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

UnitedHealthcare's Coverage Criteria for Darzalex (Daratumumab) in North Carolina: Complete Medical Necessity Guide

Answer Box: Getting Darzalex Covered by UnitedHealthcare in North Carolina

UnitedHealthcare requires prior authorization for Darzalex (daratumumab) with specific medical necessity criteria: confirmed multiple myeloma diagnosis, appropriate treatment line documentation, and FDA-approved or NCCN guideline-supported regimens. Submit PA requests through the UnitedHealthcare Provider Portal with complete clinical documentation. If denied, file internal appeals within 180 days, then external review through Smart NC within 120 days. Success rate for specialty drug appeals in NC: approximately 82%.

First step today: Verify your plan type and gather diagnostic records, treatment history, and prescriber attestation.

Table of Contents

  1. Policy Overview: How UnitedHealthcare Covers Darzalex
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Site of Care and Specialty Pharmacy Requirements
  5. Required Documentation Checklist
  6. Fastest Path to Approval: Step-by-Step Guide
  7. Common Denial Reasons and Solutions
  8. Appeals Process in North Carolina
  9. Cost Assistance and Patient Support
  10. Frequently Asked Questions

Policy Overview: How UnitedHealthcare Covers Darzalex

UnitedHealthcare classifies Darzalex (daratumumab) and Darzalex Faspro as specialty medications requiring prior authorization across all plan types—commercial, Medicare Advantage, and Medicaid managed care. The drug is typically covered under the medical benefit (Part B) rather than pharmacy benefit due to its infusion administration.

Plan Types and Coverage Variations

  • Commercial Plans: Standard PA requirements with 30-day determination timeline
  • Medicare Advantage: Enhanced documentation requirements; expedited review available for urgent cases
  • Exchange Plans: Subject to formulary tier placement; may require step therapy
Note: Self-funded employer plans may have different criteria. Verify your specific plan documents through the UnitedHealthcare member portal.

Medical Necessity Requirements

UnitedHealthcare considers Darzalex medically necessary when specific clinical criteria are met. The insurer follows FDA labeling and NCCN guidelines for coverage determinations.

FDA-Approved Indications (2024)

Indication Combination Regimens Documentation Required
Newly diagnosed multiple myeloma (transplant-ineligible) D-Rd (daratumumab + lenalidomide + dexamethasone) Transplant ineligibility justification
Newly diagnosed multiple myeloma (transplant-eligible) D-VRd (daratumumab + bortezomib + lenalidomide + dexamethasone) Transplant candidacy assessment
Relapsed/refractory multiple myeloma D-Pd, D-Kd, D-Vd combinations Prior therapy documentation
Monotherapy (3rd+ line) Daratumumab alone Evidence of double-refractory status

Key Clinical Criteria

  1. Confirmed Diagnosis: Multiple myeloma per IMWG criteria (ICD-10: C90.0)
  2. Prescriber Qualification: Oncology or hematology specialist
  3. Treatment Line Appropriateness: Must align with FDA labeling or NCCN recommendations
  4. Premedication Protocol: Documented plan for managing infusion reactions

Step Therapy and Exception Pathways

UnitedHealthcare generally does not require step therapy for Darzalex when used in FDA-approved combinations for newly diagnosed multiple myeloma. However, certain scenarios may trigger step therapy requirements.

When Step Therapy May Apply

  • Off-label combinations not supported by major guidelines
  • Use in treatment lines where standard agents haven't been tried
  • Specific plan formulary restrictions

Medical Exception Criteria

Step therapy can be bypassed when:

  • Prior therapy failure: Documented progression or intolerance to required agents
  • Contraindications: Medical conditions preventing use of step therapy drugs
  • Drug interactions: Clinically significant interactions with required medications

Documentation for exceptions: Include specific details about failed therapies, adverse events, contraindications, and clinical rationale in your PA request.

Site of Care and Specialty Pharmacy Requirements

UnitedHealthcare has implemented strict site-of-care policies for Darzalex infusions, effective through 2025.

Approved Infusion Sites

Preferred Settings:

  • Physician office infusion suites
  • Ambulatory infusion centers
  • Home infusion (when clinically appropriate)

Hospital Outpatient (Requires Justification):

  • Severe cardiopulmonary conditions
  • Documented hypersensitivity reactions
  • Complex vascular access needs
  • Initial infusion or therapy restart
Important: Hospital outpatient infusions are limited to 6 months before requiring reassessment and renewed justification.

Specialty Pharmacy Routing

All Darzalex must be sourced through UnitedHealthcare's approved specialty pharmacy network. Providers cannot use their preferred specialty pharmacy without prior approval.

Required Documentation Checklist

Complete documentation is crucial for PA approval. Missing elements are the primary cause of initial denials.

Clinical Documentation

  • Pathology Report: Confirming multiple myeloma diagnosis
  • Treatment History: Detailed record of prior therapies, responses, and reasons for discontinuation
  • Laboratory Results: Recent CBC, comprehensive metabolic panel, protein electrophoresis
  • Staging Information: ISS or R-ISS staging if available
  • Performance Status: ECOG or Karnofsky score
  • Comorbidities: Relevant medical conditions affecting treatment selection

Administrative Requirements

  • Prescriber Attestation: Confirming medical necessity and appropriate use
  • Premedication Protocol: Detailed plan for preventing infusion reactions
  • Monitoring Plan: Schedule for laboratory monitoring and response assessment
  • Site of Care Justification: If requesting hospital outpatient infusion

Fastest Path to Approval: Step-by-Step Guide

Step 1: Verify Coverage and Benefits

Who: Patient or clinic staff
Action: Check formulary status and PA requirements through UnitedHealthcare member portal
Timeline: Same day
Source: UnitedHealthcare Provider Portal

Step 2: Gather Clinical Documentation

Who: Clinical team
Action: Collect all required medical records, lab results, and treatment history
Timeline: 1-2 business days
Key: Ensure documentation is current (within 30 days for labs)

Step 3: Complete Prior Authorization Request

Who: Provider or authorized staff
Action: Submit PA through provider portal with complete documentation
Timeline: Same day submission
Source: OptumRx PreCheck System for automated review when available

Step 4: Follow Up on Determination

Who: Clinic staff
Action: Monitor PA status; respond to requests for additional information
Timeline: 2-5 business days for standard review
Expedited: 72 hours for urgent cases

Step 5: Appeal if Denied

Who: Provider with patient consent
Action: File internal appeal within 180 days of denial
Timeline: 30 days for determination
Next: External review through Smart NC if internal appeal fails

Common Denial Reasons and Solutions

Denial Reason Solution Documentation Needed
Insufficient clinical information Resubmit with complete medical records Pathology report, staging, treatment history
Step therapy not completed Request medical exception Document contraindications or prior failures
Off-label use Provide guideline support NCCN guidelines, peer-reviewed literature
Site of care not appropriate Justify medical necessity Clinical criteria for hospital outpatient use
Prescriber not qualified Transfer to specialist Oncology/hematology consultation
From Our Advocates: We've seen many Darzalex denials overturned by including specific details about why standard treatments failed or were inappropriate. The key is addressing every point in the denial letter with clinical evidence and guideline citations. Don't just resubmit the same information—add the missing pieces that address the insurer's specific concerns.

Appeals Process in North Carolina

North Carolina residents have strong appeal rights, including access to the state's external review program through Smart NC.

Internal Appeals with UnitedHealthcare

Level 1 Internal Appeal:

  • Deadline: 180 days from denial date
  • Timeline: 30 days for determination (expedited: 72 hours)
  • How to Submit: Provider portal, fax, or mail
  • Required: Denial letter, additional clinical evidence, medical necessity letter

Level 2 Internal Appeal:

  • Automatic: If Level 1 is denied
  • Timeline: 30 days for determination
  • Review: Independent medical review

External Review Through Smart NC

If UnitedHealthcare upholds the denial after internal appeals, North Carolina residents can request external review through Smart NC.

Key Features:

  • Free service provided by NC Department of Insurance
  • High success rate: Approximately 82% overturn rate for specialty drugs
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Binding decision: UnitedHealthcare must comply with favorable determinations

To Request External Review:

  1. Call Smart NC at 1-855-408-1212 for assistance
  2. Submit external review request within 120 days of final internal denial
  3. Include all denial letters, medical records, and supporting documentation

Counterforce Health specializes in turning insurance denials into successful appeals by crafting evidence-backed rebuttals that address each payer's specific requirements. Our platform analyzes denial letters and plan policies to create targeted appeals that significantly improve approval odds for complex specialty medications like Darzalex.

Cost Assistance and Patient Support

Manufacturer Support Programs

Janssen CarePath:

  • Copay assistance for eligible patients
  • Coverage gap support
  • Prior authorization assistance
  • Contact: 1-877-CAREPATH (1-877-227-3728)
  • Website: Darzalex Patient Support

Foundation Grants and State Programs

  • Patient Access Network Foundation: Multiple myeloma fund
  • HealthWell Foundation: Copay assistance for eligible patients
  • North Carolina State Health Plan: Special provisions for state employees

Frequently Asked Questions

How long does UnitedHealthcare PA take for Darzalex in North Carolina? Standard determination: 2-5 business days. Expedited review (for urgent cases): 72 hours. The OptumRx PreCheck system can provide automated approval in under 30 seconds when all criteria are met.

What if Darzalex is non-formulary on my plan? Non-formulary drugs require additional documentation demonstrating medical necessity over formulary alternatives. Consider requesting a formulary exception with strong clinical justification.

Can I request an expedited appeal if my condition is urgent? Yes. Both UnitedHealthcare and Smart NC offer expedited review for urgent cases where delay could seriously jeopardize health. Contact your provider to request expedited processing.

Does step therapy apply if I've tried treatments outside North Carolina? Treatment history from other states counts toward step therapy requirements. Ensure your provider includes complete documentation of all prior therapies, regardless of where they were received.

What happens if Smart NC denies my external review? Smart NC's decision is binding under North Carolina law. However, you may have other legal rights to pursue. Consider consulting with a healthcare attorney or patient advocate.

How do I find out if my employer plan is subject to North Carolina external review? Most individual and small group plans qualify. Large employer plans (self-funded ERISA plans) typically don't unless the employer opted in. Check with your HR department or call Smart NC at 1-855-408-1212.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with UnitedHealthcare and consult with your healthcare provider for medical decisions. For personalized assistance with insurance appeals in North Carolina, contact Counterforce Health or Smart NC at 1-855-408-1212.

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