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

Get Darzalex (Daratumumab) Covered by Cigna in Ohio: Complete Prior Authorization & Appeal Guide

Answer Box: Quick Path to Coverage

Yes, Cigna covers Darzalex (daratumumab) in Ohio, but requires prior authorization and step therapy. Your fastest path: 1) Have your oncologist submit Cigna's PA form with documentation of failed prior therapy (like lenalidomide or bortezomib), 2) If denied, file internal appeal within 180 days, 3) Request external review through Ohio Department of Insurance if needed. Most approvals come within 30 days when documentation is complete.

First step today: Ask your care team to start the Cigna prior authorization form and gather records of your previous multiple myeloma treatments.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Step Therapy Requirements
  5. Costs and Specialty Pharmacy
  6. Common Denials and How to Fix Them
  7. Appeals Process in Ohio
  8. Renewal and Ongoing Coverage
  9. Troubleshooting Common Issues
  10. FAQ

Coverage Basics

Is Darzalex Covered by Cigna?

Both Darzalex (IV daratumumab) and Darzalex Faspro (subcutaneous daratumumab with hyaluronidase) are covered by most Cigna plans in Ohio, but they require prior authorization. The drugs are classified as specialty medications and typically fall on the highest formulary tier.

Key exception: For Cigna Medicare Advantage plans, Darzalex Faspro (J9144) does not require prior authorization as of 2024.

Which Cigna Plans Cover Darzalex?

  • Commercial/Group plans: Require PA and step therapy
  • Medicare Advantage: Faspro may not need PA; IV formulation varies
  • Medicaid managed care: Follow state Medicaid guidelines plus plan requirements
Note: Coverage specifics can vary by your exact plan. Check your member portal or call the number on your insurance card to confirm your plan's requirements.

Prior Authorization Process

Who Submits the Prior Authorization?

Your oncologist or hematologist must submit the prior authorization request. Cigna requires that specialty drugs like Darzalex be prescribed by or in consultation with an appropriate specialist.

Required Documentation

The Cigna Darzalex prior authorization form requires:

  • Patient information: Name, DOB, member ID, current weight
  • Prescriber details: Name, specialty, NPI number
  • Clinical justification: Multiple myeloma diagnosis with ICD-10 code
  • Treatment history: Documentation of prior therapies tried and failed
  • Dosing details: Specific formulation, dose, frequency, duration

Step-by-Step: Fastest Path to Approval

  1. Gather medical records showing multiple myeloma diagnosis and prior treatments
  2. Complete PA form with all required fields (marked with asterisks)
  3. Attach supporting documents: Chart notes, lab results, prior therapy summaries
  4. Submit via Cigna provider portal or designated fax number
  5. Follow up within 5-7 business days if no response received
  6. Request peer-to-peer review if initial denial occurs
  7. File formal appeal within 180 days if PA is denied

Timing and Urgency

Standard Processing Times

  • Initial PA decision: Up to 30 days for standard requests
  • Expedited PA: 72 hours when delay could jeopardize health
  • Internal appeal: 30 days (72 hours if expedited)
  • External review: 30 days (72 hours if expedited)

When to Request Expedited Review

Mark your request as urgent if:

  • Delay in starting Darzalex could worsen your multiple myeloma
  • You're experiencing disease progression
  • Previous treatments have failed and immediate therapy is needed
Tip: Include physician attestation that delay "could seriously jeopardize health or ability to regain maximum function" for expedited processing.

Step Therapy Requirements

What Must You Try First?

Cigna requires documentation that you've failed, had intolerance to, or have contraindications to at least one prior multiple myeloma regimen. Common first-line treatments include:

  • Lenalidomide-based combinations (Revlimid + dexamethasone)
  • Bortezomib-based combinations (Velcade + other agents)
  • Other proteasome inhibitors (carfilzomib, ixazomib)

Documenting Treatment Failure

Your oncologist should document:

  • Specific regimens tried with dates and duration
  • Reason for discontinuation (progression, toxicity, intolerance)
  • Clinical evidence of failure (lab values, imaging, symptoms)
  • Current disease status requiring Darzalex therapy

Costs and Specialty Pharmacy

Expected Costs

Darzalex is a specialty tier medication, which typically means:

  • Higher copays or coinsurance (often 20-40% of drug cost)
  • Specialty pharmacy requirement through Accredo/Express Scripts
  • Prior authorization before any coverage begins
Important: Exact costs vary by plan. Log into your Cigna member portal to see your specific copay or coinsurance amount.

Specialty Pharmacy Requirements

Most Cigna plans require Darzalex to be dispensed through Accredo Specialty Pharmacy. Benefits include:

  • 24/7 support at 877-732-3431
  • Clinical oversight from oncology-trained pharmacists
  • Patient assistance program coordination
  • Insurance navigation and prior authorization support

Patient Assistance Options

  • Janssen CarePath: Manufacturer copay assistance for eligible commercial patients
  • Independent foundations: May help with copays for cancer patients
  • State programs: Ohio may have additional assistance programs

Contact Accredo or your care team to explore all available options.

Common Denials and How to Fix Them

Denial Reason How to Fix Required Documentation
Insufficient prior therapy Document all previous treatments with dates and outcomes Complete treatment timeline, progression notes
Missing clinical information Submit comprehensive medical records Chart notes, lab results, imaging reports
Non-formulary status Request formulary exception with medical necessity Letter of medical necessity, guideline citations
Quantity limits exceeded Justify dosing based on clinical guidelines FDA labeling, NCCN guidelines, weight-based calculations
Site of care restrictions Document medical necessity for specific setting Clinical rationale for infusion center vs. home

Appeals Process in Ohio

Internal Appeals with Cigna

Timeline: Must file within 180 days of denial

Required steps:

  1. Complete Cigna medical appeal form
  2. Attach all supporting medical records
  3. Include physician letter of medical necessity
  4. Submit via member portal or designated address

Decision timeline: 30 days (72 hours if expedited)

External Review Through Ohio

If Cigna upholds the denial, Ohio residents can request an external review through the Ohio Department of Insurance.

Key details:

  • Deadline: 180 days from final Cigna denial
  • Process: Independent medical experts review your case
  • Decision: Binding on Cigna if overturned
  • Timeline: 30 days (72 hours if expedited)

Contact Ohio Department of Insurance:

  • Phone: 1-800-686-1526
  • Process: File request with Cigna, who notifies Ohio DOI
  • Forms: Available through ODI website
From our advocates: "We've seen external reviews succeed when patients include peer-reviewed studies supporting Darzalex use in their specific situation, along with clear documentation of why standard therapies failed. The key is showing that Darzalex meets recognized treatment guidelines for their case."

Success Rates

While specific Ohio data isn't published, external review overturn rates for oncology drugs often range from 30-50% when strong clinical evidence and physician support are provided.

Renewal and Ongoing Coverage

When to Re-authorize

Most Cigna prior authorizations for Darzalex are approved for one year, but this varies by plan. Your care team should:

  • Track expiration dates and start renewal 30-60 days early
  • Document ongoing medical necessity and treatment response
  • Update any changes in clinical status or dosing

What Triggers Re-review

Cigna may require new authorization if:

  • Dosing changes beyond approved parameters
  • Treatment combination changes (adding other agents)
  • Site of care changes (switching from infusion center to home)
  • Plan year renewal or formulary updates

Troubleshooting Common Issues

Portal or System Issues

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

  • Call provider services at the number on your provider manual
  • Fax submissions to the backup number (verify current fax)
  • Request confirmation of receipt for all submissions

Missing Forms or Documentation

For patients: Contact your oncology office to ensure they have:

  • Complete insurance information
  • All prior treatment records
  • Current clinical status documentation

For providers: Use Cigna's provider portal checklist to ensure all required fields are completed before submission.

Delays in Processing

If your PA is taking longer than expected:

  • Call Cigna to check status and any missing information
  • Request expedited review if clinically appropriate
  • Document all communications for potential appeal

FAQ

How long does Cigna prior authorization take for Darzalex in Ohio? Standard requests: up to 30 days. Expedited requests: 72 hours when delay could jeopardize health.

What if Darzalex is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Include evidence that formulary alternatives are inappropriate or have failed.

Can I request an expedited appeal in Ohio? Yes, both internal appeals with Cigna and external reviews through Ohio DOI can be expedited if delay would seriously endanger your health.

Does step therapy apply if I failed treatments outside Ohio? Yes, prior treatment history from any location counts toward step therapy requirements if properly documented.

What happens if my appeal is denied? After exhausting Cigna's internal appeals, you can request external review through Ohio Department of Insurance. The external review decision is binding on Cigna.

Can I get Darzalex covered for off-label use? Cigna may cover off-label uses with strong clinical evidence and medical necessity documentation, but approval rates are lower than for FDA-approved indications.

How Counterforce Health Can Help

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Darzalex. The platform analyzes your specific denial letter and plan policy, then creates targeted, evidence-backed appeals that address each denial reason with the right clinical citations and documentation. For patients facing Cigna denials in Ohio, this can significantly improve appeal success rates by ensuring all procedural requirements and clinical criteria are properly addressed.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by individual plan. Always consult with your healthcare provider and insurance company for decisions about your specific situation. For additional help with insurance appeals in Ohio, contact the Ohio Department of Insurance at 1-800-686-1526 or visit Counterforce Health for specialized appeal assistance.

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