By Counterforce Health Team in Cimzia (certolizumab pegol) —

How to Get Cimzia (Certolizumab Pegol) Covered by Aetna (CVS Health) in North Carolina: Complete Appeals Guide and Timeline

Answer Box: Getting Cimzia Covered by Aetna in North Carolina

Eligibility: Cimzia requires prior authorization from Aetna (CVS Health) for all patients. You must have documented failure or intolerance to preferred alternatives and complete TB/hepatitis B screening.

Fastest path: Submit complete prior authorization with medical necessity letter, screening results, and prior therapy documentation through Aetna's provider portal. Standard review takes 30-45 days; expedited requests (with clinical justification) process within 72 hours.

Start today: Contact your prescriber to initiate prior authorization and gather required documentation. If denied, North Carolina's Smart NC external review offers binding decisions within 45 days (72 hours for expedited).

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Timeline
Prior Authorization Required for all Cimzia requests Aetna PA Policy 30-45 days standard
Step Therapy Must fail preferred alternatives first Aetna formulary guidelines Documented trials required
TB Screening Negative test within 6 months Clinical documentation Before initiation
Hepatitis B Screening HBsAg, anti-HBc, anti-HBs tests Lab results Before initiation
CVS Specialty Pharmacy Required site of care CVS Specialty enrollment After approval

Step-by-Step: Fastest Path to Approval

1. Confirm Medical Necessity (Patient + Prescriber)

Who does it: Your rheumatologist, gastroenterologist, or treating physician
Document needed: Clinical assessment with diagnosis confirmation (ICD-10 codes)
Timeline: 1-2 office visits

Your doctor must document that you have moderate to severe Crohn's disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or another FDA-approved indication for Cimzia.

2. Complete Required Screening (Patient + Lab/Imaging)

Who does it: Patient with physician orders
Documents needed: TB screening (PPD, IGRA, or chest X-ray), hepatitis B panel
Timeline: 1-2 weeks for results
Source: FDA prescribing information

Note: TB screening must show negative results within 6 months of starting Cimzia. An induration of 5mm or greater on PPD is considered positive.

3. Document Prior Therapy Failures (Prescriber)

Who does it: Prescriber with medical records review
Document needed: Detailed history of failed or intolerated medications
Timeline: 1-3 days chart review

Aetna requires documented inadequate response or intolerance to:

  • For RA: Methotrexate plus at least one conventional DMARD (hydroxychloroquine, sulfasalazine)
  • For Crohn's: Conventional therapies appropriate to disease severity
  • For other conditions: Condition-specific first-line treatments

4. Submit Prior Authorization Request (Prescriber)

Who does it: Prescriber or office staff
How to submit: Aetna provider portal or fax
Documents included: PA form, medical necessity letter, screening results, prior therapy documentation
Timeline: Same day submission

5. Track Request Status (Patient + Prescriber)

Who does it: Both patient and prescriber office
How to track: Aetna provider portal or member services
Timeline: Check weekly during review period

Standard prior authorization decisions are issued within 30-45 days. Expedited requests (with clinical urgency documentation) are processed within 72 hours.

6. If Approved: Enroll with CVS Specialty (Patient)

Who does it: Patient
Contact: CVS Specialty Pharmacy enrollment
Timeline: 3-5 business days

7. If Denied: Initiate Appeal Process (Patient + Prescriber)

Who does it: Patient with prescriber support
Timeline: Must appeal within 180 days of denial
Next step: See Appeals Process section below

Required Screening and Documentation

Tuberculosis Screening Checklist

  • Tuberculin skin test (TST/PPD) OR interferon-gamma release assay (IGRA)
  • Chest X-ray within 12 months
  • Assessment of TB risk factors and exposure history
  • If latent TB detected: Documentation of anti-TB treatment initiation

Hepatitis B Screening Requirements

  • HBsAg (hepatitis B surface antigen)
  • Anti-HBc (hepatitis B core antibody)
  • Anti-HBs (hepatitis B surface antibody)

Medical Necessity Letter Components

Your prescriber's letter should include:

  • Specific diagnosis with ICD-10 codes
  • Disease severity assessment with objective measures
  • Complete list of prior therapies with dates, doses, duration, and reasons for discontinuation
  • Clinical rationale for Cimzia specifically
  • Treatment goals and monitoring plan
  • References to relevant clinical guidelines

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Missing TB screening Submit negative screening results PPD/IGRA and chest X-ray within 6 months
Inadequate prior therapy Document specific failures Medication names, dates, doses, discontinuation reasons
Non-formulary status Request formulary exception Clinical rationale for Cimzia over alternatives
Quantity limits exceeded Justify dosing regimen FDA labeling, clinical guidelines supporting dose
"Experimental/investigational" Provide FDA approval evidence FDA label for specific indication
From our advocates: We've seen denials overturned most frequently when prescribers include specific dates and reasons for prior therapy failures, rather than general statements like "failed multiple treatments." The more detailed the documentation, the stronger the appeal.

Appeals Process: Aetna Internal to North Carolina External Review

Aetna Internal Appeals (First Level)

Timeline: File within 180 days of denial
Process: Submit appeal letter with additional clinical evidence
Decision timeframe: 30 days standard, 72 hours expedited
Required forms: Aetna appeals form (verify current link)

Peer-to-Peer Review Option

Before or during internal appeal, request a peer-to-peer review where your prescriber speaks directly with an Aetna medical director. This informal discussion often resolves coverage issues without formal appeals.

North Carolina Smart NC External Review

If Aetna's internal appeals are unsuccessful, North Carolina residents can request binding external review through Smart NC.

Eligibility requirements:

  • Must exhaust Aetna's internal appeals first
  • Denial based on medical necessity (not benefit exclusions)
  • State-regulated plan (not self-funded ERISA plans)
  • File within 120 days of final internal denial

Process:

  1. Submit NC DOI External Review Request Form
  2. Include all supporting documentation
  3. Smart NC assigns independent review organization (IRO)
  4. IRO issues binding decision

Timeline:

  • Standard review: 45 days maximum
  • Expedited review: 72 hours (requires physician certification of urgency)

Contact Smart NC: 1-855-408-1212 for free advocacy support

Financial Assistance and Cost Savings

CIMplicity Savings Program

Eligible commercially insured patients can pay as little as $0 per dose through UCB's manufacturer program.

Eligibility:

  • Commercial insurance (not Medicare/Medicaid)
  • Valid prescription for FDA-approved use
  • Not covered by government insurance

Enrollment: cimzia.com/signup or call 1-855-812-0403

Additional Support Options

  • UCBCares Patient Assistance: For uninsured/underinsured patients (1-866-395-8366)
  • CVS Specialty financial assistance: Coordinators help identify foundation grants and other programs
  • North Carolina prescription assistance: Contact Smart NC for state-specific programs
Note: Copay assistance programs don't cover doctor visit fees, only medication costs. Annual maximum benefits may apply.

Checklist: What to Gather Before Starting

Insurance Information:

  • Aetna member ID card
  • Policy details and formulary information
  • Previous EOBs or denial letters

Medical Documentation:

  • Complete medical records for your condition
  • List of all prior medications tried (names, dates, doses, outcomes)
  • Recent lab results and imaging studies
  • Specialist consultation notes

Screening Requirements:

  • TB screening results (within 6 months)
  • Hepatitis B panel results
  • Current vaccination records

Contact Information:

  • Prescribing physician office details
  • Preferred pharmacy information
  • Insurance customer service numbers

When to Escalate to North Carolina Regulators

If you encounter unreasonable delays or believe Aetna is not following proper procedures, you can file a complaint with North Carolina insurance regulators:

North Carolina Department of Insurance
Consumer Services Division
1201 Mail Service Center
Raleigh, NC 27699-1201
Phone: 1-855-408-1212

Include copies of all correspondence, denial letters, and appeal submissions with your complaint.

Frequently Asked Questions

Q: How long does Aetna prior authorization take in North Carolina?
A: Standard reviews take 30-45 days. Expedited requests with clinical urgency documentation are processed within 72 hours.

Q: What if Cimzia is not on Aetna's formulary?
A: Request a formulary exception through CVS Caremark with detailed clinical rationale explaining why Cimzia is medically necessary over formulary alternatives.

Q: Can I request expedited appeal in North Carolina?
A: Yes, both Aetna internal appeals and Smart NC external reviews offer expedited processing (72 hours) when delays would seriously jeopardize your health.

Q: Does step therapy apply if I failed treatments in another state?
A: Yes, documented treatment failures from any location count toward step therapy requirements. Ensure your new North Carolina provider has complete records.

Q: What happens if Smart NC external review denies coverage?
A: The IRO decision is binding on Aetna. If denied, you've exhausted administrative remedies, though you may have other legal options to explore with an attorney.

Q: How much does Cimzia cost without insurance?
A: List price is approximately $5,999 for a two-syringe maintenance pack. Patient assistance programs can significantly reduce or eliminate costs for eligible patients.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to identify specific denial reasons—whether PA criteria, step therapy, or medical necessity determinations—and drafts point-by-point rebuttals aligned with each payer's requirements. For complex cases like Cimzia approvals, we pull the right clinical evidence from FDA labeling, peer-reviewed studies, and specialty guidelines to strengthen your appeal.

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about your specific medical condition and treatment options. Insurance coverage requirements may change; verify current policies with your insurer and state regulators.

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