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

How to Get Darzalex Covered by Aetna in Florida: Prior Authorization Forms, Step Therapy, and Appeal Process

Answer Box: Getting Darzalex Covered by Aetna in Florida

Aetna requires prior authorization for Darzalex/Darzalex Faspro and enforces step therapy (typically requiring bortezomib first). To get approved: 1) Have your oncologist submit the complete PA form with clinical justification for bypassing step therapy, 2) Include documentation of prior treatments and medical necessity, 3) Submit via fax (1-888-267-3277) or Aetna's provider portal. Standard decisions take 30-45 days; expedited reviews 72 hours. If denied, you have 180 days to appeal internally, then can request external review through Florida's independent review process.

Table of Contents

Aetna's Coverage Policy Overview

Aetna classifies Darzalex (daratumumab IV) and Darzalex Faspro (daratumumab subcutaneous) as non-preferred specialty medications requiring prior authorization across all plan types—commercial, Medicare Advantage, and Medicaid managed care plans in Florida.

Plan Types and Policy Application

Commercial Plans (HMO/PPO): Follow Aetna's standard precertification requirements with step therapy enforcement. Coverage decisions typically take 30-45 days for standard requests.

Medicare Advantage: Use separate Medicare-specific forms and criteria. Step therapy requirements favor bortezomib as first-line treatment, with exceptions for documented contraindications or combination regimens.

Medicaid (Aetna Better Health): Subject to Florida Medicaid formulary restrictions plus Aetna's additional utilization management criteria.

Official Policy Documents: Find current coverage criteria in Aetna's Clinical Policy Bulletin 0904 and the annual Precertification List.

Medical Necessity Requirements

FDA-Approved Indications Covered by Aetna

Aetna covers Darzalex for these FDA-approved uses:

  • Multiple myeloma (newly diagnosed and relapsed/refractory)
  • Light chain (AL) amyloidosis (newly diagnosed, IV formulation only)

Documentation Requirements

Your oncologist must provide:

  • ICD-10 diagnosis codes (C90.00-C90.02 for multiple myeloma; E85.81 for AL amyloidosis)
  • Disease staging information (ISS/R-ISS for myeloma)
  • Transplant eligibility assessment (eligible vs. ineligible with rationale)
  • Treatment line (newly diagnosed, first relapse, etc.)

Off-Label Considerations

Off-label uses require additional justification with peer-reviewed literature and recognized compendium support (NCCN, Lexicomp, or similar). Aetna may deny off-label requests without compelling clinical evidence.

Step Therapy and Exceptions

Standard Step Therapy Requirement

Aetna requires trial of bortezomib before approving Darzalex for most multiple myeloma patients. This applies to both newly diagnosed and relapsed/refractory cases unless specific exceptions are met.

Medical Exception Pathways

Automatic Exceptions (No Additional Documentation Needed):

  • Darzalex used in combination with bortezomib
  • Darzalex + lenalidomide + dexamethasone for transplant-ineligible patients
  • Previous Darzalex therapy within 365 days

Medical Exceptions (Require Clinical Justification):

  • Contraindication to bortezomib: Document peripheral neuropathy, hypersensitivity, or other medical reasons
  • Intolerance to bortezomib: Provide records of adverse events requiring discontinuation
  • Treatment failure: Show inadequate response to bortezomib-based therapy

Exception Documentation

Include in your PA submission:

  • Prior therapy summary with dates, doses, and response assessment
  • Reason for discontinuation (progression, toxicity, intolerance)
  • Clinical rationale for Darzalex as preferred alternative
  • Supporting labs or imaging showing disease status

Quantity and Frequency Limits

Standard Dosing Limits

Darzalex IV:

  • Initial authorization: 6 months
  • Maintenance dosing: Every 4 weeks after initial weekly dosing phase
  • Maximum dose: 16 mg/kg based on actual body weight

Darzalex Faspro:

  • Initial authorization: 6 months
  • Fixed dose: 1,800 mg subcutaneous
  • Frequency: Weekly initially, then every 4 weeks

Renewal Requirements

Reauthorization requires:

  • Response assessment (imaging, lab values, clinical status)
  • Tolerability documentation (adverse events, dose modifications)
  • Continued medical necessity justification

Required Diagnostics and Documentation

Baseline Requirements

Laboratory Values (within 30 days):

  • Complete blood count with differential
  • Comprehensive metabolic panel
  • Serum protein electrophoresis (SPEP)
  • Immunofixation electrophoresis
  • Serum free light chains
  • Beta-2 microglobulin and LDH

Imaging Studies:

  • Skeletal survey or PET/CT (for myeloma)
  • Cardiac assessment if indicated
  • Bone marrow biopsy results with cytogenetics

Ongoing Monitoring Documentation

Submit with renewal requests:

  • Response criteria assessment (IMWG criteria for myeloma)
  • Safety monitoring results (CBC, chemistry panel)
  • Quality of life measures when applicable
Tip: Ensure all lab values are dated within 30 days of PA submission to avoid delays.

Site of Care and Specialty Pharmacy Rules

Administration Site Requirements

Darzalex IV: Must be administered in approved infusion centers or hospital outpatient departments. Home infusion is not typically covered.

Darzalex Faspro: Requires administration by healthcare professionals in clinical settings. Self-administration or home injection is not approved.

CVS Caremark Specialty Pharmacy

Most Aetna plans require specialty medications to be dispensed through CVS Caremark Specialty. Your clinic will need to:

  • Enroll as a CVS Specialty provider
  • Submit orders through CVS Specialty Connect
  • Coordinate delivery to the infusion site

Buy-and-Bill Coverage

For Medicare Part B coverage, include:

  • HCPCS codes (J9144 for daratumumab)
  • NDC numbers for specific formulations
  • Site of service codes (11 for office, 22 for outpatient hospital)

Evidence to Support Medical Necessity

Guideline Citations

NCCN Guidelines 2025: Daratumumab-based quadruplet regimens (D-VRd) are now preferred first-line treatment for transplant-eligible newly diagnosed multiple myeloma patients.

Key Supporting Studies:

  • PERSEUS trial (D-VRd vs VRd in transplant-eligible patients)
  • CEPHEUS study (isatuximab + VRd in transplant-ineligible)
  • IMROZ trial data supporting first-line use

How to Cite Guidelines

In your medical necessity letter, reference:

  • Specific guideline version (NCCN Version 1.2025)
  • Recommendation category (Category 1 preferred regimen)
  • Supporting evidence level (randomized controlled trial data)

Sample Medical Necessity Statement

"This 67-year-old patient presents with newly diagnosed multiple myeloma, ISS Stage II, with high-risk cytogenetics (del 17p). Per NCCN Guidelines Version 1.2025, daratumumab + lenalidomide + bortezomib + dexamethasone (D-VRd) is the preferred Category 1 regimen for transplant-eligible patients. The patient has adequate performance status (ECOG 1) and organ function for combination therapy. Baseline cardiac evaluation shows LVEF 55% without contraindications to treatment. This regimen offers superior MRD negativity rates (60.9% vs 39.4% for VRd alone) based on PERSEUS trial data, which is particularly important given the patient's high-risk disease features."

Appeals Process in Florida

Internal Appeal Timeline

Standard Appeals:

  • Filing deadline: 180 days from denial notice (commercial plans)
  • Decision timeline: 30 days for standard review
  • Submission methods: Online portal, phone (1-866-235-5660), or fax

Expedited Appeals:

  • Qualification: Clinical evidence that delay may harm health
  • Decision timeline: 72 hours
  • Required documentation: Physician attestation of urgency

External Review Process

If your internal appeal is denied:

Eligibility: Available for most commercial plans (not Medicare) Filing deadline: 4 months after final internal denial Process: Submit request to Florida's designated Independent Review Organization Timeline: 45 days for standard review, 72 hours for urgent cases Cost: No charge to patient

Florida Resources: Contact the Florida Department of Financial Services Insurance Consumer Helpline at 1-877-MY-FL-CFO (877-693-5236) for assistance with appeals.

When specialty drug coverage is denied, patients and their healthcare teams need targeted support to navigate complex insurance requirements and build strong appeals. Counterforce Health specializes in turning insurance denials into evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each payer's specific criteria.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Step therapy not met Submit exception request Prior bortezomib trial records or contraindication documentation
Insufficient clinical information Resubmit with complete PA form All required lab values, staging, and treatment history
Non-formulary status Request formulary exception Medical necessity letter with guideline citations
Quantity limits exceeded Justify dosing rationale Weight-based calculations and FDA labeling reference
Site of care restriction Confirm approved facility Infusion center credentials and network status

Peer-to-Peer Review Strategy

If initially denied, request a peer-to-peer review where your oncologist discusses the case directly with Aetna's medical director. This often resolves denials faster than formal appeals.

Preparation for peer-to-peer:

  • Have patient chart and imaging readily available
  • Prepare 2-3 key clinical points supporting medical necessity
  • Reference specific NCCN guideline recommendations
  • Document the conversation outcome and next steps

Frequently Asked Questions

How long does Aetna prior authorization take for Darzalex in Florida? Standard PA decisions take 30-45 days. Expedited requests with clinical urgency documentation are decided within 72 hours.

What if Darzalex is non-formulary on my Aetna plan? Submit a formulary exception request with your PA application. Include medical necessity justification and guideline support for coverage consideration.

Can I get an expedited appeal if my treatment is delayed? Yes, if your physician provides documentation that delay in treatment may seriously jeopardize your health or ability to regain maximum function.

Does step therapy apply if I've tried bortezomib outside Florida? Previous trials from any location count toward step therapy requirements. Provide complete treatment records from your prior oncologist.

What happens if my appeal is denied by Aetna? For commercial plans, you can request external review through Florida's Independent Review Organization. Medicare plans follow federal CMS appeal procedures.

How much does Darzalex cost without insurance in Florida? Cash prices for a single Darzalex Faspro dose typically range from $4,000-6,000. IV Darzalex costs vary based on weight-based dosing but are generally several thousand dollars per infusion.

The appeals process can feel overwhelming, but having the right documentation and understanding Aetna's specific requirements significantly improves your chances of approval. Counterforce Health helps patients and clinicians navigate these complex requirements by providing targeted, evidence-backed appeal strategies tailored to each payer's policies and procedures.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may vary by specific plan and change over time. Always verify current requirements with your insurance plan and consult with your healthcare provider for medical decisions. For assistance with insurance concerns in Florida, contact the Department of Financial Services at 1-877-MY-FL-CFO.

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