By Counterforce Health Team in Krystexxa (pegloticase) —

If Krystexxa (Pegloticase) Isn't Approved by Aetna (CVS Health) in Texas: Formulary Alternatives & Exception Paths

Answer Box: Getting Alternatives Approved When Krystexxa Is Denied

If Aetna (CVS Health) denies Krystexxa (pegloticase) in Texas, formulary alternatives include allopurinol and febuxostat (which must be tried first per step therapy). Submit a formulary exception request with medical necessity documentation within 180 days. Standard decisions take 72 hours; expedited requests get 24-hour responses. First step today: Have your rheumatologist submit the Texas Standard Prior Authorization Request Form via fax (1-866-835-9589) or provider portal with detailed failure/intolerance documentation.

Table of Contents

  1. When Alternatives Make Sense
  2. Typical Formulary Alternatives
  3. Pros & Cons Overview
  4. Exception Strategy
  5. Switching Logistics
  6. Re-trying for Krystexxa Later
  7. Appeals Playbook for Texas
  8. FAQ

When Alternatives Make Sense

Aetna (CVS Health) requires step therapy before approving Krystexxa, meaning you must try and fail conventional treatments first. This isn't necessarily a roadblock—many patients do well on these alternatives, and they're significantly less expensive.

Alternatives are appropriate when:

  • You haven't yet tried maximum doses of allopurinol (typically 800mg daily) or febuxostat (80-120mg daily)
  • Cost is a major concern (alternatives cost $20-200/month vs. $30,000+ per Krystexxa infusion)
  • You prefer oral medication over IV infusions every two weeks
  • Your gout is newly diagnosed or not yet refractory to conventional therapy

Alternatives may not be suitable if:

  • You've documented severe allergic reactions to xanthine oxidase inhibitors
  • You have chronic kidney disease with eGFR <30 mL/min (allopurinol dose-limiting)
  • Previous maximum-dose trials failed to achieve serum urate <6 mg/dL despite good adherence
Note: Even if alternatives aren't ideal for your case, documenting a proper trial strengthens your future Krystexxa appeal.

Typical Formulary Alternatives

First-Line Urate-Lowering Therapies

Allopurinol (generic, multiple manufacturers)

  • Mechanism: Xanthine oxidase inhibitor that blocks uric acid production
  • Typical dosing: Start 100mg daily, titrate to 300-800mg based on kidney function and serum urate response
  • Aetna coverage: Generally no prior authorization required for standard doses
  • Monitoring: Serum urate every 2-6 weeks during titration, then every 3-6 months

Febuxostat (Uloric) (Takeda)

  • Mechanism: Selective xanthine oxidase inhibitor, more potent than allopurinol
  • Typical dosing: 40mg daily, may increase to 80-120mg if needed
  • Aetna coverage: May require prior authorization; step therapy after allopurinol trial
  • Special considerations: FDA black box warning for cardiovascular death risk in patients with heart disease

Second-Line Options

Probenecid (generic)

  • Mechanism: Uricosuric agent that increases kidney uric acid excretion
  • Typical dosing: 250mg twice daily, may increase to 500mg twice daily
  • Requirements: Normal kidney function (eGFR >50), no history of kidney stones
  • Aetna coverage: Usually covered without prior authorization

Flare Prevention During Transition

Colchicine (Colcrys, Mitigare)

  • Purpose: Prevents gout flares during urate-lowering therapy initiation
  • Typical dosing: 0.6mg daily or twice daily for 3-6 months
  • Aetna coverage: Generic forms typically covered; brand names may need prior authorization

Pros & Cons Overview

Medication Pros Cons Access Considerations
Allopurinol • Low cost ($20-50/month)
• Decades of safety data
• No PA usually required		 • Requires dose adjustment in kidney disease
• 1-3% risk of serious skin reactions
• May take 6+ months for full effect		 • Readily available at all pharmacies
• Generic competition keeps costs low
Febuxostat • More potent than allopurinol
• Safer in mild-moderate kidney disease
• Once-daily dosing		 • Much more expensive ($200-400/month)
• CV death warning in heart patients
• May require PA/step therapy		 • Specialty pharmacy may be required
• Prior auth often needed
Probenecid • Very low cost ($30-60/month)
• Different mechanism if XOI intolerant
• Long track record		 • Requires normal kidney function
• Multiple daily dosing
• Less effective than XOIs		 • Available at retail pharmacies
• Usually no PA required

Exception Strategy

When formulary alternatives aren't appropriate, request a medical exception (formulary exception) through Aetna's formal process.

When to Request an Exception

Strong cases for exception include:

  • Documented severe allergic reactions to both allopurinol and febuxostat
  • Chronic kidney disease preventing adequate allopurinol dosing
  • Maximum-dose trials of both XOIs with persistent serum urate >6 mg/dL
  • Contraindications to uricosurics (kidney stones, severe kidney disease)

Required Documentation

Your rheumatologist must submit a medical necessity letter explaining:

  1. Why each formulary alternative is inappropriate:
    • Allopurinol: Specific adverse reaction, contraindication, or inadequate response at maximum tolerated dose
    • Febuxostat: Same documentation requirements
    • Include exact doses tried, duration of treatment, and outcomes
  2. Clinical evidence supporting Krystexxa:
    • Serum urate levels >6 mg/dL despite optimal conventional therapy
    • Frequency of gout flares (≥2 per year strengthens the case)
    • Presence of tophi or joint damage
    • Impact on quality of life and function
  3. Supporting test results:
    • G6PD enzyme test (normal results required for Krystexxa)
    • Recent serum urate levels
    • Documentation of prior medication trials with dates and outcomes

Submission Process

Submit via:

  • Provider portal: Availity (fastest processing)
  • Fax: 1-866-249-6155 (specialty drugs)
  • Phone: 1-866-814-5506 (specialty pharmacy)

Timeline: Aetna provides decisions within 72 hours for standard requests, 24 hours for expedited requests when delay would jeopardize health.

Switching Logistics

From Krystexxa to Oral Alternatives

Clinical coordination:

  1. Don't stop Krystexxa abruptly—work with your rheumatologist to plan the transition
  2. Start flare prophylaxis (colchicine or low-dose NSAID) before beginning oral urate-lowering therapy
  3. Monitor closely for increased flares during the first 3-6 months

Pharmacy coordination:

  • Specialty to retail transition: Krystexxa is dispensed through specialty pharmacies for IV infusion; oral alternatives are available at retail CVS Caremark pharmacies
  • Insurance processing: New prior authorizations may be needed even for "step therapy" medications
  • Patient education: Retail pharmacists can provide direct counseling on new oral medications

From Oral Alternatives to Krystexxa

If alternatives fail after adequate trials:

  1. Document everything: Doses tried, duration, serum urate levels, adverse effects
  2. Maintain specialist care: Rheumatology involvement strengthens Krystexxa appeals
  3. Update insurance: Submit new prior authorization with failure documentation

Re-trying for Krystexxa Later

What to Document During Alternative Trials

Essential medical record documentation:

  • Exact dosing and duration of each alternative tried
  • Serial serum urate levels showing failure to achieve <6 mg/dL target
  • Adherence assessment and any barriers addressed
  • Adverse effects with dates, severity, and management attempts
  • Gout flare frequency and impact on daily activities
  • Specialist consultation notes supporting need for escalation

Timeline Considerations

Most insurers require 3-6 months of documented trial at maximum tolerated doses before considering failure. Plan accordingly:

  • Month 1-2: Initiate alternative, titrate dose
  • Month 3-4: Assess response with serum urate levels
  • Month 5-6: Document inadequate response or intolerance
  • Month 7+: Submit Krystexxa prior authorization with comprehensive documentation
From our advocates: We've seen cases where patients documented their alternative therapy trials meticulously—including photos of gout flares, daily symptom logs, and detailed lab trends. While not required, this additional evidence helped demonstrate the real-world impact when standard lab values alone didn't tell the full story.

Appeals Playbook for Texas

Internal Appeal Process

Level 1: Standard Internal Appeal

  • Timeline: File within 180 days of denial
  • Decision deadline: 30 days for pre-service, 60 days for post-service
  • Submission: Use Aetna member portal or mail to address on denial letter

Level 2: Expedited Internal Appeal

  • When to use: Delay would seriously jeopardize health
  • Decision deadline: 72 hours
  • Documentation: Physician statement of urgency required

External Review (Texas)

If internal appeals fail, Texas law provides independent external review:

Eligibility:

  • Denial based on medical necessity, appropriateness, or experimental/investigational determination
  • Completed internal appeal process (or concurrent with expedited appeal)

Timeline:

  • File within: 4 months of final internal denial
  • Decision deadline: 20 days (standard), 5 days (expedited)
  • Cost: Paid by insurer

How to request:

  • Use IRO request form provided with final denial
  • Contact Texas Department of Insurance at 1-800-252-3439 for assistance
  • IRO information line: 1-866-554-4926

When to Escalate

Contact Texas regulators if:

  • Aetna misses decision deadlines
  • Required forms or information aren't provided
  • Process violations occur

Texas Department of Insurance Consumer Help:

Office of Public Insurance Counsel:

  • Phone: 1-877-611-6742
  • Focus: Consumer advocacy and appeals guidance

FAQ

How long does Aetna prior authorization take in Texas? Standard requests: 72 hours after complete documentation received. Expedited requests: 24 hours when delay would jeopardize health.

What if Krystexxa is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Aetna must respond within 72 hours and may approve with appropriate clinical justification.

Can I request an expedited appeal? Yes, if your physician certifies that standard timing would seriously jeopardize your health. Both internal and external expedited reviews are available in Texas.

Does step therapy apply if I failed these drugs outside Texas? Yes, but you can use previous medical records to document prior failures. Ensure your current physician reviews and confirms the documentation in your new medical record.

What counts as "maximum dose" for allopurinol? Generally 800mg daily for normal kidney function, but may be lower with kidney disease. The key is reaching the highest dose you can tolerate while monitoring serum urate response.

How much do alternatives cost compared to Krystexxa? Allopurinol: $20-50/month; Febuxostat: $200-400/month; Probenecid: $30-60/month. Krystexxa costs approximately $30,000 per infusion ($780,000 annually).

What if I can't afford the alternatives either? Check manufacturer patient assistance programs, state pharmaceutical assistance programs, and nonprofit foundations like HealthWell Foundation.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals with evidence-backed documentation. Our platform analyzes denial letters and creates targeted rebuttals aligned to each plan's specific requirements. Learn more about our coverage advocacy services.

Sources & Further Reading

This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current requirements with your insurer and consult your healthcare provider for medical decisions. For additional help with insurance appeals in Texas, contact the Texas Department of Insurance at 1-800-252-3439.

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