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

How to Get Darzalex Covered by Blue Cross Blue Shield in Washington: Complete Guide with Appeals Process

Answer Box: Getting Darzalex Covered by Blue Cross Blue Shield in Washington

Fast Track to Approval: Blue Cross Blue Shield plans in Washington require prior authorization for Darzalex (daratumumab), typically approving coverage for multiple myeloma patients who meet specific combination therapy requirements and have documented prior treatment history. Your first step: Contact your Blue Cross Blue Shield plan directly for their current medical policy on daratumumab, then gather comprehensive clinical documentation including diagnosis codes, treatment history, and combination therapy plans before submitting your prior authorization request.

If denied, Washington's strong external review process through certified Independent Review Organizations (IROs) offers an 82% appeal overturn rate for specialty medications.

Table of Contents

Understanding Darzalex Coverage Requirements

Darzalex (daratumumab) is an anti-CD38 monoclonal antibody approved for multiple myeloma treatment and newly diagnosed AL amyloidosis. Blue Cross Blue Shield plans consistently require prior authorization for this specialty medication, with coverage decisions varying by specific plan and indication.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all BCBS plans Member portal or provider directory
Formulary Status Specialty tier (highest cost) Plan-specific drug formulary
Combination Therapy Must be used with other MM drugs NCCN Multiple Myeloma Guidelines
Treatment History Documentation of prior therapies Medical records and treatment summaries
Site of Care Approved infusion centers only Network provider directory
Coverage Duration Initial 6 months with renewal Plan policy documents

Medical Necessity Criteria

Based on typical Blue Cross Blue Shield policies across states, Darzalex coverage requires:

For Newly Diagnosed Multiple Myeloma:

  • Combination with bortezomib, thalidomide, and dexamethasone
  • Combination with bortezomib, lenalidomide, and dexamethasone (renewable up to 2 years for maintenance)
  • Combination with bortezomib, cyclophosphamide, and dexamethasone

For Previously Treated Multiple Myeloma:

  • At least one prior therapy documented
  • Combination with pomalidomide and dexamethasone
  • Single agent use for relapsed or refractory disease
  • Combination with lenalidomide and dexamethasone

Pre-Authorization Preparation

Clinical Documentation Checklist

Essential Medical Records:

  • Pathology report confirming multiple myeloma diagnosis with subtype
  • Complete treatment history with dates, drugs, doses, and outcomes
  • Recent laboratory results (CBC, comprehensive metabolic panel, protein electrophoresis)
  • Imaging studies showing disease status
  • Performance status assessment
  • Documentation of treatment failures or intolerance

Prior Therapy Documentation:

  • Specific drug names, doses, and treatment duration
  • Response assessments (stable disease, progression, partial response)
  • Reasons for discontinuation (progression, toxicity, intolerance)
  • Dates of treatment initiation and completion

Clinician Corner: Medical Necessity Letter

Your oncologist's letter should include:

  1. Patient Problem: Clear diagnosis with ICD-10 codes (C90.00 for multiple myeloma)
  2. Prior Treatments: Detailed history of previous therapies and outcomes
  3. Clinical Rationale: Why Darzalex is medically necessary now
  4. Guideline Support: Reference to NCCN guidelines or FDA labeling
  5. Dosing Plan: Standard dosing schedule (16 mg/kg IV per approved regimen)
  6. Monitoring Plan: Safety assessments and response evaluations
Tip: Include specific combination partners in your request. Most approvals require Darzalex use with at least two other multiple myeloma therapies unless prescribed for maintenance therapy.

Step-by-Step Submission Process

1. Verify Your Specific Blue Cross Blue Shield Plan

Who Does It: Patient or caregiver
Document Needed: Insurance card and member ID
How to Submit: Call member services or check online portal
Timeline: Same day
Next Step: Confirm if your plan is Premera Blue Cross, Regence BlueShield, or another BCBS affiliate

2. Obtain Prior Authorization Form

Who Does It: Healthcare provider's office
Document Needed: Plan-specific PA form
How to Submit: Download from provider portal or request via phone
Timeline: 1-2 business days

3. Complete Clinical Documentation

Who Does It: Oncologist and medical team
Document Needed: Comprehensive medical necessity letter
Timeline: 3-5 business days for thorough documentation

4. Submit Prior Authorization Request

Who Does It: Provider's office (usually prior authorization specialist)
How to Submit: Provider portal, fax, or mail
Timeline: Submit at least 10-14 days before planned treatment

5. Follow Up on Decision

Who Does It: Patient and provider's office
Timeline: Most plans respond within 3-5 business days for standard review, 24-72 hours for expedited review

Note: Washington law requires insurers to make coverage decisions within specific timeframes and provide clear denial reasons if coverage is rejected.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Insufficient prior therapy Document all previous treatments Complete treatment timeline with outcomes
Missing combination therapy Specify mandatory partner drugs Updated prescription with combination partners
Lack of medical necessity Strengthen clinical rationale Enhanced medical necessity letter with guidelines
Step therapy not met Show IV daratumumab trial or contraindication Documentation of IV trial or medical contraindication
Site of care restriction Use approved infusion center Confirm treatment location is in-network

Scripts for Common Situations

Patient Phone Script for Blue Cross Blue Shield: "Hello, I'm calling about prior authorization for Darzalex for multiple myeloma treatment. My member ID is [ID number]. Can you tell me the specific requirements for coverage and provide the prior authorization form? I also need to confirm which infusion centers in my area are approved for this treatment."

Clinic Staff Script for Peer-to-Peer Request: "I'm requesting a peer-to-peer review for [patient name] regarding Darzalex coverage denial. The patient has relapsed multiple myeloma with documented progression on [prior therapies]. This treatment aligns with NCCN guidelines for their specific clinical situation. When can we schedule the physician-to-physician call?"

Washington State Appeals Process

Washington provides robust appeal rights through a multi-level process culminating in independent external review.

Internal Appeals Process

First Level Internal Appeal:

  • Deadline: 180 days from denial notice
  • How to File: Written request to Blue Cross Blue Shield
  • Timeline: Plan must respond within 30 days (standard) or 72 hours (expedited)
  • Required Documents: Original denial letter, additional medical evidence, updated clinical documentation

Second Level Internal Appeal (if available):

  • Deadline: 60 days from first-level denial
  • Process: Similar to first level with different reviewers
  • Timeline: 30 days for standard, 72 hours for expedited

External Review Through Independent Review Organizations

Washington's external review process offers strong patient protections through certified IROs.

How It Works:

  1. Request External Review: Submit within 180 days of final internal denial
  2. IRO Assignment: Washington Insurance Commissioner assigns IRO from rotational registry
  3. Document Submission: Insurer provides records to IRO within 3 business days
  4. Patient Submission: You have 5+ business days to submit additional information
  5. IRO Decision: Independent specialists review case within 30 days (72 hours for expedited)

Success Factors:

  • IRO reviewers are medical specialists in relevant fields
  • Can override plan's medical necessity standards if unreasonable
  • Decision is binding on the insurer
  • 82% overturn rate for specialty medication appeals
Key Advantage: Washington's rotational registry ensures expertise matches your specific medical condition, significantly improving approval odds for complex cases like multiple myeloma.

Filing External Review

Contact Washington Insurance Commissioner:

  • Phone: 1-800-562-6900 (Consumer Advocacy line)
  • Website: insurance.wa.gov
  • Process: Submit request to OIC or directly to insurer, which then notifies OIC

Cost-Saving Options

Manufacturer Support Programs

Johnson & Johnson Patient Assistance Foundation:

  • Free medication for eligible uninsured patients
  • Income-based qualification requirements
  • Application through healthcare provider

Copay Assistance:

  • Available for commercially insured patients (not Medicare)
  • Can significantly reduce out-of-pocket costs
  • Apply at jnjwithme.com

Independent Foundation Grants

Medicare beneficiaries may qualify for grants from independent foundations that provide copay assistance for specialty medications.

When to Escalate

Contact Washington Insurance Commissioner When:

  • Internal appeals are exhausted without resolution
  • Insurer fails to meet response deadlines
  • Process violations or unfair claim handling
  • Need guidance on external review process

Washington Insurance Commissioner:

  • Consumer Advocacy: 1-800-562-6900
  • Online Complaint: insurance.wa.gov
  • Services: Free assistance with appeals, complaint investigation, IRO process guidance
  • Pattern of inappropriate denials
  • Insurer bad faith behavior
  • Complex coverage disputes involving significant costs

FAQ

How long does Blue Cross Blue Shield prior authorization take in Washington? Most plans respond within 3-5 business days for standard review. Expedited reviews for urgent medical conditions receive decisions within 24-72 hours.

What if Darzalex is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Provide evidence that formulary alternatives are ineffective or contraindicated for your specific situation.

Can I request expedited appeal if my condition is urgent? Yes. Washington law requires expedited appeals when delay could seriously jeopardize your health. These receive decisions within 72 hours.

Does step therapy apply if I've failed treatments outside Washington? Treatment history from any location counts toward step therapy requirements. Ensure complete documentation of all prior therapies regardless of where they occurred.

What happens if the IRO overturns my denial? The insurer must provide coverage as determined by the IRO. This decision is legally binding and cannot be appealed by the insurance company.

Are there site of care restrictions for Darzalex infusions? Many plans require treatment at approved infusion centers. Verify your treatment location is in-network before starting therapy to avoid coverage issues.

How much does Darzalex cost without insurance? Single subcutaneous doses typically cost several thousand dollars. IV infusions under Medicare Part B are reimbursed using Average Sales Price (ASP) methodology plus add-on percentages.

Can I get help navigating the appeals process? Yes. Washington's Insurance Commissioner provides free consumer advocacy services at 1-800-562-6900. Counterforce Health also helps patients, clinicians, and specialty pharmacies turn insurance denials into successful, evidence-backed appeals by analyzing denial letters and drafting targeted rebuttals aligned to each plan's specific requirements.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by specific Blue Cross Blue Shield plan and individual circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance.

For additional help with insurance appeals in Washington, contact the Washington State Insurance Commissioner at 1-800-562-6900.

Counterforce Health specializes in helping patients overcome insurance barriers to essential medications. Our platform analyzes denial letters, identifies specific coverage criteria, and creates compelling appeals backed by the right clinical evidence and regulatory guidelines. By turning complex insurance policies into clear action plans, we help ensure patients get access to the treatments their doctors prescribe. Learn more at counterforcehealth.org.

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