By Counterforce Health Team in Krystexxa (pegloticase) —

How to Get Krystexxa (Pegloticase) Covered by Cigna in New York: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Krystexxa Covered by Cigna in New York

Fastest path to approval: Document failed trials of allopurinol AND febuxostat (3+ months each at max doses), get G6PD testing, and have your rheumatologist submit Cigna's Krystexxa PA form with detailed medical necessity letter. If denied, file internal appeal within 180 days, then request New York DFS external review within 4 months. Success rates for well-documented specialty drug appeals in NY often reach 50-60%.

Start today: Call Cigna at the number on your card to confirm Krystexxa's formulary status and request the prior authorization form.

Table of Contents

Understanding Cigna's Krystexxa Coverage

Krystexxa (pegloticase) is classified as a specialty medication requiring prior authorization on virtually all Cigna plans in New York. The drug costs approximately $30,000 per 8mg vial, with patients typically needing infusions every two weeks—making annual drug costs reach $780,000 or more.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Must get approval before coverage Cigna Krystexxa Policy
Specialty Tier High coinsurance (often 30-50%) Your plan's formulary
Step Therapy Must fail allopurinol AND febuxostat Cigna's 2024 policy update
Prescriber Requirement Rheumatologist or specialist PA form requirements
G6PD Testing Normal results required FDA safety requirements
Specialty Pharmacy Must use Accredo or approved network Cigna specialty drug policy

Cigna updated its Krystexxa policy in September 2024, removing the previous requirement to also fail uricosuric drugs like probenecid. Now, documented failure of both allopurinol and febuxostat typically satisfies step therapy requirements.

Prior Authorization Requirements

Cigna's coverage policy for Krystexxa focuses on "refractory chronic gout" with specific documentation requirements:

Medical Necessity Criteria

Diagnosis Requirements:

  • Confirmed chronic gout (not just asymptomatic hyperuricemia)
  • Evidence of refractory disease: frequent flares (≥2 per year), tophaceous deposits, or joint damage
  • ICD-10 codes for chronic gout with supporting clinical history

Step Therapy Documentation:

  • Allopurinol failure: Documented trial at maximally tolerated dose for ≥3 months with persistent serum uric acid >6 mg/dL
  • Febuxostat failure: Similar trial duration and inadequate response, unless contraindicated
  • Clear documentation of specific doses, duration, adherence, and objective measures of failure

Safety Requirements:

  • Normal G6PD activity (Krystexxa is contraindicated in G6PD deficiency)
  • Baseline renal function assessment
  • Current serum uric acid demonstrating uncontrolled disease

Prescriber Qualifications:

  • Must be prescribed by or in consultation with a rheumatologist
  • Detailed clinical rationale for therapy

Step-by-Step: Fastest Path to Approval

1. Verify Coverage and Get Forms

Who: Patient or clinic staff
Action: Call Cigna member services to confirm Krystexxa's formulary status and request PA forms
Timeline: Same day
Link: Use the member services number on your insurance card

2. Gather Required Documentation

Who: Patient and clinic
Documents needed:

  • Complete gout treatment history with dates, doses, and outcomes
  • Recent lab results (serum uric acid, G6PD, renal function)
  • Imaging showing tophi or joint damage (if available)
  • Documentation of flare frequency and functional impact

3. Complete G6PD Testing

Who: Prescribing physician
Action: Order G6PD activity test if not already done
Timeline: Results typically available within 1-2 days
Note: This is an absolute requirement—Krystexxa cannot be given with G6PD deficiency

4. Rheumatologist Consultation

Who: Patient
Action: If not already seeing a rheumatologist, get referral and consultation
Timeline: May take 2-4 weeks for appointment
Why: Cigna requires specialist involvement for Krystexxa approval

5. Submit Complete PA Package

Who: Prescriber's office
Documents: Completed PA form, medical necessity letter, lab results, treatment history
Submission: Via Cigna provider portal or fax
Timeline: Cigna has 15 days for standard review, 72 hours for expedited

6. Follow Up and Track

Who: Patient and clinic
Action: Monitor PA status via provider portal; call if approaching deadline
Timeline: Check status after 1 week if no response

7. Prepare for Potential Appeal

Who: Patient and clinic
Action: If denied, immediately begin gathering additional documentation for appeal
Timeline: Must file internal appeal within 180 days of denial

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
"Insufficient step therapy" Provide detailed medication history with specific doses, duration, and objective failure measures (persistent high uric acid, continued flares)
"Not medically necessary" Submit comprehensive clinical letter documenting disease severity, functional impact, and alignment with FDA labeling
"Missing G6PD results" Provide recent G6PD activity test results showing normal enzyme function
"Prescriber not qualified" Ensure rheumatologist is primary prescriber or co-signs the request
"Alternative treatments available" Document specific contraindications or failures of all formulary alternatives
"Experimental/investigational" Cite FDA approval for refractory chronic gout and established clinical guidelines

Appeals Process: Internal to External Review

Internal Appeal (First Level)

  • Deadline: 180 days from denial notice for most Cigna commercial plans
  • Process: Submit written appeal via provider portal or mail
  • Timeline: Cigna must respond within 30 days (72 hours for expedited)
  • Required: Original denial letter, additional clinical documentation, medical necessity letter

Expedited Internal Appeal

  • When to use: When delay could seriously jeopardize health
  • Timeline: 72 hours for decision
  • Documentation: Physician must explicitly state urgent medical need

External Review Through New York DFS

  • Eligibility: After exhausting internal appeals or meeting bypass criteria
  • Deadline: 4 months from final internal denial
  • Cost: Small fee (often $25 or less), waived for financial hardship
  • Success rate: 50-60% for well-documented specialty drug cases
  • Timeline: 30 days standard, 72 hours expedited, 24 hours for urgent drug denials

Cost Savings and Financial Assistance

Manufacturer Support Programs

Amgen By Your Side Copay Assistance:

  • Reduces copay to as low as $5 per infusion for commercially insured patients
  • Eligibility: Commercial insurance (not government programs), income limits may apply
  • Application: Through Amgen By Your Side

Patient Assistance Foundations

While specific foundations for Krystexxa vary, patients with chronic gout may qualify for assistance through:

  • Disease-specific foundations focusing on arthritis and rheumatologic conditions
  • General pharmaceutical assistance programs
  • Hospital financial assistance programs where infusions are administered

Specialty Pharmacy Coordination

Cigna typically requires Krystexxa to be dispensed through Accredo or approved specialty pharmacies, which often provide:

  • Benefits investigation and prior authorization support
  • Coordination with manufacturer assistance programs
  • Infusion scheduling and logistics support

New York State External Appeal Rights

New York offers one of the strongest external appeal processes in the nation for insurance denials. The system is particularly effective for specialty drug denials when proper documentation is provided.

Key Advantages in New York:

  • Independent medical review: DFS assigns external experts in the relevant specialty
  • Binding decisions: If you win, Cigna must provide coverage as directed
  • Multiple pathways: External appeal through DFS or Fair Hearing for Medicaid
  • Consumer support: Community Health Advocates provides free assistance at 888-614-5400

Filing Your External Appeal:

  1. Confirm eligibility: Must have final adverse determination from Cigna
  2. Gather documentation: All medical records, denial letters, clinical literature
  3. Submit application: Through DFS online portal or by mail
  4. Request expedited review: If delay poses serious health risk
  5. Monitor timeline: DFS must issue decision within specified timeframes

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to identify the specific denial basis and craft targeted, evidence-backed rebuttals. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeals processes.

Scripts and Templates

Patient Script for Calling Cigna

"Hi, I need to check the prior authorization requirements for Krystexxa, also called pegloticase, for chronic gout. My member ID is [ID number]. Can you tell me if it's covered on my plan, what tier it's on, and send me the PA form? I also need to confirm which specialty pharmacy I need to use."

Medical Necessity Letter Key Points

Your rheumatologist's letter should include:

  • Diagnosis: Specific type of chronic gout with ICD-10 codes
  • Disease severity: Flare frequency, tophi locations, functional limitations
  • Prior treatments: Complete medication history with doses, duration, and outcomes
  • Clinical rationale: Why Krystexxa is medically necessary and appropriate
  • Safety monitoring: G6PD results, planned monitoring protocols
  • Guidelines support: Reference to ACR guidelines or FDA labeling

FAQ

How long does Cigna prior authorization take for Krystexxa in New York? Standard review takes up to 15 days; expedited review is completed within 72 hours if urgency criteria are met.

What if Krystexxa is non-formulary on my Cigna plan? You can request a formulary exception by demonstrating medical necessity and that no formulary alternatives are appropriate. This follows the same documentation requirements as standard PA.

Can I request an expedited appeal if denied? Yes, if delay would seriously jeopardize your health. Your physician must document the specific urgent medical need in writing.

Does step therapy apply if I failed these drugs outside New York? Yes, documented treatment failures from any location count toward step therapy requirements, as long as you have proper medical records.

What happens if I win my New York external appeal? Cigna must provide coverage as directed by the external reviewer and refund your appeal filing fee. The decision is binding on the insurer.

How much will Krystexxa cost me with Cigna coverage? This depends on your specific plan's specialty tier coinsurance. With manufacturer copay assistance, eligible patients may pay as little as $5 per infusion.

This guide provides general information about insurance coverage and appeals processes. It is not medical advice. For specific questions about your coverage or treatment, consult your healthcare provider and insurance plan documents. For free assistance with insurance appeals in New York, contact Community Health Advocates at 888-614-5400.

Sources & Further Reading

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