By Counterforce Health Team in Gamifant (emapalumab-lzsg) —

How to Get Gamifant (Emapalumab-lzsg) Covered by Aetna CVS Health in New Jersey: Complete Appeal Guide with Forms and Templates

Answer Box: Getting Gamifant Covered by Aetna CVS Health in New Jersey

Gamifant (emapalumab-lzsg) requires prior authorization from Aetna CVS Health in New Jersey for primary hemophagocytic lymphohistiocytosis (HLH). The fastest path to approval: 1) Confirm HLH diagnosis meets HLH-2004 criteria or genetic testing, 2) Document failure of conventional therapy (etoposide/dexamethasone), 3) Submit complete prior authorization through Aetna's Availity portal with hematologist attestation. If denied, you have 180 days to appeal internally, then file external review with New Jersey IHCAP (1-888-393-1062).

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 Aetna CVS Health in New Jersey
  5. Medical Necessity Letter Template
  6. When to Use New Jersey's External Review (IHCAP)
  7. Costs and Patient Support Options
  8. FAQ

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required Must get approval before treatment All Aetna plans in NJ Aetna Precert List 2024
Primary HLH Diagnosis Confirmed by HLH-2004 criteria or genetics Lab results, genetic testing HLH-2004 Criteria
Conventional Therapy Failure Tried etoposide + dexamethasone ± cyclosporine Treatment records FDA Label
Hematologist Prescription Prescribed by blood cancer specialist Provider credentials Aetna Clinical Policy
Dexamethasone Combination Must use with steroids Prescription records FDA Label
Infection Screening TB screening before start Lab results FDA Label

Step-by-Step: Fastest Path to Approval

1. Confirm Your HLH Diagnosis (Patient + Clinician)

What you need: Either genetic confirmation of primary HLH or 5 out of 8 HLH-2004 clinical criteria:

  • Fever, splenomegaly, cytopenias (≥2 lineages)
  • Hypertriglyceridemia (≥3.0 mmol/L) or hypofibrinogenemia (≤1.5 g/L)
  • Hemophagocytosis in tissue biopsy
  • Elevated ferritin (≥500 μg/L)
  • Low/absent NK-cell activity
  • Elevated soluble CD25 (≥2,400 U/mL)

Timeline: Genetic testing can take 2-4 weeks Who does it: Hematologist orders tests and interprets results

2. Document Conventional Therapy History (Clinician)

What you need: Records showing:

  • Prior treatment with etoposide + dexamethasone (HLH-94 or HLH-2004 protocol)
  • Response to treatment (lab values, clinical improvement/worsening)
  • Reasons for discontinuation (progression, toxicity, intolerance)

Timeline: Gather within 1 week of PA submission Submit to: Include in prior authorization packet

3. Complete Infection Screening (Patient + Clinician)

What you need:

  • Tuberculosis screening (chest X-ray, tuberculin skin test or interferon-gamma release assay)
  • Documentation of no active infections

Timeline: Complete before PA submission Required by: FDA prescribing information

4. Submit Prior Authorization (Clinician)

Where to submit: Aetna Availity Provider Portal Include in packet:

  • Completed PA form with hematologist attestation
  • HLH diagnostic documentation (genetic or clinical criteria)
  • Conventional therapy failure records
  • Infection screening results
  • Planned dexamethasone combination therapy

Timeline: Submit ≥2 weeks before planned treatment start Decision timeframe: 30-45 days standard, ≤72 hours expedited

5. Monitor Decision and Prepare for Appeals (Patient + Clinician)

If approved: Begin treatment per approved protocol If denied: Review denial letter for specific reasons and prepare appeal within 180 days

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents Needed
"HLH diagnosis not confirmed" Submit genetic testing or complete HLH-2004 criteria documentation Genetic panel results or lab values for all 8 criteria
"Lack of conventional therapy history" Provide detailed treatment records showing etoposide/dexamethasone trial Pharmacy records, infusion logs, response assessments
"Not prescribed by specialist" Have hematologist submit or co-sign request Hematologist credentials and attestation letter
"Experimental/investigational" Cite FDA approval for primary HLH FDA approval letter and prescribing information
"Missing infection workup" Complete TB screening and document no active infections Chest X-ray, TB test results, clinical assessment

Appeals Playbook for Aetna CVS Health in New Jersey

Level 1: Internal Appeal (Standard Process)

Timeline: File within 180 days of denial How to file: Aetna member portal or call member services Decision timeframe: 30 days standard, 72 hours expedited Required documents:

  • Denial letter
  • Additional medical records addressing denial reasons
  • Updated letter of medical necessity

Level 2: Internal Appeal (Second Level)

Timeline: File within 60 days of Level 1 denial Process: Same as Level 1 but reviewed by different medical director Consider: Request peer-to-peer review with Aetna medical director

Tip: During peer-to-peer calls, have your hematologist emphasize the life-threatening nature of untreated HLH and the lack of alternative FDA-approved therapies for primary HLH.

Level 3: External Review via New Jersey IHCAP

When to use: After completing both internal appeal levels Timeline: File within 4 months (120 days) of final internal denial Contact: New Jersey IHCAP at 1-888-393-1062 Cost: Free to patients (insurer pays all costs) Decision: Binding on Aetna if overturned

Medical Necessity Letter Template

Key Components for Gamifant Prior Authorization

Patient Information Section:

  • Age, weight, BSA for dosing calculations
  • Primary HLH diagnosis with genetic confirmation or HLH-2004 criteria met
  • Current clinical status (ferritin levels, cytopenias, organ involvement)

Treatment History Section:

  • Conventional HLH therapy attempted (specific agents, doses, duration)
  • Response to prior therapy (lab improvements, clinical response)
  • Reasons for treatment failure or discontinuation

Medical Necessity Justification:

  • FDA approval for primary HLH in refractory/recurrent disease
  • Lack of alternative FDA-approved therapies for this indication
  • Plan for combination with dexamethasone
  • Bridge to hematopoietic stem cell transplantation

Clinical Monitoring Plan:

  • Infection surveillance protocol
  • Response assessment schedule (ferritin, CBC, clinical exam)
  • Duration of planned therapy (typically 2-6 months)

When to Use New Jersey's External Review (IHCAP)

New Jersey's Independent Health Care Appeals Program (IHCAP) offers one of the strongest external review processes in the nation for specialty drug denials.

Eligibility Requirements:

  • Completed both levels of internal appeals with Aetna
  • Denial based on medical necessity or experimental/investigational determination
  • NJ-regulated health plan (most employer and individual plans)

Filing Process:

  1. Submit online at njihcap.maximus.com or call 1-888-393-1062
  2. Required documents: Final denial letter, medical records, physician letter
  3. Timeline: Decision within 45 days (expedited within 48 hours for urgent cases)

Success Factors:

  • Independent physician reviewers with appropriate specialty expertise
  • Binding decision on insurance company
  • About 50% of external appeals nationwide favor consumers
From our advocates: We've seen HLH cases succeed at external review when the clinical documentation clearly establishes the genetic diagnosis and conventional therapy failure. One family's appeal was approved after the independent reviewer noted that Gamifant was the only FDA-approved therapy remaining for their child's refractory primary HLH.

Costs and Patient Support Options

Manufacturer Support Programs

Gamifant Patient Support: Visit gamifant.com for:

  • Benefits investigation assistance
  • Prior authorization support
  • Copay assistance programs (verify eligibility)

Foundation and Nonprofit Support

  • Patient Access Network Foundation: May offer grants for HLH treatments
  • HealthWell Foundation: Provides copay assistance for eligible patients
  • National Organization for Rare Disorders (NORD): Patient assistance programs

New Jersey State Resources

  • NJ Department of Human Services: Medicaid coverage options
  • NJ FamilyCare: State health insurance program for qualifying families

FAQ

How long does Aetna CVS Health prior authorization take for Gamifant in New Jersey? Standard prior authorization decisions are made within 30-45 days. Expedited requests (for urgent medical situations) are decided within 72 hours. Submit requests at least 2 weeks before planned treatment start.

What if Gamifant is not on Aetna's formulary? Gamifant may require a formulary exception. Your hematologist can request this by demonstrating medical necessity and lack of formulary alternatives for FDA-approved primary HLH treatment.

Can I request an expedited appeal if my HLH is worsening? Yes. Contact Aetna member services to request expedited review if delay would cause serious harm. Provide clinical documentation of disease progression or urgent need for treatment.

Does step therapy apply to Gamifant? Step therapy typically requires trying conventional HLH therapy (etoposide + dexamethasone) first. If you've already failed these treatments, document this clearly in your prior authorization request.

What happens if Aetna approves Gamifant but limits the duration? Initial approvals are often for 2-6 months with required reauthorization. Your hematologist will need to submit response assessments and justification for continued therapy based on clinical improvement and transplant planning.

How does CVS Specialty pharmacy handle Gamifant? CVS Specialty coordinates specialty medications like Gamifant, including delivery, patient education, and side effect monitoring. They work directly with your healthcare team for administration scheduling.

Sources & Further Reading

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals for complex medications like Gamifant. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address payer-specific requirements and procedural deadlines.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage determinations. Coverage policies may change, and individual circumstances vary. For official appeals guidance, contact the New Jersey Department of Banking and Insurance at 1-800-446-7467.

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