By Counterforce Health Team in Keytruda (pembrolizumab) —

How to Get Keytruda (pembrolizumab) Covered by Aetna CVS Health in New Jersey: Complete Appeals Guide with Templates

Answer Box: Getting Keytruda Covered by Aetna CVS Health in New Jersey

Yes, Keytruda (pembrolizumab) can be covered by Aetna CVS Health in New Jersey, but requires prior authorization with specific documentation. The fastest path: submit complete biomarker results (PD-L1 CPS when required), staging, and prior treatment history through Aetna's provider portal at least two weeks before treatment. If denied, New Jersey's IHCAP external review through Maximus offers binding decisions within 45 days. Start today by gathering your pathology report, PD-L1 testing, and oncology notes.

First step: Contact Aetna at 1-888-632-3862 (commercial) or verify current prior authorization requirements on their precertification list.

Table of Contents

  1. Understanding Your Denial Letter
  2. Common Fixable Issues
  3. Prior Authorization Requirements
  4. First-Level Appeal Process
  5. Peer-to-Peer Call Strategy
  6. New Jersey External Review (IHCAP)
  7. Appeal Letter Templates
  8. Cost and Financial Assistance
  9. When to Escalate
  10. FAQ

Understanding Your Denial Letter

When Aetna CVS Health denies Keytruda coverage, the denial letter contains critical information for your appeal. Look for these key elements:

Denial Reason Codes:

  • PA required: Prior authorization wasn't submitted or was incomplete
  • Non-formulary: Keytruda isn't on the preferred drug list for your plan
  • Medical necessity: Clinical documentation doesn't support the indication
  • Step therapy: Must try other treatments first
  • Quantity limits: Dosing or frequency exceeds plan limits

Critical Deadlines:

  • Internal appeals: Must be filed within 180 days of the denial date
  • External review: Within 4 months (120 days) of final internal denial in New Jersey
  • Continuation of care: Within 10 days if you want current treatment to continue during appeal
Tip: Circle the specific denial reason and deadline on your letter. This becomes your roadmap for the appeal.

Common Fixable Issues

Many Keytruda denials can be resolved by addressing documentation gaps:

Issue Solution Required Documentation
Missing biomarker data Submit PD-L1 CPS results Lab report with specific score and testing method
Incomplete staging Provide full pathology Complete staging workup with TNM classification
Prior therapy not documented Detail treatment history Start/stop dates, responses, adverse events
Wrong indication code Correct ICD-10 diagnosis Pathology report matching FDA-approved indication
Site of care restriction Request exception Medical necessity for specific infusion center

Quick Fix Checklist:

  • ✅ PD-L1 Combined Positive Score (CPS) ≥1 (for applicable indications)
  • ✅ Complete staging (Stage IV for most indications)
  • ✅ Prior treatment failures documented with dates
  • ✅ Current performance status noted
  • ✅ Contraindications to alternatives listed

Prior Authorization Requirements

Aetna CVS Health requires precertification for Keytruda across all plan types. Based on their 2024 precertification list, here's what you need:

Essential Documentation:

  1. Diagnosis: ICD-10 code matching FDA-approved indication
  2. Biomarker Testing: PD-L1 CPS results for relevant tumor types
  3. Staging: Complete pathology and imaging reports
  4. Treatment History: Detailed prior therapy records
  5. Clinical Notes: Recent oncology visit documenting disease status

Submission Methods:

  • Availity Provider Portal (fastest processing)
  • Fax: Check current fax number on Aetna provider portal
  • Phone: 1-888-632-3862 (commercial) or 1-800-624-0756 (Medicare)

Timeline: Submit at least 2 weeks before planned treatment start date.

First-Level Appeal Process

Step 1: Gather Complete Documentation

Medical Necessity Package:

  • Original denial letter
  • Complete medical records from oncologist
  • Pathology report with biomarker results
  • Imaging studies showing disease progression
  • Prior treatment records with failure documentation
  • FDA package insert for Keytruda
  • NCCN Guidelines supporting use (if available)

Step 2: Write Your Appeal Letter

Your appeal should address the specific denial reason point-by-point. Include:

  1. Patient identification (name, DOB, policy number)
  2. Specific denial reason being appealed
  3. Clinical rationale with guideline support
  4. Biomarker evidence (PD-L1 CPS score when applicable)
  5. Prior treatment failures with dates and outcomes
  6. Urgency factors (disease progression, lack of alternatives)

Step 3: Submit Within Deadlines

Commercial Plans: 180 days from denial date Medicare Advantage: 60 days from denial date

Submit via certified mail or Aetna's member portal for tracking.

Peer-to-Peer Call Strategy

Request a peer-to-peer review when clinical documentation is strong but the denial persists. Here's how to prepare:

Before the Call:

  • Review Aetna's published criteria for Keytruda
  • Have FDA package insert and NCCN guidelines ready
  • Prepare 3-5 key talking points about medical necessity
  • Document exact biomarker values and prior treatment dates

Key Talking Points:

  1. FDA Approval: "Keytruda is FDA-approved for [specific indication] in patients with [biomarker status]"
  2. Standard of Care: "Current NCCN guidelines recommend pembrolizumab as [line of therapy] for this indication"
  3. Prior Failures: "Patient failed [specific treatments] due to [progression/toxicity] on [dates]"
  4. Biomarker Match: "PD-L1 CPS of [X] meets FDA threshold for this indication"
  5. Clinical Urgency: "Disease progression documented on [date] imaging requires immediate treatment"

Call Scheduling: Contact Aetna's utilization management department and request peer-to-peer review within 72 hours for urgent cases.

New Jersey External Review (IHCAP)

If Aetna's internal appeals fail, New Jersey's Independent Health Care Appeals Program (IHCAP) provides binding external review through Maximus Federal Services.

Eligibility Requirements:

  • Completed Aetna's internal appeal process (or 30 days passed without response)
  • NJ-regulated insurance plan
  • Denial based on medical necessity, experimental/investigational determination, or similar coverage issue
  • Filed within 4 months of final internal denial

How to File:

Contact Information:

Required Documents:

  • External Appeal Application form (sent with denial letter)
  • All internal appeal correspondence
  • Medical records supporting Keytruda necessity
  • Oncologist's letter of medical necessity
  • Denial letters from Aetna

Timeline:

  • Standard Review: Decision within 45 days
  • Expedited Review: Decision within 48 hours for urgent cases
  • Cost: Free to patients (insurers pay all fees)
Note: IHCAP decisions are binding on both patient and insurer. If approved, Aetna must cover the treatment.

For questions, call NJ DOBI Consumer Hotline: 1-888-393-1062

Appeal Letter Templates

Medical Necessity Appeal Template

[Date]
Aetna CVS Health
Medical Review Department
[Address from denial letter]

RE: Appeal for Keytruda (pembrolizumab) Coverage
Member: [Name], DOB: [Date], ID: [Policy Number]
Provider: [Oncologist Name], NPI: [Number]

Dear Medical Director,

I am appealing the denial of Keytruda (pembrolizumab) for [patient name], diagnosed with [specific cancer type, ICD-10: ___].

CLINICAL RATIONALE:
Keytruda is FDA-approved for [specific indication] and represents standard-of-care treatment per NCCN Guidelines. Key clinical factors supporting medical necessity:

• Diagnosis: [Cancer type and stage]
• Biomarker Status: PD-L1 CPS [score] (threshold: ≥1 for this indication)
• Prior Treatments: Failed [list treatments] from [dates] due to [progression/toxicity]
• Current Status: [Recent imaging/lab findings showing progression]

SUPPORTING EVIDENCE:
• FDA approval letter (attached)
• NCCN Guidelines Category [1/2A] recommendation
• Complete pathology report with biomarker testing
• Imaging documenting disease progression
• Prior treatment records with failure documentation

This patient meets all FDA-approved criteria for Keytruda therapy. Delay in treatment poses significant risk given documented disease progression.

Respectfully requesting coverage approval.

[Physician Name, MD]
[Contact Information]

Attachments: [List all supporting documents]

Peer-to-Peer Request Script

"Hello, I'm Dr. [Name] requesting a peer-to-peer review for my patient [Name], member ID [Number]. Keytruda was denied for [indication]. The patient has confirmed PD-L1 CPS of [score], failed [prior treatments], and meets all FDA criteria. Can we schedule a call within 24-48 hours given disease progression?"

Cost and Financial Assistance

Keytruda costs approximately $23,591 per 6-week dose, making financial assistance crucial for many patients.

Assistance Programs:

  • Merck Access Program: Copay assistance and patient assistance programs
  • Cancer Financial Assistance Coalition: Multiple foundation grants
  • NJ Pharmaceutical Assistance Programs: State-specific support (verify current eligibility)

Insurance Navigation: For complex appeals and prior authorization assistance, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps patients, clinicians, and specialty pharmacies get prescription drugs approved by identifying denial reasons and drafting point-by-point rebuttals aligned to plan policies.

When to Escalate

Contact NJ Department of Banking and Insurance if:

  • Aetna fails to respond within required timeframes
  • Appeals process isn't followed properly
  • Discrimination or bad faith denial suspected

NJ DOBI Consumer Hotline: 1-888-393-1062 Online complaints: nj.gov/dobi

Document everything:

  • All phone calls (date, time, representative name)
  • Submission confirmations and tracking numbers
  • Response delays beyond required timeframes

FAQ

Q: How long does Aetna prior authorization take for Keytruda in New Jersey? A: Standard decisions within 30-45 days; expedited (urgent) cases within 72 hours. Submit at least 2 weeks before planned treatment start.

Q: What if Keytruda is non-formulary on my Aetna plan? A: Request a formulary exception with medical necessity documentation. Include evidence that formulary alternatives are inappropriate or contraindicated.

Q: Can I request expedited appeal for progressive cancer? A: Yes. Mark appeals as "urgent" and provide oncologist documentation that delay would jeopardize health or recovery. Expedited appeals receive priority review.

Q: Does step therapy apply if I failed treatments outside New Jersey? A: Treatment history from any location counts. Provide complete records with start/stop dates and failure reasons from all prior oncologists.

Q: What happens if IHCAP approves but Aetna still won't cover? A: IHCAP decisions are legally binding. If Aetna doesn't comply, contact NJ DOBI immediately at 1-888-393-1062 for enforcement action.

Q: Can my oncologist file the appeal for me? A: Yes, with your written consent. Many practices handle appeals routinely and may have better success rates due to clinical expertise.

From our advocates: "We've seen many Keytruda appeals succeed when patients include complete biomarker testing and detailed prior treatment records. The key is addressing the specific denial reason with clinical evidence, not just general medical necessity. Don't give up after the first denial—persistence with proper documentation often leads to approval."

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 clinical circumstances. Always consult with your healthcare provider and insurance plan for specific coverage determinations. For personalized assistance with complex appeals, Counterforce Health provides specialized support for prescription drug coverage challenges.

Last updated: January 2025

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