By Counterforce Health Team in Rystiggo (rozanolixizumab-noli) —

How to Get Rystiggo (Rozanolixizumab-noli) Covered by Cigna in California: Prior Authorization Guide and Appeal Scripts

Answer Box: To get Rystiggo (rozanolixizumab-noli) covered by Cigna in California, you need confirmed AChR- or MuSK-positive generalized myasthenia gravis and documented failure of standard therapies (pyridostigmine, corticosteroids, immunosuppressants). Submit prior authorization through CignaForHCP.com with complete treatment history. If denied, California's Independent Medical Review (IMR) through DMHC overturns ~72% of health plan denials. Start by calling Cigna at the number on your ID card to confirm current PA requirements.

Table of Contents

Do You Qualify for Rystiggo Coverage?

Likely Eligible:

  • Confirmed generalized myasthenia gravis with AChR- or MuSK-antibody positive status
  • Documented inadequate response or intolerance to pyridostigmine
  • Prior trial of corticosteroids (prednisone) with documented failure or side effects
  • Trial of at least one immunosuppressant (azathioprine, mycophenolate, cyclosporine)
  • Prescribed by or in consultation with a neurologist
  • MG-ADL score documented showing functional impairment

Possibly Eligible:

  • Diagnosed myasthenia gravis but missing antibody documentation
  • Some prior therapies tried but incomplete documentation
  • Contraindications to standard step therapy medications

Not Yet Eligible:

  • No confirmed antibody status (AChR or MuSK testing needed)
  • Haven't tried required prior therapies
  • Lack of neurologist involvement

Fastest Path to Approval

Step 1: Verify Coverage Requirements Call the Cigna number on your insurance card and ask:

  • Is Rystiggo covered under pharmacy or medical benefit?
  • What prior authorization requirements apply?
  • Must I use Accredo specialty pharmacy?

Step 2: Gather Required Documentation Your neurologist needs to compile:

  • AChR or MuSK antibody test results
  • MG-ADL scores and MGFA classification
  • Complete prior therapy history with specific drugs, doses, dates, and outcomes
  • Current treatment regimen and why Rystiggo is medically necessary

Step 3: Submit Prior Authorization

  • Submit through CignaForHCP.com provider portal
  • For Medicare Advantage: Use HSConnect portal or fax to 877-730-3858
  • Include all clinical documentation and step therapy justification

Step 4: Follow Up

  • Standard review: 72 hours for most plans
  • Expedited review: 24 hours if medically urgent
  • Call Cigna if no response within stated timeframe

Step 5: Coordinate with Specialty Pharmacy Once approved, contact Accredo to set up delivery and nursing support.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
Missing antibody documentation Submit AChR or MuSK test results from lab
Insufficient prior therapy Document specific trials of pyridostigmine, steroids, immunosuppressants with doses and outcomes
Not prescribed by specialist Obtain neurologist consultation or referral
Lack of severity documentation Submit MG-ADL scores, hospitalization records, functional assessments
Step therapy not met Request exception with contraindication documentation or peer-to-peer review

If You're Denied: California Appeal Process

California offers robust appeal rights through two agencies depending on your plan type:

Internal Appeals (Required First Step)

  1. File with Cigna within 180 days of denial notice
  2. Submit written appeal with supporting documentation
  3. Request expedited review if delay would harm your health
  4. Timeline: Standard appeals decided within 30 days

External Review: Independent Medical Review (IMR)

After internal appeal denial, California residents can request IMR:

For HMO/Managed Care Plans (DMHC):

  • Call DMHC Help Center: 888-466-2219
  • File online at healthhelp.ca.gov
  • Timeline: 45 days for standard, 72 hours for expedited
  • Success rate: ~72% of health plan denials overturned

For PPO/Indemnity Plans (CDI):

  • Call CDI Consumer Hotline: 800-927-4357
  • Similar timeline and binding decision process
Note: California's IMR is free to patients and has particularly high success rates for specialty medications and rare disease treatments.

Clinician Corner: Medical Necessity Documentation

Essential Elements for Prior Authorization Letter

Diagnosis Confirmation:

  • Specific myasthenia gravis subtype
  • AChR or MuSK antibody titers and dates
  • MGFA classification and MG-ADL scores
  • ICD-10 codes: G70.00 (myasthenia gravis without exacerbation)

Prior Therapy Documentation: Per Cigna's step therapy requirements, document:

  • Pyridostigmine: dose, duration, response, discontinuation reason
  • Corticosteroids: specific agent, maximum dose, side effects or inadequacy
  • Immunosuppressants: azathioprine, mycophenolate, or others tried

Clinical Rationale:

  • Current functional limitations (MG-ADL scores)
  • Why Rystiggo is appropriate over alternatives
  • Expected clinical outcomes and monitoring plan

Supporting Evidence: Reference FDA labeling and American Academy of Neurology guidelines for generalized myasthenia gravis treatment.

Scripts for Common Situations

Patient Script: Calling Cigna

"Hi, I'm calling about prior authorization for Rystiggo, also called rozanolixizumab-noli, for my myasthenia gravis. My member ID is [number]. Can you tell me what documentation is needed and whether this requires step therapy? Also, do I need to use a specific specialty pharmacy?"

Clinic Script: Requesting Peer-to-Peer Review

"I'm requesting a peer-to-peer review for [patient name] regarding denied coverage for Rystiggo. The patient has refractory generalized myasthenia gravis with documented failure of standard therapies. When can we schedule this review with your medical director?"

Appeal Letter Opening

"I am appealing the denial of coverage for Rystiggo (rozanolixizumab-noli) for [patient name], member ID [number]. This medication is medically necessary for treating confirmed AChR-positive generalized myasthenia gravis that has failed multiple standard therapies as documented below..."

Cost Support Options

Manufacturer Support:

  • UCB Patient Access Program: Check eligibility at Rystiggo patient website
  • Copay assistance may reduce out-of-pocket costs significantly

Foundation Support:

  • Patient Access Network Foundation
  • The Assistance Fund
  • Good Days (formerly Chronic Disease Fund)

State Resources:

  • California's Medi-Cal may cover if eligible
  • Covered California marketplace plans with appeals rights
From our advocates: We've seen patients initially denied for "insufficient prior therapy" successfully appeal with detailed documentation of medication trials from previous states. California's IMR process particularly values comprehensive treatment histories and specialist recommendations, so gather records from all providers who've treated your myasthenia gravis.

FAQ

Q: How long does Cigna prior authorization take in California? A: Standard review is typically completed within 72 hours. Expedited reviews for urgent cases are decided within 24 hours.

Q: What if Rystiggo is non-formulary on my Cigna plan? A: You can request a formulary exception through the same prior authorization process. Your doctor must document why formulary alternatives are inadequate or inappropriate.

Q: Can I request expedited appeal if my symptoms are worsening? A: Yes. If delay in treatment could seriously jeopardize your health, request expedited review at both internal appeal and IMR levels.

Q: Does step therapy apply if I failed therapies in another state? A: Yes, prior therapy failures from any location count toward step therapy requirements. Include complete medical records documenting previous treatments.

Q: What's the difference between DMHC and CDI appeals in California? A: DMHC oversees most HMOs and managed care plans, while CDI regulates some PPO and indemnity plans. Both offer Independent Medical Review with similar timelines and success rates.

Q: How much does Rystiggo cost without insurance? A: UCB lists the price at approximately $3,101 per mL, with total regimen costs varying by weight-based dosing. Manufacturer copay programs may significantly reduce out-of-pocket expenses.

Q: Can I appeal directly to California regulators? A: You must first complete Cigna's internal appeal process before requesting Independent Medical Review through DMHC or CDI.

Q: What documents should I keep during the appeal process? A: Save all denial letters, appeal submissions, medical records, and correspondence with Cigna. These may be needed for external review or future reauthorizations.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each plan's own rules, pulling the right evidence and weaving it into appeals that meet procedural requirements while tracking deadlines and required documentation.

This guide is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For additional help with California insurance appeals, contact the DMHC Help Center at 888-466-2219 or visit healthhelp.ca.gov.

Sources & Further Reading

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