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

How to Get Darzalex (Daratumumab) Covered by Aetna CVS Health in California: Complete Prior Authorization Guide

Quick Answer: Getting Darzalex Covered by Aetna CVS Health in California

Darzalex requires prior authorization from Aetna CVS Health. The fastest path: (1) Submit complete PA forms with documentation showing bortezomib failure/intolerance, (2) Include detailed medical necessity letter with ICD-10 codes and treatment history, (3) If denied, file internal appeal within 180 days, then request California Independent Medical Review (IMR) with 73% success rate. Start by downloading Aetna's Darzalex precertification form and gathering prior therapy documentation today.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Documentation
  5. Submission Process
  6. California Appeals Process
  7. Common Denial Reasons & Solutions
  8. Costs & Patient Assistance
  9. When to Escalate
  10. Frequently Asked Questions

Who Should Use This Guide

This guide helps California patients and their healthcare teams navigate Aetna CVS Health's prior authorization process for Darzalex (daratumumab) and Darzalex Faspro. Use this if you're dealing with:

  • Multiple myeloma requiring daratumumab treatment
  • AL amyloidosis (for Darzalex Faspro subcutaneous formulation)
  • Initial prior authorization requests
  • Denied coverage appeals
  • Step therapy requirements

Expected outcome: With proper documentation, most medically appropriate requests are approved. California's Independent Medical Review process has a 73% overturn rate for specialty drug appeals.

Member & Plan Basics

Coverage Requirements

Requirement Details Source
Prior Authorization Required for all Aetna plans Aetna Precert List
Formulary Status Non-preferred (bortezomib preferred) Aetna Clinical Policy
Benefit Type Medical benefit (not pharmacy) CVS Specialty Coverage
Site of Care Hospital outpatient/oncology centers only Aetna Policy 0904

Plan Type Verification

Check your Aetna plan type—commercial vs. Medicare require different forms:

Clinical Criteria Requirements

Step-by-Step: Fastest Path to Approval

  1. Confirm FDA-approved indication (Patient/Clinic)
    • Multiple myeloma: various treatment lines
    • AL amyloidosis: Darzalex Faspro only
    • Timeline: Immediate verification
    • Source: FDA label information
  2. Document bortezomib trial/failure (Clinic)
  3. Complete medical necessity letter (Prescriber)
    • Include diagnosis, prior therapies, treatment plan
    • Reference NCCN guidelines when applicable
    • Timeline: 2-3 business days
    • Template: See Clinician Corner below
  4. Submit via correct portal (Clinic staff)
    • Availity for electronic submission preferred
    • Fax backup: verify current number
    • Timeline: Same day submission
    • Confirmation: Save reference numbers
  5. Track status (Patient/Clinic)
    • Standard decisions: 30-45 days
    • Expedited: 72 hours if urgent
    • Portal: Aetna provider or member login
    • Phone: Member services on insurance card

Clinical Documentation Checklist

Required elements for approval:

  • ✓ Confirmed multiple myeloma or AL amyloidosis diagnosis
  • ✓ ICD-10 codes (C90.00-C90.02 for myeloma, E85.81 for AL amyloidosis)
  • ✓ Treatment line (first-line, relapsed/refractory)
  • ✓ Transplant eligibility status
  • ✓ Combination regimen specified
  • ✓ Bortezomib trial documentation or contraindication
  • ✓ Premedication protocol included
  • ✓ Dosing schedule and duration

Coding and Documentation

Essential Codes

Code Type Code Description Use Case
ICD-10 C90.00 Multiple myeloma not in remission Active disease
ICD-10 C90.01 Multiple myeloma in remission Maintenance therapy
ICD-10 C90.02 Multiple myeloma in relapse Relapsed disease
ICD-10 E85.81 AL amyloidosis Darzalex Faspro indication
HCPCS J9145 Daratumumab injection, 10 mg IV Darzalex
HCPCS J9144 Daratumumab/hyaluronidase, 10 mg Darzalex Faspro SC

Source: HCPCS coding guidance and ICD-10 oncology codes

Documentation Packet Requirements

Provider note must include:

  • Complete diagnosis with staging
  • Prior therapy history with dates and outcomes
  • Current performance status
  • Laboratory values (within 30 days)
  • Treatment goals and expected duration
  • Site of care justification

Letter of medical necessity components:

  • Patient demographics and insurance information
  • Clinical indication with supporting literature
  • Prior authorization criteria addressed point-by-point
  • Contraindications to preferred alternatives
  • Expected clinical outcomes

Submission Process

Form Selection and Completion

Commercial plans:

Medicare plans:

Submission Methods

  1. Electronic (preferred): Availity portal for fastest processing
  2. Fax: Verify current fax numbers on forms
  3. Phone: 1-866-503-0857 (Medicare) or member services number
Tip: Electronic submissions typically process 2-3 days faster than fax submissions.

California Appeals Process

Internal Appeal (First Level)

Timeline: File within 180 days of denial Process:

  1. Submit written appeal with additional documentation
  2. Include point-by-point response to denial reasons
  3. Attach new clinical evidence or studies
  4. Request peer-to-peer review if appropriate

Decision timeframe: 30 days standard, 72 hours expedited

California Independent Medical Review (IMR)

California offers robust external review rights through the Department of Managed Health Care (DMHC).

When to use IMR:

  • Internal appeal denied or delayed beyond 30 days
  • Denial based on "not medically necessary"
  • Experimental/investigational determination

IMR Process:

  1. File online at DMHC website
  2. No fee required
  3. Independent physician experts review case
  4. Success rate: 73% for all appeals
  5. Decision is binding on Aetna

Timeline:

  • Standard IMR: 30 days
  • Expedited IMR: 3-7 days for urgent cases
  • Implementation: 5 days after favorable decision
Note: California's IMR success rate is among the highest in the nation for specialty drug appeals.

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
Step therapy not met Document bortezomib failure/intolerance Treatment dates, outcomes, adverse events
Insufficient clinical information Submit comprehensive medical necessity letter Complete treatment history, labs, imaging
Non-formulary status Request formulary exception Clinical justification, alternative failures
Site of care restriction Justify medical necessity for location Provider capabilities, patient safety factors
Experimental/investigational Provide FDA approval evidence Label information, guideline support

Counterforce Health can help streamline this process by automatically generating targeted appeals that address each specific denial reason with appropriate clinical evidence and regulatory citations, significantly improving approval rates.

Costs & Patient Assistance

Financial Support Options

Manufacturer assistance:

State resources:

  • Covered California premium subsidies
  • Medi-Cal coverage for qualifying patients
  • California prescription drug discount programs

Typical costs:

  • Cash price: Several thousand dollars per dose
  • Insurance coverage: Varies by plan design
  • Medicare Part B: Covered at ASP + 6% methodology

When to Escalate

DMHC Help Center

Contact the DMHC Help Center at 888-466-2219 if:

  • Aetna fails to respond within required timeframes
  • Appeal process is delayed or mishandled
  • You need assistance filing an IMR

Additional Resources

Health Consumer Alliance: Nonprofit providing free appeal assistance Legal aid organizations: For complex cases involving discrimination or bad faith denials California Department of Insurance: For plans not regulated by DMHC

Frequently Asked Questions

How long does Aetna prior authorization take in California? Standard requests: 30-45 days. Expedited requests for urgent medical situations: 72 hours. Electronic submissions process faster than fax.

What if Darzalex is non-formulary on my plan? Request a formulary exception with clinical documentation. If denied, California's IMR process can override non-formulary restrictions when medically necessary.

Can I request expedited review? Yes, if delaying treatment poses serious health risks. Your physician must provide written documentation of medical urgency.

Does step therapy apply if I tried bortezomib outside California? Yes, prior therapy from any location counts. Provide complete documentation of treatment dates, outcomes, and adverse events.

What's the difference between Darzalex and Darzalex Faspro coverage? Both require prior authorization. Darzalex Faspro (subcutaneous) is approved for AL amyloidosis; IV Darzalex is not. Different HCPCS codes apply (J9144 vs J9145).

How much does an IMR cost in California? Nothing. California law prohibits fees for Independent Medical Review requests.

What happens if Aetna doesn't implement a favorable IMR decision? The DMHC can fine Aetna and enforce compliance. Contact the Help Center immediately if implementation is delayed.

Can I use Counterforce Health for my appeal? Yes, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for specialty medications like Darzalex, with expertise in California's regulatory environment.

From our advocates: We've seen many Darzalex appeals succeed when patients provide complete documentation of bortezomib intolerance, even from years earlier. Don't assume old adverse events are irrelevant—detailed records of prior treatment failures significantly strengthen your case. This is a composite example based on common successful appeal patterns, not a guarantee of outcomes.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider and insurance plan for specific guidance. For personalized assistance with appeals and prior authorization, consider consulting with Counterforce Health, which specializes in helping patients navigate complex coverage challenges for specialty medications.

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