How to Get Darzalex/Darzalex Faspro (Daratumumab) Covered by Cigna in California: Complete Prior Authorization & Appeals Guide
Answer Box: Getting Darzalex Covered by Cigna in California
Darzalex/Darzalex Faspro requires prior authorization from Cigna, but approval is achievable with proper documentation. In California, you have strong appeal rights through the DMHC's Independent Medical Review process if initially denied.
Fastest path to approval:
- Submit Cigna's prior authorization form with complete clinical documentation
- Document prior therapy failures (lenalidomide, bortezomib, or other required treatments)
- If denied, file internal appeal within 180 days, then request California IMR
First step today: Contact your oncologist to gather prior therapy records and confirm your multiple myeloma diagnosis documentation is complete.
Table of Contents
- Before You Start: Plan Verification
- What You Need to Gather
- Step-by-Step: Fastest Path to Approval
- Coverage Requirements at a Glance
- Follow-Up and Timeline Management
- Common Denial Reasons & How to Fix Them
- Appeals Playbook for California
- Patient Phone Scripts
- Costs and Financial Assistance
- FAQ: California-Specific Questions
Before You Start: Plan Verification
Confirm your Cigna plan type by checking your member ID card or logging into your Cigna portal. Most Cigna plans in California manage specialty drugs like Darzalex through Express Scripts/Accredo specialty pharmacy.
Key verification steps:
- Check if Darzalex is on your plan's formulary (typically Tier 5 specialty)
- Confirm your oncologist is in-network with Cigna
- Verify whether you need referrals for specialty care
- Note that Darzalex is covered under the medical benefit (not pharmacy benefit)
Tip: Call the number on your insurance card to confirm your specific plan's requirements before starting the prior authorization process.
What You Need to Gather
Clinical Documentation:
- Multiple myeloma diagnosis with ICD-10 codes (C90.00, C90.01, or C90.02)
- Pathology reports confirming diagnosis
- Staging information and disease progression notes
- Complete list of prior therapies with dates, doses, and outcomes
Prior Therapy Documentation (Required):
- At least one prior multiple myeloma regimen must be documented
- Common required therapies: lenalidomide-based combinations, bortezomib-based regimens, or other proteasome inhibitors
- Documentation of failure, intolerance, or contraindications to prior treatments
Additional Requirements:
- Current lab results (CBC, comprehensive metabolic panel, protein electrophoresis)
- Prescriber's NPI number and specialty certification
- Patient's current weight and performance status
Step-by-Step: Fastest Path to Approval
1. Complete Cigna's Prior Authorization Form
Who does it: Your oncologist's office
Document needed: Cigna Darzalex PA form
How to submit: CoverMyMeds portal or fax to (855) 840-1678
Timeline: Submit immediately after gathering documentation
2. Submit Supporting Clinical Evidence
Who does it: Medical office staff
Documents needed: Prior therapy summaries, lab results, progress notes
How to submit: Attach to PA form or submit separately via portal
Timeline: Same day as PA form submission
3. Route Through Specialty Pharmacy
Who does it: Prescriber
Action needed: Ensure prescription is sent to Accredo or approved specialty pharmacy
Why important: Cigna often requires specialty pharmacy dispensing
Timeline: Coordinate with PA submission
4. Follow Up Within 72 Hours
Who does it: Patient or caregiver
Action: Call Cigna to confirm receipt and get reference number
Phone number: Number on insurance card
Timeline: 2-3 business days after submission
5. Track Decision Timeline
Standard processing: 15 business days for non-urgent requests
Expedited processing: 72 hours if marked urgent with clinical justification
California requirement: Cigna must respond within state-mandated timeframes
6. Prepare for Potential Peer-to-Peer
Who participates: Your oncologist and Cigna medical director
When requested: If initial review needs clarification
Preparation: Have NCCN guidelines and clinical rationale ready
7. Plan Renewal Strategy
Timeline: Reauthorization typically needed every 12 months
Documentation: Updated response assessment and continued medical necessity
Coverage Requirements at a Glance
| Requirement | Details | Where to Find | Source |
|---|---|---|---|
| Prior Authorization | Required for all plans | PA form submission | Cigna Policy |
| Formulary Tier | Tier 5 (Specialty) | Plan formulary document | Cigna Formulary |
| Step Therapy | 1+ prior MM regimen | Clinical documentation | Cigna PA requirements |
| Prescriber Specialty | Oncology/Hematology | Provider credentials | Cigna network directory |
| Diagnosis Codes | C90.00-C90.02 | Medical records | ICD-10 coding manual |
| Appeals Deadline | 180 days (commercial) | Denial letter | Cigna Appeals |
Follow-Up and Timeline Management
California-Specific Timelines:
- Standard PA decision: 5-15 business days
- Expedited PA decision: 72 hours with clinical urgency
- Internal appeal decision: 30 days standard, 72 hours expedited
- IMR decision: 30 days standard, 3 days expedited
When to Call Cigna:
- Day 3: Confirm receipt of PA request
- Day 10: Check status if no decision received
- Day 16: If approaching deadline, request expedited review
Note: Document all phone calls with Cigna, including representative names, reference numbers, and promised follow-up dates.
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Documentation |
|---|---|---|
| Medical necessity not established | Submit NCCN guideline citations | Clinical notes showing disease progression |
| Prior therapy not documented | Provide detailed treatment history | Pharmacy records, infusion records |
| Wrong prescriber specialty | Update provider credentials | Oncologist NPI and board certification |
| Step therapy not met | Document failed prior regimens | Treatment summaries with outcomes |
| Quantity limits exceeded | Justify dosing per FDA label | Weight-based dosing calculations |
Appeals Playbook for California
Internal Appeal (First Level)
Deadline: 180 days from denial (commercial plans), 65 days (Medicare)
How to file: Cigna appeals portal or written request
Required documents: Denial letter, medical records, prescriber letter
Decision timeline: 30 days standard, 72 hours expedited
Peer-to-Peer Review
When available: After written appeal or upon request
Process: Your oncologist speaks directly with Cigna medical director
Preparation: Have clinical guidelines, patient history, and treatment rationale ready
California Independent Medical Review (IMR)
Eligibility: After internal appeal denial or 30-day wait
How to apply: DMHC website or call (888) 466-2219
Cost: Free to patients
Decision timeline: 30 days standard, 3 days expedited
Success rate: Approximately 61% of health plan decisions overturned
California Advantage: The DMHC's IMR process is binding on Cigna and has strong success rates for specialty drug appeals with proper clinical documentation.
Patient Phone Scripts
Checking PA Status
"Hi, I'm calling to check the status of a prior authorization request for Darzalex. My member ID is [number], and the PA was submitted on [date]. Can you provide the reference number and current status?"
Requesting Expedited Review
"I need to request expedited processing for my Darzalex prior authorization. My oncologist has documented that any delay could seriously impact my health due to disease progression. Can you escalate this to urgent status?"
Appeal Follow-Up
"I'm following up on my appeal for Darzalex coverage. The reference number is [number]. Can you confirm the appeal was received and provide the expected decision date?"
Costs and Financial Assistance
Manufacturer Support:
- Janssen CarePath offers copay assistance for eligible patients
- Income-based eligibility requirements apply
- May reduce out-of-pocket costs significantly
California State Programs:
- Medi-Cal coverage for eligible low-income patients
- California Prescription Drug Discount Program
- Health Consumer Alliance for appeal assistance
Foundation Grants:
- Multiple myeloma-specific foundations offer treatment grants
- Patient Advocate Foundation copay relief programs
From our advocates: We've seen patients successfully reduce Darzalex costs from thousands per month to under $100 by combining manufacturer copay cards with thorough insurance appeals. The key is applying for financial assistance early in the treatment process, even before insurance approval.
FAQ: California-Specific Questions
How long does Cigna prior authorization take in California?
Standard requests take 5-15 business days. Expedited requests with clinical urgency are processed within 72 hours. California regulations require timely processing.
What if Darzalex is non-formulary on my plan?
You can request a formulary exception through Cigna's appeals process. Your oncologist must provide clinical justification for why covered alternatives are inappropriate.
Can I request an expedited appeal in California?
Yes, if your oncologist documents that delay could seriously jeopardize your health. Both Cigna and California's IMR process offer expedited timelines.
Does step therapy apply if I've tried treatments outside California?
Yes, prior therapy documentation from any state counts toward step therapy requirements. Ensure your new California oncologist has complete treatment records.
What's the difference between Cigna's appeal and California's IMR?
Cigna's internal appeal is the first step. If denied, California's IMR provides an independent medical review by specialists not employed by Cigna. IMR decisions are binding.
How much does Darzalex cost without insurance in California?
A single dose can cost several thousand dollars. Annual treatment costs often exceed $150,000, making insurance coverage essential.
Can I use any oncologist for Darzalex in California?
Your oncologist must be in Cigna's network and board-certified in oncology or hematology. Out-of-network providers may require additional authorization.
What happens if I miss the appeal deadline?
California law provides some flexibility for good cause delays. Contact the DMHC Help Center immediately to discuss options if you've missed deadlines.
Getting Expert Help
Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Darzalex. Their platform analyzes denial letters, identifies specific appeal strategies, and drafts evidence-backed responses that align with each payer's requirements. For patients facing Cigna denials in California, this targeted approach can significantly improve approval odds while reducing the administrative burden on patients and clinicians.
When appeals become complex or time-sensitive, working with specialists who understand both Cigna's specific requirements and California's regulatory framework can make the difference between approval and continued delays. The combination of proper clinical documentation, strategic appeal timing, and California's strong patient protection laws creates a favorable environment for overturning initial denials.
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider regarding treatment decisions and with qualified professionals for insurance or legal matters. Coverage policies and requirements can change; verify current information with Cigna and California regulators.
Sources & Further Reading
- Cigna Darzalex Prior Authorization Form (PDF)
- California DMHC Independent Medical Review
- Cigna Appeals and Grievances Process
- Cigna Medicare Appeals Information
- DMHC Help Center: (888) 466-2219
- Janssen CarePath Patient Support
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