By Counterforce Health Team in Pemazyre (pemigatinib) —

How to Get Pemazyre (pemigatinib) Covered by Aetna (CVS Health) in Pennsylvania: Complete Appeals Guide with Forms and Timelines

Answer Box: Getting Pemazyre Covered in Pennsylvania

Pemazyre (pemigatinib) requires prior authorization from Aetna CVS Health for FGFR2 fusion-positive cholangiocarcinoma. In Pennsylvania, you have strong appeal rights including a new state external review program with 50%+ overturn rates. First step today: Have your oncologist submit PA via Aetna's provider portal with FGFR2 testing results and prior therapy documentation. If denied, file internal appeal within 60 days, then request Pennsylvania's independent external review within 4 months of final denial.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Playbook for Pennsylvania
  5. Scripts and Templates
  6. Cost Assistance Programs
  7. When to Escalate to State Regulators
  8. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Pemazyre prescriptions Aetna provider portal Aetna Precertification Lists
FGFR2 Testing Documented fusion/rearrangement via FDA-approved test Molecular pathology report FDA Approval
Prior Therapy At least one prior systemic treatment Treatment records showing progression Aetna Clinical Policy
Diagnosis Unresectable/metastatic cholangiocarcinoma Pathology and imaging reports FDA Label
Ophthalmology Baseline eye exam required Eye doctor consultation Product Labeling

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation

Who: Patient and clinic staff
Timeline: 1-2 days
Documents needed:

  • FGFR2 fusion/rearrangement test results from CLIA-certified lab
  • Prior systemic therapy records (dates, drugs, progression imaging)
  • Baseline ophthalmology exam or scheduled appointment
  • Current staging scans showing unresectable/metastatic disease

2. Submit Prior Authorization

Who: Oncologist or authorized staff
Timeline: Same day
How: Electronic prior authorization through Aetna provider portal or fax to 1-855-633-7673
Include: All documentation plus completed PA form with clinical rationale

3. Track Decision Timeline

Standard review: 72 hours from complete submission
Expedited review: 24 hours for urgent cases
Contact: Call 1-866-785-5714 for status updates

4. If Approved: Coordinate Specialty Pharmacy

Most Aetna plans route Pemazyre through Biologics by McKesson rather than CVS Specialty. The specialty pharmacy will contact you within 1-2 business days to arrange shipment and copay assistance.

5. If Denied: Immediate Next Steps

  • Request copy of denial letter with specific reasons
  • File internal appeal within 60 days
  • Consider requesting expedited appeal if delay risks serious harm
Tip: Pennsylvania's new external review program has overturned more than 50% of appealed denials in its first year, so don't give up after an initial denial.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
"No FGFR2 testing documented" Submit molecular pathology report CLIA-certified NGS or FISH results
"Insufficient prior therapy" Provide treatment timeline Chemotherapy records, progression scans
"Not medically necessary" Reference FDA indication and NCCN guidelines Letter of medical necessity
"Step therapy required" Document contraindications to alternatives Clinical notes on why other options inappropriate
"Experimental/investigational" Cite FDA approval and plan policy FDA label, Aetna clinical criteria

Appeals Playbook for Pennsylvania

Internal Appeals with Aetna CVS Health

Level 1 Internal Appeal

  • Deadline: 60 days from denial date
  • How to file: Aetna member portal or mail to address on denial letter
  • Timeline: 30 days for standard review, 72 hours for expedited
  • Required: Denial letter, medical records, letter of medical necessity

Expedited Internal Appeal

  • When to use: Life-threatening conditions or serious harm risk
  • Timeline: 48 hours (if Aetna fails to decide in time, denial is automatically overturned per Pennsylvania law)
  • Documentation: Physician attestation of urgency

Pennsylvania's Independent External Review

Pennsylvania launched a state-run external review program in 2024 that has proven highly effective for patients.

Key Benefits:

  • More than 50% of denials overturned in first year
  • Independent physician reviewers
  • Binding decisions on insurers
  • Free to patients

Process:

  1. Eligibility: Must complete internal appeals first
  2. Deadline: 4 months from final internal denial
  3. How to file: Pennsylvania Insurance Department online portal or mail
  4. Timeline: 45 days for standard review, 72 hours for urgent cases
  5. Cost: Free

What to Include:

  • Final denial letter from Aetna
  • All medical records and test results
  • Letter from oncologist explaining medical necessity
  • Any new evidence not previously submitted

Scripts and Templates

Patient Phone Script for Aetna

"Hi, I'm calling about a prior authorization for Pemazyre for my FGFR2-positive cholangiocarcinoma. My member ID is [ID number]. Can you tell me the status of PA request [number] submitted on [date]? If it's been denied, I'd like to request an expedited internal appeal because my oncologist says delay could cause serious harm."

Oncologist Peer-to-Peer Script

"This is a [age]-year-old with unresectable metastatic cholangiocarcinoma, ECOG [status]. The tumor harbors an FGFR2 fusion confirmed by [test type] on [date]. Patient received prior systemic therapy with [regimen] from [dates] with documented progression on [date]. Pemazyre is FDA-approved and listed in your own policy for adults with previously treated unresectable FGFR2-rearranged cholangiocarcinoma. This patient meets every criterion. Baseline eye exam is completed and monitoring is in place. The denial appears inconsistent with your written criteria."

Medical Necessity Letter Template

[Date]
[Payer Name] Medical Review Department

RE: [Patient Name], DOB: [Date], Member ID: [ID]
Request for Pemazyre (pemigatinib) Coverage

This letter provides medical justification for Pemazyre in this patient with FGFR2 fusion-positive cholangiocarcinoma.

CLINICAL SUMMARY:
[Patient] is a [age]-year-old with unresectable metastatic cholangiocarcinoma diagnosed [date]. Molecular testing on [date] confirmed FGFR2 fusion/rearrangement via [test name].

PRIOR TREATMENTS:
- [List all prior systemic therapies with dates and outcomes]
- Disease progression documented on imaging [date]

RATIONALE FOR PEMAZYRE:
1. FDA-approved indication: Previously treated unresectable/metastatic cholangiocarcinoma with FGFR2 fusion
2. NCCN Category 1 recommendation for this clinical scenario  
3. No other FGFR-targeted options available
4. Patient has good performance status (ECOG [X]) and can tolerate oral therapy

MONITORING PLAN:
- Baseline ophthalmology exam completed [date]
- Ongoing ophthalmologic monitoring every 2-3 months
- Laboratory monitoring including phosphate levels

This treatment is medically necessary and meets all coverage criteria in your Pemazyre policy. Please approve immediately.

[Physician signature and credentials]

Cost Assistance Programs

IncyteCARES for PEMAZYRE

  • Copay assistance: Up to $25,000 annually for eligible commercial patients
  • Patient assistance: Free drug for uninsured/underinsured patients
  • How to enroll: IncyteCARES website or call 1-855-426-2989
  • Timeline: Applications processed within 48-72 hours

Foundation Grants

Many cancer foundations provide grants for specialty medications. Your specialty pharmacy can help screen for available programs.

Counterforce Health helps patients navigate insurance denials by analyzing denial letters and crafting targeted appeals. Their platform identifies specific denial reasons and generates evidence-based rebuttals aligned to your plan's own policies, potentially saving weeks in the appeal process.

When to Escalate to State Regulators

Contact the Pennsylvania Insurance Department if:

  • Aetna fails to respond within required timeframes
  • Denials appear to contradict written policy
  • You need help navigating the external review process

Pennsylvania Insurance Department Consumer Services:

  • Phone: Available on pa.gov
  • Online: Consumer complaint portal
  • Services: Free assistance with appeals and external reviews

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take in Pennsylvania? Standard review takes up to 72 hours from complete submission. Expedited review for urgent cases is completed within 24 hours.

What if Pemazyre is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and lack of appropriate formulary alternatives. Include documentation of contraindications or failures with preferred drugs.

Can I request an expedited appeal? Yes, if your oncologist certifies that delay could seriously jeopardize your health. Pennsylvania law requires expedited appeals to be decided within 48 hours, and if Aetna fails to meet this deadline, the denial is automatically overturned.

Does step therapy apply if I received prior treatment outside Pennsylvania? No, prior treatments received anywhere count toward step therapy requirements. Provide complete treatment records from all providers.

What's the success rate for external reviews in Pennsylvania? Pennsylvania's new external review program has overturned more than 50% of appealed denials, significantly higher than many other states.

How much does Pemazyre cost without insurance? Monthly costs typically reach four to five figures. However, IncyteCARES provides significant financial assistance, and Counterforce Health can help optimize your appeal to get insurance coverage approved.

What happens if my appeal is successful? If your appeal is approved, Aetna must provide coverage immediately. If you paid out-of-pocket during the appeal, you may be eligible for retroactive reimbursement.

Can my oncologist help with the appeal process? Yes, physician involvement significantly improves appeal success rates. Your oncologist can provide medical necessity letters, participate in peer-to-peer reviews, and submit additional clinical evidence.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for guidance specific to your situation. Insurance policies and procedures may change; verify current requirements with your plan.

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