By Counterforce Health Team in Pemazyre (pemigatinib) —

Aetna (CVS Health)'s Coverage Criteria for Pemazyre (pemigatinib) in Virginia: What Counts as "Medically Necessary"?

Quick Answer: Getting Pemazyre (pemigatinib) Covered by Aetna (CVS Health) in Virginia

Pemazyre requires prior authorization from Aetna (CVS Health) and is typically non-formulary, requiring a formulary exception. The fastest path to approval: (1) Submit complete documentation including positive FGFR2/FGFR1 molecular test results, prior therapy history, and baseline ophthalmologic exam through your provider's Aetna portal, (2) If denied, file an internal appeal within 180 days with additional clinical justification, (3) If still denied, request external review through Virginia's State Corporation Commission Bureau of Insurance within 120 days using Form 216-A.

Start today: Have your oncologist gather your molecular pathology report and treatment history for the prior authorization submission.

Table of Contents

  1. Policy Overview: How Aetna (CVS Health) Handles Pemazyre
  2. FDA Indication Requirements
  3. Step Therapy & Medical Exceptions
  4. Quantity and Dosing Limits
  5. Required Diagnostics & Monitoring
  6. CVS Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Narrative
  9. Appeals Playbook for Virginia
  10. Common Denial Reasons & Solutions
  11. Costs & Patient Assistance
  12. FAQ

Policy Overview: How Aetna (CVS Health) Handles Pemazyre

Aetna (CVS Health) treats Pemazyre (pemigatinib) as a specialty medication requiring prior authorization across all plan types—HMO, PPO, and Medicare Advantage. The drug is typically non-formulary, meaning it requires a formulary exception in addition to standard prior authorization.

Coverage at a Glance

Requirement What It Means Where to Find It Timeline
Prior Authorization Required for all plans Aetna provider portal 30-45 days standard
Formulary Exception Non-formulary status Plan formulary document Included in PA review
FGFR Testing Molecular confirmation required Lab pathology report Before submission
Ophthalmologic Exam Baseline eye exam with OCT Specialist report Before first dose
CVS Specialty Must use specialty pharmacy CVS Specialty Pharmacy After approval

The policy applies consistently whether you have employer-sponsored coverage, individual marketplace plans, or Medicare Advantage through Aetna. All documentation must be submitted through your healthcare provider—patients cannot submit prior authorizations directly.

FDA Indication Requirements

Pemazyre has two FDA-approved indications that Aetna recognizes for coverage:

  1. Cholangiocarcinoma (CCA): Previously treated, unresectable or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement
  2. Myeloid/lymphoid neoplasms (MLN): Relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement

Documentation Requirements

  • ICD-10 diagnosis code matching the approved indication
  • Pathology report confirming the specific cancer type
  • Molecular testing results showing FGFR2 fusion/rearrangement (for CCA) or FGFR1 rearrangement (for MLN)

Off-label use is generally not covered without exceptional circumstances and comprehensive supporting evidence from medical literature.

Step Therapy & Medical Exceptions

Aetna typically requires step therapy for Pemazyre, meaning patients must have tried and failed at least one prior systemic therapy before approval. This is particularly strict for cholangiocarcinoma patients.

Required Prior Therapies

  • For CCA: Documentation of progression on or intolerance to standard chemotherapy (typically gemcitabine plus cisplatin or similar regimen)
  • For MLN: Evidence of relapsed or refractory disease after appropriate prior treatment

Medical Exception Pathways

Step therapy can be bypassed if you can document:

  • Contraindications to first-line therapies
  • Previous intolerance with specific adverse events documented
  • Rapid disease progression requiring immediate targeted therapy
  • Clinical circumstances where delay would be detrimental
Tip: Virginia law provides special protections for cancer patients—you may be able to bypass step therapy requirements if your oncologist certifies that standard therapies are inappropriate for your specific situation.

Quantity and Dosing Limits

Aetna follows FDA-approved dosing for quantity limits:

Standard Dosing Protocol

  • 13.5 mg once daily for 14 days, followed by 7 days off (21-day cycles)
  • Maximum quantity: 14 tablets per 21-day cycle
  • Dose reductions: 9 mg or 4.5 mg daily for toxicity management

Renewal Requirements

  • Clinical response assessment every 2-3 cycles
  • Toxicity monitoring with dose adjustment documentation
  • Ophthalmologic follow-up results every 2 months initially, then every 3 months

Aetna may approve dose reductions but will require clinical justification for any deviations from standard protocols.

Required Diagnostics & Monitoring

Mandatory Pre-Treatment Testing

  1. FGFR molecular testing: Must show specific fusion/rearrangement
  2. Comprehensive ophthalmologic exam including optical coherence tomography (OCT)
  3. Baseline laboratory values: Complete metabolic panel, phosphate levels
  4. Performance status assessment: ECOG or Karnofsky scale documentation

Ongoing Monitoring Requirements

  • Ophthalmologic exams: Every 2 months for first 6 months, then every 3 months
  • Laboratory monitoring: Serum phosphate levels regularly
  • Clinical assessments: Disease response evaluation per standard oncology practice
Note: Missing any of these baseline assessments is a common reason for initial denial. Ensure all testing is complete before submission.

CVS Specialty Pharmacy Requirements

Pemazyre must be dispensed through CVS Specialty Pharmacy—it cannot be filled at regular retail pharmacies, including standard CVS locations.

Dispensing Process

  1. Prior authorization approval must be obtained first
  2. Prescription routing to CVS Specialty automatically after approval
  3. Patient enrollment in CVS Specialty programs
  4. Home delivery or specialty clinic pickup options available

Required Documentation for Dispensing

  • Valid prescription with FDA indication specified
  • Confirmation of baseline ophthalmologic exam
  • Patient education acknowledgment forms
  • Insurance verification and copay assistance enrollment

Evidence to Support Medical Necessity

Primary Evidence Sources

  • FDA prescribing information for approved indications
  • NCCN Guidelines for cholangiocarcinoma or myeloid neoplasms
  • Peer-reviewed clinical trials supporting efficacy
  • Molecular pathology reports confirming biomarker status

Clinical Documentation Checklist

  • Confirmed diagnosis with staging information
  • FGFR molecular testing results
  • Complete prior treatment history with dates and outcomes
  • Current performance status
  • Baseline ophthalmologic assessment
  • Rationale for Pemazyre over alternative therapies

Guidelines to Reference

When building your case, cite these authoritative sources:

  • FDA-approved prescribing information
  • NCCN Clinical Practice Guidelines (subscription required, but abstracts available)
  • Published clinical trial data from peer-reviewed oncology journals

Sample Medical Necessity Narrative

Here's a template structure for the medical necessity letter your oncologist should include:

"This 62-year-old patient has unresectable cholangiocarcinoma with confirmed FGFR2 fusion by molecular testing (attach report). Following progression on first-line gemcitabine/cisplatin therapy (dates and response documented in attached notes), the patient requires targeted therapy. Pemazyre (pemigatinib) is FDA-approved for this specific indication and biomarker profile. Baseline ophthalmologic examination has been completed (attach report) and ongoing monitoring plan is established. Alternative therapies are limited for FGFR2-positive disease, making Pemazyre the most appropriate treatment option. Request approval for standard dosing: 13.5 mg daily for 14 days of each 21-day cycle."

This narrative addresses diagnosis, biomarker status, prior therapy failure, FDA indication, safety monitoring, and dosing—all key elements Aetna evaluates.

Appeals Playbook for Virginia

If your initial prior authorization is denied, Virginia provides robust appeal rights through multiple levels.

Internal Appeals (Aetna)

  • Timeline: Must file within 180 days of denial
  • Process: Submit through Aetna provider portal or member services
  • Standard review: 30-45 days for decision
  • Expedited review: 24-72 hours for urgent medical situations
  • Required documents: Original denial letter, additional clinical evidence, updated medical necessity letter

External Review (Virginia State)

If Aetna upholds the denial, you can appeal to Virginia's independent review process:

Virginia Advantage: Cancer patients can sometimes request external review without completing internal appeals if treatment delay would be harmful.

Contact Information

  • Virginia State Corporation Commission Bureau of Insurance
  • Phone: (877) 310-6560
  • Address: P.O. Box 1157, Richmond, VA 23218
  • Website: scc.virginia.gov

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
No FGFR testing Submit molecular pathology report Lab report showing specific fusion/rearrangement
Step therapy not met Document prior therapy failure Treatment notes with dates, response, progression
Off-label use Provide clinical justification Medical literature, guideline support
Missing eye exam Complete ophthalmologic assessment Baseline exam with OCT results
Experimental/investigational Emphasize FDA approval FDA label, indication-specific evidence

Peer-to-Peer Review

If facing denial, request a peer-to-peer review where your oncologist can speak directly with Aetna's medical director. This often resolves coverage issues when clinical nuances need explanation.

Costs & Patient Assistance

Pemazyre costs approximately $15,499 per 28-day cycle. Even with insurance coverage, copays can be substantial.

Financial Assistance Options

  • Incyte Cares Patient Assistance Program: Up to $25,000 annual copay assistance for eligible patients
  • Cancer financial assistance foundations: Organizations like CancerCare and Patient Advocate Foundation
  • State pharmaceutical assistance: Virginia may have additional programs for residents

For comprehensive support navigating insurance denials and appeals, Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals that align with each payer's specific requirements.

FAQ

How long does Aetna (CVS Health) prior authorization take in Virginia? Standard reviews take 30-45 days. Expedited reviews for urgent medical situations are completed within 24-72 hours.

What if Pemazyre is non-formulary on my plan? Submit a formulary exception request along with your prior authorization. This is common and often approved with proper clinical justification.

Can I request an expedited appeal? Yes, if your doctor certifies that delay could seriously harm your health. Cancer treatments often qualify for expedited review.

Does step therapy apply if I failed therapies in another state? Yes, prior therapy documentation from any location counts toward step therapy requirements.

What happens if both internal and external appeals are denied? You retain rights to legal action and may consult with healthcare attorneys specializing in insurance coverage disputes.

How do I know if my molecular testing is adequate? The test must specifically identify FGFR2 fusion/rearrangement for cholangiocarcinoma or FGFR1 rearrangement for myeloid/lymphoid neoplasms. Generic "FGFR positive" results are not sufficient.

From our advocates: We've seen cases where initial denials were overturned simply by resubmitting with complete ophthalmologic documentation. One patient's appeal succeeded after their oncologist provided a detailed timeline of prior therapy failures and emphasized the FDA-approved indication. These details matter—thoroughness in documentation often makes the difference between approval and denial.

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 additional assistance with insurance appeals and coverage issues, contact the Virginia State Corporation Commission Bureau of Insurance at (877) 310-6560.

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