By Counterforce Health Team in Krystexxa (pegloticase) —

Renewing Krystexxa (Pegloticase) Coverage with Cigna in North Carolina: Complete Guide for 2025

Answer Box: Renewing Krystexxa Coverage with Cigna in North Carolina

Cigna requires prior authorization renewal for Krystexxa (pegloticase) every 12 months with strict documentation of ongoing response. Start your renewal 2-4 weeks before expiration to avoid treatment gaps. Essential requirements: serum uric acid levels below 6 mg/dL before infusions, physician attestation of continued benefit, and documentation of immunomodulator therapy (unless contraindicated). If denied, North Carolina offers expedited external review through Smart NC within 72 hours for urgent cases. First step today: Contact your rheumatologist to schedule renewal submission and confirm your current authorization expiration date.

Table of Contents

Renewal Triggers: When to Start the Process

Cigna typically approves Krystexxa (pegloticase) authorizations for 12-month periods. You should begin the renewal process when:

  • 2-4 weeks before expiration (standard timeline)
  • 6 weeks early if you've had prior authorization delays
  • Immediately if you notice any signs of treatment failure (serum uric acid rising above 6 mg/dL)
  • When changing prescribers or infusion sites
Tip: Set a calendar reminder 6 weeks before your authorization expires. Most patients receive their initial approval date in their first prior authorization approval letter.

Red flags that signal you should start early:

  • Recent lab results showing uric acid levels approaching 6 mg/dL
  • New side effects or tolerability issues
  • Changes to your immunomodulator therapy (methotrexate)
  • Upcoming changes to your Cigna plan

Evidence Update: What Cigna Needs to See

For Krystexxa renewal, Cigna requires documentation of continued therapeutic response and ongoing medical necessity. Based on current Cigna policies, renewal criteria include:

Clinical Response Documentation

Requirement What It Means Documentation Needed
Serum uric acid <6 mg/dL Levels measured before each infusion Most recent 3-6 lab results
No loss of therapeutic benefit Sustained response to treatment Physician attestation of continued improvement
Adherence to dosing 8 mg IV every 2 weeks maximum Infusion center records
Immunomodulator use Methotrexate unless contraindicated Current medication list and rationale

Monitoring Requirements

Your rheumatologist must document:

  • Serum uric acid trends over the past 6-12 months
  • Clinical improvement in gout symptoms, flares, or tophi
  • Tolerability assessment and management of any adverse effects
  • Adherence to the infusion schedule
Note: Recent policy updates have relaxed some requirements. As of 2025, some plans no longer require strict documentation of "two consecutive uric acid levels below 6 mg/dL" for renewal.

Renewal Documentation Packet

Core Documents Required

  1. Completed Prior Authorization Form
    • Available through Cigna provider portal (verify current link)
    • Include patient demographics, Cigna ID, and prescriber information
  2. Updated Letter of Medical Necessity
  3. Recent Clinical Notes (past 3-6 months)
    • Rheumatologist visit notes
    • Infusion center records
    • Any emergency department visits for gout flares
  4. Laboratory Results
    • Serum uric acid levels before recent infusions
    • G6PD status (if not previously documented)

Letter of Medical Necessity Renewal Elements

Your physician's letter should include:

Patient-specific renewal rationale:

  • Current gout status and symptom control
  • Response to Krystexxa therapy since initiation
  • Most recent serum uric acid levels and trends
  • Justification for continued therapy

Clinical documentation:

  • ICD-10 diagnosis codes (typically M10.09X0 for chronic gout)
  • Current dosing regimen (8 mg IV every 2 weeks)
  • Immunomodulator therapy status
  • Any dose adjustments or treatment modifications
From our advocates: We've seen renewals approved faster when physicians include a brief summary table showing pre-treatment vs. current uric acid levels and flare frequency. This visual comparison helps utilization review teams quickly assess ongoing benefit.

Timeline and Submission Process

Standard Renewal Timeline

Step Timeframe Responsible Party
Initiate renewal 2-4 weeks before expiration Patient/clinic
Cigna review 7-14 business days Cigna
Decision notification Within 2 weeks of submission Cigna
Appeal deadline 180 days if denied Patient

Submission Methods

  1. Online: Cigna provider portal (fastest)
  2. Fax: Submit to Cigna's prior authorization fax line (verify with current source)
  3. Mail: Check current Cigna address for your specific plan

Expedited Review: If you're at risk of treatment interruption, your physician can request expedited review, which Cigna must complete within 24 hours of receipt.

If Your Authorization Lapses

Cigna does not automatically provide bridge therapy when prior authorizations lapse. However, you have several options:

Immediate Actions

  1. Contact your prescriber immediately to request a new prior authorization
  2. Request expedited review if treatment interruption poses immediate health risks
  3. File an appeal if the lapse was due to processing delays

Emergency Override Process

For urgent situations where treatment interruption could cause serious harm:

  • Your physician can request expedited exception review (24-hour turnaround)
  • Document clinical urgency and potential consequences of treatment delay
  • Submit through Cigna's expedited review pathway

Bridge Therapy Considerations

While not guaranteed, discuss these options with your healthcare team:

  • Temporary conventional therapy (if tolerated) to manage acute flares
  • Corticosteroids for symptom management during authorization gaps
  • Patient assistance programs for temporary coverage

Annual Changes to Watch

2025 Policy Updates

Recent changes affecting Krystexxa coverage include:

  • Relaxed methotrexate requirements on some plans
  • Modified renewal criteria focusing on clinical benefit rather than strict lab thresholds
  • Streamlined documentation for established responders

Plan Design Shifts

Monitor your Cigna plan for:

  • Formulary tier changes (typically announced in October for following year)
  • Prior authorization policy updates
  • Network changes affecting infusion centers
  • Copay or coinsurance modifications

What to Re-verify Annually

  • Infusion center remains in-network
  • Prescribing rheumatologist accepts your Cigna plan
  • Current prior authorization forms and submission processes
  • Any new step therapy requirements

Appeals Process in North Carolina

North Carolina offers robust consumer protections through Smart NC, the state's external review program.

Internal Appeals (Cigna)

  1. First-level appeal: 180 days to file after denial
  2. Second-level appeal: Available if first appeal denied
  3. Expedited appeals: 24-72 hour turnaround for urgent cases

External Review (Smart NC)

If Cigna denies your internal appeals, you can request external review through North Carolina's Department of Insurance:

Contact Smart NC:

  • Phone: 1-855-408-1212 (free advocacy support)
  • Process: Submit external review request form
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Cost: Free to consumers

Eligibility requirements:

  • State-regulated plan (not self-funded employer plans unless opted in)
  • Denial based on medical necessity
  • Exhausted internal appeals (or qualify for expedited review)
Note: Smart NC staff can help you complete the external review request and gather supporting documentation. The Independent Review Organization's decision is binding on Cigna.

Personal Renewal Tracker

Use this checklist to track your renewal progress:

6 Weeks Before Expiration

  • Schedule appointment with rheumatologist
  • Request recent lab results
  • Verify Cigna plan details and formulary status

4 Weeks Before Expiration

  • Physician completes renewal documentation
  • Submit prior authorization packet to Cigna
  • Confirm receipt of submission

2 Weeks Before Expiration

  • Follow up on authorization status
  • Prepare appeal documentation if needed
  • Coordinate with infusion center for scheduling

If Denied

  • Review denial reason carefully
  • Gather additional supporting documentation
  • File internal appeal within 180 days
  • Consider Smart NC external review if needed

FAQ

How long does Cigna take to process Krystexxa renewals in North Carolina? Standard renewals typically take 7-14 business days. Expedited reviews must be completed within 24 hours if clinical urgency is documented.

What if my serum uric acid levels fluctuate around 6 mg/dL? Recent policy updates focus on overall clinical benefit rather than strict adherence to the 6 mg/dL threshold. Your physician should document the trend and clinical response.

Can I request an expedited renewal? Yes, if treatment interruption would pose immediate health risks. Your physician must document the clinical urgency when requesting expedited review.

Does step therapy apply to Krystexxa renewals? No, step therapy requirements typically apply only to initial authorizations. Renewals focus on continued response and medical necessity.

What if my rheumatologist changes? A new prescriber may need to submit a fresh prior authorization rather than a renewal, potentially requiring updated step therapy documentation.

How does North Carolina's external review work for specialty drugs? Smart NC assigns an Independent Review Organization that specializes in the relevant medical area. For rare disease treatments like Krystexxa, they often overturn denials when proper clinical evidence is provided.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals with targeted, evidence-backed strategies. Our platform analyzes denial letters and plan policies to create point-by-point rebuttals that align with payer requirements. For complex renewals like Krystexxa, Counterforce Health can help ensure your documentation meets Cigna's specific criteria and deadlines.

If you're facing challenges with your Krystexxa renewal or need help navigating Cigna's requirements, consider leveraging North Carolina's excellent consumer protections through Smart NC. The state's external review process has helped many patients access lifesaving specialty medications when initial denials seemed insurmountable.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage decisions are made by your insurance plan based on your specific policy terms and clinical circumstances. For personalized guidance, consult with your healthcare provider and contact Smart NC at 1-855-408-1212 for free advocacy support with North Carolina insurance appeals.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.