By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

How to Get Breyanzi (Lisocabtagene Maraleucel) Covered by Cigna in North Carolina: Complete PA Guide and Appeals Process

Quick Answer: Getting Breyanzi Covered by Cigna in North Carolina

Breyanzi (lisocabtagene maraleucel) requires prior authorization from Cigna and must be administered at a FACT-accredited facility. The fastest path: 1) Confirm your treatment center has FACT accreditation for immune effector cell therapy, 2) Submit PA through CoverMyMeds or Accredo with complete diagnosis documentation and prior treatment history, 3) If denied, use North Carolina's Smart NC external review system within 120 days. Start today by calling Cigna member services to confirm your plan's specialty pharmacy requirements and PA submission process.

Table of Contents

Why North Carolina State Rules Matter

North Carolina's insurance regulations create important protections that work alongside Cigna's national policies. While Cigna manages specialty drugs like Breyanzi through Express Scripts and Accredo, North Carolina law adds extra layers of consumer protection that can help overturn denials.

The key difference: North Carolina requires insurers to follow specific timelines for PA decisions and provides robust external review rights through Smart NC. These protections apply to most individual and small group plans, though self-funded employer plans (ERISA) have different rules.

Note: Medicare Advantage plans follow federal Medicare rules, while commercial Cigna plans must comply with North Carolina state regulations.

Cigna's PA Requirements for Breyanzi

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all CAR-T therapies Cigna PA Requirements
Facility Accreditation FACT-accredited for immune effector cell therapy Cigna Advanced Cellular Therapy Policy
Specialty Pharmacy Managed through Accredo Cigna Specialty Pharmacy
Diagnosis Requirements Relapsed/refractory large B-cell lymphoma or CLL/SLL per FDA label FDA Prescribing Information
Prior Treatment ≥2 prior systemic therapies documented FDA Prescribing Information

Counterforce Health helps patients and clinicians navigate these complex PA requirements by automatically generating evidence-backed appeals that align with Cigna's specific policies and North Carolina's regulatory framework. The platform identifies denial reasons and crafts targeted rebuttals using peer-reviewed studies and specialty guidelines.

Key Clinical Documentation Needed

Cigna requires comprehensive documentation including:

  • Diagnosis confirmation with appropriate ICD-10 codes
  • Complete prior treatment history showing failure or intolerance to at least two prior lines
  • ECOG performance status and organ function assessments
  • Treatment facility verification of FACT accreditation
  • Plan for managing adverse events including cytokine release syndrome

Step-by-Step: Fastest Path to Approval

1. Verify Facility Accreditation (Week 1)

Who does it: Treatment center staff
What's needed: Confirm FACT accreditation for immune effector cell therapy
Timeline: Same day verification
Link: FACT Accreditation Search

2. Gather Required Documentation (Week 1-2)

Who does it: Patient and oncology team
Documents needed:

  • Complete medical records showing diagnosis
  • Documentation of ≥2 prior treatment failures
  • Current labs and imaging
  • Insurance card and policy information

3. Submit PA Through Preferred Channel (Week 2)

Who does it: Prescribing physician or staff
How to submit: CoverMyMeds portal or directly through Accredo
Expected timeline: 15 business days for standard review

4. Follow Up on PA Status (Week 3)

Who does it: Patient or clinic staff
Action: Call Cigna member services or check online portal
Timeline: Check status after 10 business days

5. Prepare for Potential Peer-to-Peer (Week 3-4)

Who does it: Treating oncologist
What's needed: Clinical rationale and supporting literature ready
Timeline: Usually scheduled within 3-5 business days of request

North Carolina Step Therapy Protections

North Carolina enacted comprehensive step therapy reform that creates specific override criteria for patients and prescribing practitioners. These protections became effective October 1, 2015, and apply to state-regulated health plans.

Override Exception Criteria

Step therapy override requests must be granted when:

  • The required step therapy drug has not been approved by the FDA for the patient's condition
  • A provider demonstrates medical necessity for an alternative medication
  • The patient has previously tried and failed the step therapy drug
  • The step therapy drug is contraindicated or likely to cause adverse reactions
Tip: Use North Carolina's specific step therapy exception request form when seeking overrides for Breyanzi. Document why required step therapies are not medically appropriate, including FDA approval status and previous treatment failures.

Continuity of Care During Transitions

North Carolina General Statutes § 58-67-88 requires health plans to ensure continuity of care for patients with ongoing treatment needs, including those with terminal illnesses or chronic conditions requiring specialized therapy.

For CAR-T therapy patients:

  • Grace period provisions may apply when switching between Cigna plans
  • Ongoing treatment protections for patients mid-therapy
  • Provider network changes must include transition assistance

Contact Smart NC at 1-855-408-1212 if you're facing coverage disruptions during insurance transitions.

Appeals Playbook for North Carolina

Internal Appeals with Cigna

First Level Internal Appeal:

  • Timeline: 30 days for standard, 72 hours for urgent
  • How to file: Cigna member portal or written request
  • Required documents: Denial letter, medical records, prescriber letter

Second Level Internal Appeal:

  • Timeline: 30 days for standard review
  • Trigger: Automatic if first appeal denied
  • Review: Independent medical reviewer

Smart NC External Review

When eligible: After completing Cigna's internal appeals (or for urgent cases)
Timeline: 120 days from final internal denial to file
Success rate: 40-60% for cancer drug appeals
Contact: 1-855-408-1212

Expedited External Review:

  • Timeline: 72 hours for urgent cases, 24-72 hours for urgent drug denials
  • Eligibility: When delay would seriously jeopardize life or ability to regain function
  • Advantage: Can bypass internal appeals requirement

When to Use Smart NC External Review

Smart NC external review has proven particularly effective for expensive cancer treatments and specialty drugs. The system successfully overturns approximately 40-60% of cancer drug appeals, with documented cases where Independent Review Organizations have reversed denials for CAR-T therapies when provided with peer-reviewed studies.

Strengthening Your External Review

Include in your submission:

  • Peer-reviewed studies specific to your cancer subtype and Breyanzi
  • Documentation from treating oncologists about clinical urgency
  • Complete prior treatment records from all insurance plans
  • Evidence of disease progression risk without prompt treatment
From our advocates: We've seen external reviews succeed when patients include comprehensive documentation showing not just treatment failures, but also the specific reasons why Breyanzi is the most appropriate next step. Independent reviewers respond well to clear timelines showing disease progression and detailed explanations of why alternative treatments aren't suitable.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not FDA approved for indication" Provide FDA prescribing information showing approved indications FDA Label for Breyanzi
"Insufficient prior treatment" Document all prior therapies with dates and outcomes Medical records showing ≥2 prior lines
"Facility not qualified" Verify FACT accreditation status FACT accreditation certificate
"Experimental/investigational" Cite FDA approval and Medicare NCD coverage Medicare NCD 110.24
"Medical necessity not established" Provide comprehensive clinical rationale Oncologist letter with supporting literature

Practical Scripts for Cigna Calls

Patient Script for Member Services

"Hi, I'm calling about prior authorization for Breyanzi, a CAR-T cell therapy. My member ID is [ID]. I need to confirm: 1) Is this covered under my plan's specialty pharmacy benefit through Accredo? 2) What's the current PA submission process? 3) Under North Carolina law, what are my appeal rights if the PA is denied?"

Clinic Script for Peer-to-Peer Request

"This is Dr. [Name] requesting a peer-to-peer review for Breyanzi PA [reference number]. The patient has relapsed/refractory large B-cell lymphoma after two prior lines of therapy. Under North Carolina step therapy protections, this patient qualifies for override criteria due to medical necessity. Can we schedule the peer-to-peer within the required timeframe?"

ERISA Plan Limitations

Self-funded employer plans (ERISA) have different rules than state-regulated insurance:

  • Not subject to North Carolina step therapy protections
  • Limited external review rights (must be specified in plan documents)
  • Federal ERISA appeals process instead of Smart NC
  • Plan document governs coverage decisions
Note: Contact your HR department to determine if your plan is self-funded and what appeals processes are available.

FAQ: Breyanzi Coverage in North Carolina

How long does Cigna PA take in North Carolina?
Standard PA reviews take up to 15 business days. Urgent reviews are completed within 72 hours. North Carolina law doesn't change these federal timelines for specialty drugs.

What if Breyanzi is non-formulary on my Cigna plan?
Request a formulary exception through your prescribing physician. Include clinical rationale and supporting literature. If denied, use North Carolina's external review process.

Can I request an expedited appeal in North Carolina?
Yes. Cigna offers expedited internal appeals (72 hours), and Smart NC provides expedited external review (72 hours) when delay would jeopardize your health.

Does North Carolina step therapy apply if I failed treatments in another state?
Yes. North Carolina law recognizes prior treatment failures regardless of where they occurred, as long as they're properly documented.

What's the difference between Medicare Advantage and commercial Cigna coverage?
Medicare Advantage follows federal Medicare rules and coverage decisions. Commercial plans must comply with North Carolina state regulations and Smart NC external review rights.

How much does Breyanzi cost without insurance?
The wholesale acquisition cost (WAC) is approximately $447,000-$487,000 per treatment, not including administration and supportive care costs.

For patients facing coverage challenges, Counterforce Health provides comprehensive support by analyzing denial letters and generating evidence-backed appeals that specifically address Cigna's coverage criteria while leveraging North Carolina's consumer protections.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for specific coverage questions. For assistance with appeals and coverage issues, contact Smart NC at 1-855-408-1212.

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