Is continuation of Rystiggo (rozanolixizumab) therapy medically necessary for a patient with Myasthenia Gravis (MG) who has received therapy but shows no improvement in MG-ADL score or MG Manual Muscle Test (MMT), is currently on prednisone, mestinon, and azathioprine, and has a history of increased symptoms when attempting to wean off prednisone?

Continuation of Rystiggo Therapy is NOT Medically Necessary in This Case

Based on the Aetna criteria and current clinical guidelines, continuation of rozanolixizumab (Rystiggo) therapy does not meet medical necessity criteria because the patient has not yet received any treatment with this medication and therefore cannot demonstrate a positive response to therapy. 1

Critical Issue: No Prior Rozanolixizumab Treatment

The fundamental problem with this authorization request is that the patient is requesting "continuation" therapy when they have never received rozanolixizumab. The clinical documentation states: "Previously, [PATIENT] had attempted to get coverage for rozanolixizumab; however, this was denied by insurance." 1

• The Aetna continuation criteria explicitly require "no evidence of unacceptable toxicity or disease progression while on the current regimen" and demonstration of "a positive response to therapy (e.g., improvement in MG-ADL score, MG Manual Muscle Test (MMT), MG Composite)." 1
• Without any prior treatment with rozanolixizumab, it is impossible to document response, tolerability, or lack of disease progression on this specific medication 1

Current Disease Status and Optimization of Standard Therapy

The patient's MG-ADL score has worsened from 0-1 to 3, indicating disease progression despite triple therapy with prednisone 15 mg, mestinon, and azathioprine. However, this progression does not automatically justify bypassing initial authorization requirements. 2, 3

Standard Treatment Algorithm Not Fully Optimized

• Prednisone dosing at 15 mg daily is suboptimal for MuSK-positive generalized myasthenia gravis (MGFA Class IIIb). Guidelines recommend prednisone 1-1.5 mg/kg orally daily for moderate to severe disease 2, 3
• The patient reports side effects limiting prednisone increases, but alternative steroid-sparing immunosuppressants beyond azathioprine have not been documented as tried or failed 4, 5
• Pyridostigmine optimization status is unclear - the documentation does not specify the current dose or whether it has been titrated to the maximum of 120 mg four times daily 2, 3, 6

Appropriate Authorization Pathway

This case requires INITIAL authorization for rozanolixizumab, not continuation authorization. The patient must meet initial therapy criteria, which typically include:

• Documented inadequate response to or intolerance of standard immunosuppressive therapies 2
• Confirmed AChR or MuSK antibody-positive generalized myasthenia gravis (MGFA Class II-IVa) - CONFIRMED: MuSK-positive, MGFA Class IIIb 1, 7
• MG-ADL score ≥3 with non-ocular symptoms - CONFIRMED: MG-ADL = 3 1, 7
• Stable baseline therapy for adequate duration before adding rozanolixizumab 1, 7

Evidence for Rozanolixizumab Efficacy

While rozanolixizumab has demonstrated significant efficacy in the MycarinG phase 3 trial, this does not circumvent the need for proper initial authorization:

• In the pivotal trial, rozanolixizumab 7 mg/kg and 10 mg/kg both showed statistically significant improvements in MG-ADL scores compared to placebo (least-squares mean difference -2.59 and -2.62 points respectively, p<0.0001) 7
• Treatment consisted of subcutaneous infusions once weekly for 6 weeks, followed by observation 1, 7
• The FDA approval is based on this single 6-week treatment cycle design, not continuous maintenance therapy 1

Recommended Clinical Action

The reviewer should DENY this continuation request and redirect to initial authorization with the following requirements:

• Complete documentation of current medication doses (prednisone, pyridostigmine, azathioprine) and duration of stable therapy 2, 3
• Documentation of inadequate response to optimized standard therapy or specific intolerances that prevent optimization 2, 3
• Baseline MG-ADL and QMG scores for comparison after treatment initiation 1, 7
• Confirmation of serum IgG ≥5.5 g/L (required per FDA labeling) 1
• Plan for response assessment at day 43 after treatment initiation to determine if future cycles are warranted 1, 7

Critical Pitfall to Avoid

Do not conflate disease severity or progression with automatic qualification for continuation therapy. Even patients with worsening disease who are excellent candidates for rozanolixizumab must first receive initial authorization, complete at least one treatment cycle, and demonstrate positive response before continuation criteria apply. 1, 7

The distinction between initial and continuation authorization exists specifically to ensure appropriate patient selection and to document treatment response before committing to repeated expensive treatment cycles. 1