serum uric acid levels: Pre- and post-treatment levels showing inadequate response (≥6 mg/dL despite maximum tolerated therapy)
  • Clinical severity: Evidence of frequent flares (≥2 per year), persistent tophi, or joint damage

Medical Necessity Criteria

BCBS policies typically require:

  • Diagnosis of chronic gout refractory to conventional therapy
  • Failed or intolerant to both allopurinol AND febuxostat
  • G6PD screening completed (not deficient)
  • Serum uric acid persistently >6 mg/dL despite treatment
  • Rheumatology consultation recommended
Clinician Corner: Include FDA labeling excerpts showing the patient meets approved indications, peer-reviewed studies supporting use in refractory gout, and American College of Rheumatology guidelines recommending pegloticase for treatment-resistant cases.

Switching Logistics

Provider Coordination

  1. Schedule transition appointment: Plan timing to avoid treatment gaps
  2. Laboratory monitoring: Order baseline labs before starting new therapy
  3. Flare prophylaxis: Prescribe colchicine or NSAIDs to prevent gout flares during transition
  4. Patient education: Explain expected timeline for conventional therapy benefits

Pharmacy Coordination

  • Insurance verification: Confirm coverage for new medications
  • Prior authorization: Submit PA requests for non-formulary alternatives if needed
  • Dosing guidance: Provide clear titration schedules
  • Monitoring schedule: Coordinate lab draws with provider

Timeline Expectations

  • Allopurinol/Febuxostat: Start low, titrate every 2-4 weeks based on uric acid levels
  • Target achievement: May take 3-6 months to reach serum uric acid <6 mg/dL
  • Flare management: Prophylaxis typically needed for 6 months after starting therapy
From our advocates: We've seen patients successfully transition from denied Krystexxa to effective conventional therapy by working closely with their rheumatologist to optimize dosing and manage flares. The key is patience during the titration period and consistent monitoring.

Re-Trying for Krystexxa Later

If conventional alternatives fail after adequate trials, document the following for future Krystexxa authorization:

Treatment Documentation

  • Duration: Minimum 3 months at maximum tolerated dose for each therapy
  • Adherence: Medication compliance records
  • Outcomes: Serial uric acid levels, flare frequency, tophi measurements
  • Side effects: Any adverse reactions or intolerances

Failure Criteria

  • Inability to achieve serum uric acid <6 mg/dL
  • Persistent frequent flares (≥2 per year)
  • Progressive joint damage or tophi
  • Intolerable side effects at therapeutic doses

Counterforce Health helps patients and clinicians prepare comprehensive prior authorization requests by analyzing denial letters, identifying specific coverage criteria, and drafting evidence-based appeals that address payer requirements point-by-point.

Appeals Playbook for Washington

Internal Appeals

Timeline: File within 30 days of denial notice Process: Submit written request with:

  • Original denial letter
  • Additional medical records
  • Provider letter explaining medical necessity
  • Updated lab results or clinical notes

Decision: Premera Blue Cross and other Washington Blues must respond within 30 calendar days.

External Review

Eligibility: Available after final internal denial Timeline: Request within 180 days of final denial Process:

  1. Submit request to BCBS (they notify Washington Office of Insurance Commissioner)
  2. Independent Review Organization (IRO) assigned within 3 days
  3. Medical records sent to IRO within 3 business days
  4. You have 5 business days to submit additional information
  5. IRO decision within 30 days (72 hours for expedited cases)

Contact: Washington Office of Insurance Commissioner Consumer Advocacy: 1-800-562-6900

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
Lack of step therapy Document allopurinol/febuxostat failures Treatment records showing ≥3 months each therapy, uric acid levels, adverse reactions
Missing G6PD test Submit lab results G6PD enzyme activity test showing normal levels
Insufficient documentation Provide comprehensive records Complete treatment history, rheumatology consultation, imaging if available
Not medically necessary Submit clinical evidence Peer-reviewed studies, FDA labeling, professional guidelines
Prescriber not specialist Obtain rheumatology consultation Referral to rheumatologist for evaluation and treatment recommendation

FAQ

How long does Blue Cross Blue Shield PA take in Washington? Standard prior authorization decisions are made within 14 days for non-urgent requests, 72 hours for urgent requests per Washington state regulations.

What if Krystexxa is non-formulary? Request a formulary exception through your provider. Include medical necessity documentation and evidence that formulary alternatives are inappropriate.

Can I request an expedited appeal? Yes, if delays could seriously harm your health. Expedited internal appeals are decided within 72 hours, expedited external reviews within 72 hours.

Does step therapy apply if I failed treatments in another state? Medical records from any provider can document treatment failures. Ensure records clearly show medication names, doses, duration, and outcomes.

What costs should I expect with alternatives? Allopurinol typically costs $20-40 monthly, febuxostat $100-200 monthly. Most BCBS plans cover these with standard copays after deductible.

When should I contact the Insurance Commissioner? If BCBS misses appeal deadlines, denies without proper review, or you need help understanding your rights. The OIC provides free consumer assistance.

This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider about treatment decisions. For assistance with insurance appeals in Washington, contact the Office of the Insurance Commissioner at 1-800-562-6900.

About Counterforce Health: Counterforce Health transforms insurance denials into successful appeals by analyzing payer policies, identifying denial reasons, and crafting targeted rebuttals backed by clinical evidence. The platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes.

Sources & Further Reading

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