By Counterforce Health Team in Pemazyre (pemigatinib) —

Pemazyre (Pemigatinib) Approval with Cigna in Ohio: Answers to the Most Common Questions

Answer Box: Getting Pemazyre Covered by Cigna in Ohio

Eligibility: Cigna covers Pemazyre (pemigatinib) with prior authorization for adults with unresectable/metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement after prior systemic therapy, or myeloid/lymphoid neoplasms with FGFR1 rearrangement.

Fastest path: Your oncologist submits PA via Cigna provider portal with FGFR testing report, prior therapy history, and baseline eye exam with OCT. Standard decisions take 5 business days; urgent cases 24-72 hours.

Start today: Call Cigna member services to confirm formulary status and PA requirements for your specific plan.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Medical Necessity Criteria
  5. Cost and Coverage Details
  6. Denials and Appeals
  7. Renewal Requirements
  8. Specialty Pharmacy Process
  9. Troubleshooting Common Issues
  10. Frequently Asked Questions

Coverage Basics

Is Pemazyre Covered by Cigna?

Yes, Cigna covers Pemazyre as a specialty oral oncology medication, but prior authorization is required for all uses. The drug is typically placed on specialty tiers with higher coinsurance rates.

Which Cigna Plans Cover Pemazyre?

Coverage applies to:

Note: Self-funded employer plans follow ERISA rules but often use similar PA criteria.

Prior Authorization Process

Who Submits the Prior Authorization?

Your oncologist or hematologist must submit the PA request. Cigna requires the prescriber to be a specialist for FGFR inhibitors like Pemazyre.

How to Submit

  1. Cigna Provider Portal (fastest option)
  2. CoverMyMeds electronic platform
  3. Fax submission to Express Scripts/Accredo (verify current fax number)

Required Documentation

Document Purpose Where to Get
FGFR testing report Confirms FGFR2/FGFR1 alteration Molecular pathology lab
Prior therapy records Documents treatment history Oncology clinic notes
Baseline eye exam with OCT Safety requirement Ophthalmologist
Medical necessity letter Clinical justification Prescribing oncologist

Timing and Urgency

Standard Prior Authorization Timeline

  • Commercial plans: 5 business days typical
  • Medicare plans: Up to 14 days allowed by CMS
  • Expedited review: 24-72 hours with clinical urgency documentation

When to Request Expedited Review

Mark as urgent when:

  • Rapid disease progression documented
  • Hospitalization risk due to treatment delay
  • Patient's condition could seriously deteriorate
Tip: Include specific clinical details about why delay would be harmful in your urgency request.

Medical Necessity Criteria

For Cholangiocarcinoma (FGFR2)

Cigna requires all of the following:

✓ Age ≥18 years
✓ Unresectable or metastatic cholangiocarcinoma
✓ Documented FGFR2 fusion or rearrangement by validated testing
✓ At least one prior systemic therapy (e.g., gemcitabine + cisplatin)
✓ Baseline comprehensive ophthalmologic exam with OCT
✓ Prescriber is oncologist/hematologist

For Myeloid/Lymphoid Neoplasms (FGFR1)

✓ Myeloid/lymphoid neoplasm with FGFR1 rearrangement
✓ Prior appropriate therapies tried or contraindicated
✓ Safety monitoring plan in place

Step Therapy Requirements

Cigna's step therapy for Pemazyre is built into the "prior systemic therapy" requirement rather than a formal multi-drug sequence. Plans may vary, so confirm your specific requirements.

Cost and Coverage Details

Typical Cost Structure

  • Specialty tier placement: Usually 20-50% coinsurance
  • Monthly cost: High four to five figures before insurance
  • Out-of-pocket maximum: ACA plans cap annual costs

Financial Assistance Options

IncyteCARES Patient Support

  • Commercial copay assistance (non-government insurance)
  • Patient assistance program for uninsured/underinsured
  • Bridge supply during coverage delays

Accredo Specialty Pharmacy

Important: Medicare and Medicaid patients cannot use manufacturer copay cards but may qualify for patient assistance programs.

Denials and Appeals

Common Denial Reasons

Denial Reason How to Fix
Missing FGFR testing Submit complete molecular pathology report
No baseline eye exam Provide ophthalmology note with OCT documentation
Insufficient prior therapy Add detailed treatment history with dates and outcomes
Off-label use Include medical necessity letter with guideline citations

Internal Appeals Process

Timeline: 180 days from denial notice to file internal appeal

Steps:

  1. Review denial letter for specific reasons
  2. Gather missing documentation
  3. Have oncologist write detailed appeal letter
  4. Request peer-to-peer review if available
  5. Submit within deadline

Ohio External Review

After exhausting internal appeals, Ohio residents can request external review through the Ohio Department of Insurance:

  • File within: 180 days of final internal denial
  • Decision timeline: 30 days standard, 72 hours expedited
  • Contact: 800-686-1526 or [email protected]
  • Process: Independent medical experts review your case
Key advantage: Ohio allows external review even if insurer claims ineligibility - the Department can override this determination.

Renewal Requirements

When to Renew

Pemazyre approvals typically last up to 12 months. Start renewal process 30-60 days before expiration.

Renewal Documentation

  • Clinical benefit assessment (imaging, labs, performance status)
  • Tolerability evaluation
  • Continued indication confirmation
  • Updated ophthalmologic monitoring

Specialty Pharmacy Process

Why Specialty Pharmacy?

Cigna routes most specialty oral oncology drugs through Express Scripts/Accredo for:

  • Prior authorization processing
  • Clinical monitoring
  • Financial assistance coordination
  • Home delivery

What to Expect

  1. Prescription transfer to Accredo after PA approval
  2. Benefits verification and copay assistance setup
  3. Clinical consultation with specialty pharmacist
  4. Home delivery coordination

Troubleshooting Common Issues

Portal Problems

  • Provider portal down: Use CoverMyMeds or fax backup
  • Missing forms: Contact Cigna provider services for current forms
  • Status updates: Check portal regularly or call specialty pharmacy

Documentation Issues

  • FGFR test not accepted: Ensure report shows specific alteration and lab CLIA certification
  • Eye exam insufficient: Confirm OCT was performed and documented
  • Prior therapy unclear: Provide detailed regimen names, dates, and outcomes

Frequently Asked Questions

Q: How long does Cigna prior authorization take for Pemazyre in Ohio? A: Standard review takes 5 business days for commercial plans. Expedited review with clinical urgency can be completed in 24-72 hours.

Q: What if Pemazyre is non-formulary on my plan? A: Request a formulary exception through the same PA process, emphasizing medical necessity and lack of therapeutic alternatives.

Q: Can I get expedited appeals in Ohio? A: Yes, both Cigna internal appeals and Ohio external reviews offer expedited timelines when delay would seriously jeopardize health.

Q: Does step therapy apply if I failed treatments outside Ohio? A: Yes, prior therapy documentation from any state counts toward Cigna's step therapy requirements.

Q: What counts as adequate FGFR testing? A: A validated molecular assay (NGS, FISH, etc.) showing FGFR2 fusion/rearrangement for cholangiocarcinoma or FGFR1 rearrangement for myeloid/lymphoid neoplasms.

Q: Why was my prescription transferred to Accredo? A: Cigna requires specialty oral oncology drugs to be dispensed through their contracted specialty pharmacy network for clinical monitoring and cost management.

Q: Can I appeal if I have Medicare Advantage through Cigna? A: Yes, Medicare Advantage follows similar internal appeal processes, with external review available through CMS after internal levels are exhausted.

From Our Advocates

In our experience working with Cigna Pemazyre cases, the most common approval delays stem from incomplete FGFR testing documentation. Patients who proactively obtain comprehensive molecular reports and baseline ophthalmologic exams before PA submission typically see faster approvals. This preparation can save weeks in the approval process.

When to Get Help

Contact these resources if you need assistance:

Ohio Department of Insurance Consumer Services

IncyteCARES for Pemazyre

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each payer's specific requirements. We pull the right evidence - from FDA labeling to peer-reviewed studies - and weave it into appeals that meet procedural requirements while tracking deadlines and required documentation.

Glossary

Prior Authorization (PA): Insurance requirement to approve coverage before dispensing FGFR: Fibroblast Growth Factor Receptor - protein targeted by Pemazyre
OCT: Optical Coherence Tomography - eye imaging required for safety monitoring Step Therapy (ST): Requirement to try preferred drugs before covering others Peer-to-Peer (P2P): Doctor-to-doctor review of coverage decisions Medical Necessity: Clinical justification that treatment is appropriate and necessary

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For additional help with Ohio health insurance appeals, contact the Ohio Department of Insurance at 800-686-1526.

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