By Counterforce Health Team in Cimzia (certolizumab pegol) —

How to Get Cimzia (Certolizumab Pegol) Covered by Humana in North Carolina: Prior Authorization, Appeals, and Step Therapy Guide

Quick Answer: Getting Cimzia Covered by Humana in North Carolina

Step 1: Your doctor submits a prior authorization request to Humana, documenting your diagnosis and failed treatments with preferred anti-TNF biologics (step therapy requirement). Step 2: If denied, file an internal appeal within 65 days. Step 3: If still denied, request external review through North Carolina's Smart NC program within 120 days. Call Smart NC at 1-855-408-1212 for free advocacy support. Most denials stem from incomplete step therapy documentation or missing TB/hepatitis B screening results.

Table of Contents

  1. Humana's Coverage Policy for Cimzia
  2. Step Therapy Requirements & Exceptions
  3. Prior Authorization Process
  4. Required Documentation & Lab Work
  5. Common Denial Reasons & Solutions
  6. Appeals Process in North Carolina
  7. External Review Through Smart NC
  8. Cost Assistance Programs
  9. FAQ

Humana's Coverage Policy for Cimzia

Cimzia (certolizumab pegol) is covered by Humana Medicare Advantage plans but requires prior authorization across all plan types. The medication is subject to step therapy requirements as of 2025, meaning you must typically try Humana's preferred anti-TNF biologics first.

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all Humana plans Humana PA List
Step Therapy Must try preferred anti-TNF agents first Step Therapy List
Formulary Tier Varies by plan (check your specific formulary) Drug List Tool
Specialty Pharmacy May require specialty pharmacy dispensing Provider Resources

Plan Types Affected

Cimzia's prior authorization applies to:

  • Medicare Advantage plans
  • Medicare Part D plans
  • Employer-sponsored plans through Humana
  • Some Medicaid managed care plans

Step Therapy Requirements & Exceptions

Humana requires patients to try and fail preferred anti-TNF biologics before approving Cimzia. The specific requirements vary by condition:

Required First-Line Treatments

For Rheumatoid Arthritis (office-administered):

  • Must document failure or serious side effects with Inflectra/Avsola AND Simponi Aria

For Crohn's Disease (office-administered):

  • Must document failure or serious side effects with two of: Inflectra/Avsola, Entyvio, Stelara/Selarsdi/Yesintek, or Tremfya

Medical Exceptions to Step Therapy

You can bypass step therapy if you have:

  • Contraindications to preferred agents (documented allergies, drug interactions)
  • Previous treatment failures with preferred drugs (within past 5 years)
  • Clinical urgency where delay would cause serious harm
Tip: Keep detailed records of all previous biologic treatments, including dates, dosages, and reasons for discontinuation. This documentation is crucial for step therapy exceptions.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Prescriber submits PA request via Humana provider portal or fax to 1-888-447 (verify current fax with Humana)
  2. Include complete documentation (see Required Documentation section below)
  3. Humana reviews within 30 days for standard requests, 72 hours for expedited
  4. If approved, prescription can be filled through specialty pharmacy network
  5. If denied, you have 65 days to file an internal appeal
  6. Peer-to-peer review available if initial request denied - prescriber can request direct discussion with Humana medical director
  7. External review through North Carolina if internal appeals fail

Submission Methods

  • Online: Humana provider portal (prescribers only)
  • Phone: 800-555-CLIN (2546), Monday–Friday, 8 a.m.–8 p.m.
  • Fax: 877-486-2621 (verify current number)

Required Documentation & Lab Work

Essential Clinical Information

Your prescriber must include:

Diagnosis Documentation:

  • ICD-10 code for qualifying condition
  • Disease severity assessment
  • Duration of symptoms

Treatment History:

  • Complete list of previous therapies tried
  • Dates of treatment
  • Reasons for discontinuation (inefficacy, intolerance, contraindication)
  • Documentation of adequate trial duration

Safety Screening:

  • Tuberculosis screening (chest X-ray, tuberculin skin test or interferon-gamma release assay)
  • Hepatitis B surface antigen and antibody tests
  • Complete blood count with differential
  • Liver function tests
Note: TB and hepatitis B screening must be current (typically within 6 months) as anti-TNF biologics increase infection risk.

Dosing and Administration Plan

For self-administered Cimzia (home use):

  • Limited to 200 mg doses and above
  • Requires patient education documentation

For office-administered Cimzia:

  • Available for all dose strengths
  • Must specify administration site and frequency

Common Denial Reasons & Solutions

Denial Reason How to Fix Required Evidence
Incomplete step therapy Document previous anti-TNF failures Treatment records, dates, outcomes
Missing TB screening Submit current screening results Chest X-ray, TST/IGRA results
Lack of diagnosis severity Provide disease activity scores Lab values, imaging, clinical assessments
Insufficient trial duration Show adequate treatment periods Pharmacy records, chart notes
Missing hepatitis B screening Submit HBV testing HBsAg, anti-HBs, anti-HBc results

Medical Necessity Letter Checklist

When appealing a denial, ensure your prescriber's letter includes:

  • Problem statement: Clear diagnosis with ICD-10 code
  • Treatment history: Chronological list of failed therapies
  • Clinical rationale: Why Cimzia is medically necessary
  • Guideline support: Reference to ACR, AGA, or other relevant guidelines
  • Monitoring plan: How treatment response will be assessed
  • Safety considerations: Screening completed and ongoing monitoring plan

Appeals Process in North Carolina

Internal Appeals with Humana

Timeline: 65 days from denial notice to file appeal

Process:

  1. Submit written appeal to Humana
  2. Include all supporting documentation
  3. Request expedited review if medically urgent
  4. Humana responds within 30 days (standard) or 72 hours (expedited)

Contact Information:

  • Member Services: 800-444-9137 (TTY: 711)
  • Hours: Monday–Friday, 7 a.m.–7 p.m. Eastern

When to Request Expedited Review

Request expedited appeals when:

  • Delay would seriously jeopardize your health
  • Standard timeline would significantly increase pain or suffering
  • You're currently hospitalized
  • Treatment is needed to prevent serious deterioration

External Review Through Smart NC

If Humana's internal appeals are unsuccessful, North Carolina residents can request external review through the state's Smart NC program.

Eligibility Requirements

  • Must have exhausted Humana's internal appeal process
  • Denial must be based on medical necessity
  • Must have state-regulated insurance plan
  • Request must be filed within 120 days of final internal denial

How to File External Review

Contact Smart NC:

Required Documents:

  • External review request form
  • Copy of final internal denial letter
  • All relevant medical records
  • Prescriber's supporting letter

Timeline and Process

  • Standard review: Decision within 45 days
  • Expedited review: Decision within 72 hours for urgent cases
  • 24-72 hour decisions for urgent non-formulary drug denials
Important: Smart NC provides free advocacy services. Their staff can help you complete forms, gather records, and navigate the process.

External Review Outcomes

If the Independent Review Organization (IRO) overturns Humana's denial:

  • Humana must provide coverage within 3 business days
  • Decision is binding on the insurer

Cost Assistance Programs

While pursuing coverage approval, consider these cost assistance options:

Manufacturer Support

  • UCB Patient Assistance: Income-based free drug program
  • Cimzia Savings Program: Copay assistance for eligible patients
  • Contact: Visit UCB's patient support website (verify current programs)

Foundation Grants

  • Patient Access Network Foundation
  • Good Days (formerly Chronic Disease Fund)
  • HealthWell Foundation

State Programs

  • North Carolina's expanded Medicaid (effective 2024) may provide additional coverage options for qualifying individuals

At Counterforce Health, we specialize in turning insurance denials into successful appeals by creating targeted, evidence-backed prior authorization requests and appeal letters. Our platform analyzes denial letters and plan policies to identify the specific criteria needed for approval, then drafts point-by-point rebuttals that address payer requirements while incorporating the right clinical evidence and guidelines.

FAQ

How long does Humana prior authorization take for Cimzia in North Carolina? Standard prior authorization decisions are made within 30 days. Expedited requests are processed within 72 hours if medical urgency is documented.

What if Cimzia is non-formulary on my Humana plan? You can request a formulary exception through the prior authorization process. Your prescriber must demonstrate medical necessity and why formulary alternatives are inappropriate.

Can I request an expedited appeal if my initial PA is denied? Yes, if you can demonstrate that delay would seriously jeopardize your health or significantly increase pain and suffering.

Does step therapy apply if I failed anti-TNF biologics outside North Carolina? Yes, documented treatment failures from other states count toward step therapy requirements. Ensure your prescriber includes complete treatment records.

What happens if both internal appeals and external review fail? While external review decisions are typically final for administrative purposes, you may have additional legal rights. Consult with a healthcare attorney if you believe the denial was inappropriate.

How much does Cimzia cost without insurance coverage? The U.S. list price is approximately $5,999 for a two-syringe maintenance pack. Manufacturer assistance programs may significantly reduce out-of-pocket costs for eligible patients.

Can I use specialty pharmacies other than Humana's preferred network? Humana typically requires use of their specialty pharmacy network for biologics like Cimzia. Using out-of-network pharmacies may result in higher costs or coverage denial.

What TB screening is required before starting Cimzia? Standard screening includes chest X-ray and either tuberculin skin test (TST) or interferon-gamma release assay (IGRA). Results must typically be current within 6 months.

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 circumstances and plan specifics. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For assistance with North Carolina insurance appeals, contact Smart NC at 1-855-408-1212.

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