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

Do You Qualify for Darzalex Coverage by UnitedHealthcare in New York? Complete Decision Tree & Appeals Guide

Answer Box: Your Path to Darzalex Coverage

UnitedHealthcare requires prior authorization for Darzalex/Darzalex Faspro in New York, with coverage tied to FDA-approved indications and NCCN guidelines. Most likely eligible: confirmed multiple myeloma with specialist prescribing and documented treatment line. First step today: Have your oncologist gather pathology reports, prior treatment history, and cytogenetics, then submit PA via UHC Provider Portal. If denied: New York offers robust external appeals through DFS within 4 months, with 38-45% overturn rates for specialty drugs. Free help available at 888-614-5400.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Your Action Plan
  4. If "Possibly Eligible": Tests and Timeline
  5. If "Not Yet": Alternatives and Exceptions
  6. If Denied: New York Appeals Roadmap
  7. Coverage at a Glance
  8. Common Denial Reasons & Solutions
  9. FAQ: Your Top Questions Answered
  10. Free Resources and Support

How to Use This Decision Tree

This guide walks you through UnitedHealthcare's coverage criteria for Darzalex (IV daratumumab) and Darzalex Faspro (subcutaneous) in New York. Work through each section to determine your eligibility, gather the right documents, and navigate appeals if needed.

Note: This applies to UnitedHealthcare commercial, Medicare Advantage, and Exchange plans in New York. Medicaid managed care may have different pathways.

Eligibility Triage: Do You Qualify?

✅ Likely Eligible if you have:

  • Confirmed multiple myeloma diagnosis (ICD-10 C90.0) with pathology report
  • Oncology or hematology specialist prescribing treatment
  • FDA-approved indication matching your treatment line:
    • Newly diagnosed (transplant-eligible or ineligible)
    • Relapsed/refractory after ≥2 prior therapies including PI + IMiD
  • NCCN-supported regimen (D-Rd, D-VRd, D-Pd, D-Kd, or monotherapy)
  • Recent labs and imaging showing active disease or progression

⚠️ Possibly Eligible if you have:

  • Multiple myeloma diagnosis but missing recent staging workup
  • Off-label combination not explicitly in NCCN guidelines
  • First-line use without clear transplant eligibility assessment
  • Newly diagnosed AL amyloidosis (IV formulation only)

❌ Not Yet Eligible if you have:

  • No confirmed plasma cell disorder diagnosis
  • Non-oncology prescriber without specialist involvement
  • Experimental combinations lacking evidence base
  • Missing documentation of disease progression or prior failures

If "Likely Eligible": Your Action Plan

Document Checklist

Your oncologist should gather:

Essential Documents:

  • Pathology report confirming multiple myeloma
  • Bone marrow biopsy with cytogenetics (del17p, t(4;14), etc.)
  • Recent labs: SPEP, UPEP, free light chains, beta-2 microglobulin
  • Imaging: skeletal survey, MRI, or PET-CT
  • Performance status assessment (ECOG 0-2)

Treatment History:

  • Complete list of prior therapies with dates, doses, duration
  • Documentation of progression or intolerance to each regimen
  • Response assessments (IMWG criteria preferred)

Regimen Justification:

  • Specific Darzalex combination (D-Rd, D-VRd, etc.)
  • NCCN guideline citation for your treatment line
  • Formulation choice (IV vs subcutaneous) with rationale

Submission Path

  1. Submit via UHC Provider Portal using Cancer Therapy Pathways Program
  2. Include J-code: J9145 (IV) or J9144 (subcutaneous)
  3. Specify site of care: office-based preferred over hospital outpatient
  4. Expected timeline: 2-5 business days for standard review
Tip: UnitedHealthcare's Cancer Therapy Pathways Program can auto-approve NCCN-aligned regimens when all criteria are met.

If "Possibly Eligible": Tests and Timeline

Additional Testing Needed

For staging completion:

  • Bone marrow biopsy with flow cytometry and cytogenetics
  • Baseline imaging (whole-body low-dose CT or PET-CT)
  • Cardiac and pulmonary function tests if combination therapy planned

For treatment line clarification:

  • Document specific prior regimens and response durations
  • Obtain progression imaging or lab evidence
  • Consider MRD testing if in apparent remission

Timeline to Re-apply

  • Gather missing data: 2-4 weeks
  • Specialist consultation: 1-2 weeks if not established
  • Resubmit PA: immediately once documentation complete

If "Not Yet": Alternatives and Exceptions

Discuss with Your Oncologist

Immediate alternatives:

  • Lenalidomide + dexamethasone (Rd)
  • Bortezomib-based regimens (VRd, VMP)
  • Carfilzomib combinations (KRd)
  • Clinical trial enrollment

Exception Request Strategy:

  • Document contraindications to standard alternatives
  • Highlight high-risk cytogenetics requiring aggressive therapy
  • Provide peer-reviewed evidence supporting early daratumumab use

If Denied: New York Appeals Roadmap

New York offers some of the strongest patient appeal rights in the nation. Here's your step-by-step path:

Level 1: Internal Appeal (UnitedHealthcare)

Timeline: 180 days from denial date
Process: Submit written appeal with additional clinical evidence
Expected response: 30 days (expedited: 72 hours if urgent)

What to include:

  • Detailed medical necessity letter from oncologist
  • Updated NCCN guideline citations
  • Peer-reviewed studies supporting your specific case
  • Documentation of failed alternatives or contraindications

Level 2: External Appeal (New York DFS)

If internal appeal fails, New York's external review is binding on UnitedHealthcare.

Timeline: 4 months from final adverse determination
Cost: Up to $25 (waived for financial hardship/Medicaid)
Decision timeframe: 30 days standard, 72 hours expedited
Overturn rate: 38-45% overall for specialty drugs

How to file:

  1. Download NY External Appeal Application
  2. Submit via DFS Portal or mail
  3. Include all medical records, denial letters, and physician certification
From our advocates: We've seen New York external appeals succeed for Darzalex when oncologists provide detailed progression evidence and cite specific NCCN recommendations. The key is showing that standard alternatives have failed or are contraindicated, with clear documentation of disease advancement requiring immediate treatment.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for both IV and SC UHC Provider Portal UHC Medical Benefit Drug List
Formulary Status Covered as oncology injectable J9145 (IV), J9144 (SC) UHC IFP Clinical Program
Step Therapy Not typically required for FDA-approved combinations Plan-specific Cancer Therapy Pathways
Site of Care Office-based preferred Medical necessity review UHC Oncology Policy
Appeals Deadline 180 days (UHC), 4 months (NY DFS) Denial letter NY DFS External Appeals

Common Denial Reasons & Solutions

Denial Reason How to Overturn
"Not medically necessary" Submit detailed treatment history, progression evidence, NCCN citations
"Experimental/investigational" Provide FDA labeling, published studies, guideline recommendations
"Step therapy required" Document contraindications or failures of preferred alternatives
"Wrong treatment line" Clarify prior regimens with response durations and progression dates
"Site of care restriction" Justify medical need for hospital vs office-based administration

FAQ: Your Top Questions Answered

Q: How long does UnitedHealthcare PA take in New York?
A: Standard review takes 2-5 business days. Urgent cases (when delay would jeopardize health) get 72-hour decisions.

Q: What if Darzalex is non-formulary on my plan?
A: Both IV and SC formulations are typically covered as medical-benefit drugs under J-codes. Check your specific plan's medical benefit drug list.

Q: Can I request an expedited appeal in New York?
A: Yes. If your health is at serious risk, you can get expedited external appeals decided within 72 hours (24 hours for urgent drug denials).

Q: Does step therapy apply if I failed treatments outside New York?
A: Prior treatment history from any location counts. Document all regimens tried, regardless of where treatment occurred.

Q: What's the difference between IV Darzalex and Darzalex Faspro coverage?
A: Both require PA and are covered under medical benefit. SC formulation may have more flexible site-of-care options due to shorter administration time.

Q: How much does Darzalex cost with UnitedHealthcare?
A: As a medical-benefit drug, you'll pay your plan's coinsurance (typically 10-40%) after deductible. Manufacturer copay assistance may be available for commercially insured patients.

Free Resources and Support

Counterforce Health helps patients navigate insurance denials by turning rejection letters into targeted, evidence-backed appeals. The platform analyzes denial reasons and drafts point-by-point rebuttals using the right medical evidence and payer-specific requirements. Visit Counterforce Health to learn how their system can help streamline your Darzalex appeal with UnitedHealthcare.

New York-Specific Help:

  • Community Health Advocates: Free insurance counseling at 888-614-5400
  • NY DFS Consumer Helpline: File complaints and get external appeal guidance
  • Legal Aid: Pro bono assistance for complex insurance disputes

National Resources:

  • Patient Advocate Foundation: Copay assistance and appeals support
  • CancerCare: Free counseling and financial assistance programs
  • Leukemia & Lymphoma Society: Patient aid programs for blood cancers

Manufacturer Support:

  • J&J withMe Program: Reimbursement guidance and copay assistance
  • Darzalex Access Solutions: Prior authorization and appeals letter templates

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage policies change frequently. Always verify current requirements with UnitedHealthcare and consult your healthcare team for treatment decisions. For personalized insurance help in New York, contact Community Health Advocates at 888-614-5400.

Sources & Further Reading

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