By Counterforce Health Team in Pemazyre (pemigatinib) —

How to Get Pemazyre (Pemigatinib) Covered by Aetna CVS Health in Washington: Appeals, Forms & Timelines

Answer Box: Getting Pemazyre Covered by Aetna CVS Health in Washington

Pemazyre (pemigatinib) requires prior authorization from Aetna CVS Health and is typically non-formulary, requiring a formulary exception. Key requirements: FDA-approved test confirming FGFR2 fusion/rearrangement, previous systemic therapy failure, and comprehensive clinical documentation. First step: Have your oncologist submit a complete prior authorization request with molecular pathology report and treatment history. If denied: Appeal within 180 days using Aetna's process, then pursue Washington state external review through an Independent Review Organization (IRO) within 60 days of final internal denial.

Table of Contents

  1. Understanding Aetna CVS Health Coverage for Pemazyre
  2. Prior Authorization Requirements
  3. Common Denial Reasons and How to Fix Them
  4. Step-by-Step Appeal Process in Washington
  5. External Review Through Washington State
  6. Appeal Letter Templates and Scripts
  7. Cost-Saving Programs and Alternatives
  8. When to Contact Washington Insurance Commissioner
  9. Frequently Asked Questions

Understanding Aetna CVS Health Coverage for Pemazyre

Pemazyre (pemigatinib) is an oral FGFR inhibitor approved by the FDA for adults with previously treated, unresectable or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. Most Aetna CVS Health plans classify Pemazyre as non-formulary, meaning it's not on their preferred drug list and requires both prior authorization and a formulary exception.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans Aetna provider portal Aetna PA Process
Formulary Status Non-formulary (most plans) Plan formulary document Aetna Formulary
FGFR2 Testing FDA-approved test required FoundationOne CDx or equivalent FDA Label
Prior Therapy ≥1 systemic treatment Medical records NCCN Guidelines
Appeal Deadline 180 days from denial Denial letter Aetna Appeals

Prior Authorization Requirements

Medical Necessity Criteria for Pemazyre approval typically include:

  • Confirmed diagnosis of unresectable locally advanced or metastatic cholangiocarcinoma
  • FGFR2 fusion or rearrangement detected by FDA-approved test (such as FoundationOne CDx)
  • Disease progression after at least one prior systemic therapy
  • Adult patient (≥18 years old)
  • Plan for monitoring adverse effects, especially hyperphosphatemia and ocular toxicity
Clinician Corner: Your medical necessity letter should include the patient's ICD-10 diagnosis code (C22.1 for intrahepatic cholangiocarcinoma), specific FGFR2 alteration from molecular testing, complete prior treatment history with dates and outcomes, current performance status, and monitoring plan for known adverse effects.

Documentation Checklist

Before submitting your prior authorization:

  • Pathology report confirming cholangiocarcinoma diagnosis
  • FDA-approved molecular testing report showing FGFR2 fusion/rearrangement
  • Complete treatment history with dates, drugs used, and reason for discontinuation
  • Current imaging showing disease progression
  • Baseline ophthalmologic exam results
  • Baseline phosphate levels
  • Medical necessity letter addressing all PA criteria

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documentation
"No FGFR2 alteration documented" Submit FDA-approved test results FoundationOne CDx or equivalent report
"Not tried preferred alternatives" Document contraindications or failures Prior treatment records, intolerance notes
"Experimental/investigational" Cite FDA approval and NCCN guidelines FDA approval letter, NCCN Category 2A recommendation
"Non-formulary drug" Request formulary exception Clinical justification for why alternatives won't work
"Quantity limits exceeded" Justify dosing per FDA label Prescribing information showing 13.5mg daily

Step-by-Step Appeal Process in Washington

Level 1: Internal Appeal with Aetna CVS Health

Timeline: Submit within 180 days of denial; decision within 45-60 business days

  1. Gather denial documentation - Save your denial letter, EOB, and original PA request
  2. Complete appeal form - Use Aetna's provider or member appeal form (available on their website)
  3. Write comprehensive appeal letter - Address each denial reason specifically
  4. Submit supporting evidence - Include new clinical data not in original request
  5. Track your appeal - Use Aetna's online portal or call customer service
  6. Request peer-to-peer - Ask for clinical review with Aetna's medical director
  7. Document everything - Keep copies and confirmation numbers
Tip: For urgent cases where delay could jeopardize health, request an expedited appeal. Aetna must decide within 36-72 hours for pre-service urgent appeals.

Peer-to-Peer Review Process

If your initial appeal is denied, request a peer-to-peer call with Aetna's medical director:

Preparation checklist:

  • Review patient's complete medical history
  • Have molecular testing results readily available
  • Prepare talking points about why alternatives won't work
  • Reference NCCN guidelines and FDA labeling
  • Document any contraindications to preferred alternatives

During the call:

  • Be concise and evidence-based
  • Emphasize the patient-specific factors
  • Cite relevant medical literature
  • Ask about specific concerns and address them directly

External Review Through Washington State

If Aetna's internal appeals fail, Washington residents can request an Independent Review Organization (IRO) external review.

Washington External Review Timeline

Review Type Decision Timeline When to Use
Standard Review 20 days (fully-insured plans) Non-urgent denials
Standard Review 45 days (self-insured plans) Non-urgent denials
Expedited Review 72 hours Life-threatening situations

How to Request External Review

  1. Confirm eligibility - Must have completed Aetna's internal appeal process
  2. Submit within deadline - 60 days from final internal denial
  3. Complete forms - Use Washington state external review request form
  4. Include documentation - All previous appeal materials plus any new evidence
  5. Submit additional evidence - You have 5 business days after IRO assignment
Note: The IRO decision is binding on Aetna. If they approve coverage, your insurer must provide the treatment.

Contact the Washington State Office of the Insurance Commissioner at 1-800-562-6900 for help with the external review process.

Appeal Letter Templates and Scripts

Medical Necessity Appeal Letter Template

[Date]

[Aetna Medical Director]
[Address from denial letter]

RE: Appeal for Prior Authorization Denial
Member: [Patient Name]
Policy #: [Policy Number]
Claim #: [Reference Number]

Dear Medical Director,

I am writing to formally appeal your denial of coverage for Pemazyre (pemigatinib) for my patient [Name], who has metastatic cholangiocarcinoma with confirmed FGFR2 fusion.

**Denial Reason Addressed**: [Quote exact reason from denial letter]

**Medical Necessity Justification**:
- Patient has histologically confirmed intrahepatic cholangiocarcinoma (ICD-10: C22.1)
- Molecular testing via [test name] confirmed FGFR2 fusion/rearrangement (attached report)
- Disease progressed after [prior therapy] completed on [date]
- NCCN Guidelines recommend Pemazyre as Category 2A preferred therapy for this indication
- FDA approved Pemazyre specifically for this patient population

**Supporting Evidence Attached**:
- Molecular pathology report
- Prior treatment records
- Current imaging showing progression
- NCCN guideline excerpts
- FDA prescribing information

This treatment is medically necessary and appropriate for my patient's condition. I request immediate approval.

Sincerely,
[Physician Name, Credentials]
[Contact Information]

Patient Phone Script for Aetna Customer Service

"Hello, I'm calling about a prior authorization denial for Pemazyre. My member ID is [number]. The denial reference is [number]. I'd like to understand the specific reasons for denial and start the appeal process. Can you transfer me to someone who can help with oncology drug appeals?"

Cost-Saving Programs and Alternatives

While pursuing coverage, explore these financial assistance options:

Manufacturer Support:

Foundation Grants:

  • CancerCare Financial Assistance - Up to $500 for treatment-related costs
  • Patient Advocate Foundation - Copay relief programs
  • Leukemia & Lymphoma Society - Financial aid for blood cancer patients

State Programs:

  • Washington State Prescription Drug Program - For uninsured/underinsured residents
  • Apple Health (Medicaid) - May cover if you qualify

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals. Their platform identifies the specific denial basis and drafts point-by-point rebuttals aligned to your plan's own rules, significantly improving approval chances for complex medications like Pemazyre.

When to Contact Washington Insurance Commissioner

Contact the Washington State Office of the Insurance Commissioner if:

  • Aetna doesn't respond to appeals within required timeframes
  • You need help understanding your appeal rights
  • You want to file a complaint about claims handling
  • You need assistance with the external review process

Contact Information:

From our advocates: We've seen cases where patients initially gave up after the first denial, but those who persisted through the full appeal process—including external review—often succeeded. One composite case involved a cholangiocarcinoma patient whose Pemazyre was approved after external review, even though two internal appeals had failed. The key was comprehensive molecular testing documentation and expert clinical testimony.

Frequently Asked Questions

Q: How long does Aetna CVS Health prior authorization take in Washington? A: Standard PA decisions typically take 30-45 days. Expedited reviews for urgent cases are decided within 36-72 hours.

Q: What if Pemazyre is completely excluded from my formulary? A: Request a formulary exception with clinical justification. Emphasize that Pemazyre is FDA-approved for your specific indication and cite NCCN guidelines.

Q: Can I get an expedited appeal if my cancer is progressing? A: Yes. If delay could seriously jeopardize your health, request an expedited appeal. Include documentation from your oncologist about disease progression.

Q: Does Washington state law help with cancer drug appeals? A: Yes. Washington has strong consumer protections including mandatory external review by independent medical experts and binding IRO decisions.

Q: What if my employer plan is self-insured? A: Self-insured plans follow federal ERISA rules, but many voluntarily use state external review processes. Contact your HR department to confirm your appeal rights.

Q: How much does Pemazyre cost without insurance? A: Specialty cash pricing varies but is typically in the high four to five-figure range monthly. Manufacturer assistance programs may help reduce costs.

Q: Can I appeal if I haven't tried other FGFR inhibitors? A: Yes, if other FGFR inhibitors are contraindicated, unavailable, or if Pemazyre is the only FDA-approved option for your specific FGFR alteration.

Q: What happens after external review in Washington? A: The IRO decision is binding on your insurer. If approved, they must provide coverage. If denied, you may still file complaints with state regulators.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For personalized help with complex appeals, platforms like Counterforce Health can assist in creating targeted, evidence-based appeal strategies tailored to your specific insurer and clinical situation.

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