How to Get Arcalyst (rilonacept) Covered by Aetna CVS Health in Virginia: Complete Prior Authorization and Appeals Guide
Answer Box: Getting Arcalyst (rilonacept) Covered by Aetna CVS Health in Virginia
Arcalyst (rilonacept) requires prior authorization from Aetna CVS Health for all FDA-approved indications including CAPS, DIRA, and recurrent pericarditis. Fastest path to approval: Submit complete PA documentation through CVS Caremark Specialty (1-866-237-5512) with diagnosis confirmation, prior therapy failures, and specialist consultation notes. If denied, Virginia's State Corporation Commission Bureau of Insurance offers external review within 120 days of final denial. Start today: Call Aetna member services to confirm your specific PA requirements and obtain the current forms.
Table of Contents
- Coverage Overview
- Prior Authorization Requirements
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons & Fixes
- Appeals Process in Virginia
- Cost-Saving Options
- When to Escalate
- FAQ
Coverage Overview
Arcalyst (rilonacept) is a specialty biologic medication manufactured by Regeneron that requires prior authorization from Aetna CVS Health for coverage. The drug is FDA-approved for treating cryopyrin-associated periodic syndromes (CAPS), deficiency of interleukin-1 receptor antagonist (DIRA), and recurrent pericarditis.
Coverage at a Glance
Requirement | Details | Source |
---|---|---|
Prior Authorization | Required for all indications | Aetna Precertification List |
Formulary Status | Specialty tier (varies by plan) | Plan-specific formulary |
Age Restrictions | ≥12 years for CAPS/pericarditis; ≥10kg for DIRA | Aetna Policy |
Specialist Required | Rheumatologist (CAPS), Cardiologist/Rheumatologist (pericarditis) | CVS Caremark PA criteria |
Step Therapy | May require failed conventional therapies | Plan-specific |
Quantity Limits | 4-5 vials per 28 days typical | CVS Caremark |
Prior Authorization Requirements
Aetna CVS Health requires comprehensive documentation for Arcalyst approval. The medication is processed through CVS Caremark Specialty Pharmacy for most plans.
Required Documentation
- Diagnosis confirmation with appropriate ICD-10 codes:
- M04.2 (CAPS)
- E88.89 (DIRA)
- I31.9 (Recurrent pericarditis)
- Specialist consultation notes from rheumatology or cardiology
- Prior therapy documentation including:
- Failed or intolerant medications (names, doses, durations)
- Clinical response and reasons for discontinuation
- For recurrent pericarditis: evidence of colchicine and NSAID failure
- Laboratory results:
- Elevated inflammatory markers (CRP, ESR)
- Genetic testing results (if applicable)
- Treatment plan with dosing rationale and monitoring schedule
Billing Information
- Pharmacy benefit: NDC 73604-914-01 or 73604-914-04
- Medical benefit: HCPCS J2793 (rilonacept, 1 mg per unit)
- Administration: Subcutaneous, weekly dosing
Step-by-Step: Fastest Path to Approval
1. Verify Benefits and PA Requirements
- Call Aetna member services at the number on your insurance card
- Confirm your plan covers specialty medications
- Request current PA forms and submission requirements
- Timeline: 15-30 minutes
2. Gather Clinical Documentation
- Obtain complete medical records from your specialist
- Collect lab results showing elevated inflammatory markers
- Document all prior therapies attempted and their outcomes
- Timeline: 1-3 business days
3. Complete Prior Authorization Form
- Use CVS Caremark Specialty PA form
- Ensure all required fields are completed
- Attach all supporting documentation
- Timeline: 30-60 minutes
4. Submit PA Request
- Fax: 1-866-237-5512 (CVS Caremark Specialty)
- Phone: 1-800-294-5979
- Online: Through Availity portal (providers)
- Timeline: Same day submission
5. Track Your Request
- Call CVS Caremark within 2-3 business days to confirm receipt
- Standard review: 24-72 hours
- Expedited review available for urgent cases
- Timeline: 1-3 business days for decision
6. Receive Decision
- Approval: Prescription can be filled immediately
- Denial: Review denial letter for specific reasons
- Timeline: Decision communicated within 72 hours
7. Appeal if Denied
- File internal appeal within 60 days of denial
- Gather additional supporting evidence
- Consider peer-to-peer review with medical director
- Timeline: 30-45 days for internal appeal decision
Common Denial Reasons & Fixes
Denial Reason | How to Fix | Required Documentation |
---|---|---|
Incomplete diagnosis documentation | Submit detailed specialist notes with ICD-10 codes | Rheumatology/cardiology consultation with clear diagnosis |
Lack of prior therapy failure | Document specific medications tried, doses, durations, and outcomes | Pharmacy records, physician notes, treatment timeline |
Non-specialist prescriber | Have appropriate specialist co-sign or take over prescription | Rheumatologist (CAPS/DIRA) or cardiologist (pericarditis) consultation |
Missing lab values | Submit recent inflammatory markers and relevant tests | CRP, ESR, genetic testing results (if applicable) |
Age restrictions not met | Verify patient meets minimum age/weight requirements | Birth certificate, weight documentation |
Appeals Process in Virginia
Virginia provides robust patient protections through the State Corporation Commission Bureau of Insurance external review process.
Internal Appeals with Aetna CVS Health
- Deadline: 60 days from denial notice
- Submit to: Use denial letter instructions or member services
- Timeline: 30-45 days for standard review, 72 hours for expedited
- Required: Denial letter, additional clinical evidence, prescriber letter
Virginia External Review Process
If your internal appeal is denied, Virginia law provides an independent external review option.
Eligibility
- Must complete Aetna's internal appeals process first
- Denial must be based on medical necessity or experimental/investigational designation
- Must file within 120 days of final internal denial
How to File
- Complete Form 216-A (External Review Request)
- Submit supporting documentation
- Contact: Virginia State Corporation Commission Bureau of Insurance
- Fax: (804) 371-9915
- Email: [email protected]
- Address: P.O. Box 1157, Richmond, VA 23218
Timeline
- Initial eligibility review: 1 business day
- Assignment to Independent Review Organization: 1 business day
- Final decision: 45 days (72 hours for expedited)
- Success rate: External reviews overturn approximately 50% of denials in similar cases
From our advocates: "We've seen Virginia's external review process work particularly well for specialty drug denials when patients provide comprehensive clinical documentation. The independent medical reviewers often have more specialized knowledge than initial insurance reviewers. One key tip: submit any new evidence or studies published since your original denial—fresh clinical data can be the difference maker."
Cost-Saving Options
Manufacturer Support Programs
- Regeneron offers copay assistance for eligible commercially insured patients
- May reduce out-of-pocket costs to $0 per month for qualifying individuals
- Not available for government insurance (Medicare, Medicaid)
- Contact: Regeneron customer support
Patient Assistance Programs
- Free medication available for uninsured or underinsured patients
- Financial eligibility requirements apply
- Application facilitated through specialty pharmacy or manufacturer
CVS Specialty Pharmacy Support
- Case management services included
- Help with insurance navigation and copay program enrollment
- Coordination with manufacturer assistance programs
When to Escalate
Contact Virginia regulators if you experience:
- Repeated denials despite meeting all criteria
- Excessive delays in processing
- Lack of response to appeals
Virginia State Corporation Commission Bureau of Insurance
- Phone: 1-877-310-6560
- Website: SCC Bureau of Insurance
- Services: Consumer assistance, complaint filing, external review guidance
Counterforce Health specializes in turning insurance denials into successful appeals by creating targeted, evidence-backed rebuttals that align with each payer's specific requirements. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization processes and appeals for medications like Arcalyst.
FAQ
How long does Aetna CVS Health prior authorization take for Arcalyst in Virginia? Standard PA decisions are typically made within 24-72 hours of receiving complete documentation. Expedited reviews for urgent cases may be completed within 24 hours.
What if Arcalyst is not on my Aetna formulary? You can request a formulary exception by demonstrating medical necessity and providing evidence that preferred alternatives are inappropriate or have failed.
Can I request an expedited appeal in Virginia? Yes, expedited appeals are available if your physician certifies that waiting could seriously jeopardize your health. These are decided within 72 hours.
Does step therapy apply if I've tried similar medications outside Virginia? Yes, prior therapy documentation from any location is typically accepted. Ensure you have complete records of medications tried, including doses and outcomes.
What happens if my Aetna plan is self-funded by my employer? Self-funded plans may not be subject to Virginia's external review process. Check with your HR department or plan administrator for your specific appeal rights.
How much does Arcalyst cost without insurance in Virginia? Cash prices typically range from several thousand dollars per kit, varying by pharmacy. Manufacturer assistance programs may be available to reduce costs.
Can my doctor request a peer-to-peer review with Aetna's medical director? Yes, peer-to-peer reviews are available and can be effective for complex cases. Your prescribing physician can request this through CVS Caremark Specialty.
What should I do if I'm already taking Arcalyst and my renewal is denied? File an appeal immediately and ask your doctor about temporary supplies or alternative arrangements while the appeal is processed. Don't stop treatment without medical guidance.
For additional support navigating Arcalyst coverage with Aetna CVS Health, Counterforce Health provides specialized assistance with prior authorizations and appeals, helping ensure patients get access to the medications they need.
Sources & Further Reading
- Aetna Precertification Requirements
- CVS Caremark Arcalyst PA Form
- Virginia External Review Process
- Virginia State Corporation Commission
- Arcalyst FDA Prescribing Information
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for the most current requirements and procedures. Coverage policies may vary by specific plan and can change over time.
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