By Counterforce Health Team in Tavalisse (fostamatinib disodium hexahydrate) —

Do You Qualify for Tavalisse Coverage by Aetna CVS Health in North Carolina? Decision Tree & Next Steps

Answer Box: Quick Path to Tavalisse Coverage

Yes, you likely qualify if you have chronic ITP (platelets <100,000 for ≥12 months), failed corticosteroids/IVIG, have platelets <50,000 or bleeding symptoms, and see a hematologist. Fastest approval: Submit Aetna's PA through Availity portal with complete prior therapy documentation and current platelet counts. First step today: Contact your hematologist's office to gather treatment history and request they initiate the prior authorization. If denied, North Carolina's Smart NC external review provides binding appeal rights within 120 days.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Your Action Plan
  4. If "Possibly Eligible": Tests and Timeline
  5. If "Not Yet": Alternatives and Exception Paths
  6. If Denied: North Carolina Appeal Options
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & How to Fix Them
  9. Frequently Asked Questions

How to Use This Decision Tree

This guide helps patients and clinicians navigate Aetna (CVS Health) coverage for Tavalisse (fostamatinib disodium hexahydrate) in North Carolina. Work through the eligibility questions below, then follow the specific action plan for your situation.

Tavalisse costs approximately $14,000-$16,000 per 60-tablet bottle, making prior authorization essential. North Carolina residents have strong appeal rights through the state's Smart NC program when denials occur.

Important: This guide covers Aetna commercial and exchange plans. Medicare Advantage and self-funded employer plans may have different processes.

Eligibility Triage: Do You Qualify?

Step 1: Confirm Your Diagnosis

You need ALL of these:

  • ✅ Adult chronic immune thrombocytopenia (ITP) lasting ≥12 months
  • ✅ Platelet count <100,000/µL on multiple occasions
  • ✅ Other causes of low platelets excluded (no liver disease, HIV, medications causing thrombocytopenia)
  • ✅ Care managed by or in consultation with a hematologist

Sources: Aetna Tavalisse Policy 2560-A

Step 2: Check Severity and Prior Treatments

Aetna requires ONE of these platelet/bleeding criteria:

  • Untransfused platelet count <30,000/µL, OR
  • Platelets 30,000-50,000/µL PLUS symptomatic bleeding or bleeding risk factors

AND documented failure/intolerance to:

  • Corticosteroids (prednisone, methylprednisolone)
  • Immunoglobulins (IVIG)

Bleeding risk factors include: peptic ulcer disease, hypertension, mandatory anticoagulation, high-risk profession, or contact sports.

Step 3: Check Exclusions

You CANNOT receive Tavalisse if:

  • Currently taking TPO receptor agonists (Promacta/eltrombopag, Nplate/romiplostim, Doptelet, Mulpleta)
  • Prescribed by non-hematologist without hematology consultation

If "Likely Eligible": Your Action Plan

Document Checklist

Gather these before submitting your prior authorization:

Clinical Documentation:

  • CBC results showing platelets <100,000 for ≥12 months
  • Most recent platelet count (within 30 days)
  • Hematology consultation notes confirming chronic ITP diagnosis
  • Documentation of bleeding episodes or risk factors
  • Complete list of prior ITP treatments with dates, doses, and outcomes

Prior Therapy Documentation:

  • Corticosteroid trial details (drug, dose, duration, response, side effects)
  • IVIG treatment history (dates, response, any adverse reactions)
  • Any other treatments tried (rituximab, splenectomy, TPO-RAs)

Submission Path

  1. Contact Method: Have your hematologist submit through Aetna's Availity portal or call 1-855-582-2025
  2. Timeline: Submit at least 14 days before needed
  3. Decision Window: Aetna must decide within 72 hours (standard) or 24 hours (urgent)
  4. Approval Duration: Initial approval typically 12 weeks, then 3-12 months based on response
Tip: If Aetna doesn't respond within 72 hours for non-urgent requests, the prior authorization may be considered approved under their 2024 policy.

If "Possibly Eligible": Tests and Timeline

Missing Documentation to Obtain

If you haven't tried required therapies:

  • Schedule appointment with hematologist to discuss corticosteroid trial
  • Plan IVIG treatment if corticosteroids fail or are contraindicated
  • Document any contraindications to standard treatments

If diagnosis needs confirmation:

  • Request CBC with differential and peripheral smear
  • Ensure secondary causes ruled out (HIV, HCV, liver function tests)
  • Consider bone marrow biopsy if atypical features present

Re-application Timeline

Plan for 3-6 months to complete required prior therapies and gather documentation. Most patients need at least one adequate corticosteroid trial (typically 4-6 weeks) before Aetna considers second-line agents.

If "Not Yet": Alternatives and Exception Paths

Alternative Treatments to Discuss

While building your case for Tavalisse, consider these covered options:

  • TPO receptor agonists: Promacta (eltrombopag), Nplate (romiplostim)
  • Immunosuppressants: Rituximab, mycophenolate
  • Surgical options: Splenectomy (if appropriate candidate)

Exception Request Strategy

If you don't meet standard criteria, request a medical exception through Aetna's formulary exception process:

  1. Have your hematologist document why standard criteria don't apply
  2. Include literature supporting off-label use or special circumstances
  3. Request expedited review if urgent (24-hour decision)

If Denied: North Carolina Appeal Options

North Carolina offers robust appeal rights through the Smart NC program, which has overturned many specialty drug denials.

Internal Appeals (Required First)

First-Level Appeal:

  • Deadline: Usually 60-180 days from denial (check your plan documents)
  • Method: Online portal, phone, or written request
  • Timeline: 30-45 days for standard review, 72 hours for urgent

Peer-to-Peer Review:

  • Request your hematologist speak directly with Aetna's medical director
  • Often resolves denials when clinical nuances are discussed

North Carolina External Review

If internal appeals fail, North Carolina's Smart NC external review provides binding decisions.

Eligibility:

  • Completed Aetna's internal appeals
  • Denial based on medical necessity (not benefit exclusion)
  • Fully insured plan (not self-funded employer plan)

Timeline:

  • Standard: 45 days for decision
  • Expedited: 72 hours if delay would jeopardize health
  • Filing deadline: 120 days from final internal denial

How to File:

  1. Complete NC External Review Request Form
  2. Attach Aetna's final denial letter and supporting medical records
  3. Include physician statement explaining medical necessity
  4. Submit to Smart NC at NC Department of Insurance

Contact Smart NC: Call 1-855-408-1212 for free assistance with your appeal.

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Diagnosis Adult chronic ITP ≥12 months Hematology notes, CBC trends Aetna Policy
Platelet Count <30,000 OR 30-50,000 + bleeding risk Recent CBC, bleeding history Aetna Policy
Prior Therapy Failed corticosteroids + IVIG Treatment records with outcomes Aetna Policy
Prescriber Hematologist or consultation Specialist involvement documented Aetna Policy
Exclusions No concurrent TPO-RAs Current medication list Aetna Policy

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Insufficient prior therapy" Document failed corticosteroids + IVIG Treatment dates, doses, outcomes, side effects
"Platelets not low enough" Provide multiple CBCs showing <30,000 or bleeding with 30-50,000 Recent lab results, bleeding episodes
"Not prescribed by hematologist" Obtain hematology consultation Specialist evaluation and recommendation
"Concurrent TPO-RA use" Discontinue other agents or request exception Current medication reconciliation
"Experimental/investigational" Cite FDA approval for chronic ITP FDA label, clinical guidelines

Frequently Asked Questions

How long does Aetna prior authorization take in North Carolina? Standard requests: 72 hours. Urgent requests: 24 hours. If Aetna misses these deadlines, your request may be automatically approved under their 2024 policy.

What if Tavalisse is non-formulary on my plan? Request a formulary exception with clinical justification. Your hematologist must document why covered alternatives aren't appropriate.

Can I request an expedited appeal? Yes, if waiting for standard review (72 hours for PA, 45 days for external review) could seriously jeopardize your health. Your doctor must certify the urgency.

Does step therapy apply if I failed treatments outside North Carolina? Yes, Aetna accepts documented treatment failures from other states. Ensure you have complete records from previous providers.

What's the cost without insurance? Approximately $14,000-$16,000 per month. Check Rigel's patient assistance programs for potential savings if coverage is denied.

How does Smart NC external review work? It's a free, binding review by independent medical experts. If they overturn Aetna's denial, your insurance must cover the treatment. Success rates are significant for well-documented cases.

About Counterforce Health

Counterforce Health specializes in transforming insurance denials into successful appeals for patients, clinicians, and specialty pharmacies. Our platform analyzes denial letters, plan policies, and clinical notes to create evidence-backed appeals that align with each payer's specific requirements. For complex cases like Tavalisse prior authorizations, we help identify the exact clinical documentation and guideline citations needed to meet Aetna's criteria and strengthen North Carolina external review submissions.

When facing a Tavalisse denial from Aetna, Counterforce Health can help craft targeted appeals that address specific denial reasons while incorporating the right medical literature and procedural requirements for both internal appeals and Smart NC external review.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan and clinical situation. Consult your healthcare provider and insurance plan documents for personalized guidance. For additional help with North Carolina insurance appeals, contact Smart NC at 1-855-408-1212.

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