Rystiggo MG denied for failing step therapy by Cigna?

Cigna's specific coverage criteria for rystiggo mg are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

## Why Cigna Requires Step Therapy Before Rystiggo — and How to Appeal

Rystiggo (rozanolixizumab-noli) is approved for generalized myasthenia gravis (gMG) in adults who are anti-AChR or anti-MuSK antibody positive. Cigna's step-therapy protocol typically requires documented trials of one or more earlier-line therapies — often acetylcholinesterase inhibitors and/or corticosteroids and/or non-steroidal immunosuppressants — before authorizing a newer FcRn-targeted biologic. The denial means Cigna's system did not find adequate proof that those earlier steps were tried and failed, caused intolerable side effects, or are clinically contraindicated for this patient.

### Why This Is Appealable

Step-therapy denials are routinely overturned when a prescriber documents: (a) prior therapies that were tried, the dates, and the objective outcomes; (b) specific reasons those therapies are insufficient or inappropriate for this patient; and (c) why Rystiggo is now medically necessary. Many states have enacted step-therapy exception laws that prohibit plans from requiring a step that is contraindicated or that the patient has already failed.

### Federal Appeal Framework

• Internal appeal (ERISA §503 / ACA §2719): You are entitled to a full-and-fair internal review. Non-urgent decisions must be issued within 60 days; expedited urgent requests within 72 hours or less.
• External review (ACA §2719): If the internal appeal is denied, request independent external review. The filing window is generally about four months from the final denial notice — verify the exact date on your letter.
• State step-therapy exception laws: Depending on your state and plan type, you may have a statutory right to a step-therapy exception. Ask Cigna in writing which exception criteria apply.

### Appeal Process and Timeline

1. Obtain Cigna's current Rystiggo/gMG coverage policy and the specific step-therapy requirements. 2. Have the treating neurologist document every prior therapy tried — drug name, approximate dates, doses attempted (refer to the prescribing label for what was indicated), and why each was inadequate. 3. File the written internal appeal within the deadline shown on the denial letter. 4. If upheld, file for external review before the four-month window closes.

### Documentation to Gather

• Prior-treatment history: Chart notes, prescription records, and pharmacy records showing each required step therapy, duration, and clinical outcome or adverse event.
• Diagnosis and antibody status: Confirmed anti-AChR or anti-MuSK seropositivity; neurologist diagnosis notes.
• Clinical severity: Functional assessment scores in the chart demonstrating ongoing or worsening disease despite prior treatment.
• Step-therapy exception basis: If a required step is clinically inappropriate, the prescriber must explain why in writing, citing the applicable guideline organization (e.g., the Myasthenia Gravis Foundation of America treatment guidance) without inventing specific numbers.
• Prescriber medical-necessity letter: Directly addresses each step Cigna requires, confirms what was tried and why Rystiggo is the appropriate next step.

### Criteria-Mapping Structure

List each step-therapy requirement from Cigna's policy. On the same line, cite the chart record that proves compliance with — or a valid exception to — that requirement. A side-by-side table submitted with the appeal letter demonstrates thoroughness and reduces the reviewer's interpretive burden.