By Counterforce Health Team in Arcalyst (rilonacept) —

How to Get Arcalyst (rilonacept) Covered by Blue Cross Blue Shield in Pennsylvania: Complete Guide to Prior Authorization and Appeals

Answer Box: Getting Arcalyst Covered by Blue Cross Blue Shield in Pennsylvania

Blue Cross Blue Shield requires prior authorization for Arcalyst (rilonacept) in Pennsylvania for all FDA-approved indications. The fastest path to approval: 1) Have your prescriber submit a complete PA request with diagnosis (CAPS, DIRA, or recurrent pericarditis), ICD-10 codes, and documentation of medical necessity, 2) Include evidence of failed prior therapies if required by step therapy protocols, and 3) If denied, appeal within the plan's timeframe and leverage Pennsylvania's new external review program, which overturns about 50% of denials. Start today by calling the member services number on your insurance card to confirm your plan's specific PA requirements.

Table of Contents

Why Pennsylvania State Rules Matter

Pennsylvania's insurance landscape has evolved significantly, especially for specialty drug coverage. The state's major Blue Cross Blue Shield plans—including Highmark Blue Shield in western Pennsylvania and Independence Blue Cross in the Philadelphia region—must follow both federal regulations and Pennsylvania's enhanced consumer protection laws.

In January 2024, Pennsylvania launched its Independent External Review Program, giving consumers a powerful new tool when insurers deny coverage. This state-supervised process has already overturned roughly 50% of appealed denials, forcing insurers to cover treatments they initially refused.

For Arcalyst (rilonacept), this matters because the medication treats rare conditions—CAPS (cryopyrin-associated periodic syndromes), DIRA (deficiency of interleukin-1 receptor antagonist), and recurrent pericarditis—where standard treatments often fail and specialty expertise is crucial.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required All BCBS PA plans require PA for Arcalyst Plan formulary documents
FDA-Approved Indications Only CAPS, DIRA, recurrent pericarditis (ages vary by indication) FDA prescribing information
Step Therapy May Apply NSAIDs + colchicine failure often required for pericarditis Plan-specific policies
Specialty Pharmacy May require designated specialty pharmacy Member services confirmation
12-Month Approval Period Standard authorization length if approved PA request forms

Step-by-Step: Fastest Path to Approval

1. Confirm Your Plan Requirements (Patient + Clinic)

Call the member services number on your insurance card. Ask specifically about Arcalyst PA requirements, formulary status, and whether step therapy applies to your diagnosis.

2. Gather Required Documentation (Clinic)

Your prescriber needs:

  • Confirmed diagnosis with ICD-10 codes
  • Documentation of prior therapy trials and outcomes (especially for recurrent pericarditis)
  • Clinical notes supporting medical necessity
  • Patient weight and dosing calculations

3. Submit Complete PA Request (Prescriber)

Most BCBS plans accept electronic submissions through platforms like SureScripts or plan-specific portals. Include all required clinical information in the initial submission to avoid delays.

Timeline: Standard requests decided within 72 hours; urgent requests within 24 hours.

4. Monitor for Decision (Patient + Clinic)

Both patient and prescriber receive written notification. If approved, confirm specialty pharmacy arrangements. If denied, review the denial letter immediately for appeal instructions.

5. Appeal if Denied (Within Plan Timeframes)

Most BCBS plans allow 60-180 days for internal appeals. Submit additional clinical documentation addressing each denial reason.

6. Request External Review if Needed (Within 4 Months)

If internal appeals fail, Pennsylvania residents can request external review through the state within four months of the final internal denial.

Pennsylvania's Step Therapy Protections

Pennsylvania's recent reforms, including SB 225, provide stronger protections when insurers require you to fail cheaper treatments first.

Medical Exception Criteria

You can request an exception to step therapy if:

  • Prior drug caused harm or adverse reactions (document specific reactions)
  • Prior drug was ineffective (include treatment duration and outcomes)
  • You're stable on the requested medication (pharmacy records help)
  • Step therapy protocol isn't clinically appropriate for your specific condition

Documentation That Helps

For recurrent pericarditis patients, document:

  • Specific NSAID trials with dates, doses, and outcomes
  • Colchicine response and any intolerance
  • CRP or other inflammatory markers showing "inflammatory phenotype"
  • Cardiology specialist involvement
From Our Advocates: We've seen step therapy exceptions succeed when providers clearly document not just that NSAIDs "didn't work," but specific details like "ibuprofen 600mg TID for 4 weeks resulted in continued chest pain and CRP elevation at 15 mg/L, with GI intolerance requiring discontinuation." Specific clinical details make the difference.

Continuity of Care and Ongoing Therapy

If you're already stable on Arcalyst and switching insurance or facing coverage changes, Pennsylvania provides some protections:

  • Transition periods: New plans may need to provide temporary coverage while reviewing your case
  • Ongoing therapy: If you've been on Arcalyst successfully, document this stability in any new PA requests
  • Grace periods: Some plans provide 30-90 day continuation while processing new authorizations

Contact Counterforce Health for assistance navigating these transitions, especially when dealing with complex prior therapy documentation requirements.

Appeals Process: Internal to External Review

Internal Appeals (First Step)

  • Timeline: Most BCBS plans allow 60-180 days from denial notice
  • Submission: Written appeal with additional clinical documentation
  • Review: Plan's medical directors review against their policies
  • Outcome: Approval, continued denial, or request for more information

Pennsylvania External Review (Second Step)

Pennsylvania's new program provides independent review after internal appeals fail:

  • Eligibility: Must have completed internal appeals first
  • Timeline: 4 months from final internal denial to request external review
  • Process: Submit online or by mail/fax
  • Review: Independent medical experts review your case
  • Decision: Standard reviews within 45 days; expedited within 72 hours
  • Success Rate: Approximately 50% of denials overturned

Required Documents for External Review

  • Final denial letter from your insurance plan
  • All medical records related to your condition
  • Provider statements supporting medical necessity
  • Any additional evidence (research studies, guidelines)

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
"Not FDA approved for this indication" Provide FDA prescribing information showing approved use
"Step therapy not completed" Document specific prior therapy failures with clinical details
"Not prescribed by specialist" Get referral to rheumatologist or cardiologist, or provide specialist consultation
"Insufficient medical necessity" Submit comprehensive letter addressing diagnosis, prior treatments, clinical rationale
"Experimental/investigational" Cite FDA approval and established clinical guidelines

When to Contact Pennsylvania Regulators

Contact the Pennsylvania Insurance Department if:

  • Your insurer isn't following proper PA procedures
  • Appeal deadlines aren't being honored
  • You need help understanding your external review rights
  • You suspect discriminatory coverage practices

The Pennsylvania Health Law Project provides free legal assistance for insurance appeals. Call their helpline at 1-800-274-3258 (Mondays and Wednesdays).

Practical Scripts and Templates

Patient Phone Script for BCBS

"I need information about prior authorization requirements for Arcalyst, generic name rilonacept, for [your diagnosis]. Can you tell me what documentation my doctor needs to include, whether step therapy applies, and your current processing timeline?"

Clinic Script for Peer-to-Peer Review

"I'm requesting a peer-to-peer review for my patient's Arcalyst denial. This patient has [specific diagnosis] with documented failure of [specific prior therapies] and meets your plan's medical necessity criteria as outlined in policy [reference policy if known]."

Medical Necessity Letter Template

Your provider should address:

  1. Specific diagnosis with ICD-10 codes
  2. Prior treatment trials with dates, doses, and outcomes
  3. Why alternatives are inappropriate or contraindicated
  4. Expected clinical benefits of Arcalyst
  5. Monitoring plan and safety considerations

Limits: ERISA and Self-Funded Plans

Important limitation: If your employer self-funds its health benefits (common for large companies), Pennsylvania state protections may not apply. These ERISA-governed plans follow federal rules only.

How to check: Ask your HR department or look for "self-funded" language in your plan documents. Self-funded plans often still follow similar PA processes but may have different appeal rights.

For self-funded plans, you'll typically have access to federal external review through your insurer rather than Pennsylvania's state program.

FAQ

How long does BCBS prior authorization take in Pennsylvania? Standard requests: 72 hours. Urgent requests: 24 hours. Appeals typically take 30-60 days for internal review, then up to 45 days for Pennsylvania external review.

What if Arcalyst isn't on my plan's formulary? You can request a formulary exception. Your provider needs to document why formulary alternatives aren't appropriate and submit clinical evidence supporting Arcalyst's necessity for your condition.

Can I get expedited review for Arcalyst? Yes, if delay would jeopardize your health. Your provider must certify the urgency. Both PA requests and appeals can be expedited.

Does step therapy apply if I failed treatments outside Pennsylvania? Yes, documented treatment failures from other states count. Provide medical records showing specific therapies tried, duration, and outcomes.

What's the cost of Arcalyst without insurance? Cash prices typically run several thousand dollars per monthly kit. Regeneron offers patient assistance programs that may help with costs during coverage appeals.

How do I know if my BCBS plan is regulated by Pennsylvania? Most individual and small group plans are state-regulated. Large employer plans may be self-funded (ERISA) and follow federal rules only. Check with your HR department or plan documents.

Counterforce Health helps patients and providers navigate complex insurance appeals by turning denials into targeted, evidence-backed requests. Their platform analyzes denial letters and plan policies to create compelling appeals that address each payer's specific requirements.

Disclaimer: This information is for educational purposes only and doesn't constitute medical or legal advice. Insurance policies vary significantly, and requirements change frequently. Always consult your specific plan documents and healthcare providers for personalized guidance. For complex cases, consider consulting with Counterforce Health or the Pennsylvania Health Law Project for professional assistance.

Sources & Further Reading

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