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

How to Get Darzalex / Darzalex Faspro (daratumumab) Covered by Cigna in Virginia: Prior Authorization, Appeals, and Cost Support

Answer Box: Getting Darzalex / Darzalex Faspro Covered by Cigna in Virginia

Cigna requires prior authorization for Darzalex / Darzalex Faspro (daratumumab) in Virginia. Your oncologist must submit clinical documentation showing FDA-approved indication, prior therapy history, and compliance with Cigna's multiple myeloma criteria. If denied, you have internal appeal rights plus Virginia's external review process through the State Corporation Commission. First step today: Have your doctor complete Cigna's Darzalex PA form with detailed treatment history and guideline citations.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Clinical Criteria
  5. Costs and Financial Support
  6. Denials and Appeals
  7. Virginia External Review
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. FAQ

Coverage Basics

Is Darzalex / Darzalex Faspro Covered by Cigna?

Yes, but with restrictions. Darzalex (daratumumab) and Darzalex Faspro are typically covered on Cigna's specialty tier (Tier 5) for FDA-approved indications including multiple myeloma and AL amyloidosis. Coverage requires prior authorization and adherence to specific clinical criteria.

Coverage varies by plan type:

  • Commercial/ACA plans: Usually 50% coinsurance after deductible for Tier 5 specialty drugs
  • Medicare Advantage: Subject to $2,000 annual out-of-pocket maximum for Part D drugs
  • Employer plans: Varies by specific benefit design

Which Cigna Plans Cover Darzalex?

All Cigna health plans in Virginia that include prescription drug coverage can cover Darzalex, but the cost-sharing and authorization requirements differ:

Plan Type Typical Coverage Patient Cost Prior Auth Required
Commercial/ACA Tier 5 Specialty 50% coinsurance Yes
Medicare Part D Specialty tier Varies, capped at $2,000/year Yes
Medicare Part B Medical benefit 20% coinsurance Yes

Prior Authorization Process

Who Submits the Prior Authorization?

Your oncologist or hematologist must submit the prior authorization request. Patients cannot submit PA requests directly to Cigna.

Step-by-Step: Fastest Path to Approval

  1. Doctor completes Cigna's Darzalex PA form - Download the official form
  2. Gather required clinical documentation (see Clinical Criteria section below)
  3. Submit via Cigna provider portal or fax (confirm current submission method with your clinic)
  4. Cigna reviews within 72 hours for urgent requests, 15 days for standard
  5. If approved: Authorization valid for 6-12 months typically
  6. If denied: Internal appeal rights begin immediately

Required Documentation Checklist

Before your doctor submits, ensure these items are ready:

  • Pathology report confirming multiple myeloma or AL amyloidosis diagnosis
  • Complete treatment history with dates, drugs, and outcomes
  • Evidence of prior proteasome inhibitor AND immunomodulatory agent exposure
  • Current disease status and staging information
  • Specific Darzalex regimen requested (combination partners)
  • NCCN or FDA guideline citations supporting the regimen

Timing and Urgency

How Long Does Cigna Prior Authorization Take?

  • Standard requests: Up to 15 calendar days
  • Urgent requests: 72 hours when delay could seriously jeopardize health
  • Incomplete submissions: Additional 15 days after missing information provided

When to Request Expedited Review

Request urgent processing if:

  • Multiple myeloma is rapidly progressing
  • Patient is experiencing significant symptoms affecting daily function
  • Delay in treatment could worsen prognosis or cause irreversible harm

Your oncologist must provide clinical justification for urgency in the PA request.

Clinical Criteria

What Counts as Medical Necessity for Darzalex?

Cigna's coverage policy requires documentation that the requested regimen matches FDA-approved indications or established clinical guidelines.

For Multiple Myeloma, Cigna typically requires:

Indication Required Prior Therapies Acceptable Combinations
Newly diagnosed (transplant-ineligible) None D-VMP, D-Rd
Relapsed/refractory (≥1 prior line) PI + IMiD exposure D-Pd, D-Vd, D-Kd
Relapsed/refractory (≥3 prior lines) PI + IMiD + anti-CD38 Per NCCN guidelines

Key Documentation Requirements:

  • ICD-10 codes: C90.00-C90.02 for multiple myeloma
  • Prior therapy details: Drug names, start/stop dates, best response, reason for discontinuation
  • Current disease status: Relapsed vs. refractory, cytogenetic risk factors if available

Common Reasons for Initial Denial

Based on Cigna's PA form questions, denials often occur when:

  • Missing documentation of required prior PI + IMiD exposure
  • Requested combination not matching Cigna's accepted regimens
  • Insufficient detail about line of therapy or treatment history
  • Off-label use without strong guideline support

Costs and Financial Support

What Will I Pay for Darzalex with Cigna?

Commercial/ACA Plans in Virginia (2025):

  • After meeting deductible: 50% coinsurance for Tier 5 specialty drugs
  • Annual out-of-pocket maximum caps total yearly costs
  • Example: For a plan with $4,400 deductible and $9,100 OOP max, you'd pay the deductible plus 50% coinsurance until reaching $9,100 total

Medicare Plans:

  • Part D coverage capped at $2,000 annual out-of-pocket maximum
  • Part B coverage (infusion setting): 20% coinsurance after Part B deductible

Manufacturer Support Programs

J&J withMe Cost Support:

  • Copay assistance program for eligible commercial insurance patients
  • Patient assistance program for uninsured/underinsured patients meeting income criteria
  • Insurance navigation support for prior authorization and appeals
Note: Manufacturer copay cards cannot be used with Medicare coverage due to federal regulations.

Additional Financial Resources

  • Medicare Extra Help: Reduces Part D premiums, deductibles, and copays for qualifying low-income beneficiaries
  • Virginia Medicaid: May provide additional coverage for dual-eligible patients
  • Hospital financial assistance: Many Virginia cancer centers offer charity care or payment plans

Denials and Appeals

Why Was My Darzalex Request Denied?

Common Cigna denial reasons include:

  • "Not medically necessary" - usually means missing clinical documentation
  • "Step therapy not satisfied" - prior required therapies not documented
  • "Non-formulary" - drug not on your plan's covered list
  • "Quantity limits exceeded" - dosing or frequency outside policy limits

Internal Appeal Process

Timeline: Must appeal within 180 days of denial notice

Required Steps:

  1. Gather the denial letter - identifies specific reason(s) for denial
  2. Doctor submits appeal letter addressing each denial reason point-by-point
  3. Include additional evidence:
    • Updated clinical notes
    • Peer-reviewed studies supporting the regimen
    • NCCN guideline excerpts
    • Letters from other specialists if applicable

Peer-to-Peer Review: Request a clinical discussion between your oncologist and Cigna's medical director. This often resolves denials when the issue is clinical interpretation rather than missing documentation.

Virginia External Review

When Can I Request External Review?

After completing Cigna's internal appeal process, Virginia residents with fully-insured plans can request independent external review through the Virginia State Corporation Commission Bureau of Insurance.

Key Features:

  • Timeline: Must file within 120 days of final internal denial
  • Process: Independent Review Organization (IRO) with oncology expertise reviews your case
  • Decision timeframe: 45 days for standard review, 72 hours for expedited urgent cases
  • Binding result: If IRO overturns denial, Cigna must provide coverage

How to File External Review in Virginia

  1. Complete Form 216-A (External Review Request Form)
  2. Attach required documents:
    • Final denial letter from Cigna
    • Medical records supporting necessity
    • Treating physician's letter
  3. Submit to Virginia Bureau of Insurance within 120-day deadline
  4. Pay no fees - Virginia provides free external review
Tip: Contact the Bureau of Insurance Consumer Services at 1-877-310-6560 for guidance before submitting your request.

Specialty Pharmacy Requirements

Why Was Darzalex Transferred to Specialty Pharmacy?

Cigna typically requires specialty drugs like Darzalex to be dispensed through their contracted specialty pharmacy network (often Express Scripts Accredo). This ensures:

  • Proper handling of temperature-sensitive medications
  • Clinical monitoring and adherence support
  • Coordination with your oncology team

What to Expect from Specialty Pharmacy

  • Initial contact: Pharmacy will call to verify insurance and set up delivery
  • Clinical assessment: Pharmacist may review your treatment plan and side effects
  • Delivery coordination: Medications shipped to your home or infusion center
  • Ongoing support: Refill reminders and adherence monitoring

Troubleshooting Common Issues

Portal or System Problems

If Cigna's provider portal is down or forms aren't accessible:

  • Backup submission: Fax PA requests to the number listed on the Darzalex form
  • Phone follow-up: Call Cigna provider services to confirm receipt
  • Document everything: Keep fax confirmations and call reference numbers

Missing Prior Authorization Forms

If your clinic can't locate current PA forms:

  • Official source: Cigna's Darzalex PA form
  • Provider portal: Log in to Cigna's provider resources section
  • Customer service: Call the provider line on your insurance card

FAQ

Q: How long does Cigna PA take for Darzalex in Virginia? A: Standard requests take up to 15 days; urgent requests are decided within 72 hours when clinical justification supports expedited review.

Q: What if Darzalex is non-formulary on my Cigna plan? A: Your doctor can request a formulary exception with clinical justification showing medical necessity and lack of suitable formulary alternatives.

Q: Can I request an expedited appeal if Cigna denies Darzalex? A: Yes, if your oncologist certifies that delay in treatment could seriously jeopardize your health or ability to regain function.

Q: Does step therapy apply if I've tried other treatments outside Virginia? A: Yes, prior therapies from other states count toward step therapy requirements if properly documented in your medical records.

Q: What's the difference between Darzalex and Darzalex Faspro coverage? A: Both formulations require prior authorization. Darzalex Faspro (subcutaneous) may have different site-of-care requirements than IV Darzalex - verify with Cigna for your specific plan.

Q: How do I know if my Virginia Cigna plan is eligible for state external review? A: Fully-insured commercial plans are eligible. Self-funded employer plans may opt in. Check your denial letter or contact the Virginia Bureau of Insurance for confirmation.

When to Get Additional Help

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex specialty medications like Darzalex. The platform helps patients, clinicians, and specialty pharmacies navigate prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with each payer's specific rules. For Cigna members in Virginia facing Darzalex denials, Counterforce Health can provide the specialized expertise needed to address complex coverage determinations and appeals processes.

If you're struggling with repeated denials or complex clinical situations, consider getting professional help with your appeal. The stakes are too high for multiple myeloma treatment to accept an inappropriate denial without a fight.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage determinations. Coverage policies and requirements may change; verify current information with Cigna and Virginia regulators before making decisions.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.