By Counterforce Health Team in Cimzia (certolizumab pegol) —

How to Get Cimzia (Certolizumab Pegol) Covered by Blue Cross Blue Shield of North Carolina: Complete Guide to Prior Authorization, Appeals, and State Protections

Answer Box: Getting Cimzia Covered in North Carolina

Cimzia (certolizumab pegol) requires prior authorization from Blue Cross Blue Shield of North Carolina and is subject to step therapy requirements. The fastest path to approval: 1) Submit PA with documented failure of preferred TNF inhibitors, 2) Include TB/HBV screening and FDA-approved diagnosis, 3) If denied, file internal appeal within 180 days, then external review through Smart NC within 120 days. Start by contacting your provider to gather prior treatment records and submit the Blue Cross NC prior authorization form.

Table of Contents

Why North Carolina State Rules Matter

North Carolina's insurance laws provide strong consumer protections that work alongside Blue Cross Blue Shield of North Carolina's (Blue Cross NC) coverage policies. Unlike self-funded employer plans that follow federal ERISA rules, state-regulated plans in North Carolina must comply with specific timelines for prior authorization decisions, step therapy exception processes, and appeals.

These protections are particularly important for specialty medications like Cimzia, which costs approximately $5,999 for a two-syringe maintenance pack. North Carolina's recent legislative updates, including the CARE FIRST Act provisions, strengthen requirements for prompt decisions and continuity of care during treatment transitions.

Note: If you have a self-funded employer plan (check your insurance card or HR department), some North Carolina protections may not apply, but you still have federal appeal rights.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Cimzia prescriptions Blue Cross NC PA page Blue Cross NC
Step Therapy Must try preferred TNF inhibitors first Plan formulary documents Blue Cross NC
TB/HBV Screening Required before starting treatment Medical records FDA labeling
FDA-Approved Diagnosis Crohn's, RA, PsA, AS, psoriasis, JIA only Provider documentation FDA Access Data
Appeal Deadline 180 days from denial notice Member handbook Blue Cross NC
External Review 120 days after final internal denial Smart NC website NC DOI

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient + Clinic)

Collect your insurance card, prior treatment records showing failed TNF inhibitors, TB/HBV screening results, and current clinical notes documenting disease severity. Timeline: 1-2 weeks | Submit via: Provider portal

2. Submit Prior Authorization Request (Provider)

Your doctor submits the Blue Cross NC PA form with medical necessity letter, diagnosis codes, and step therapy documentation. Timeline: Same day | Expected response: 15 business days

3. Request Expedited Review if Urgent (Provider)

If your condition is rapidly worsening, request expedited review citing medical urgency. Timeline: Same day | Expected response: 72 hours

4. Appeal if Denied (Patient or Provider)

File internal appeal within 180 days using Blue Cross NC appeals process with additional clinical evidence. Timeline: Must file within 180 days | Expected response: 30 days

5. Request External Review (Patient)

Contact Smart NC at 1-855-408-1212 within 120 days of final internal denial for independent review. Timeline: Must file within 120 days | Expected response: 45 days (standard) or 72 hours (urgent)

Step Therapy Protections in North Carolina

North Carolina law requires Blue Cross NC to provide clear exceptions to step therapy requirements. You can request an override if:

  • Contraindicated: The required drug would cause harm or adverse reactions
  • Previously failed: You've tried the required drug under current or previous insurance
  • Ineffective: The required drug is expected to be ineffective for your condition
  • Stable on current therapy: Switching would risk loss of disease control
  • Clinical rationale: Your doctor provides medical justification for Cimzia
Clinician Corner: Document any previous TNF inhibitor failures with specific details: drug name, duration tried, reason for discontinuation (lack of efficacy, adverse events, contraindications), and current disease activity scores when available.

Counterforce Health helps patients and providers navigate these complex step therapy requirements by analyzing denial letters and crafting targeted appeals that align with both state law and payer-specific criteria.

Appeals Process and Timelines

Internal Appeals with Blue Cross NC

Standard Appeals: 30 calendar days for decision

  • Submit within 180 days of denial
  • Fax: 919-287-8709 (medical necessity)
  • Include updated clinical documentation and medical necessity letter

Expedited Appeals: 72 hours for decision

  • Required for urgent medical situations
  • Document why delay would cause harm
  • Same submission methods as standard appeals

Required Documentation for Appeals

  • Original denial letter
  • Updated clinical notes showing disease progression
  • Letters from treating physicians
  • Relevant lab results or imaging
  • Documentation of failed prior therapies

External Review Through Smart NC

If Blue Cross NC upholds their denial after internal appeals, North Carolina residents can request an independent external review through Smart NC, a free service provided by the North Carolina Department of Insurance.

How to Request External Review

  1. Call Smart NC: 1-855-408-1212
  2. Submit within 120 days of final internal denial
  3. Provide documentation: Medical records, denial letters, and clinical justification
  4. Wait for decision: 45 days for standard review, 72 hours for expedited

Success Rates

Approximately 50% of specialty drug denials appealed through Smart NC are overturned. If Smart NC rules in your favor, Blue Cross NC must provide coverage within 3 business days.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Missing TB/HBV screening Submit screening results Lab reports, chest X-ray
Step therapy not met Document failed preferred agents Treatment records, adverse events
Not FDA-approved indication Confirm diagnosis matches label ICD-10 codes, clinical notes
Quantity limits exceeded Justify medical necessity Dosing rationale, weight-based calculations
"Not medically necessary" Provide clinical evidence Guidelines, peer-reviewed studies

Costs and Patient Assistance

Manufacturer Support

UCB offers the Cimzia Complete Support Program which may provide copay assistance for eligible patients with commercial insurance. Income and insurance requirements apply.

State Programs

North Carolina residents may qualify for additional assistance through:

  • North Carolina AIDS Drug Assistance Program (for HIV-related conditions)
  • Patient Advocate Foundation copay relief programs
  • Local hospital charity care programs
Tip: Apply for manufacturer assistance even if you're unsure about eligibility—many programs have expanded criteria for specialty medications.

FAQ

How long does Blue Cross NC prior authorization take for Cimzia? Standard PA decisions are made within 15 business days. Expedited requests (for urgent medical situations) receive decisions within 72 hours.

What if Cimzia isn't on my Blue Cross NC formulary? You can request a formulary exception by submitting clinical justification for why Cimzia is medically necessary compared to formulary alternatives.

Can I get expedited appeals for Cimzia denials? Yes, if delaying treatment would seriously jeopardize your health or ability to function. Document the urgency in your appeal request.

Does step therapy apply if I failed TNF inhibitors in another state? Yes, previous treatment failures should count toward step therapy requirements. Provide documentation from your previous providers.

What happens if Smart NC overturns the denial? Blue Cross NC must provide coverage within 3 business days of the Smart NC decision. The external review decision is binding on the insurer.

How much does Cimzia cost without insurance in North Carolina? The list price is approximately $5,999 for a two-syringe maintenance pack, though actual costs may vary by pharmacy and location.

From Our Advocates

We've seen many Cimzia appeals succeed when patients provide comprehensive documentation of failed step therapy drugs, including specific adverse events or lack of efficacy. One key factor is timing—submitting appeals quickly with all required documentation often leads to faster approvals than piecemeal submissions over several weeks.

The complexity of prior authorization requirements for specialty biologics like Cimzia can be overwhelming for patients already managing serious chronic conditions. Counterforce Health's platform streamlines this process by automatically identifying denial reasons and generating evidence-backed appeals that address Blue Cross NC's specific criteria, helping patients get the medications they need without unnecessary delays.

Sources and Further Reading

This guide is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and verify current insurance requirements with Blue Cross Blue Shield of North Carolina. For assistance with insurance appeals and prior authorization, contact Smart NC at 1-855-408-1212 or visit the North Carolina Department of Insurance website.

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