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

How to Get Gamifant (emapalumab-lzsg) Covered by Aetna (CVS Health) in Washington: Complete Appeal Guide with Forms and Timelines

Quick Answer: Getting Gamifant Approved by Aetna (CVS Health) in Washington

If Aetna (CVS Health) denied your Gamifant (emapalumab-lzsg) for primary HLH, you have strong appeal rights in Washington. First step: Request internal appeal within 180 days using Aetna's member portal or the phone number on your ID card. Key requirement: Document that conventional HLH therapy (etoposide + dexamethasone) failed or caused intolerance, and cite Aetna's Medical Policy Bulletin 0948 directly. If denied: Request external review through Washington's Independent Review Organization (IRO) – Washington overturns 82% of specialty drug denials. Timeline: 180 days for internal appeals, 30 days for IRO decisions (72 hours if urgent).

Table of Contents

  1. Understanding Your Denial Letter
  2. Common Fixable Issues
  3. Step-by-Step: Fastest Path to Approval
  4. Internal Appeal Strategy
  5. Peer-to-Peer Review Preparation
  6. Washington External Review (IRO) Process
  7. Appeal Letter Templates
  8. Costs and Financial Assistance
  9. When to Escalate
  10. Frequently Asked Questions

Understanding Your Denial Letter

Your Aetna (CVS Health) denial letter contains critical information for your appeal strategy. Look for these key elements:

Denial Reason Codes:

  • Medical necessity: Aetna believes Gamifant isn't medically necessary for your condition
  • Step therapy: You haven't tried required first-line treatments
  • Non-formulary: Gamifant isn't on your plan's covered drug list
  • Experimental/investigational: Aetna considers the treatment unproven

Appeal Deadlines: Washington residents typically have 180 days from the denial date to file internal appeals. Mark this deadline immediately – missing it forfeits your appeal rights.

Benefit Type: Determine if Gamifant was processed under your medical benefit or pharmacy benefit. This affects which appeals process applies and whether CVS Specialty Pharmacy needs to be involved.

Common Fixable Issues

Many Gamifant denials can be overturned by addressing these documentation gaps:

Issue Fix Required Documentation
Missing HLH diagnosis proof Submit genetic testing or HLH-2004 criteria checklist Lab values for ≥5 of 8 criteria (fever, splenomegaly, cytopenias, ferritin >500 µg/L, etc.)
Insufficient conventional therapy documentation Detail etoposide + dexamethasone failure/intolerance Treatment dates, doses, response, reasons for discontinuation
Wrong benefit channel Verify medical vs. pharmacy benefit routing Check with Aetna member services; may need to resubmit through correct pathway
Coding mismatch Align HCPCS codes with diagnosis Ensure ICD-10 codes match approved indication

Step-by-Step: Fastest Path to Approval

Step 1: Gather Essential Documents (Day 1)

  • Insurance ID card and policy documents
  • Complete denial letter with reason codes
  • Medical records showing HLH diagnosis
  • Documentation of failed conventional therapy
  • Current lab values and clinical status

Step 2: Contact Aetna Member Services (Day 2-3) Call the number on your ID card to:

  • Confirm appeal deadline (typically 180 days in Washington)
  • Verify if prior authorization was attempted
  • Request copy of medical policy used in denial decision
  • Ask for expedited review if medically urgent

Step 3: Work with Your Hematologist (Day 3-5) Your specialist should prepare:

  • Medical necessity letter citing Aetna Policy Bulletin 0948
  • Documentation that patient meets primary HLH criteria
  • Evidence of conventional therapy failure or intolerance
  • Treatment plan and monitoring approach

Step 4: Submit Internal Appeal (Day 5-7) File through Aetna's member portal or fax with:

  • Completed appeal form
  • Medical necessity letter
  • Supporting clinical documentation
  • Request for peer-to-peer review if available

Step 5: Request Peer-to-Peer Review (Day 10-14) If initial appeal is denied, request a clinical discussion between your hematologist and Aetna's medical director.

Step 6: File External Review if Needed (Within 180 days of final internal denial) Submit request to Washington's Office of the Insurance Commissioner for Independent Review Organization (IRO) review.

Internal Appeal Strategy

Your internal appeal must directly address Aetna's specific denial reasons while demonstrating that Gamifant meets their published criteria.

Key Arguments for Primary HLH:

According to Aetna's Medical Policy Bulletin 0948, Gamifant is considered medically necessary for primary HLH when:

  1. Diagnosis confirmed by molecular testing or ≥5 HLH-2004 criteria
  2. Conventional therapy failure with etoposide-dexamethasone regimens
  3. Disease is refractory, recurrent, or progressive despite standard treatment
  4. Used under specialist supervision (hematologist/oncologist/immunologist)

Required Clinical Documentation:

  • Genetic testing results showing HLH-associated mutations, OR
  • Lab documentation of HLH-2004 criteria (fever >38.5°C, splenomegaly, cytopenias in ≥2 lineages, hypertriglyceridemia/hypofibrinogenemia, hemophagocytosis, low NK-cell activity, ferritin ≥500 µg/L, elevated sCD25)
  • Treatment history with conventional HLH therapy including dates, doses, and outcomes
  • Current disease status showing ongoing HLH activity
  • Treatment plan for Gamifant as bridge to stem cell transplant
Clinician Corner: Your medical necessity letter should explicitly state: "This patient has genetically confirmed primary HLH [or meets X of 8 HLH-2004 criteria] and has refractory/progressive disease despite conventional therapy with etoposide and dexamethasone, meeting Aetna Medical Policy Bulletin 0948 criteria for Gamifant coverage."

Peer-to-Peer Review Preparation

If your written appeal is denied, request a peer-to-peer review between your hematologist and Aetna's medical director.

Preparation Checklist:

  • Schedule within Aetna's specified timeframe (usually 10-14 days)
  • Prepare concise talking points addressing each denial reason
  • Have patient chart and lab values readily available
  • Document the call date, time, and participants

Key Talking Points:

  • "Patient has primary HLH confirmed by [genetic testing/HLH-2004 criteria]"
  • "Conventional therapy with etoposide-dexamethasone failed due to [specific reasons]"
  • "Gamifant is FDA-approved for exactly this indication and meets your policy criteria"
  • "Treatment is intended as bridge to stem cell transplant, the definitive cure"
  • "Without IFN-γ blockade, patient faces significant mortality risk"

Washington External Review (IRO) Process

If internal appeals fail, Washington residents can request external review through an Independent Review Organization (IRO). Washington has one of the strongest external review processes in the country, with 82% overturn rates for specialty drug denials.

Eligibility Requirements:

  • Completed all required internal appeals
  • Denial based on medical necessity, experimental/investigational determination, or coverage terms
  • Request filed within 180 days of final internal denial

Process Timeline:

  • Standard review: 30 calendar days from complete submission
  • Expedited review: 72 hours for urgent medical situations
  • Aetna response time: Must assign IRO within 3 business days

How to Request:

  1. Contact Washington Office of the Insurance Commissioner at 1-800-562-6900
  2. Submit external review request form to Aetna or directly to OIC
  3. Provide all relevant medical documentation
  4. Clearly state if situation is urgent and requires expedited review

IRO Decision: The IRO's decision is binding on Aetna. If they overturn the denial, Aetna must provide coverage for Gamifant.

Note: Self-funded employer plans may not be subject to Washington's IRO process and instead use federal ERISA external review procedures.

Appeal Letter Templates

Sample Opening Paragraph: "I am writing to formally appeal Aetna's denial of coverage for Gamifant (emapalumab-lzsg) for my [child's/my] primary hemophagocytic lymphohistiocytosis (HLH). This denial is inconsistent with Aetna Medical Clinical Policy Bulletin 0948 and the FDA-approved indication for this medication."

Medical Necessity Section: "The patient meets Aetna's criteria for Gamifant coverage as outlined in CPB 0948:

  1. Primary HLH diagnosis: [Confirmed by genetic testing showing X mutation / Meets 6 of 8 HLH-2004 criteria including fever, splenomegaly, cytopenias, ferritin of X µg/L, etc.]
  2. Conventional therapy failure: [Patient received etoposide X mg/m² and dexamethasone X mg/m²/day from DATE to DATE with inadequate response/intolerance as evidenced by persistent fever, cytopenias, ferritin >X]
  3. Specialist supervision: Treatment supervised by Dr. [NAME], board-certified hematologist/oncologist"

Closing: "Given the life-threatening nature of uncontrolled HLH and the clear alignment with your published policy criteria, I request immediate approval of Gamifant coverage. Please contact Dr. [NAME] at [PHONE] to arrange peer-to-peer review if additional clinical discussion would be helpful."

Costs and Financial Assistance

While pursuing your appeal, explore these cost-assistance options:

Manufacturer Support:

  • Gamifant Cares offers benefits investigation, prior authorization support, and financial assistance
  • Copay assistance programs may be available for eligible patients
  • Patient assistance programs for uninsured or underinsured individuals

Foundation Grants: Research disease-specific foundations that provide grants for HLH treatments. Many require proof of financial need and insurance denial.

Hospital Financial Assistance: If receiving treatment at a hospital, inquire about charity care or payment plan options while appeals are pending.

When to Escalate

Contact the Washington Office of the Insurance Commissioner if:

  • Aetna fails to respond within required timeframes
  • You need help understanding your appeal rights
  • You believe Aetna is not following Washington insurance laws
  • External review deadlines are being missed

Contact Information:

  • Phone: 1-800-562-6900
  • Website: insurance.wa.gov
  • File complaints online through the OIC portal

The OIC can also help determine if your plan is subject to Washington state law or federal ERISA rules, which affects your appeal options.

From our advocates: In our experience helping families navigate HLH treatment approvals, the combination of detailed clinical documentation addressing specific policy criteria and persistent follow-up through Washington's robust consumer protection system often leads to successful outcomes, even after initial denials. The key is matching your clinical story precisely to the insurer's published requirements.

Frequently Asked Questions

How long does Aetna prior authorization take for Gamifant in Washington? Standard PA decisions are typically made within 30-45 days. Expedited reviews for urgent situations may be completed within 72 hours. Washington's prior authorization modernization law requires electronic PA decisions within 3 calendar days for standard requests and 1 day for urgent requests.

What if Gamifant is non-formulary on my Aetna plan? Non-formulary status doesn't automatically mean denial. Request a formulary exception demonstrating medical necessity and that formulary alternatives are inappropriate or ineffective for your condition.

Can I request an expedited appeal if my condition is urgent? Yes. If delay would seriously jeopardize your health, request expedited internal appeal and external IRO review. Provide documentation from your physician explaining the urgent medical need.

Does step therapy apply if I failed treatments outside Washington? Treatment history from other states should be accepted if properly documented. Provide complete records showing dates, doses, and reasons for discontinuation of conventional HLH therapies.

What happens if the IRO upholds Aetna's denial? IRO decisions are generally final for insurance coverage purposes. Options include exploring manufacturer assistance programs, seeking care at academic medical centers with research protocols, or consulting with patient advocacy organizations.

How do I know if my plan is subject to Washington state law? Check your denial letter and plan documents. Fully insured plans and Washington Health Benefit Exchange plans are typically subject to state law. Self-funded employer plans may use federal ERISA appeal procedures instead.

Navigating insurance denials for life-saving treatments like Gamifant can feel overwhelming, but Washington residents have strong consumer protections and appeal rights. The key to success is thorough documentation, persistence, and understanding your rights under both your insurance policy and Washington state law.

For families facing HLH, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps patients, clinicians, and specialty pharmacies get prescription drugs approved by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to insurers' own rules.

Whether you're just starting the prior authorization process or facing your second appeal, remember that many seemingly impossible cases are ultimately approved when the clinical evidence clearly demonstrates medical necessity according to the insurer's published criteria. Washington's external review process provides an additional safety net, with independent medical experts making binding coverage decisions when insurers get it wrong.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider regarding treatment decisions and with qualified professionals regarding insurance matters. Coverage decisions depend on individual plan terms and medical circumstances.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.