By Counterforce Health Team in Arcalyst (rilonacept) —

A Realistic Arcalyst (rilonacept) Approval Scenario with Aetna (CVS Health) in California: From Request to Yes

Answer Box: Getting Arcalyst Approved by Aetna in California

Yes, Arcalyst (rilonacept) can be covered by Aetna (CVS Health) in California. The fastest path: 1) Your cardiologist submits a complete prior authorization packet via Availity portal documenting recurrent pericarditis and failed NSAIDs/colchicine, 2) Aetna reviews within 15 business days, 3) If denied, file internal appeal within 180 days, then request California DMHC Independent Medical Review if needed. Start today by asking your prescriber to complete the Aetna Specialty Medication Precertification form and enroll you in Kiniksa OneConnect for financial assistance.

Table of Contents

  1. Patient Profile: Sarah's Recurrent Pericarditis Journey
  2. Pre-Authorization Preparation
  3. Submission Process
  4. Initial Outcome
  5. The Appeal Process
  6. Final Resolution
  7. What We'd Do Differently
  8. Templates & Checklists
  9. FAQ

Patient Profile: Sarah's Recurrent Pericarditis Journey

Sarah, a 34-year-old marketing manager in San Francisco, experienced her first episode of pericarditis after a viral infection in early 2024. Despite treatment with ibuprofen 800mg three times daily and colchicine 0.5mg daily for three months, she had two more episodes within six months—each requiring emergency room visits and high-dose steroids.

Her cardiologist at UCSF diagnosed recurrent idiopathic pericarditis and recommended Arcalyst (rilonacept) after Sarah developed steroid-induced diabetes and couldn't tolerate higher colchicine doses due to severe diarrhea. Sarah has Aetna commercial insurance through her employer.

Her goals: Get Arcalyst approved quickly, minimize out-of-pocket costs, and prevent future hospitalizations.

Pre-Authorization Preparation

Sarah's cardiologist knew Aetna requires prior authorization for Arcalyst and began gathering documentation:

Clinical Documentation Checklist

  • Confirmed diagnosis: Recurrent pericarditis (ICD-10: I31.9)
  • Disease history: Three documented episodes with elevated CRP (>10 mg/L each time)
  • Prior therapies and failures:
    • Ibuprofen 800mg TID × 3 months (incomplete response, persistent symptoms)
    • Colchicine 0.5mg daily × 3 months (GI intolerance at higher doses)
    • Prednisone 40mg daily × 2 weeks (effective but caused hyperglycemia)
  • Supporting evidence: ER records, echocardiograms showing pericardial effusion, elevated inflammatory markers
  • Specialist involvement: Cardiology consultation notes

Letter of Medical Necessity Template

The cardiologist drafted a letter following Aetna's specific criteria:

"Patient has recurrent idiopathic pericarditis with ≥2 documented recurrences and elevated acute-phase reactants. She has demonstrated inadequate response to NSAIDs and colchicine, and corticosteroid dependence with significant adverse effects (hyperglycemia). Arcalyst is medically necessary to reduce recurrence risk and steroid dependence per FDA-approved indication and 2025 ACC Clinical Guidance."

Submission Process

Step-by-Step Submission

Week 1: Initial Submission

  1. Form completion: Clinic staff completed the Aetna Specialty Medication Precertification form
  2. Portal submission: Submitted via Availity provider portal (preferred method)
  3. Supporting documents: Medical necessity letter, clinic notes, lab results, ER records
  4. Manufacturer enrollment: Simultaneously enrolled Sarah in Kiniksa OneConnect for copay assistance

Required packet contents:

  • Completed precertification form
  • ICD-10 diagnosis code (I31.9)
  • Detailed treatment history with dates and outcomes
  • Recent CRP/ESR levels during flares
  • Cardiology consultation notes
  • Planned dosing: 320mg loading dose, then 160mg weekly

Initial Outcome

Day 12: Aetna issued a denial citing "insufficient documentation of step therapy compliance."

Denial reasoning:

  • "Patient has not tried adequate trial of corticosteroids as required step therapy"
  • "Medical necessity not established for IL-1 inhibitor therapy"

Sarah's cardiologist recognized this as a technical denial—Aetna's policy actually supports Arcalyst for recurrent pericarditis when standard therapies fail, but the reviewer missed the steroid intolerance documentation.

From our advocates: We see this pattern frequently—initial denials often result from incomplete documentation rather than true medical necessity issues. The key is having a systematic appeal strategy ready before you even submit the first request.

The Appeal Process

Internal Appeal (Level 1)

Day 15: Filed internal appeal within Aetna's 180-day deadline

Enhanced appeal packet:

  • Detailed rebuttal letter addressing each denial reason
  • 2025 ACC Consensus Clinical Guidance supporting IL-1 inhibitors as preferred second-line therapy for inflammatory recurrent pericarditis
  • Steroid intolerance documentation: Endocrinology consult confirming steroid-induced diabetes
  • Cost-effectiveness analysis: Three ER visits ($15,000) vs. annual Arcalyst cost
  • FDA label excerpts confirming approved indication

Peer-to-Peer Review

Day 25: Requested peer-to-peer review when initial appeal was pending

Key talking points for the cardiologist:

  • Patient meets all criteria in Aetna's own Arcalyst policy
  • Steroid dependence with serious adverse effects documented
  • IL-1 inhibition is now preferred over steroids per 2025 guidelines
  • Cost offset through reduced hospitalizations

Day 28: Internal appeal approved after peer-to-peer discussion

The reviewing physician (also a cardiologist) agreed that Sarah met criteria and that the initial denial was based on incomplete review of steroid intolerance documentation.

Final Resolution

Approval terms:

  • Duration: 12-month authorization
  • Quantity: One 220mg vial per week
  • Specialty pharmacy: CVS Specialty (Aetna's preferred)
  • Prior authorization: Required for renewals

Financial assistance:

  • Kiniksa copay program: Reduced Sarah's cost to $0/month
  • CVS Specialty coordination: Automatic application of manufacturer assistance

Timeline summary:

  • Day 1: Initial submission
  • Day 12: Initial denial
  • Day 15: Appeal filed
  • Day 25: Peer-to-peer requested
  • Day 28: Final approval

What We'd Do Differently

Key Success Factors

  1. Complete documentation upfront: Include detailed intolerance/failure documentation for all prior therapies
  2. Use Aetna's exact policy language: Mirror the criteria in your medical necessity letter
  3. Engage manufacturer support early: Kiniksa OneConnect helped coordinate the entire process
  4. Request peer-to-peer proactively: Don't wait for a second denial

Common Pitfalls to Avoid

  • Incomplete step therapy documentation: Clearly document doses, duration, and specific reasons for failure
  • Missing specialist involvement: Ensure cardiology/rheumatology is clearly documented as prescriber
  • Inadequate cost-effectiveness argument: Include specific data on hospitalizations and ER visits

Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, targeted rebuttals that align with each payer's specific criteria. Their platform helps patients and clinicians navigate complex prior authorization requirements and appeal processes more effectively.

Templates & Checklists

Pre-Submission Checklist

  • Confirmed diagnosis with ICD-10 code
  • Documented ≥2 recurrent episodes
  • Prior therapy trials with specific doses, duration, outcomes
  • Elevated inflammatory markers during flares
  • Specialist prescriber involvement
  • Kiniksa OneConnect enrollment initiated

Appeal Letter Template Structure

  1. Patient identification and diagnosis
  2. Specific response to each denial reason
  3. Medical necessity justification using Aetna's criteria
  4. Evidence-based support (guidelines, FDA label)
  5. Cost-effectiveness analysis
  6. Request for peer-to-peer review

California-Specific Rights

If internal appeals fail, California residents can request Independent Medical Review (IMR) through DMHC:

  • Success rate: 60-70% for specialty drug denials
  • Timeline: 45 days standard, 7 days expedited
  • Cost: Free to patients
  • Binding: Decision is final and enforceable

FAQ

Q: How long does Aetna prior authorization take in California? A: Standard reviews take up to 15 business days; expedited reviews for urgent cases can be completed within 24-72 hours.

Q: What if Arcalyst is non-formulary on my plan? A: Request a formulary exception with medical necessity documentation. Aetna covers Arcalyst when criteria are met, even if it requires step therapy.

Q: Can I get financial assistance with Medicare? A: Medicare patients cannot use manufacturer copay cards but may qualify for Kiniksa's Patient Assistance Program (free drug) based on income.

Q: Does California have step therapy protections? A: California doesn't prohibit step therapy, but you can appeal requirements that don't align with medical necessity or cause harm.

Q: What happens if my appeal is denied? A: You can request DMHC Independent Medical Review within 180 days of the final internal denial—this has a 60-70% success rate for specialty drugs.

Q: How much does Arcalyst cost without insurance? A: Cash prices typically range from several thousand dollars per monthly kit, but manufacturer assistance programs can reduce costs significantly.

This article is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific guidance. For additional support with California insurance appeals, contact the DMHC Help Center at (888) 466-2219.

Sources & Further Reading

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