By Counterforce Health Team in Krystexxa (pegloticase) —

Getting Krystexxa (Pegloticase) Covered by Cigna in Michigan: Complete Prior Authorization and Appeals Guide

Answer Box: Get Krystexxa (Pegloticase) Covered by Cigna in Michigan

Fastest path to approval: 1) Have your rheumatologist document failed allopurinol and febuxostat trials (minimum 3 months each) with persistent uric acid >6 mg/dL, 2) Submit Cigna's Krystexxa Prior Authorization Form with G6PD test results and methotrexate co-therapy plan, 3) If denied, file internal appeal within 60 days, then external review with Michigan DIFS within 127 days. Start today: Contact your rheumatologist to gather documentation of prior gout therapy failures and current uric acid levels.

Table of Contents

  1. Policy Overview: How Cigna Covers Krystexxa in Michigan
  2. Medical Necessity Requirements
  3. Step Therapy & Exception Pathways
  4. Required Diagnostics & Lab Values
  5. Specialty Pharmacy Requirements
  6. Evidence to Support Approval
  7. Appeals Process for Michigan Patients
  8. Common Denial Reasons & Solutions
  9. Cost Savings & Patient Support
  10. FAQ

Policy Overview: How Cigna Covers Krystexxa in Michigan

Cigna classifies Krystexxa (pegloticase) as a specialty medication requiring prior authorization across all plan types in Michigan—whether you have an HMO, PPO, or Medicare Advantage plan. The drug must be dispensed through Accredo Specialty Pharmacy, Cigna's preferred specialty pharmacy network, and follows strict medical necessity criteria updated as recently as September 2024.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans Cigna PA Form Cigna Policy
Formulary Status Specialty tier (high copay) myCigna portal Plan documents
Step Therapy Must fail allopurinol + febuxostat Policy criteria Coverage Position
Specialty Pharmacy Accredo only Provider enrollment Accredo Referral
Prescriber Rheumatologist required PA form Cigna criteria
Initial Approval 6 months (changed Sept 2024) Policy update Sept 2024 Updates

Michigan patients benefit from strong state insurance protections under the Patient's Right to Independent Review Act, which provides binding external review if Cigna denies coverage.

Medical Necessity Requirements

Cigna's 2024 criteria for Krystexxa require documentation of chronic gout that's refractory to conventional therapy. Here's exactly what your rheumatologist needs to prove:

Core Diagnosis Requirements

  • Chronic gout diagnosis with ICD-10 code (M10.9 is most common)
  • Refractory disease defined as persistent serum uric acid >6 mg/dL despite treatment
  • Disease burden evidenced by tophi, frequent flares (≥2/year), or joint damage

Treatment History Documentation

Your doctor must document both of these failed therapies:

  1. Allopurinol trial (minimum 3 months at appropriate dose)
  2. Febuxostat trial (minimum 3 months at appropriate dose)

If either drug couldn't be used, document the specific contraindication or intolerance with dates and clinical details.

Clinician Corner: Medical Necessity Letter Checklist

✓ Patient demographics and chronic gout diagnosis (ICD-10)
✓ Allopurinol details: dose, duration, reason for discontinuation, lab results
✓ Febuxostat details: dose, duration, reason for discontinuation, lab results
✓ Current serum uric acid >6 mg/dL (within 30 days)
✓ G6PD test results (normal—deficiency is contraindication)
✓ Methotrexate co-therapy plan (unless contraindicated)
✓ Treatment goals and monitoring plan

Step Therapy & Exception Pathways

Cigna requires documented failure of xanthine oxidase inhibitors (XOIs) before approving Krystexxa. As of September 2024, the combination requirement with uricosurics was removed, simplifying the step therapy pathway.

Required Steps:

  1. Allopurinol trial - Titrated to maximum tolerated dose for ≥3 months
  2. Febuxostat trial - Appropriate dose for ≥3 months
  3. Persistent hyperuricemia - Serum uric acid remains >6 mg/dL

Medical Exception Pathways:

  • Contraindications to XOIs (document with clinical details)
  • Severe intolerance (rash, GI effects, liver toxicity)
  • Drug interactions preventing safe XOI use

The key change in 2024: Cigna no longer requires uricosuric trials (like probenecid) before Krystexxa, streamlining approvals for appropriate candidates.

Required Diagnostics & Lab Values

Cigna mandates specific laboratory documentation to approve Krystexxa:

Essential Lab Work

Test Requirement Timing Purpose
Serum Uric Acid >6 mg/dL Within 30 days Confirms active disease
G6PD Activity Normal levels Before starting Safety screening
Renal Function Baseline values Recent Dosing/monitoring

Documentation Tips

  • G6PD testing is mandatory - Deficiency is an absolute contraindication due to hemolysis risk
  • Serial uric acid levels strengthen your case - show persistent elevation despite XOI therapy
  • Include reference ranges from your lab to help reviewers interpret results
Note: Cigna added G6PD screening to their 2024 policy updates following FDA safety communications about hemolytic anemia risk.

Specialty Pharmacy Requirements

All Cigna plans in Michigan require Krystexxa dispensing through Accredo Specialty Pharmacy. This isn't optional—using other pharmacies will result in claim denials.

Accredo Enrollment Process:

  1. Provider submits Accredo referral form
  2. Accredo coordinates with your infusion site
  3. Patient enrollment via phone (877-826-7657)
  4. Shipment coordination to infusion center

The medication ships directly to your infusion center—typically a rheumatology clinic or hospital outpatient department. Home infusion isn't appropriate for Krystexxa due to anaphylaxis risk requiring immediate medical intervention.

Evidence to Support Approval

When appealing denials, cite evidence that aligns with Cigna's medical policies:

Primary Sources to Reference

  • FDA prescribing information - Establishes approved indications
  • 2020 ACR Gout Guidelines - Support for refractory gout management
  • Methotrexate co-therapy studies - Improved response rates and reduced immunogenicity

Sample Evidence Statement

"Per FDA labeling, Krystexxa is indicated for chronic gout in adult patients refractory to conventional therapy. The 2020 ACR Guidelines recommend uricase therapy when XOIs fail to achieve target uric acid levels. Recent studies demonstrate methotrexate co-therapy improves response rates from 42% to 71% (Botson et al, Arthritis Rheumatol 2021)."

Appeals Process for Michigan Patients

If Cigna denies your Krystexxa prior authorization, Michigan law provides a structured appeals pathway with binding external review.

Step-by-Step Appeals Timeline:

  1. Internal Appeal (File within 60 days of denial)
    • Submit to: Cigna appeals department (address on denial letter)
    • Include: New clinical documentation, peer-reviewed studies, specialist letter
    • Timeline: 30 days for standard, 72 hours for urgent
  2. Second-Level Internal Appeal (If first appeal denied)
    • Automatic in many cases
    • Timeline: Additional 30 days
  3. External Review with Michigan DIFS (File within 127 days of final denial)
    • Submit: DIFS External Review Form
    • Timeline: 60 days standard, 72 hours expedited
    • Contact: 877-999-6442
    • Binding decision - Cigna must comply if overturned
Tip: Michigan's 127-day external review deadline is longer than the federal 120-day minimum, giving you extra time to prepare a comprehensive appeal.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Insufficient XOI trial" Provide detailed medication history Pharmacy records, clinic notes, lab trends
"Missing G6PD test" Submit normal G6PD results Lab report within 90 days
"Not prescribed by rheumatologist" Specialist consultation Rheumatology referral/consultation note
"Methotrexate not considered" Document MTX plan or contraindication Treatment plan or medical contraindication
"Coding error" Verify J2507 billing Confirm 8 units per 8mg vial

From Our Advocates: We've seen Michigan Cigna denials overturned when families provided comprehensive pharmacy records showing months of failed allopurinol therapy with documented side effects, plus recent uric acid levels demonstrating ongoing disease activity. The key was organizing all documentation chronologically and having the rheumatologist write a detailed letter explaining why Krystexxa was the only remaining option.

Cost Savings & Patient Support

Krystexxa costs approximately $30,000 per infusion, making financial assistance crucial for most patients.

Available Support Programs:

  • Amgen Assist - Manufacturer copay assistance and free drug program
  • State pharmaceutical assistance - Michigan residents may qualify for additional support
  • Foundation grants - Patient Advocate Foundation, others for rare disease support

Even with insurance approval, specialty tier copays can reach $500-1,000+ per month. Apply for assistance programs before starting therapy.

At Counterforce Health, we help patients navigate these complex approval processes by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and crafts point-by-point rebuttals aligned to each payer's specific criteria, significantly improving approval rates for specialty medications like Krystexxa.

FAQ

How long does Cigna prior authorization take in Michigan? Standard PA decisions take up to 5 business days. Urgent requests (with physician attestation of medical urgency) are decided within 72 hours.

What if Krystexxa isn't on Cigna's formulary? Submit a formulary exception request with your PA. Include clinical evidence showing Krystexxa is medically necessary and no formulary alternatives are appropriate.

Can I get expedited appeals in Michigan? Yes. If delay would seriously jeopardize your health, request expedited internal appeal (72 hours) and expedited external review through DIFS (72 hours with physician letter).

Does step therapy apply if I tried XOIs outside Michigan? Yes. Cigna accepts documented XOI failures from any provider, regardless of state. Include all medical records and pharmacy claims.

What happens if DIFS external review denies my appeal? Michigan law allows judicial review in circuit court within 60 days, though this is uncommon and requires legal representation.

How often do Michigan external reviews overturn Cigna denials? While specific statistics aren't published, Counterforce Health reports favorable outcomes for rare disease medications when appeals include comprehensive clinical documentation and evidence-based medical necessity arguments.

Disclaimer: This information is for educational purposes and doesn't constitute medical or legal advice. Insurance policies and state regulations change frequently. Always verify current requirements with Cigna and consult your healthcare provider for medical decisions.

Sources & Further Reading:

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