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

How to Get Darzalex / Darzalex Faspro (daratumumab) Covered by Aetna in Michigan: Prior Authorization Guide and Appeals Process

Answer Box: Getting Darzalex / Darzalex Faspro Covered by Aetna in Michigan

Aetna requires prior authorization for both Darzalex (IV) and Darzalex Faspro (subcutaneous) in Michigan. Submit your PA request to (866) 752-7021 or fax (888) 267-3277 with complete clinical documentation including diagnosis, prior therapy failures, and treatment plan. If denied, you have 180 days to appeal internally, then 127 days to file for external review with Michigan DIFS. Most approvals come within 30-45 days when step therapy requirements are met.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Process in Michigan
  5. Clinician Documentation Checklist
  6. Cost-Saving Options
  7. When to Escalate
  8. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before first dose Aetna precertification team Aetna PA Policy
Formulary Tier Specialty Tier 4-5 Member portal/plan documents Aetna Formulary
Step Therapy Must try alternatives first Clinical documentation Aetna Multiple Myeloma Policy
Site of Care Medical benefit (clinic) or specialty pharmacy Provider choice CVS Specialty
Appeals Deadline 180 days internal, 127 days external Michigan DIFS Michigan External Review

Step-by-Step: Fastest Path to Approval

1. Verify Coverage and Benefits

Who: Patient or clinic staff
Action: Call Aetna member services at the number on your insurance card
What to ask: Formulary status, prior authorization requirements, specialty pharmacy network
Timeline: Same day

2. Gather Required Documentation

Who: Clinical team
Documents needed:

  • Complete diagnosis with ICD-10 code
  • Documentation of prior therapies and outcomes
  • Recent labs (M-protein, CBC, CMP from past 30 days)
  • Recent imaging (bone survey, PET/CT, or MRI)
  • Treatment plan with dosing and duration

3. Submit Prior Authorization Request

Who: Prescriber or clinic staff
How: Call (866) 752-7021 or fax (888) 267-3277
Forms: Aetna Precertification Form
Timeline: Submit 5-7 business days before needed start date

4. Follow Up on Decision

Timeline: Standard decisions within 30-45 days, expedited within 72 hours
If approved: Coordinate with CVS Specialty or infusion center
If denied: Request detailed denial letter and begin appeal process

Tip: For urgent cases, request expedited review with physician documentation of medical necessity and potential harm from delay.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Step therapy not met Document prior failures/intolerance Detailed treatment history, side effects, progression notes
Off-label use Provide guideline support NCCN Guidelines, FDA labeling, peer-reviewed studies
Insufficient clinical information Submit complete records Labs, imaging, physician notes, treatment rationale
Non-formulary status Request formulary exception Medical necessity letter, alternative failures
Quantity/dosing limits Justify weight-based dosing Patient weight, BSA calculation, FDA dosing guidelines

Appeals Process in Michigan

Internal Appeal (Level 1)

  • Timeline: Must file within 180 days of denial
  • Decision: Within 30 days (expedited: 72 hours)
  • How to file: Call Aetna member services or submit written appeal
  • Required: Denial letter, additional clinical documentation, physician letter

External Review with Michigan DIFS

  • Timeline: Must file within 127 days of final internal denial
  • Decision: Within 60 days (expedited: 72 hours)
  • How to file: Michigan DIFS External Review Form or call (877) 999-6442
  • Cost: Free to patients
  • Decision: Binding on Aetna
Note: For expedited external review, your physician must provide a letter stating that delay would seriously jeopardize your health.

Clinician Documentation Checklist

Medical Necessity Letter Must Include:

Diagnosis and Staging:

  • Multiple myeloma subtype and stage
  • ICD-10 code (C90.00 for multiple myeloma, not having achieved remission)
  • Date of initial diagnosis

Prior Treatment History:

  • Specific drugs tried (bortezomib, lenalidomide, etc.)
  • Duration of each treatment
  • Reason for discontinuation (progression, intolerance, contraindication)
  • Response to prior therapies

Clinical Rationale:

  • Why daratumumab is medically necessary
  • Why alternatives are inappropriate
  • Treatment goals and expected outcomes
  • Dosing rationale (16 mg/kg actual body weight)

Supporting Evidence:

Cost-Saving Options

Manufacturer Support

  • Janssen CarePath: Patient assistance and copay support
  • Eligibility: Most commercial insurance plans
  • Apply: JanssenCarePath.com or call (877) 227-3728

Foundation Programs

  • Patient Access Network (PAN): Multiple myeloma fund
  • HealthWell Foundation: Oncology assistance
  • Good Days: Chronic disease fund

State Resources

  • Michigan Department of Health: Prescription assistance programs
  • Area Agency on Aging: Medicare Part D support for seniors
From our advocates: "We've seen patients successfully appeal Darzalex denials by working closely with their oncology team to document clear treatment failures with standard therapies. The key is showing that alternatives either didn't work or caused intolerable side effects. Most appeals succeed when the clinical story is complete and well-documented."

When to Escalate

Contact Michigan Department of Insurance and Financial Services (DIFS) if:

  • Aetna fails to meet decision deadlines
  • You believe the denial violates Michigan insurance law
  • The appeals process isn't working properly

Contact DIFS:

What to include:

  • Complete appeals timeline
  • All denial letters and documentation
  • Evidence of procedural violations

Frequently Asked Questions

How long does Aetna prior authorization take for Darzalex in Michigan? Standard PA decisions are made within 30-45 days. Expedited requests (for urgent medical need) are decided within 72 hours when supported by physician documentation.

What if Darzalex is not on my Aetna formulary? You can request a formulary exception by demonstrating medical necessity and that covered alternatives are ineffective or inappropriate. Submit supporting clinical documentation with your request.

Can I get an emergency supply while waiting for approval? Yes, Aetna provides a 31-day emergency supply for non-formulary drugs while exceptions are pending. Your pharmacy can request this override.

Does step therapy apply if I tried alternatives outside Michigan? Yes, documented treatment history from any state counts toward step therapy requirements. Ensure your Michigan provider has complete records from previous oncologists.

What's the difference between Darzalex and Darzalex Faspro for insurance purposes? Both require prior authorization, but Darzalex Faspro (subcutaneous) may have different site-of-care requirements. IV Darzalex is typically covered under medical benefits; Darzalex Faspro may go through specialty pharmacy.

How do I request a peer-to-peer review? If initially denied, your oncologist can request to speak directly with Aetna's medical director. This often resolves clinical disagreements more efficiently than written appeals.

What happens if my appeal is denied? After exhausting Aetna's internal appeals, you have 127 days to file for external review with Michigan DIFS. Their decision is binding and often favors patients when medical necessity is clearly documented.

Can I switch between IV and subcutaneous formulations? Yes, both formulations have the same approval criteria. Switching typically doesn't require new prior authorization if you're already approved for one formulation.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Darzalex. Our platform analyzes denial letters, identifies the specific coverage criteria, and generates evidence-backed appeals that speak directly to payer policies. For Michigan patients facing Aetna denials, we help ensure your clinical story is told completely and persuasively.

When dealing with specialty drug appeals, having the right documentation and understanding payer-specific requirements can make the difference between approval and denial. Counterforce Health helps patients and providers navigate these complex processes more effectively.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance plan's official procedures for coverage determinations. Coverage policies and requirements may change; verify current information with Aetna and Michigan DIFS.

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