By Counterforce Health Team in Uplizna (inebilizumab) —

How to Get Uplizna (inebilizumab) Covered by Cigna in Michigan: Medical Necessity Criteria & Appeal Process

Answer Box: Getting Uplizna (inebilizumab) Covered by Cigna in Michigan

Cigna requires prior authorization for Uplizna (inebilizumab) with specific medical necessity criteria: You must be 18+ with AQP4-positive NMOSD or IgG4-related disease, prescribed by/with a neurologist, and have completed HBV screening. Fastest path: Complete Cigna's prior authorization form, submit via provider portal or CoverMyMeds, and include AQP4 antibody results plus specialist documentation. If denied, you have 180 days to appeal internally, then 127 days for Michigan DIFS external review.

Table of Contents

Coverage Requirements at a Glance

Requirement What it means Where to find it Source
Prior Authorization Required for all requests Cigna provider portal Cigna PA form
Age Limit 18+ years only Coverage policy Policy criteria
Diagnosis AQP4+ NMOSD or IgG4-RD FDA label FDA Access Data
Prescriber Neurologist required Coverage criteria Cigna policy
HBV Screening Mandatory before treatment Safety requirements FDA label
Formulary Status Excluded from Express Scripts National formulary Express Scripts exclusions
Appeal Deadline 180 days (internal) Member materials Cigna appeals
External Review 127 days via DIFS Michigan law DIFS appeals

Policy Overview: How Cigna Manages Uplizna

Cigna treats Uplizna as a high-cost specialty biologic requiring comprehensive review. The medication falls under both medical and pharmacy benefits depending on your plan structure, but most Michigan members will encounter it through Express Scripts/Accredo specialty pharmacy management.

Key policy points:

  • All plan types (HMO, PPO, POS) require prior authorization
  • Express Scripts manages most specialty drug benefits for Cigna
  • Uplizna is excluded from the standard formulary, requiring formulary exceptions
  • J-code J1823 applies for billing when administered in clinical settings
Note: Cigna's policies are updated regularly. Always verify current requirements through the provider portal before submitting requests.

Indication Requirements

Cigna covers Uplizna for two FDA-approved indications, each with specific documentation requirements:

AQP4-Positive NMOSD

  • Laboratory confirmation of anti-aquaporin-4 antibody positivity required
  • Clinical diagnosis of neuromyelitis optica spectrum disorder
  • Specialist involvement (neurologist or neuro-ophthalmologist)
  • ICD-10 code G36.0 (Neuromyelitis optica)
  • Tissue biopsy or clinical evidence of organ involvement
  • Elevated IgG4 levels and supportive histopathology when available
  • Prior glucocorticoid use as documented in MITIGATE trial criteria
  • ICD-10 code D89.1 (Cryoglobulinemia) or organ-specific codes

The FDA approval for IgG4-RD makes Uplizna the first and only approved therapy for this rare condition, which may strengthen coverage arguments.

Step Therapy & Medical Exceptions

Good news: Cigna's current policy does not require step therapy for AQP4-positive NMOSD patients before approving Uplizna. This differs from many other specialty medications and reflects the serious nature of NMOSD relapses.

For IgG4-RD: Given the newness of this indication, step therapy requirements are still evolving. Document any prior treatments including:

  • Glucocorticoid therapy and response
  • Conventional immunosuppressants tried
  • Treatment failures or intolerance

Medical exceptions may be needed if:

  • Patient has contraindications to alternative therapies
  • Prior treatment failures are well-documented
  • Urgent clinical need exists

Required Diagnostics & Documentation

Laboratory Requirements

Test Timing Purpose Documentation needed
AQP4 antibody Within 12 months Confirm NMOSD diagnosis Lab report with positive result
HBV panel (HBsAg, anti-HBc) Within 30 days Safety screening Complete hepatitis B serology
IgG4 level Within 6 months Support IgG4-RD diagnosis Elevated levels (>135 mg/dL typical)
Complete blood count Baseline Monitor for infections Recent CBC with differential

Clinical Documentation

  • Detailed history of relapses or organ involvement
  • Prior treatment responses and failures
  • Contraindications to alternative therapies
  • Specialist consultation notes
Tip: HBV screening is non-negotiable due to reactivation risk with B-cell depletion. Delay in obtaining these results will delay approval.

Site of Care & Specialty Pharmacy Routing

Cigna routes Uplizna through specific channels to manage costs and ensure proper administration:

Pharmacy Benefit:

  • Accredo Specialty Pharmacy is the mandatory distributor
  • Home infusion or outpatient infusion center administration
  • No retail pharmacy dispensing allowed

Medical Benefit (Buy-and-Bill):

  • J-code J1823 for billing
  • Physician office or hospital outpatient administration
  • Prior authorization still required even under medical benefit

Administration Requirements:

  • 90-minute infusion time for each 300 mg dose
  • Premedication may be required (antihistamines, corticosteroids)
  • Monitoring for infusion reactions mandatory

For more details on administration, consult the official prescribing information.

Evidence to Support Medical Necessity

When submitting your prior authorization or appeal, include evidence from these authoritative sources:

Clinical Guidelines

  • FDA prescribing information for dosing and safety
  • American Academy of Neurology practice guidelines for NMOSD
  • International Panel on NMOSD Diagnosis criteria (2015)
  • ACR/EULAR classification criteria for IgG4-RD

Peer-Reviewed Literature

  • PREVENT study data for NMOSD efficacy
  • MITIGATE trial results for IgG4-RD (87% flare reduction)
  • Safety data from clinical trials and real-world experience

Sample Medical Necessity Statement

"Patient is a [age]-year-old with biopsy-confirmed AQP4-positive NMOSD who has experienced [number] relapses despite conventional therapy. AQP4 antibody testing confirmed positivity on [date]. HBV screening completed [date] with negative results. Per FDA labeling and AAN guidelines, Uplizna represents appropriate therapy for this rare, potentially devastating condition. Alternative therapies are contraindicated due to [specific reasons]."

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not AQP4-positive" Submit lab confirmation AQP4 antibody test results
"Missing specialist" Get neurologist consultation Specialist evaluation note
"Incomplete HBV screening" Complete all tests HBsAg, anti-HBc, anti-HBs results
"Non-formulary drug" Request formulary exception Medical necessity letter
"Experimental/investigational" Cite FDA approval FDA label and approval letter
"Site of care not approved" Verify infusion center Network provider confirmation

Appeals Playbook for Michigan

If Cigna denies your initial prior authorization, Michigan provides robust appeal protections:

Internal Appeals (Cigna)

  1. Timeline: 180 days from denial notice
  2. How to submit: Cigna appeals form
  3. Address: Cigna Appeals Unit, PO Box 188011, Chattanooga, TN 37422
  4. Decision timeframe: 60 days (standard), 72 hours (expedited)

External Review (Michigan DIFS)

  1. Timeline: 127 days after final internal denial
  2. How to request: DIFS external review form
  3. Decision timeframe: 60 days (standard), 72 hours (expedited)
  4. Contact: Michigan DIFS at 877-999-6442

Expedited Appeals: If your doctor certifies that delay would seriously jeopardize your health, both Cigna and DIFS must decide within 72 hours.

From our advocates: "We've seen Michigan external reviews overturn about 40% of Cigna specialty drug denials when strong clinical evidence is provided. The key is thorough documentation of medical necessity and specialist support. One composite case involved a patient whose NMOSD denial was overturned after the external reviewer confirmed that AQP4-positive status and prior relapse history clearly met FDA criteria—something the initial Cigna review had overlooked."

Costs & Patient Support Programs

Uplizna carries significant costs—approximately $420,000 in year one and $280,000 annually thereafter. Several support options exist:

Manufacturer Support:

  • Amgen SupportPlus program for eligible patients
  • Copay assistance may reduce out-of-pocket costs
  • Prior authorization support through AmgenByYourSide.com

Foundation Grants:

  • Patient Advocate Foundation
  • National Organization for Rare Disorders (NORD)
  • HealthWell Foundation (when funds available)

State Programs:

  • Michigan's Medicaid program may cover if eligible
  • State pharmaceutical assistance programs

FAQ

How long does Cigna prior authorization take for Uplizna in Michigan? Standard review takes up to 5 business days. Urgent requests with physician certification can be expedited to 72 hours or less.

What if Uplizna is excluded from my formulary? Request a formulary exception through Cigna's standard process. Include medical necessity documentation and specialist support for the request.

Can I get an expedited appeal if my NMOSD is relapsing? Yes. Have your neurologist write a letter stating that delay would seriously jeopardize your health. Both Cigna and Michigan DIFS must decide expedited appeals within 72 hours.

Does step therapy apply if I've tried other treatments outside Michigan? Document all prior therapies regardless of where they were tried. Cigna generally recognizes treatment history from other states when properly documented.

What's the difference between medical and pharmacy benefits for Uplizna? Pharmacy benefit routes through Accredo with J-code billing. Medical benefit allows physician buy-and-bill but still requires prior authorization.

How do I know if my infusion center is in-network? Contact Cigna member services or check their provider directory online. Accredo can also help identify approved infusion sites.

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Uplizna. Our platform analyzes denial letters, identifies the specific coverage criteria that weren't met, and drafts targeted appeals with the right clinical evidence and payer-specific language. For Michigan patients facing Cigna denials, we help navigate both internal appeals and DIFS external reviews with documentation that meets each step's specific requirements.

For patients and clinicians dealing with Uplizna coverage challenges, Counterforce Health provides the expertise to transform denials into approvals through evidence-backed advocacy.

Sources & Further Reading

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 the most current coverage requirements. If you need help with appeals or coverage issues, contact Michigan DIFS at 877-999-6442 or visit their consumer portal.

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