By Counterforce Health Team in Pemazyre (pemigatinib) —

How to Get Pemazyre (Pemigatinib) Covered by Aetna CVS Health in New York: Prior Authorization Guide and Appeals Process

Answer Box: Getting Pemazyre Covered by Aetna CVS Health in New York

Pemazyre (pemigatinib) requires prior authorization with Aetna CVS Health plans and is often non-formulary, requiring a formulary exception. Success depends on three key elements: documented FGFR2/FGFR1 molecular testing results, comprehensive treatment history, and baseline ophthalmologic exam. First step: Have your oncologist gather your FGFR biomarker report and submit a formulary exception request via the Aetna provider portal. If denied, New York residents can file an external appeal through the state's Department of Financial Services within four months, with decisions binding on Aetna.

Table of Contents

Aetna CVS Health Plan Types & Coverage Implications

Your specific Aetna plan type affects how Pemazyre coverage works in New York:

Commercial Plans (HMO/PPO/EPO): Most require prior authorization and may have step therapy requirements unless you qualify for New York's metastatic cancer exemption. PPO plans typically offer more flexibility in specialist access.

Medicare Advantage: Subject to additional CMS guidelines with specific formulary requirements. Appeals follow both Aetna and Medicare timelines.

Medicaid Managed Care: Coverage varies by county and managed care organization. New York's Medicaid program generally covers FDA-approved cancer drugs with proper documentation.

Note: New York law exempts stage IV, advanced, or metastatic cancer patients from step therapy requirements on many plans, which applies to most Pemazyre candidates.

Pemazyre Formulary Status and Tier Placement

Current Status: Pemazyre is frequently non-formulary on Aetna CVS Health plans as of 2024, meaning it requires a formulary exception rather than standard prior authorization.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Formulary Exception Drug not on standard formulary Your plan's drug guide Aetna Formulary Lookup
Prior Authorization Always required when covered Provider portal submission Aetna PA Requirements
FGFR Testing Molecular diagnostic required Lab pathology report FDA labeling requirement
Ophthalmologic Exam Baseline eye exam mandatory Provider documentation Safety monitoring protocol
Step Therapy May be waived for metastatic cancer Plan documents New York state law

Prior Authorization and Utilization Controls

Aetna requires comprehensive documentation for Pemazyre approval:

Essential Documentation Requirements

  • FGFR2/FGFR1 molecular testing results with specific fusion/rearrangement identification
  • Complete oncology treatment history with dates and response summaries
  • Baseline ophthalmologic examination results
  • Letter of medical necessity from prescribing oncologist
  • Diagnosis confirmation with appropriate ICD-10 codes

Step Therapy Considerations

New York residents with advanced or metastatic cancer may be exempt from step therapy requirements. Your oncologist should reference this exemption when submitting the prior authorization.

CVS Specialty Pharmacy Setup Process

Most Aetna plans route Pemazyre through CVS Specialty Pharmacy. The enrollment process requires:

Required Forms and Information

  • CVS Specialty Oncology Oral Medications Enrollment Form
  • Patient information: Full demographics, insurance details, contact preferences
  • Prescriber information: NPI, DEA, state license, practice details
  • Insurance documentation: Copies of prescription and medical insurance cards
Tip: Complete enrollment can take 5-10 business days. Start this process while awaiting prior authorization approval to avoid delays.

Cost-Share Considerations

Pemazyre typically falls under specialty drug cost-sharing, which varies by plan:

  • Deductible: May apply before coverage begins
  • Coinsurance: Often 20-40% for specialty drugs
  • Out-of-pocket maximum: Provides annual cost protection

Financial Assistance Options:

  • IncyteCARES Patient Assistance Program: May provide free drug for qualifying patients
  • Copay assistance: Available for commercially insured patients
  • Foundation grants: Various cancer-focused foundations offer support

Submission Requirements and Forms

Provider Submission Checklist

  1. Aetna prior authorization form (plan-specific)
  2. Clinical documentation supporting medical necessity
  3. FGFR molecular testing report with detailed results
  4. Treatment history documenting prior therapies
  5. Ophthalmologic exam results
  6. ICD-10 diagnosis codes and staging information

Submission Methods

  • Aetna Provider Portal: Primary submission method
  • Fax submission: Available as backup (verify current fax with Aetna)
  • Phone support: 1-855-240-0535 for provider assistance

Common Approval Patterns

Successful Pemazyre approvals typically include:

Strong Clinical Narrative: Clear explanation of FGFR-positive disease and treatment rationale Comprehensive Testing Documentation: Detailed molecular pathology report showing specific alterations Treatment History: Documentation of appropriate prior therapies or contraindications Safety Monitoring Plan: Evidence of ophthalmologic surveillance protocol

New York Appeals Process

New York offers robust appeal rights for specialty drug denials:

Internal Appeals

  • Timeline: Must file within 180 days of denial
  • Decision timeframe: 30-45 days standard, 24-72 hours expedited
  • Required: Must complete before external appeal

External Appeals Through New York DFS

  • Eligibility: After completed internal appeal
  • Timeline: 4 months to file from final denial
  • Decision time: 30 days standard, 72 hours expedited
  • Cost: Up to $25 filing fee (waived for financial hardship)
  • Outcome: Binding decision on Aetna
Important: New York's external appeal decisions are binding and have a strong track record of overturning specialty drug denials with proper documentation.

Step-by-Step: Fastest Path to Approval

  1. Confirm FGFR testing - Ensure molecular pathology report shows specific FGFR2 fusion or FGFR1 rearrangement
  2. Schedule baseline eye exam - Required for safety monitoring before treatment
  3. Gather treatment history - Document all prior cancer therapies with dates and outcomes
  4. Submit formulary exception - Have oncologist submit via Aetna provider portal with all documentation
  5. Track submission - Follow up within 5-7 business days for status updates
  6. Prepare for appeal - If denied, immediately begin internal appeal process
  7. Consider external review - New York residents have strong external appeal rights

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
No FGFR alteration documented Submit detailed molecular pathology report with specific fusion/rearrangement
Off-label use Provide FDA labeling and clinical evidence supporting indication
No ophthalmologic monitoring Include baseline eye exam and monitoring plan
Step therapy not completed Reference New York metastatic cancer exemption
Experimental/investigational Cite FDA approval and NCCN guidelines

Patient Resources and Financial Assistance

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with payer requirements, making the appeals process more effective for complex specialty drugs like Pemazyre.

Key Resources

FAQ

How long does Aetna CVS Health prior authorization take in New York? Standard review takes 30-45 days, but expedited review for urgent cases can be completed in 24-72 hours with proper clinical justification.

What if Pemazyre is non-formulary on my plan? Submit a formulary exception request with comprehensive clinical documentation. Non-formulary status doesn't prevent coverage with proper justification.

Can I request an expedited appeal in New York? Yes, both Aetna internal appeals and New York external appeals offer expedited review for urgent medical situations.

Does step therapy apply if I'm receiving treatment for metastatic cancer? New York law exempts stage IV, advanced, or metastatic cancer patients from step therapy requirements on most plans.

What happens if my external appeal is approved? The decision is binding on Aetna, and they must provide coverage. The filing fee is also refunded if the appeal succeeds.

How do I prove medical necessity for Pemazyre? Provide FGFR molecular testing results, comprehensive treatment history, and a detailed letter from your oncologist explaining the clinical rationale.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always consult your healthcare provider and insurance plan documents for the most current information. For personalized assistance with insurance appeals and prior authorization, consider consulting with Counterforce Health, which specializes in turning insurance denials into successful appeals for specialty medications.

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