By Counterforce Health Team in Pemazyre (pemigatinib) —

How to Get Pemazyre (Pemigatinib) Covered by Cigna in New Jersey: Prior Authorization Forms, Appeal Scripts, and External Review Guide

Answer Box: Quick Path to Pemazyre Coverage

To get Pemazyre (pemigatinib) covered by Cigna in New Jersey: 1) Have your doctor submit a prior authorization with FGFR2 fusion testing results, baseline eye exam, and documented prior therapy failures. 2) If denied, file an internal appeal within 180 days using Cigna's formulary exception process. 3) After exhausting internal appeals, request external review through New Jersey's Independent Health Care Appeals Program (IHCAP) via Maximus Federal Services. Cigna typically processes PA requests within 72 hours for urgent cases.

Table of Contents

  1. When Pemazyre Alternatives Make Sense
  2. Available FGFR Inhibitor Alternatives
  3. Pros and Cons of Each Option
  4. Formulary Exception Strategy
  5. Switching Between Treatments
  6. Re-trying for Pemazyre Later
  7. Appeals Process in New Jersey
  8. FAQ

When Pemazyre Alternatives Make Sense

If Cigna denies Pemazyre (pemigatinib) coverage in New Jersey, exploring formulary alternatives can be a strategic first step while pursuing your appeal. Consider alternatives when:

  • Cigna requires step therapy through a preferred FGFR inhibitor first
  • Non-formulary status makes Pemazyre prohibitively expensive
  • Prior authorization delays are affecting treatment timing
  • Your cancer has specific molecular features that may respond better to newer agents
Note: All FGFR inhibitors require confirmed FGFR2 fusion or rearrangement via molecular testing (NGS preferred) and baseline ophthalmologic evaluation with OCT.

Coverage Requirements That Apply to All Options

Requirement Details Documentation Needed
Molecular Testing FGFR2 fusion/rearrangement confirmed NGS or FISH report from CLIA-certified lab
Prior Therapy Previously treated with ≥1 systemic therapy Medical records showing gemcitabine/cisplatin or equivalent
Baseline Eye Exam OCT and visual acuity testing Ophthalmology report with monitoring plan
Diagnosis Confirmation Locally advanced/metastatic cholangiocarcinoma Pathology report with staging

Available FGFR Inhibitor Alternatives

FDA-Approved FGFR Inhibitors for Cholangiocarcinoma

Futibatinib (Lytgobi) - Third-generation irreversible FGFR1-4 inhibitor

  • Approval: FDA-approved for previously treated, locally advanced/metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement
  • Efficacy: ORR 41.7%, median PFS 6.9 months, median OS 20-21.1 months
  • Key advantage: Can overcome pemigatinib resistance mutations (e.g., V565L)
  • Cigna coverage: Typically requires similar PA process as pemigatinib

Infigratinib - FGFR1-4 inhibitor

  • Approval: FDA-approved for previously treated FGFR2 fusion-positive cholangiocarcinoma
  • Coverage status: May have different formulary positioning than pemigatinib
  • Monitoring: Similar ophthalmologic requirements

For Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement

Pemazyre remains the primary targeted option for relapsed/refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. Alternative approaches typically involve:

  • Clinical trials with investigational FGFR inhibitors
  • Conventional chemotherapy regimens
  • Stem cell transplantation evaluation

Pros and Cons of Each Option

Drug Formulary Access Testing Requirements Monitoring Burden Resistance Profile
Pemazyre Often non-formulary FGFR2 fusion + eye exam Every 2 months × 6 months Can develop V565L mutations
Futibatinib Similar PA requirements Same as Pemazyre Similar frequency Overcomes pemigatinib resistance
Infigratinib Varies by plan Same as Pemazyre Similar to others Limited resistance data

Access Considerations

  • Express Scripts/Accredo (Cigna's specialty pharmacy partner) manages all these medications
  • Electronic submission through Cigna's provider portal processes 2-3 days faster than fax
  • Urgent requests can be processed within 24-72 hours with proper medical urgency documentation

Formulary Exception Strategy

When to Request an Exception

Request a formulary exception for Pemazyre when:

  1. Alternative FGFR inhibitors failed or caused intolerable side effects
  2. Specific molecular profile suggests better response to pemigatinib
  3. Clinical trial data supports pemigatinib for your specific situation
  4. Physician expertise with pemigatinib management

Evidence That Helps Your Case

Medical Necessity Documentation:

  • Detailed letter explaining why Pemazyre is medically necessary
  • Peer-reviewed literature supporting FGFR inhibitor use in your cancer type
  • NCCN guideline citations for targeted therapy recommendations
  • Documentation of contraindications to formulary alternatives

Required Clinical Information:

  • Complete molecular testing report with specific FGFR alteration
  • Prior therapy history with dates and outcomes
  • Baseline ophthalmologic evaluation results
  • Treatment goals and monitoring plan
Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals. Their platform identifies specific denial reasons and drafts point-by-point rebuttals aligned to each plan's requirements, streamlining the approval process for specialty medications like Pemazyre.

Submission Process

Step 1: Complete Cigna's Formulary Exception Form

Step 2: Physician certifies in writing that formulary alternatives have been:

  • Detrimental to patient's health, OR
  • Ineffective in treating the condition

Step 3: Submit via electronic portal (fastest) or fax to Express Scripts

Timeline: 72 hours for standard review; 24-48 hours for urgent requests

Switching Between Treatments

Coordination Steps

  1. Discuss with oncologist the rationale for switching
  2. Document current treatment response and any side effects
  3. Coordinate with Cigna to ensure seamless coverage transition
  4. Schedule ophthalmologic monitoring for new FGFR inhibitor
  5. Plan washout period if clinically appropriate

Pharmacy Coordination

  • Notify Express Scripts/Accredo of the medication change
  • Confirm prior authorization is in place before stopping current therapy
  • Arrange delivery timing to avoid treatment gaps

Re-trying for Pemazyre Later

What to Document During Alternative Treatment

  • Response to alternative therapy (imaging, tumor markers, symptoms)
  • Side effects or tolerability issues with detailed dates and severity
  • Progression or treatment failure with objective evidence
  • Changes in clinical status that might support Pemazyre use

When to Resubmit

  • Treatment failure of formulary alternative with documented progression
  • Intolerable side effects requiring discontinuation
  • New clinical evidence supporting Pemazyre for your specific case
  • Changes in Cigna's formulary that improve Pemazyre's status
From our advocates: "We've seen cases where patients initially denied Pemazyre coverage successfully obtained approval after documenting treatment failure with a formulary alternative. The key was maintaining detailed records of response and side effects, which strengthened the medical necessity argument on resubmission."

Appeals Process in New Jersey

Internal Appeals with Cigna

First-Level Internal Appeal:

  • Timeline: File within 180 days of denial
  • Decision time: 30 days (60 days for retrospective claims)
  • Requirements: Written request with supporting documentation

Second-Level Internal Appeal:

  • Independent medical reviewer evaluates the case
  • Timeline: 30-45 days for decision
  • Required: Must complete first-level appeal first

External Review Through New Jersey IHCAP

After exhausting Cigna's internal appeals, you can request external review through New Jersey's Independent Health Care Appeals Program (IHCAP).

Key Details:

  • Managed by: Maximus Federal Services (contracted by NJ DOBI)
  • Filing deadline: 4 months (180 days) from final internal denial
  • Cost: Free to consumers (insurers pay all costs)
  • Decision timeline: 45 days for standard review; expedited available for urgent cases

How to File:

  1. Submit external appeal directly to Maximus (not NJ DOBI)
  2. Include all medical records and physician letters
  3. Maximus performs preliminary eligibility review (5 business days)
  4. Independent physician reviewers evaluate medical necessity

Success Rate: External appeals nationwide favor consumers in approximately 50% of cases.

When External Review Applies

  • Medical necessity denials for covered services
  • Experimental/investigational determinations
  • Prior authorization denials based on clinical criteria
  • Step therapy requirement disputes

For assistance, contact:

  • IHCAP Hotline: 1-888-393-1062
  • NJ DOBI Consumer Hotline: 1-800-446-7467

FAQ

How long does Cigna prior authorization take for Pemazyre in New Jersey? Standard requests take 5 business days; urgent cases with documented medical necessity can be processed within 24-72 hours.

What if Pemazyre is non-formulary on my Cigna plan? You can request a formulary exception by having your physician certify that formulary alternatives are detrimental or ineffective for your condition.

Can I request an expedited appeal if treatment is urgent? Yes, both Cigna's internal appeals and New Jersey's external review process offer expedited pathways when delays could cause serious harm.

Does step therapy apply if I failed treatments outside New Jersey? Prior therapy failures from any location count toward step therapy requirements, provided you have proper documentation.

What molecular testing is required for FGFR inhibitor coverage? NGS or FISH testing confirming FGFR2 fusion/rearrangement from a CLIA-certified laboratory is required for cholangiocarcinoma; FGFR1 rearrangement for myeloid/lymphoid neoplasms.

How much does Pemazyre cost without insurance? Specialty cash pricing varies but typically ranges in the high four- to five-figure monthly range. Incyte offers patient assistance programs that may help with costs.

What ophthalmologic monitoring is required? Baseline OCT and visual acuity testing, then every 2 months for 6 months, then every 3 months. This applies to all FGFR inhibitors.

Can my doctor appeal on my behalf? Yes, New Jersey allows providers to file external appeals on behalf of patients with proper consent.

Sources & Further Reading

Counterforce Health specializes in turning insurance denials into successful appeals by providing targeted, evidence-backed strategies tailored to each payer's specific requirements.

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 guidance specific to your situation. For official appeals processes and forms, refer to your plan documents and New Jersey Department of Banking and Insurance resources.

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