By Counterforce Health Team in Tavneos (avacopan) —

Aetna (CVS Health)'s Coverage Criteria for Tavneos (avacopan) in Washington: What Counts as "Medically Necessary"?

Answer Box: Getting Tavneos (avacopan) Covered by Aetna (CVS Health) in Washington

Aetna (CVS Health) requires prior authorization for Tavneos (avacopan) with strict medical necessity criteria: severe active ANCA-associated vasculitis (GPA/MPA), specialist prescriber, and use as adjunctive therapy with rituximab or cyclophosphamide. Your fastest path to approval: Have your rheumatologist, nephrologist, or pulmonologist submit the Aetna PA form with ANCA lab results, biopsy reports, and documentation of current standard therapy. If denied, you have 180 days to appeal and can request external review through Washington's Independent Review Organization system.

Table of Contents

  1. Policy Overview
  2. Indication Requirements
  3. Step Therapy & Exceptions
  4. Quantity and Frequency Limits
  5. Required Diagnostics
  6. Site of Care & Specialty Pharmacy
  7. Evidence to Support Medical Necessity
  8. Sample "Meets Criteria" Narrative
  9. Edge Cases
  10. Quick Reference Table
  11. Appeals Process for Washington
  12. FAQ

Policy Overview

Aetna (CVS Health) covers Tavneos (avacopan) under their pharmacy benefit with mandatory prior authorization across all plan types—HMO, PPO, and Medicare Advantage. The drug falls under CVS Caremark specialty pharmacy management, requiring both clinical and administrative approval before coverage begins.

Plan Types Affected:

  • Commercial individual and group plans
  • Medicare Advantage (Part D coverage)
  • Medicaid managed care (varies by state contract)
Note: Self-funded employer plans may have different criteria, though most mirror Aetna's standard policies.

Washington residents benefit from strong state insurance protections, including guaranteed external review rights through the Office of the Insurance Commissioner when appeals are necessary.

Indication Requirements

Aetna's medical necessity criteria mirror the FDA-approved indication: adjunctive treatment of severe active ANCA-associated vasculitis in adults, specifically granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Required Diagnosis Elements:

  • Primary diagnosis: Severe active GPA (ICD-10: M31.31) or MPA (ICD-10: M31.7)
  • ANCA status: Documented PR3-ANCA (for GPA) or MPO-ANCA (for MPA) positivity
  • Disease activity: Evidence of active vasculitis requiring immunosuppressive therapy
  • Organ involvement: Kidney, lung, or other organ system damage documented by biopsy, imaging, or laboratory findings

Off-Label Use: Aetna generally denies coverage for eosinophilic granulomatosis with polyangiitis (EGPA) or other vasculitis types not included in the FDA indication.

Step Therapy & Exceptions

Unlike many specialty medications, Tavneos doesn't typically require traditional step therapy since it's only approved as adjunctive therapy—never as monotherapy. However, Aetna requires documentation that the patient is receiving or will receive standard immunosuppressive therapy.

Required Standard Therapies:

  • Induction therapy: Rituximab or cyclophosphamide plus glucocorticoids
  • Combination requirement: Tavneos must be prescribed alongside, not instead of, these agents

Medical Exception Pathways: If standard therapies are contraindicated, document:

  • Specific contraindications (e.g., severe immunodeficiency, active infections)
  • Prior adverse reactions with dates and severity
  • Alternative treatment plan rationale
Tip: The combination therapy requirement is actually protective—it ensures you're getting evidence-based care while adding Tavneos for its steroid-sparing benefits.

Quantity and Frequency Limits

Aetna enforces strict quantity limits aligned with FDA dosing: 180 capsules per 30 days, reflecting the standard dose of 30 mg (three 10 mg capsules) twice daily with food.

Dosing Requirements:

  • Standard dose: 6 capsules daily (180 per month)
  • Dose adjustments: May be reduced to once daily with strong CYP3A4 inhibitors
  • Duration: No automatic time limits, but requires periodic reauthorization (typically annual)

Renewal Criteria:

  • Continued disease activity or maintenance therapy need
  • Absence of prohibitive adverse effects
  • Ongoing specialist management

Required Diagnostics

Aetna requires comprehensive diagnostic documentation to establish both the diagnosis and ongoing need for treatment.

Essential Laboratory Tests:

  • ANCA serology: PR3-ANCA or MPO-ANCA with titers
  • Liver function: Baseline ALT, AST, and bilirubin (due to hepatotoxicity risk)
  • Renal function: Creatinine, eGFR, urinalysis
  • Complete blood count: To assess disease activity and monitor for treatment effects

Imaging and Tissue Diagnosis:

  • Tissue biopsy: Kidney, lung, or other affected organ showing necrotizing vasculitis
  • Imaging studies: CT chest/abdomen/pelvis documenting organ involvement
  • Disease activity measures: BVAS (Birmingham Vasculitis Activity Score) when available

Timing Requirements:

  • Labs must be current within 30-90 days of PA submission
  • Imaging should correlate with current disease activity
  • ANCA testing must confirm the diagnosis

Site of Care & Specialty Pharmacy

Tavneos is dispensed exclusively through CVS Caremark specialty pharmacies due to its high cost and monitoring requirements.

Pharmacy Network Requirements:

  • Must use CVS Specialty or approved network specialty pharmacy
  • Cannot be filled at retail pharmacies
  • Prior authorization required before first fill

Administration Details:

  • Oral medication taken at home
  • No infusion or injection requirements
  • Patient education on timing with food and drug interactions

Evidence to Support Medical Necessity

Strong medical necessity letters reference established guidelines and clinical evidence supporting Tavneos use in ANCA-associated vasculitis.

Key Evidence Sources:

  • FDA prescribing information: Demonstrates on-label use
  • ACR/EULAR guidelines: Support combination therapy approach
  • ADVOCATE trial data: Shows efficacy as adjunctive therapy with steroid-sparing benefits
  • Kidney Disease: Improving Global Outcomes (KDIGO): Provides treatment framework for ANCA-associated vasculitis

Clinical Rationale Elements:

  • Disease severity and organ-threatening features
  • Steroid-related toxicity risk or intolerance
  • Need for sustained remission with reduced glucocorticoid exposure
  • Specialist recommendation based on individual patient factors
From our advocates: We've seen strongest approval rates when letters emphasize the steroid-sparing benefits of Tavneos in patients already experiencing glucocorticoid toxicity. Quantify the steroid burden (cumulative dose, duration, specific side effects) to make the case compelling.

Sample "Meets Criteria" Narrative

Here's a template paragraph structure for medical necessity documentation:

"[Patient name] is a [age]-year-old [gender] with severe active [GPA/MPA] confirmed by [PR3-ANCA/MPO-ANCA] positivity and [tissue biopsy/imaging findings]. Current disease activity includes [specific organ involvement] with [quantified measures like creatinine, BVAS score]. The patient is receiving standard induction therapy with [rituximab/cyclophosphamide] and high-dose prednisone [dose] daily, but has developed [specific steroid-related complications]. Tavneos is requested as adjunctive therapy to facilitate glucocorticoid tapering while maintaining disease control, consistent with FDA-approved indications and current treatment guidelines. This combination approach addresses both disease activity and steroid toxicity risk in this complex case."

Edge Cases

Pediatric Patients: Tavneos is not FDA-approved for patients under 18. Aetna typically denies pediatric requests unless extraordinary circumstances warrant off-label use with extensive documentation.

Pregnancy: Limited safety data exists. Requires risk-benefit analysis and specialist consultation with maternal-fetal medicine.

Liver Disease: Patients with baseline liver impairment need careful monitoring and may require dose adjustments or alternative therapies.

Drug Interactions: Strong CYP3A4 inhibitors require dose reduction. Document medication reconciliation and interaction management.

Escalation Paths:

  • Peer-to-peer review with Aetna medical director
  • Internal appeals process
  • Washington state external review through certified IRO

Quick Reference Table

Requirement What It Means Documentation Needed Source
Prior Authorization Required before coverage Aetna PA form Aetna policy
Specialist Prescriber Rheumatology, nephrology, or pulmonology Provider credentials, NPI FDA label
Diagnosis Severe active GPA or MPA ANCA labs, biopsy, ICD-10 codes FDA indication
Combination Therapy Must use with rituximab or cyclophosphamide Current medication list, treatment plan Clinical guidelines
Quantity Limit 180 capsules per 30 days Standard dosing documentation CVS Caremark policy
Liver Monitoring Baseline and ongoing LFTs Lab results within 30 days FDA safety requirements

Appeals Process for Washington

Washington residents have robust appeal rights when Aetna denies Tavneos coverage.

Internal Appeals:

  • Deadline: 180 days from denial notice
  • Standard timeline: 30-45 days for decision
  • Expedited option: 72 hours for urgent cases
  • Submission: Aetna member portal or appeals department

External Review:

  • When available: After final internal denial
  • Deadline: 180 days from final internal denial
  • Process: Administered by Washington Office of the Insurance Commissioner
  • Decision timeline: 30 days for standard, 72 hours for expedited
  • Binding: IRO decision is final and binding on Aetna

Required Documents:

  • Original denial letter
  • Complete medical records
  • Specialist letters of medical necessity
  • Supporting clinical evidence
  • Treatment history documentation

FAQ

How long does Aetna prior authorization take for Tavneos in Washington? Standard PA decisions typically take 30-45 days. Expedited reviews for urgent cases must be completed within 72 hours when medically necessary.

What if Tavneos is non-formulary on my plan? Request a formulary exception with documentation of medical necessity and failure of formulary alternatives. The combination therapy requirement often supports these requests.

Can I request an expedited appeal if denied? Yes, if delay could seriously jeopardize your health or ability to regain function. Your specialist must certify the urgent nature of the request.

Does step therapy apply if I've failed treatments outside Washington? Treatment history from any location counts toward step therapy requirements. Provide complete documentation of prior therapies and outcomes.

What's the typical cost after Aetna approval? Costs vary by plan design. Tavneos typically has specialty tier copays ($100-500+ monthly) or coinsurance (20-50% of ~$17,000 monthly cost). Check Amgen patient assistance programs for additional support.

When navigating Aetna's coverage criteria for Tavneos, success depends on thorough documentation of the diagnosis, combination therapy approach, and medical necessity. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each payer's specific requirements.

For Washington residents facing denials, the state's strong external review system provides an additional safety net. The key is building a comprehensive case that clearly demonstrates how Tavneos fits within Aetna's medical necessity framework while addressing any specific denial reasons with targeted clinical evidence.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Consult your healthcare provider and insurance plan documents for guidance specific to your situation.

Sources & Further Reading

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