Neighborhood Health Plan RI Rystiggo Coverage Update

Coverage Criteria for Rystiggo (rozanolixizumab-noli)

Initial Therapy — Initial Approval Criteria

Covered when ALL of the following are met for initiation (Initial Approval Criteria):

Age and prescribing restrictions: Member is at least 18 years of age; prescribed by, or in consultation with, a neurologist; will not be used in combination with other immunomodulatory biologic therapies (e.g., nipocalimab, efgartigimod, efgartigimod alfa with hyaluronidase, eculizumab, ravulizumab, inebilizumab, zilucoplan, etc.); and the member does NOT have any FDA-labeled contraindications to the requested agent.

Diagnosis and disease severity: Submission of medical records to support a diagnosis of generalized myasthenia gravis (gMG); MGFA Clinical Classification II to IVb; positive serologic test for anti-AChR or anti-MuSK antibodies; baseline neurological examination documenting objective signs of weakness and fatiguability (e.g., QMG); and baseline MG-ADL total score of at least 3 with at least 3 points from non-ocular symptoms.

Prior conventional therapy or exceptions: Member has tried and had an inadequate response to at least ONE conventional agent for MG (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) OR has intolerance/hypersensitivity to ONE conventional agent OR has an FDA-labeled contraindication to ALL conventional agents OR required chronic IVIG OR required chronic plasmapheresis/plasma exchange.

Specific biologic requirement: Member must have an inadequate response, intolerance, or FDA-labeled contraindication to Uplizna (inebilizumab) with medical documentation provided.

Dosing documentation: Prescribed dose is provided and is in accordance with FDA-approved labeling based on the member's current documented weight (dosing tiers per labeling).

Rystiggo dosing: once weekly for 6 weeks; <50 kg: 420 mg; 50 to <100 kg: 560 mg; ≥100 kg: 840 mg. Do not initiate subsequent cycles sooner than 63 days from prior cycle start.

Continuation/Renewal Therapy — Renewal Criteria

Renewal covered when ALL of the following are met (Renewal Criteria):

Prior approval and prescriber: Member was previously approved for the requested agent through the plan's Medical Drug Review process; prescribed by, or in consultation with, a neurologist; will not be used in combination with other specified immunomodulatory biologic therapies; member does NOT have any FDA-labeled contraindications; and prescribed dose is provided and in accordance with FDA labeling and documented weight.

Clinical response: Member has an improvement (reduction) of at least 2 points from baseline in the MG-ADL total score sustained for at least 4 weeks OR (if available) an improvement of at least 3 points from baseline in the QMG total score sustained for at least 4 weeks; and improvement in muscle strength testing with fatigue maneuvers compared to baseline.

A minimum of 63 days must have elapsed from the start of the previous treatment cycle.

Ongoing need: Member requires continuous treatment after an initial beneficial response due to new or worsening disease activity.

General coverage criteria

Covered when clinical use aligns with FDA-approved labeling and adopted P&T criteria; Medicare members only when no NCD/LCD exists.

P&T-adopted coverage criteria: Use consistent with FDA labeling and relevant clinical literature; Neighborhood's P&T Committee adopted these clinical coverage criteria to ensure use according to FDA-approved indications and to promote cost-effective options when appropriate.

For Medicare members, these criteria apply only in the absence of a National Coverage Determination (NCD) or Local Coverage Determination (LCD). Individual consideration will be given to each request based on prescriber-submitted information.

Requests for Rystiggo (rozanolixizumab-noli) must not be used in combination with other immunomodulatory biologic therapies. Examples of prohibited concurrent biologics include Imaavy (nipocalimab), Vyvgart (efgartigimod) / Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase), Soliris/Epljivri/Bkemv (eculizumab), Ultomiris (ravulizumab), Uplizna (inebilizumab), and Zilbrysq (zilucoplan) among others; combination use is excluded from coverage.

For Medicare members, the clinical coverage criteria in this policy apply only when there is no applicable National Coverage Determination (NCD) or Local Coverage Determination (LCD). If an NCD or LCD exists for the requested use, that NCD/LCD takes precedence over the plan’s criteria; the plan will provide individual consideration based on prescriber-submitted information where appropriate.

Treatment with Rystiggo is not supported when the member is under 18 years of age. Requests without required diagnostic confirmation will be considered not medically necessary; required documentation includes positive anti‑AChR or anti‑MuSK serology, MGFA Clinical Classification of Class II to IVb, a baseline neurological examination documenting objective weakness/fatiguability (e.g., QMG), and a baseline MG‑ADL total score ≥3 with at least 3 non‑ocular points. Requests lacking these baseline measures or the specified documentation of prior therapies (or valid reasons for not using them) may be denied.

Requests that do not meet the adopted clinical coverage criteria or that lack sufficient prescriber‑submitted documentation may be considered not medically necessary. The plan will review individual requests and may deny coverage when the information provided does not support use consistent with FDA labeling, the P&T‑adopted criteria, or medically accepted indications.

Coding and Billing

Covered HCPCS CodeHCPCSCovered

J9333

Injection, rozanolixizumab-noli, 1 mg; 1 billable unit = 1 mg

NDCsNDC

50474-0980-xx	Rystiggo 280mg/2mL single-dose vial
50474-0981-xx	Rystiggo 420 mg/3 mL single-dose vial
50474-0982-xx	Rystiggo 560 mg/4 mL single-dose vial
50474-0983-xx	Rystiggo 840 mg/6 mL single-dose vial

Covered Diagnosis CodesICD-10Covered

G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation

Medicare Part B / MAC jurisdictionsmixed

MAC jurisdictions text

Listings of Medicare Part B Administrative Contractor jurisdictions and applicable states; Medicare Part B covered diagnosis codes: N/A

MG-ADL baseline and response thresholds — baseline and renewal response criteria

Baseline requirementMG-ADL total score ≥3 with at least 3 points from non-ocular symptoms (documented at baseline).

Renewal clinical responseImprovement of ≥2 points from baseline in MG-ADL total score sustained for ≥4 weeks (alternative: ≥3-point improvement in QMG sustained ≥4 weeks).

Objective strengthDocumentation of improved muscle strength testing with fatigue maneuvers compared to baseline is required for renewal.

Timing requirementA minimum of 63 days must have elapsed from the start of the previous treatment cycle before initiating a subsequent cycle.

Dosing thresholds — weight-based dosing and maximum dose limits

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for this therapy. Initial approvals follow the clinical coverage criteria adopted by the P&T Committee; Medicare members with an applicable NCD/LCD are subject to those determinations instead. Medicare members who have received this medication within the past 365 days are exempt from step therapy requirements for initial approval.

Prior authorization required for non-emergent requests
Medicare NCD/LCD take precedence over plan criteria
Medicare members treated with the agent in the past 365 days: no step therapy

Step Therapy

Step Therapy Intent and Requirements

Step therapy is intended to ensure trials of conventional, less costly, or clinically appropriate therapies before approval of this biologic agent when clinically reasonable.

Step therapy requires trial of at least ONE conventional immunosuppressive agent (e.g., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) unless there is documented intolerance, hypersensitivity, or an FDA-labeled contraindication to that agent

Definitions and Clinical Scales

Myasthenia Gravis Activities of Daily Living (MG-ADL) total score — definition and policy thresholds

What it measuresPatient-reported scale measuring activities of daily living affected by myasthenia gravis (MG-ADL).

Baseline policy thresholdPolicy requires a baseline MG-ADL total score of ≥3 with at least 3 points from non-ocular symptoms for initiation.

Use in pivotal trialPhase 3 trial enrolled patients with MG-ADL ≥3 (median baseline MG-ADL = 8); treatment demonstrated greater reduction vs placebo at Day 43.

Renewal responseRenewal requires ≥2-point reduction from baseline sustained for ≥4 weeks (or substitute ≥3-point QMG improvement sustained ≥4 weeks).

MGFA Clinical Classification — disease class requirement (Class II–IVb)

MGFA classes overview

Background

Rystiggo (rozanolixizumab‑noli) is an FcRn blocker indicated for the treatment of generalized myasthenia gravis in adults who are seropositive for anti‑AChR or anti‑MuSK antibodies. The Neighborhood Health Plan of Rhode Island P&T Committee adopted coverage criteria to align use with FDA‑approved labeling and relevant clinical literature, aiming to ensure medically accepted use, minimize adverse effects, and encourage cost‑effective treatment sequencing.

OpenPayer

Rystiggo (rozanolixizumab-noli) (Subcutaneous) — Coverage Criteria

Coverage Criteria for Rystiggo (rozanolixizumab-noli)

Coding and Billing

Provider Actions, Prior Authorization, and Documentation

Definitions and Clinical Scales

Background