By Counterforce Health Team in Keytruda (pembrolizumab) —

How to Get Keytruda (Pembrolizumab) Covered by Cigna in North Carolina: Complete Prior Authorization and Appeal Guide

Answer Box: Getting Started in North Carolina

Keytruda (pembrolizumab) requires prior authorization from Cigna in North Carolina. Your fastest path to approval: 1) Download Cigna's Keytruda PA form, 2) Ensure your oncologist documents required biomarkers (PD-L1 CPS, MSI-H/TMB-H where applicable) and prior therapy failures, 3) Submit via CoverMyMeds or Accredo Specialty Pharmacy. Standard review takes 5 business days; expedited urgent cases get 72-hour decisions. If denied, you have 180 days to appeal internally, then can request external review through North Carolina's Smart NC program (1-855-408-1212) for binding independent review.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timeline Expectations
  6. If You Need to Provide Additional Information
  7. If Your Request is Denied: Appeals Process
  8. Renewal and Re-Authorization
  9. Cost Savings and Patient Support
  10. Quick Reference Checklist

What This Guide Covers

This comprehensive guide helps North Carolina patients and their oncologists navigate Cigna's prior authorization process for Keytruda (pembrolizumab), a PD-1 inhibitor used to treat multiple cancer types including melanoma, lung cancer, kidney cancer, and others. Keytruda costs approximately $23,591 per six-week dose, making insurance approval crucial for most patients.

Who this guide helps:

  • North Carolina residents with Cigna commercial insurance
  • Oncology patients whose doctors recommend Keytruda
  • Healthcare providers submitting PA requests
  • Patients facing initial denials who need to appeal

We'll walk you through the fastest approval paths, common denial reasons, and North Carolina's robust external review rights through Smart NC.

Before You Start: Verify Your Coverage

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required All Keytruda uses need approval Cigna PA form required Cigna PA Policy
Formulary Tier Specialty tier (20-40% coinsurance) Check myCigna app/website Cigna Member Portal
Preferred Pharmacy Accredo Specialty Pharmacy Must use for coverage Accredo Info
Step Therapy May require failed prior treatments Varies by cancer type Oncology Policy
Appeals Deadline 180 days from denial Calendar days, not business days North Carolina DOI

Verify Your Plan Type

Before starting, confirm:

  • You have Cigna commercial insurance (not self-funded employer plan)
  • Your plan includes specialty pharmacy benefits
  • Keytruda is covered for your specific cancer diagnosis
Tip: Call Cigna member services at 1-800-244-6224 to verify coverage details and confirm your plan's specific requirements.

Gather Required Documentation

Essential Documents Checklist

Clinical Information:

  • Complete cancer diagnosis with ICD-10 codes
  • Cancer staging reports (TNM/AJCC staging)
  • Pathology reports confirming tumor type
  • Required biomarker test results (see table below)
  • Prior therapy history with dates, doses, and outcomes
  • Current performance status documentation

Biomarker Requirements by Cancer Type

Cancer Type Required Test Acceptable Results Notes
NSCLC (first-line) PD-L1 CPS ≥1% via 22C3 pharmDx Must confirm no ALK/EGFR/ROS1 mutations
Ovarian (platinum-resistant) PD-L1 CPS ≥1% via FDA-approved assay Post 1-2 prior regimens
Any solid tumor MSI-H or dMMR NGS or IHC confirmation Biomarker-based approval
Select solid tumors TMB-H ≥10 mutations/Mb Via validated assay (e.g., FoundationOne)

Prior Therapy Documentation:

  • Medication names, doses, and treatment duration
  • Reason for discontinuation (progression, toxicity, intolerance)
  • Imaging showing disease progression
  • Lab values demonstrating treatment failure
Clinician Corner: Medical necessity letters should cite specific NCCN guidelines supporting Keytruda use for your patient's exact diagnosis and stage. Include patient weight for dosing calculations and specify monitoring plan.

Submit Your Prior Authorization Request

Step-by-Step: Fastest Path to Approval

Step 1: Download the Correct Form

Step 2: Complete All Required Sections

  • Patient demographics and insurance information
  • Prescriber details and DEA number
  • Specific indication with supporting documentation
  • Pharmacy information (specify Accredo if preferred)
  • Infusion site details and justification

Step 3: Submit via Preferred Method

  • Electronic: CoverMyMeds portal (fastest processing)
  • EHR Integration: SureScripts or EviCore ePA system
  • Fax: Include all supporting documents with case reference number

Step 4: Route Through Accredo For fastest processing, coordinate with Accredo Specialty Pharmacy as Cigna's preferred specialty provider.

Common Submission Mistakes to Avoid

  • Incomplete biomarker documentation
  • Missing prior therapy failure evidence
  • Wrong cancer staging information
  • Unsigned prescriber attestation
  • Outdated PA form version

Follow-Up and Timeline Expectations

Standard Timelines

Review Type Timeline When to Use
Standard PA 5 business days Non-urgent cases
Expedited PA 72 hours Urgent medical situations
Peer-to-Peer Review Same day scheduling After initial questions/denial

Follow-Up Best Practices

Week 1: Call Cigna PA department (1-800-882-4462) to confirm receipt and completeness Week 2: If no decision, request status update and estimated timeline Beyond 5 days: Consider expedited review if clinically appropriate

Sample Call Script for Patients: "Hi, I'm calling to check on the status of my Keytruda prior authorization. My member ID is [ID], and the request was submitted on [date]. Can you tell me if you need any additional information and when I can expect a decision?"

If You Need to Provide Additional Information

Handling Medical Necessity Requests

If Cigna requests additional clinical information:

Respond within 24-48 hours to avoid delays Provide specific documentation addressing their exact questions Include relevant literature supporting your indication

Common Information Requests:

  • Additional biomarker testing results
  • More detailed prior therapy timeline
  • Specialist consultation notes
  • Updated imaging or lab results
  • Peer-reviewed studies supporting off-label use

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to payer policies. Their platform helps identify exactly what documentation payers need and pulls the right clinical evidence to support approval.

If Your Request is Denied: Appeals Process

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Insufficient biomarker data Submit complete test reports PD-L1 CPS, MSI-H, or TMB-H results from FDA-approved assays
Step therapy not met Document prior failures Detailed records of previous treatments and outcomes
Wrong line of therapy Clarify treatment history Chronological therapy timeline with progression evidence
Off-label indication Provide compendium support NCCN guidelines or peer-reviewed literature

North Carolina Appeals Process

Internal Appeals (Required First Step):

  • First-Level Appeal: File within 180 days of denial
  • Timeline: 30 days for standard review, 72 hours for expedited
  • How to File: Cigna member portal or mail to address on denial letter
  • Required: Copy of denial letter, medical records, physician letter of support

Second-Level Internal Appeal:

  • Timeline: 60 days to file after first-level decision
  • Enhanced Documentation: Additional clinical evidence and guidelines

External Review Through Smart NC

If Cigna's internal appeals fail, North Carolina residents have strong external review rights through the Smart NC program.

Key Benefits:

  • Free assistance: Call 1-855-408-1212 for help with forms and process
  • Binding decisions: If approved, Cigna must provide coverage within 3 business days
  • Expert review: Independent medical reviewers evaluate your case
  • Fast timelines: 45 days for standard review, 72 hours for urgent cases

To Request External Review:

  1. Complete North Carolina's external review form
  2. Submit within 120 days of final internal appeal denial
  3. Include all medical records and supporting documentation
  4. Smart NC assigns independent reviewer on rotating basis
From Our Advocates: We've seen many Keytruda denials overturned at the external review level when patients included comprehensive biomarker testing results and clear documentation of prior therapy failures. The key is providing complete clinical evidence that directly addresses the original denial reasons - North Carolina's independent reviewers thoroughly evaluate the medical necessity based on current guidelines.

Peer-to-Peer Review Strategy

Request immediately after denial - don't wait for formal appeal Prepare your oncologist with NCCN guidelines and patient-specific evidence Schedule through EviCore portal or Cigna provider services Document the conversation and request written follow-up

Renewal and Re-Authorization

Planning for Continued Coverage

Start renewal process 30 days early to avoid treatment gaps Update documentation with current imaging, labs, and response to treatment Include progression-free survival data and tolerability information Confirm continued medical necessity with updated physician assessment

Most Keytruda approvals are granted for 6-12 months, requiring periodic renewal with evidence of ongoing benefit and acceptable toxicity profile.

Cost Savings and Patient Support

Financial Assistance Options

Merck Patient Assistance Program:

  • Income-based eligibility (typically up to 400% of federal poverty level)
  • Can significantly reduce or eliminate out-of-pocket costs
  • Apply at MerckHelps.com

Cigna Coverage Gap Assistance:

  • May help with specialty tier coinsurance
  • Contact Cigna member services for eligibility

Foundation Grants:

  • Patient Advocate Foundation
  • CancerCare Co-Payment Assistance
  • Leukemia & Lymphoma Society (for blood cancers)

Quick Reference Checklist

Before Submitting PA Request

  • Verify Cigna coverage and specialty pharmacy benefits
  • Confirm cancer diagnosis with ICD-10 codes
  • Obtain required biomarker test results
  • Document all prior therapy failures
  • Download current Cigna Keytruda PA form
  • Complete all form sections with prescriber signature

After Submission

  • Call within 3 days to confirm receipt
  • Request peer-to-peer if questions arise
  • Respond to information requests within 24 hours
  • File appeal within 180 days if denied
  • Contact Smart NC if internal appeals fail
  • Apply for financial assistance programs

Emergency Contacts

  • Cigna PA Department: 1-800-882-4462
  • Smart NC (External Review): 1-855-408-1212
  • Accredo Specialty Pharmacy: 1-800-803-2523

Disclaimer: This guide provides general information about insurance processes and should not be considered medical advice. Treatment decisions should always be made in consultation with qualified healthcare providers. Insurance coverage varies by plan, and requirements may change. Always verify current policies and procedures with your insurer and healthcare team.

For complex cases requiring detailed appeal strategies, Counterforce Health offers specialized support in transforming insurance denials into successful approvals through evidence-based appeals that align with payer-specific requirements.

Sources & Further Reading

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