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

Blue Cross Blue Shield Virginia's Coverage Criteria for Darzalex/Darzalex Faspro: What Counts as "Medically Necessary"?

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

Blue Cross Blue Shield Virginia requires prior authorization for daratumumab (Darzalex/Darzalex Faspro) with specific medical necessity criteria. To get approved: (1) Have your oncologist document FDA-approved diagnosis (multiple myeloma or AL amyloidosis) with ICD-10 codes, (2) Submit complete prior therapy history showing step therapy compliance or exceptions, and (3) Use Anthem's PA form with supporting clinical documentation. If denied, Virginia's external review process through the State Corporation Commission provides binding appeal rights within 120 days. Start with Anthem's provider portal for current forms and submission guidelines.

Table of Contents

Policy Overview

Anthem Blue Cross Blue Shield Virginia, the state's largest commercial insurer with approximately 43% market share, implemented mandatory prior authorization for daratumumab effective July 1, 2024. This applies to all plan types—HMO, PPO, and POS—for both IV Darzalex and subcutaneous Darzalex Faspro when billed under the medical benefit.

The policy covers Virginia state-regulated commercial plans and some self-funded employer plans that opt into Virginia's regulatory framework. Medicaid and Medicare Advantage plans may have different criteria, though they often mirror commercial requirements.

Where to Find Official Documents:

  • Current PA forms: Anthem Virginia Provider Portal
  • Clinical criteria updates: Provider newsletters (July, November, December 2024)
  • Member coverage details: Individual plan documents and formularies

Indication Requirements

Daratumumab approval hinges on FDA-approved indications with proper diagnostic documentation:

Approved Indications:

  • Multiple myeloma (newly diagnosed and relapsed/refractory)
  • Systemic AL amyloidosis (newly diagnosed)

Documentation Must Include:

  • Confirmed diagnosis with appropriate ICD-10 codes
  • Pathology reports showing clonal plasma cell disorder
  • For AL amyloidosis: Congo red-positive biopsy with light chain typing
  • Evidence of organ involvement or myeloma-defining events (CRAB criteria)

Off-Label Considerations: Off-label uses require additional justification through peer-reviewed literature, NCCN guidelines, or recognized drug compendia. Anthem's medical directors review these requests individually, often requiring peer-to-peer discussions.

Step Therapy & Exceptions

Virginia has strong step therapy protections, but Anthem typically requires patients to try preferred agents first:

Standard Step Therapy Pathway:

  1. Bortezomib-based regimen (preferred first-line proteasome inhibitor)
  2. Lenalidomide or other immunomodulatory drugs
  3. Daratumumab (after documented failure or intolerance)

Medical Exception Pathways: Virginia law allows step therapy overrides when:

  • Previous therapy caused adverse reactions or intolerance
  • Contraindications exist based on comorbidities
  • Clinical evidence shows preferred therapy would be ineffective
  • Emergency situations require immediate access

Documenting Exceptions: Your oncologist must provide detailed records of:

  • Specific adverse events with dates and severity
  • Laboratory evidence of toxicity
  • Clinical notes explaining contraindications
  • Treatment response data showing inadequate efficacy
Tip: Virginia's step therapy protection law requires insurers to respond to exception requests within 72 hours for standard cases, 24 hours for urgent situations.

Quantity and Frequency Limits

Anthem enforces quantity limits aligned with FDA labeling and clinical guidelines:

Dosing Restrictions:

  • IV Darzalex: Maximum per FDA weight-based dosing (16 mg/kg)
  • Darzalex Faspro: 1,800 mg subcutaneous per approved schedule
  • Frequency limits match standard treatment protocols (weekly, then every 2-4 weeks)

Renewal Requirements:

  • Initial approval: Typically 6 months
  • Renewal criteria: Evidence of clinical response or stable disease
  • Progression documentation may require treatment plan modification

Titration and Dose Modifications: Dose reductions for toxicity require clinical documentation and may need separate PA review for non-standard dosing.

Required Diagnostics

Baseline Requirements:

  • Complete blood count with differential
  • Comprehensive metabolic panel
  • Liver function tests
  • Quantitative immunoglobulins
  • Serum protein electrophoresis (SPEP) and immunofixation
  • Serum free light chain assay
  • Beta-2 microglobulin and LDH

Imaging Studies:

  • Skeletal survey or PET/CT for multiple myeloma
  • Echocardiogram for AL amyloidosis cardiac involvement
  • Additional organ-specific imaging as clinically indicated

Documentation Timing: All diagnostic tests should be within 30 days of PA submission unless otherwise specified in treatment protocols.

Site of Care and Specialty Pharmacy

Approved Administration Sites:

  • Hospital outpatient infusion centers
  • Physician office-based infusion suites (with appropriate emergency equipment)
  • Certified ambulatory infusion centers

Specialty Pharmacy Requirements: Anthem mandates use of designated specialty pharmacy networks for daratumumab dispensing. The medication is typically shipped directly to the administration site, not to patients for home storage.

Site of Care Considerations:

  • IV Darzalex: Requires 3-4 hour infusion time with emergency preparedness
  • Darzalex Faspro: 3-5 minute subcutaneous injection, more flexible site options
  • Home administration: Rarely approved, requires exceptional circumstances

Evidence to Support Necessity

Primary Evidence Sources:

  • FDA prescribing information
  • NCCN Clinical Practice Guidelines in Oncology
  • International Myeloma Working Group (IMWG) recommendations
  • Peer-reviewed clinical trials published in major hematology journals

Key Clinical Data Points:

  • Response rates in relevant patient populations
  • Progression-free survival benefits
  • Safety profile compared to alternatives
  • Quality of life improvements

Citation Strategy: Reference specific guideline versions, publication dates, and page numbers. Link to PubMed abstracts or official society websites when possible.

Sample Medical Necessity Narrative

Template Structure for Clinicians:

"Patient is a [age]-year-old with biopsy-confirmed [diagnosis] diagnosed on [date]. Relevant diagnostic studies include [list key findings]. Prior treatments include [specific agents, dates, outcomes]. Current disease status shows [progression/stable/response] based on [specific criteria].

Daratumumab is FDA-approved for this indication and recommended by NCCN guidelines as [line of therapy]. The requested regimen of [specific combination] aligns with published clinical trial data showing [specific efficacy endpoints]. Alternative therapies are not appropriate due to [specific contraindications/prior failures].

Expected treatment duration is [timeframe] with monitoring via [specific assessments]. This treatment represents the most appropriate evidence-based therapy for this patient's clinical situation."

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
Step therapy not met Submit exception request Prior therapy records, adverse event documentation
Insufficient diagnosis documentation Provide complete pathology Bone marrow biopsy, flow cytometry, cytogenetics
Non-formulary status Request formulary exception Comparative effectiveness data, cost analysis
Quantity limit exceeded Justify medical necessity Weight-based dosing calculations, treatment protocol
Missing prior authorization Resubmit with complete forms All required clinical documentation

Virginia Appeals Process

Internal Appeal (Level 1):

  • Timeline: File within 30 days of denial
  • Response time: 15 business days (72 hours urgent)
  • Submission: Anthem member portal or provider portal

External Review: If internal appeals fail, Virginia's State Corporation Commission Bureau of Insurance provides independent review:

  • Eligibility: Medical necessity denials, experimental treatment determinations
  • Timeline: 120 days from final denial to file Form 216-A
  • Process: Independent Review Organization (IRO) conducts binding review
  • Expedited: 72 hours for urgent cases, 6 business days for experimental treatments
  • Contact: Virginia Bureau of Insurance at 1-877-310-6560

Required Documents:

  • Completed Form 216-A
  • Final denial letter from Anthem
  • Medical records release authorization
  • Insurance card copy
  • Supporting clinical documentation
Note: Virginia's external review process has strong patient protections, including expedited cancer treatment reviews that don't require exhausting internal appeals first.

When Coverage Appeals Work

Counterforce Health helps patients and clinicians navigate complex prior authorization denials by turning insurance rejections into targeted, evidence-backed appeals. The platform analyzes denial letters, identifies specific policy gaps, and drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements. For specialty drugs like Darzalex, this systematic approach significantly improves approval rates by ensuring all medical necessity criteria are properly addressed with appropriate supporting documentation.

FAQ

How long does Blue Cross Blue Shield PA take in Virginia? Standard prior authorization decisions are made within 15 business days. Urgent requests receive responses within 72 hours. Incomplete submissions may cause delays.

What if Darzalex is non-formulary on my plan? Request a formulary exception by demonstrating medical necessity and providing comparative effectiveness data. Your oncologist should document why formulary alternatives are inappropriate.

Can I request an expedited appeal? Yes, if your physician certifies that delays could seriously jeopardize your health. Virginia allows expedited external reviews within 72 hours for urgent medical situations.

Does step therapy apply if I failed treatments in another state? Yes, documented treatment failures from any location count toward step therapy requirements. Ensure complete records are transferred to your Virginia oncologist.

What happens if my employer plan is self-funded? Self-funded plans may opt into Virginia's external review process. If not, federal external review through HHS may be available. Contact the Bureau of Insurance for guidance.

How much does external review cost in Virginia? External review is free for patients. Virginia does not charge filing fees for independent review requests.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always consult your specific insurance documents and healthcare providers for personalized guidance. For assistance with complex appeals, platforms like Counterforce Health can help navigate payer-specific requirements and improve approval outcomes.

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