By Counterforce Health Team in Darzalex / Darzalex Faspro (daratumumab) —

How to Get Darzalex (Daratumumab) Covered by Aetna in Texas: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Darzalex Covered by Aetna in Texas

Aetna requires prior authorization for Darzalex (daratumumab) for multiple myeloma and AL amyloidosis. Key steps: 1) Ensure FDA-approved indication with proper line of therapy documentation, 2) Submit precertification request via Aetna provider portal with clinical notes and prior treatment records, 3) If denied, file internal appeal within 180 days. Texas law provides automatic external review through Independent Review Organizations (IRO) within 4 months of final denial. Success rate for specialty drug appeals exceeds 80% with proper documentation.

Table of Contents

Aetna's Coverage Policy Overview

Aetna (CVS Health) covers Darzalex (daratumumab) and Darzalex Faspro (daratumumab-fihj) for FDA-approved indications under medical benefit, not pharmacy benefit. This means the drug is administered in clinical settings and billed through your medical insurance rather than picked up at a retail pharmacy.

Plan Types and Coverage:

  • Commercial plans: Standard prior authorization required
  • Medicare Advantage: Uses Medicare-specific forms and criteria
  • Medicaid managed care: State-specific guidelines apply

All Aetna participating providers must obtain precertification before administering Darzalex. The approval process typically takes 30-45 days for standard requests and up to 72 hours for expedited cases involving urgent medical situations.

Medical Necessity Requirements

FDA-Approved Indications

Aetna considers Darzalex medically necessary for:

Multiple Myeloma:

  • Newly diagnosed patients ineligible for autologous stem cell transplant (in combination with lenalidomide and dexamethasone)
  • Patients with relapsed or refractory disease who have received at least one prior therapy
  • First-line treatment for transplant-eligible patients (in combination with VRd regimen)

AL Amyloidosis:

  • Newly diagnosed light chain amyloidosis (intravenous formulation only)

Required Documentation

Your oncologist must provide:

  • Diagnosis confirmation: ICD-10 codes (C90.00 for multiple myeloma, E85.81 for AL amyloidosis)
  • Disease staging: ISS staging for myeloma, organ involvement for amyloidosis
  • Prior therapy history: Complete list of previous treatments, responses, and reasons for discontinuation
  • Current disease status: Recent labs, imaging, and performance status
  • Treatment plan: Specific regimen, dosing schedule, and monitoring plan

Step Therapy and Exception Pathways

Standard Step Therapy Requirements

For relapsed/refractory multiple myeloma, Aetna typically requires documentation of:

  1. First-line therapy failure: Usually lenalidomide-based or bortezomib-based regimen
  2. Adequate trial duration: Minimum 2-3 cycles unless discontinued due to toxicity
  3. Disease progression: Documented by IMWG criteria or clinical progression

Medical Exception Criteria

Step therapy can be bypassed if:

  • Contraindications exist: Document specific medical reasons (e.g., peripheral neuropathy precluding bortezomib)
  • Previous intolerance: Grade 3-4 toxicities requiring discontinuation
  • Drug interactions: Significant interactions with concurrent medications
  • Urgent clinical need: Rapidly progressive disease requiring immediate treatment
Tip: Texas law requires automatic approval of step therapy exceptions within 72 hours for standard cases and 24 hours for life-threatening situations if proper documentation is provided.

Quantity Limits and Dosing Guidelines

Approved Dosing Schedules

Intravenous Darzalex:

  • Standard dose: 16 mg/kg body weight
  • Initial schedule: Weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks
  • First dose may be split over 2 consecutive days to reduce infusion reactions

Subcutaneous Darzalex Faspro:

  • Fixed dose: 1,800 mg (15 mL)
  • Same frequency schedule as IV formulation
  • 3-5 minute injection with 2-hour observation for first dose

Quantity Limits

Aetna's quantity limits align with FDA-approved dosing:

  • Weekly dosing: Maximum 1 dose per 7 days during induction
  • Maintenance dosing: Maximum 1 dose per 28 days
  • Annual limits: Based on approved indication and treatment duration

Appeals for quantity limit overrides require documentation of:

  • Medical necessity for dose intensification
  • Clinical trial data supporting modified dosing
  • Specialist recommendation with rationale

Site of Care Requirements

Approved Administration Sites

Darzalex must be administered at:

  • Hospital outpatient departments
  • Oncology infusion centers
  • Specialty clinics with emergency management capabilities

Not permitted:

  • Home administration
  • Retail pharmacy settings
  • Non-specialty clinics without emergency support

CVS Specialty Pharmacy Requirements

For subcutaneous Darzalex Faspro, Aetna may require:

  • Specialty pharmacy distribution through CVS Specialty
  • Provider enrollment in specialty network
  • Patient enrollment and education completion

Prior Authorization Process

Step-by-Step Submission

  1. Gather Documentation (allow 3-5 business days):
    • Complete medical records
    • Prior authorization request form
    • Laboratory results (within 30 days)
    • Imaging studies (if applicable)
  2. Submit Request:
    • Phone: 1-866-752-7021 (providers only)
    • Fax: 1-888-267-3277
    • Online: Aetna provider portal (verify current URL with Aetna)
  3. Track Status:
    • Standard decisions: 30 days maximum
    • Expedited decisions: 72 hours maximum
    • Check status via provider portal or phone

Required Forms

  • Commercial plans: Standard Darzalex precertification request
  • Medicare Advantage: Medicare-specific Darzalex form
  • All plans: Clinical documentation and treatment history

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, payer policies, and clinical notes to create targeted, evidence-backed responses. Their platform identifies specific denial reasons and drafts point-by-point rebuttals aligned with each plan's requirements.

Appeals Process in Texas

Internal Appeals

Timeline: File within 180 days of denial

Required Information:

  • Original denial letter
  • Additional clinical documentation
  • Medical necessity letter from prescribing physician
  • Relevant clinical guidelines and literature

Decision Timeline:

  • Standard appeals: 30 days
  • Expedited appeals: 72 hours

External Review (IRO)

If internal appeal is denied, Texas law provides automatic access to Independent Review Organization (IRO) review:

Timeline: File within 4 months (120 days) of final internal denial

Process:

  • Aetna automatically submits case to Texas Department of Insurance
  • TDI assigns case to certified IRO
  • IRO reviews medical necessity independently

Decision Timeline:

  • Standard cases: 20 days
  • Urgent cases: 5 days

Binding Result: If IRO overturns denial, Aetna must provide coverage

Cost: No charge to patient; Aetna pays review fees

Note: IRO decisions are binding on Aetna and have approximately 82% overturn rate for properly documented specialty drug appeals.

Texas Resources

  • Texas Department of Insurance: 1-800-252-3439
  • IRO Information Line: 1-866-554-4926
  • Office of Public Insurance Counsel: 1-877-611-6742

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Not FDA-approved indication Appeal with FDA labeling FDA prescribing information, diagnosis confirmation
Insufficient prior therapy Document treatment history Complete prior therapy records, response assessments
Non-formulary status Request formulary exception Medical necessity letter, clinical guidelines
Quantity limits exceeded Appeal with dosing rationale Specialist recommendation, clinical evidence
Site of care restriction Confirm approved facility Facility credentials, emergency protocols

Medical Necessity Letter Template

Your oncologist's letter should include:

  • Patient identification: Name, DOB, member ID
  • Diagnosis: Specific type and stage of disease
  • Treatment history: Previous therapies, responses, toxicities
  • Clinical rationale: Why Darzalex is appropriate now
  • Alternative consideration: Why other options are unsuitable
  • Monitoring plan: How safety and efficacy will be assessed

Cost Assistance Programs

Manufacturer Support

Janssen CarePath:

  • Copay assistance for commercially insured patients
  • Maximum annual benefit varies by plan
  • Eligibility verification required

Foundation Assistance

Patient Access Network Foundation:

  • Grants for multiple myeloma patients
  • Income-based eligibility
  • Apply online at panfoundation.org

HealthWell Foundation:

  • Financial assistance for specialty medications
  • Disease-specific funds available
  • Application process through healthwellfoundation.org

Texas-Specific Resources

Texas Department of State Health Services:

  • Medication assistance programs
  • Resource directory for uninsured patients

For patients facing financial hardship, Counterforce Health can help identify additional assistance programs and ensure appeals include all relevant cost-effectiveness arguments that payers consider.

FAQ

Q: How long does Aetna prior authorization take for Darzalex in Texas? A: Standard requests take up to 30 days. Expedited requests for urgent medical situations are processed within 72 hours. Submit complete documentation to avoid delays.

Q: What if Darzalex is not on Aetna's formulary? A: Request a formulary exception by demonstrating medical necessity. Include documentation that formulary alternatives are inappropriate, contraindicated, or previously failed.

Q: Can I get an expedited appeal in Texas? A: Yes, if delay would jeopardize your health. Both internal appeals and external IRO reviews can be expedited, with decisions in 72 hours and 5 days respectively.

Q: Does step therapy apply if I received treatment outside Texas? A: No, prior therapy documentation from any location counts toward step therapy requirements. Provide complete treatment records regardless of where care was received.

Q: What happens if Aetna doesn't respond within required timeframes? A: Under Texas law, failure to respond within mandated timeframes may result in automatic approval. Contact Texas Department of Insurance if deadlines are missed.

Q: Can I appeal a quantity limit denial? A: Yes, quantity limits can be appealed with clinical justification. Document medical necessity for the requested quantity and frequency with supporting literature.

Q: Is peer-to-peer review available? A: Yes, your oncologist can request peer-to-peer review with Aetna's medical director. This often resolves denials without formal appeals when clinical rationale is clearly communicated.

Q: What if I have Medicare Advantage through Aetna? A: Medicare Advantage plans follow Medicare appeals processes rather than Texas state law. However, similar timelines and external review rights apply through Medicare's system.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual circumstances, plan specifics, and current policies. Always consult with your healthcare provider about treatment options and verify current requirements with Aetna and Texas regulatory agencies. For personalized assistance with complex appeals, consider working with organizations like Counterforce Health that specialize in insurance coverage advocacy.

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