By Counterforce Health Team in Arcalyst (rilonacept) —

Get Arcalyst (Rilonacept) Covered by Blue Cross Blue Shield in New York: Complete Guide to Prior Authorization and Appeals

Quick Answer: Getting Arcalyst Covered in New York

Yes, Blue Cross Blue Shield plans in New York cover Arcalyst (rilonacept) for approved conditions—but prior authorization is required. The fastest path: Have your specialist submit a PA request with complete documentation of your diagnosis (CAPS, DIRA, or recurrent pericarditis), prior therapy failures, and clinical necessity. If denied, you can appeal through Blue Cross Blue Shield's internal process, then escalate to New York's external review system through the Department of Financial Services. Start today: Contact your prescriber to initiate the prior authorization process and gather all required clinical documentation.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Clinical Criteria and Requirements
  5. Understanding Your Costs
  6. When You're Denied: Appeals Process
  7. Renewal Requirements
  8. Specialty Pharmacy Network
  9. Common Problems and Solutions
  10. Frequently Asked Questions

Coverage Basics

Is Arcalyst Covered by Blue Cross Blue Shield in New York?

Arcalyst (rilonacept) is covered by Blue Cross Blue Shield plans in New York for three FDA-approved conditions:

  • Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS)
  • Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
  • Recurrent pericarditis (to reduce risk of recurrence)

Coverage requires prior authorization regardless of which Blue Cross Blue Shield plan you have in New York, including Excellus BCBS, BCBS of Western New York, and other regional affiliates.

Which Plans Include Arcalyst?

All Blue Cross Blue Shield plans in New York include Arcalyst on their formularies as a specialty medication, but it's typically placed on the highest cost-sharing tier. This includes:

  • Commercial employer plans
  • Individual marketplace plans
  • Medicare Advantage plans (for eligible conditions)
  • Some Medicaid managed care plans
Note: Specific coverage details vary by plan design. Check your Summary of Benefits and Coverage or contact member services for your exact copay amounts.

Prior Authorization Process

Who Submits the Request?

Your prescribing physician—typically a rheumatologist, immunologist, or cardiologist—must submit the prior authorization request. Patients cannot submit PA requests directly.

Step-by-Step: Fastest Path to Approval

  1. Specialist Evaluation (1-2 weeks)
    • See an appropriate specialist for your condition
    • Complete diagnostic workup and documentation
  2. Gather Required Documentation (3-5 days)
    • Medical records showing diagnosis
    • Documentation of prior therapy failures
    • Lab results and imaging studies
    • Specialist's clinical notes
  3. Submit Prior Authorization (Same day)
    • Provider submits via Blue Cross Blue Shield portal or fax
    • Include all required clinical documentation
    • Request expedited review if urgent
  4. Insurance Review (5-15 business days)
    • Standard review: up to 15 business days
    • Expedited review: 72 hours for urgent cases
  5. Approval and Specialty Pharmacy Setup (3-5 days)
    • If approved, medication transferred to specialty pharmacy
    • Pharmacy contacts patient for delivery coordination
  6. First Dose Delivery (1-3 days)
    • Specialty pharmacy ships medication
    • Clinical support and injection training provided

Required Documentation Checklist

  • Confirmed diagnosis with appropriate diagnostic codes
  • Age verification (12 years or older for most indications)
  • Documentation of prior therapy trials and outcomes
  • Current lab values (inflammatory markers, if applicable)
  • Specialist's letter of medical necessity
  • Treatment plan and monitoring schedule

Timing and Urgency

Standard Timeline

  • Prior authorization decision: Up to 15 business days
  • Appeal decision (internal): 30 days
  • External appeal decision: 30 days (72 hours if expedited)

When to Request Expedited Review

Request expedited review if:

  • Patient's health would be seriously jeopardized by delay
  • Current treatment is failing rapidly
  • Risk of permanent organ damage without prompt treatment

Contact your Blue Cross Blue Shield plan directly to request expedited processing—decisions must be made within 72 hours.

Clinical Criteria and Requirements

Coverage Requirements by Condition

Condition Age Requirement Key Clinical Criteria Documentation Needed
CAPS (FCAS/MWS) 12+ years Confirmed genetic diagnosis or clinical syndrome Genetic testing, inflammatory markers, specialist evaluation
DIRA 10+ kg body weight Confirmed diagnosis, disease in remission Genetic confirmation, absence of active symptoms
Recurrent Pericarditis 12+ years ≥2 episodes, cardiologist recommendation Echo/imaging, inflammatory markers, prior therapy failures

Step Therapy Requirements

Before Arcalyst approval, patients typically must have tried and failed:

  • NSAIDs (ibuprofen, naproxen, or others)
  • Colchicine (for pericarditis cases)
  • Corticosteroids (prednisone or equivalent)

Documentation must show inadequate response, intolerance, or contraindications to these therapies.

Clinician Corner: Your medical necessity letter should address each prior therapy specifically—include drug names, doses, duration of trial, and reason for discontinuation. Reference relevant guidelines from the American College of Cardiology or American College of Rheumatology when applicable.

Understanding Your Costs

Typical Cost Structure

Arcalyst is classified as a specialty medication, placing it on the highest formulary tier:

  • Copay plans: $100-$500+ per month
  • Coinsurance plans: 30-50% of drug cost
  • Deductible plans: Full cost until deductible met, then copay/coinsurance applies

Cash prices typically range several thousand dollars per monthly kit, making insurance coverage essential.

Financial Assistance Options

  1. Regeneron Co-pay Program
    • Available for commercially insured patients
    • May reduce copay to $5-$10 per month
    • Income and insurance restrictions apply
  2. Patient Assistance Programs
  3. State Programs
    • New York State of Health premium tax credits
    • Medicaid coverage for eligible patients

When You're Denied: Appeals Process

Common Denial Reasons and Solutions

Denial Reason How to Overturn
"Not medically necessary" Submit detailed specialist letter with clinical rationale and guidelines
"Step therapy not met" Document all prior therapy trials with specific reasons for failure
"Non-specialist prescriber" Transfer care to rheumatologist, immunologist, or cardiologist
"Insufficient documentation" Provide complete medical records, lab results, and imaging studies

Blue Cross Blue Shield Internal Appeals

Timeline: Must file within 60 days of denial

How to Submit:

  1. Complete appeals form (available on member portal)
  2. Include denial letter and supporting documentation
  3. Submit via member portal, fax, or mail
  4. Request expedited review if urgent

What to Include:

  • Completed appeal form
  • Copy of original denial
  • Updated medical necessity letter from specialist
  • Additional clinical documentation
  • Relevant medical literature or guidelines

New York External Appeals

If your internal appeal is denied, New York law provides a second chance through the Department of Financial Services (DFS).

Key Benefits:

  • Independent medical review
  • Decision is binding on insurance company
  • Strong track record for specialty drug approvals

Timeline:

  • Must file within 4 months of final internal denial
  • Standard decision: 30 days
  • Expedited decision: 72 hours

How to File:

  1. Complete DFS External Appeal Application
  2. Include all medical documentation
  3. Submit online, by mail, or fax
  4. Pay $25 fee (waived for Medicaid/hardship)
From Our Advocates: We've seen several Arcalyst denials overturned on external appeal in New York when providers included strong medical literature supporting off-label uses and documented why standard therapies weren't appropriate. The key is comprehensive documentation and citing peer-reviewed evidence.

Appeal Scripts

Phone Script for Blue Cross Blue Shield Member Services:

"I'm calling to file an appeal for a prior authorization denial for Arcalyst. My member ID is [ID number]. I received the denial on [date] and want to start the internal appeals process. Can you walk me through the steps and send me the required forms?"

Email Template for Clinical Documentation:

Subject: Urgent: Additional Documentation Needed for Arcalyst Appeal

Dear [Provider Name],

I need to appeal Blue Cross Blue Shield's denial of Arcalyst. Could you please provide:

  • Updated letter of medical necessity
  • Documentation of all prior therapy failures
  • Recent lab results and clinical notes
  • Any relevant imaging or genetic testing

The appeal deadline is [date]. Please let me know if you need any additional information.

Thank you, [Your name]

Renewal Requirements

When to Reauthorize

Most Arcalyst approvals are valid for 12 months. Your specialty pharmacy will typically contact you 60-90 days before expiration to coordinate renewal.

What Changes at Renewal

  • Updated clinical assessment from specialist
  • Documentation of continued benefit
  • Current lab values and safety monitoring
  • Confirmation that alternative therapies remain inappropriate

Renewal Documentation

Your provider will need to submit:

  • Treatment response assessment
  • Any adverse events or side effects
  • Updated treatment goals
  • Continued medical necessity justification

Specialty Pharmacy Network

Why Specialty Pharmacy is Required

Arcalyst requires:

  • Special handling and storage
  • Patient education and injection training
  • Clinical monitoring and support
  • Coordination with healthcare providers

What to Expect

  1. Pharmacy Contact: Specialty pharmacy will call within 24-48 hours of approval
  2. Benefits Verification: Pharmacy confirms your coverage and copay
  3. Clinical Assessment: Brief health screening and medication counseling
  4. Delivery Coordination: Scheduled delivery with signature required
  5. Ongoing Support: Regular check-ins and refill coordination

Counterforce Health helps patients navigate the complex prior authorization process by turning insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals aligned with each plan's specific requirements.

Common Problems and Solutions

Portal Access Issues

Problem: Can't access Blue Cross Blue Shield member portal Solution: Call member services at the number on your ID card to reset password or create account

Missing Documentation

Problem: Provider says they submitted everything but insurer requests more Solution: Request specific list of missing items and resubmit with tracking confirmation

Specialist Referral Delays

Problem: Primary care physician won't refer to specialist Solution: Request referral in writing; if denied, file grievance with insurance plan

Pharmacy Transfer Issues

Problem: Local pharmacy can't fill Arcalyst prescription Solution: This is normal—Arcalyst must be dispensed through specialty pharmacy network

Frequently Asked Questions

How long does Blue Cross Blue Shield prior authorization take in New York?

Standard prior authorization decisions are made within 15 business days. Expedited requests (for urgent medical needs) must be decided within 72 hours.

What if Arcalyst is non-formulary on my plan?

Even if non-formulary, Blue Cross Blue Shield must cover medically necessary treatments. Your provider can request a formulary exception with appropriate documentation.

Can I request an expedited appeal?

Yes, if your health would be seriously jeopardized by delay. Both internal appeals and New York external appeals offer expedited processing with faster decision timelines.

Does step therapy apply if I tried medications outside New York?

Yes, prior therapy documentation from any location counts toward step therapy requirements. Ensure your new provider has complete medical records.

What happens if my appeal is denied?

After internal appeal denial, you can file an external appeal with New York's Department of Financial Services. Their decision is binding on your insurance company.

Who pays for the medication during appeals?

Insurance companies may continue coverage during appeals if you request continuation within 10 days of the denial. Otherwise, you're responsible for costs until the appeal is resolved.

Can my family doctor prescribe Arcalyst?

While any licensed physician can technically prescribe Arcalyst, Blue Cross Blue Shield typically requires specialists (rheumatologists, immunologists, or cardiologists) for coverage approval.

How do I find an in-network specialist?

Use your Blue Cross Blue Shield member portal or call member services. Request providers who specialize in your specific condition (CAPS, DIRA, or recurrent pericarditis).

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and should not replace professional medical advice. Always consult with your healthcare provider and insurance company for personalized guidance. Coverage policies and requirements may change—verify current information with official sources.

About Counterforce Health: We help patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform ingests denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each plan's specific rules, improving approval rates and reducing administrative burden.

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