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

How to Get Darzalex / Darzalex Faspro (daratumumab) Covered by Humana in California: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Darzalex / Darzalex Faspro Covered by Humana in California

Yes, Humana covers both Darzalex (IV) and Darzalex Faspro (subcutaneous) daratumumab in California, but prior authorization is required. Your fastest path to approval: 1) Have your oncologist submit a complete PA request through Humana's provider portal with full treatment history and medical necessity documentation, 2) If denied, file an internal appeal within 65 days, then 3) Request California's Independent Medical Review (IMR) through the DMHC for binding external review. Start today by calling Humana at the number on your insurance card to confirm your plan's specific requirements.

Table of Contents

  1. Humana Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Network
  5. Cost-Sharing & Financial Assistance
  6. Submission Process & Required Forms
  7. Appeals Process in California
  8. Common Denial Reasons & Solutions
  9. FAQ

Humana Plan Types & Coverage Implications

Understanding your specific Humana plan type is crucial for navigating Darzalex / Darzalex Faspro coverage in California:

Medicare Advantage Plans: Most Humana members in California have Medicare Advantage coverage. Darzalex is typically covered under Part B (medical benefit) when administered in clinical settings, requiring prior authorization with relatively low denial rates (~3.5%) compared to other major insurers.

Commercial Plans: If you have employer-sponsored Humana coverage, both formulations require PA but may have different tier placements and step therapy requirements than Medicare plans.

Medicaid (Medi-Cal) Plans: Humana's California Medicaid plans follow state-specific formularies with their own PA criteria, often more restrictive than Medicare.

Note: Network restrictions matter significantly. HMO plans require referrals to oncology specialists, while PPO plans offer more flexibility in choosing providers for infusion services.

Formulary Status & Tier Placement

Coverage at a Glance

Requirement Darzalex IV (J9145) Darzalex Faspro SC (J9144) Source
Prior Authorization Required Required Humana PA List
Formulary Tier Specialty (Tier 5) Specialty (Tier 5) Humana Drug List
Step Therapy Yes (varies by indication) Yes (varies by indication) Plan-specific
Site of Care Clinic/Hospital Clinic/Outpatient/Limited Home Coverage policy
Benefit Category Part B (Medical) Part B (Medical) Medicare guidelines

Both formulations are listed on Humana's formulary but placement on the specialty tier means higher coinsurance rates (typically 20-33% after deductible).

Alternative Agents: If denied, Humana may suggest trying isatuximab (Sarclisa), proteasome inhibitors like bortezomib, or IMiDs like lenalidomide first, depending on your treatment history.

Prior Authorization Requirements

Essential Documentation Checklist

Clinical Requirements:

  • Multiple myeloma diagnosis with ICD-10 code (C90.0-) and pathology confirmation
  • Current staging and laboratory results
  • Complete prior therapy history with dates, responses, and discontinuation reasons
  • Body surface area/weight for accurate dosing calculations
  • Premedication protocol for infusion reaction prevention

Provider Requirements:

  • Prescription from board-certified oncologist or hematologist
  • Medical necessity statement referencing FDA labeling or recognized compendia
  • Treatment plan including monitoring schedule

Administrative Details:

  • Current Humana member ID and plan information
  • Correct HCPCS codes (J9145 for IV, J9144 for subcutaneous)
  • Site of care specification and network provider confirmation
Clinician Corner: Medical necessity letters should address the specific indication, document prior therapy failures or contraindications, cite relevant guidelines (NCCN, FDA label), and justify the chosen formulation. Include current disease status and expected treatment duration.

Specialty Pharmacy Network

Humana's preferred specialty pharmacy partner is CenterWell Specialty Pharmacy (formerly Humana Pharmacy), which provides:

  • Streamlined prior authorization coordination
  • Clinical support and adherence monitoring
  • Financial assistance program navigation
  • Home infusion coordination when medically necessary

Key Process Steps:

  1. Your oncologist e-prescribes or faxes the prescription to CenterWell
  2. CenterWell initiates the PA process with your provider
  3. Once approved, they coordinate delivery and administration scheduling
  4. For home infusion, additional medical necessity review is required
Tip: Using CenterWell can expedite the approval process since they're familiar with Humana's specific requirements and can troubleshoot documentation issues directly.

Cost-Sharing & Financial Assistance

Typical Out-of-Pocket Costs

Medicare Advantage: 20% coinsurance after meeting Part B deductible ($240 in 2024), with annual out-of-pocket maximums providing protection against catastrophic costs.

Commercial Plans: Variable based on plan design, typically $100-500+ per administration until reaching annual maximums.

Financial Assistance Options

For Commercial Patients:

  • Janssen copay cards can reduce costs to as low as $5 per treatment
  • Employer-sponsored patient assistance programs

For Medicare Patients:

  • Foundation grants from HealthWell Foundation, Leukemia & Lymphoma Society
  • State pharmaceutical assistance programs
  • Medicare Part B's annual out-of-pocket maximum protection

For All Patients:

Submission Process & Required Forms

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Caregiver): Collect insurance cards, prior treatment records, and recent lab results
  2. Provider Submits PA (Oncologist): Use Humana's provider portal or fax completed forms with all required clinical documentation
  3. Standard Review (7-30 days): Humana reviews submission; expedited review available for urgent cases (72 hours)
  4. Approval Processing: If approved, CenterWell coordinates prescription fulfillment and administration scheduling
  5. Coverage Verification: Confirm benefits, copays, and any site-of-care restrictions before first administration
  6. Ongoing Monitoring: Most approvals require reauthorization every 6 months with progression-free evidence
Provider Script: "I'm calling to submit an urgent prior authorization for daratumumab for my multiple myeloma patient. The patient has failed [specific prior therapies] and requires immediate treatment initiation. I have complete documentation ready including pathology, staging, and treatment history."

Appeals Process in California

California offers robust patient protections through a dual regulatory system and Independent Medical Review (IMR) process.

Internal Appeals Timeline

Level 1 - Redetermination (65 days to file):

  • Standard review: 7 days for Part D, 30 days for Part C
  • Expedited review: 72 hours when health is at risk
  • Submit via Humana's appeals portal with supporting clinical documentation

Level 2 - Independent Review Entity (60 days to file):

  • External reviewer examines Humana's decision
  • Same timelines as Level 1
  • Automatic if you disagree with Level 1 outcome

California Independent Medical Review

After exhausting Humana's internal process, California residents can request an IMR through the Department of Managed Health Care (DMHC):

Timeline: File within 6 months of final denial Decision: 30 days standard, 7 days expedited
Cost: Free to patients Binding: Humana must comply with IMR decisions

How to File:

  1. Complete the IMR application online or call 888-466-2219
  2. Submit denial letters, medical records, and physician statements
  3. DMHC assigns independent medical experts to review your case
From Our Advocates: We've seen multiple myeloma patients successfully overturn Humana denials through California's IMR process, particularly when the denial was based on "experimental" designations for FDA-approved combinations. The key is submitting comprehensive clinical evidence showing medical necessity and appropriate use according to established guidelines.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Step Therapy Not Met Document prior therapy failures or contraindications Treatment timeline, toxicity reports, progression notes
Not Medically Necessary Provide guideline-based justification NCCN guidelines, FDA labeling, peer-reviewed studies
Off-Label Use Reference recognized compendia Micromedex, Lexicomp, clinical literature
Site of Care Restriction Justify medical necessity for specific setting Clinical assessment, safety considerations
Quantity/Frequency Limits Align with FDA-approved dosing Prescriber attestation, BSA calculations

For complex appeals, consider working with Counterforce Health, which specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific requirements.

FAQ

How long does Humana prior authorization take in California? Standard review takes 7-30 days depending on benefit type. Expedited review for urgent cases is completed within 72 hours.

What if Darzalex is non-formulary on my plan? You can request a formulary exception with medical necessity documentation. California's IMR process provides additional appeal rights if denied.

Can I get Darzalex Faspro administered at home? Home administration requires additional prior authorization and must be performed by contracted network providers, not self-administered.

Does step therapy apply if I was treated outside California? Yes, but out-of-state treatment records can satisfy step therapy requirements if properly documented.

How much will I pay out-of-pocket? Medicare patients typically pay 20% coinsurance after deductible. Commercial patients' costs vary by plan design and available assistance programs.

What's the difference between IV and subcutaneous coverage? Both require PA and are covered under Part B when provider-administered. Darzalex Faspro offers shorter administration time but similar coverage requirements.

When to Escalate

Contact California regulators if Humana fails to follow proper procedures:

Department of Managed Health Care (DMHC): 888-466-2219 for HMO and most PPO plans California Department of Insurance: 800-927-4357 for other health policies State Health Insurance Assistance Program (SHIP): Free Medicare counseling at 800-434-0222

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each payer's own rules, incorporating the right medical evidence and procedural requirements to maximize approval success.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies change frequently; always verify current requirements with Humana and consult your healthcare provider for medical decisions. For personalized assistance with complex appeals, consider consulting with healthcare coverage advocates or legal professionals specializing in insurance matters.

Sources & Further Reading

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