DraftMass General Brigham Health PlanPolicy N/A

Complement Inhibitors and Miscellaneous Immunosuppressive Agents

Prior authorization, coverage criteria, and continuation requirements for specified complement inhibitors and related immunosuppressive biologics for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyComplement Inhibitors and Miscellaneous Immunosuppressive Agents

Policy CodePolicy N/A

Change TypeMultiple material revisions (agent additions, criteria updates, durations)

Effective Date02/18/2025

Next Review DateN/A

Key ActionObtain prior authorization and submit required specialist documentation and recent labs (e.g., Hb, antibody or IgG results) per the specific agent criteria.

SourceLink

POLICY UPDATE CHANGES

Added Rystiggo and Vyvgart Hytrulo to policy requiring prior authorization through the medical benefit.

Criteria added for Soliris for the off-label diagnosis of PLE/CHAPLE and a new appendix with age‑adjusted serum IgG reference ranges was created.

Initial approval and reauthorization durations updated for multiple agents (examples: Soliris 6 months; Vyvgart 2 months; Rystiggo/CIDP 3 months).

Myasthenia gravis criteria now include disease severity and requirement for trial with IVIG or plasmapheresis with glucocorticoids.

Removed vaccination requirement and moved certain products between medical and pharmacy management (e.g., Tavneos removed from MB).

~12named products covered

2-6 monthsinitial approval timeframes

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up to 1 yrreauthorization

multipletherapies listed

Coverage Criteria and Initial/Continuation Rules

inv-01: Enjaymo (sutimlimab-jome) Initial Therapy

Covered when ALL of the following are met:

Enjaymo initial criteria: 1) Diagnosis of cold agglutinin disease (CAD); 2) Prescriber is a hematologist or consult notes from a specialist are provided; 3) Member is ≥18 years of age; 4) Hemoglobin (Hb) <10 g/dL documented within the last 60 days; 5) Requested dosing is appropriate per product labeling.<10 g/dL (within 60 days)

inv-02: Rystiggo (rozanolixizumab-noli) Initial Therapy

Covered when ALL of the following are met:

Rystiggo initial criteria: 1) Diagnosis of generalized myasthenia gravis; 2) Member is ≥18 years of age; 3) Member is AChR or MuSK antibody positive; 4) Prescriber is a neurologist or neurology consult notes are provided; 5) Inadequate response, adverse reaction, or contraindication to pyridostigmine; 6) BOTH of the following: (a) ONE of: member has severe disease requiring faster-onset medication OR inadequate response/adverse reaction/contraindication to IVIG or plasmapheresis with glucocorticoids; (b) Inadequate response or adverse reaction to TWO of the following (or contraindication to all): azathioprine, cyclosporine, mycophenolate, glucocorticoids (e.g., prednisone), tacrolimus; 7) OR inadequate response, adverse reaction, or contraindication to Vyvgart (efgartigimod) or Vyvgart Hytrulo when applicable (e.g., alternative therapy trial requirement); 8) Requested dosing is appropriate per product labeling.

Step-therapy logic requires documentation of trials or contraindications as specified.

inv-03: Soliris (eculizumab) Initial Therapy

Covered when ALL of the following are met for each indicated diagnosis:

Soliris for atypical HUS (aHUS): 1) Diagnosis of atypical hemolytic-uremic syndrome (aHUS); 2) Prescriber is a hematologist or nephrologist or consult notes from a specialist are provided; 3) Requested dosing is appropriate per product labeling.

Soliris for generalized myasthenia gravis: 1) Diagnosis of generalized myasthenia gravis; 2) Member is ≥18 years of age; 3) Member is AChR antibody positive; 4) Prescriber is a neurologist or neurology consult notes are provided; 5) Inadequate response, adverse reaction, or contraindication to pyridostigmine; 6) BOTH of the following: (a) ONE of: member has severe disease requiring faster-onset medication OR inadequate response/adverse reaction/contraindication to IVIG or plasmapheresis with glucocorticoids; (b) Inadequate response or adverse reaction to TWO of the following (or contraindication to all): azathioprine, cyclosporine, mycophenolate, glucocorticoids (e.g., prednisone), tacrolimus; 7) Requested dosing is appropriate per product labeling.

inv-04: NMOSD Initial Therapy

Covered when ALL of the following are met:

NMOSD criteria: 1) Diagnosis of neuromyelitis optica spectrum disorder (NMOSD); 2) Documentation of a positive serologic test for anti–aquaporin-4 (AQP4) antibodies; 3) Member is ≥18 years of age; 4) Requested dosing is appropriate per product labeling.

Applies to NMOSD agents listed (e.g., Soliris, Uplizna).

inv-05: PNH Initial Therapy

Covered when ALL of the following are met:

PNH criteria: 1) Appropriate diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); 2) Member is ≥18 years of age; 3) Requested dosing is appropriate per product labeling.

inv-06: PLE/CHAPLE Initial Therapy

Covered when ALL of the following are met (off‑label CHAPLE/PLE requests):

PLE/CHAPLE initial criteria: 1) Diagnosis of CD55‑deficient protein‑losing enteropathy (PLE) or CHAPLE disease (complement hyperactivation, angiopathic thrombosis, and protein‑losing enteropathy); 2) Member is ≥2 months of age; 3) Prescriber is a specialist in rare genetic or hematologic diseases or consult notes from a specialist are provided; 4) Requested dosing is appropriate per product labeling; 5) For recertification: documentation of clinical improvement or no worsening of symptoms (e.g., abdominal pain, bowel movements, edema) AND either an increase in serum albumin from baseline or stabilization above the lower threshold for normal range, and ONE of: increase in serum IgG from baseline or IgG stabilized above the age‑adjusted lower threshold (see appendix age‑adjusted IgG reference ranges).

Providers must submit serum IgG laboratory testing; lab‑specified age‑adjusted reference ranges in the medical record are acceptable in lieu of the appendix table.

inv-07: Syfovre (pegcetacoplan) Initial Therapy

Covered when ALL of the following are met:

Syfovre initial criteria: 1) Diagnosis of geographic atrophy (GA) secondary to age‑related macular degeneration (AMD); 2) Prescriber is an ophthalmologist; 3) Member is >50 years of age; 4) Absence of choroidal neovascularization (CNV/wet AMD) in the treatment eye; 5) Normal luminance best‑corrected visual acuity (BCVA) ≥24 letters (20/320 equivalent); 6) Total GA lesion area ≥2.5 mm^2 and <17.5 mm^2, with at least one lesion ≥1.25 mm^2 if multifocal; 7) Presence of any hyperautofluorescence pattern in the junctional zone of GA; 8) Requested dosing of pegcetacoplan 15 mg every 25 to 60 days is appropriate.>50 years; BCVA ≥24 letters; lesion area 2.5–<17.5 mm^2

Exact lesion size thresholds are taken from the source.

inv-08: Vyvgart Hytrulo / Vyvgart Initial Therapy

Covered when ALL of the following are met depending on indication:

Vyvgart Hytrulo / Vyvgart criteria: Branch A — Generalized Myasthenia Gravis: 1) Diagnosis of generalized MG; 2) Member is ≥18 years of age; 3) Prescriber is a neurologist or neurology consult notes provided; 4) Member is AChR antibody positive; 5) Inadequate response, adverse reaction, or contraindication to pyridostigmine; 6) BOTH of the following: (a) ONE of: member has severe disease requiring faster‑onset medication OR inadequate response/adverse reaction/contraindication to IVIG or plasmapheresis with glucocorticoids; (b) Inadequate response or adverse reaction to TWO of the following (or contraindication to all): azathioprine, cyclosporine, mycophenolate, glucocorticoids (e.g., prednisone), tacrolimus; 7) Requested dosing is appropriate. Branch B — CIDP: 1) Diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP); 2) Member is ≥18 years of age; 3) Prescriber is a neurologist or consult notes provided; 4) Inadequate response, adverse reaction, or contraindication to immune globulin AND ONE of: inadequate response/adverse reaction/contraindication to plasma exchange OR inadequate response/adverse reaction to glucocorticoids; OR BOTH: contraindication to glucocorticoids and inadequate response/adverse reaction to listed immunosuppressants (e.g., azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, rituximab); 5) Requested dosing is appropriate.

Multiple indication‑specific branches included; approval depends on the applicable branch.

inv-09: Initial Approval Durations

Coverage is provided with prior authorization and limited initial approval durations that vary by agent and indication.

Initial Approval Durations: Initial approvals will be granted for specified agents and indications with durations as listed: generalized MG (Rystiggo) and CIDP (Vyvgart Hytrulo): 3 months; CAD/Generalized MG (Soliris) and GA (Syfovre): 6 months; generalized MG (Vyvgart, Vyvgart Hytrulo): 2 months. These are examples—refer to the policy limitations for the complete list of agent‑ and indication‑specific durations.duration-based

See policy limitations for full list of initial approval timeframes.

inv-10: Reauthorization

Reauthorizations will be granted per the following:

Reauthorizations for most indications will be granted for 1 year; agent‑specific shorter intervals apply where listed in the limitations (e.g., certain indications may have shorter reauthorization intervals).1 year

Refer to limitations section for agent‑specific exceptions.

Products obtained as samples or provided through a manufacturer's patient assistance program are not eligible for the “currently receiving treatment” pathway when requesting prior authorization; such products are excluded from consideration under that provision. Authorization for members new to the plan may still be granted when all other listed criteria are met and required documentation is submitted.

Tavneos has been removed from the medical‑benefit policy and is now managed through the pharmacy benefit; it is therefore excluded from coverage and prior‑authorization requirements in this medical‑benefit policy effective 02/18/2025.

Requests that do not meet the specific coverage criteria for the requested agent or that lack the required specialist prescriber or consult documentation are ineligible for approval. Authorization may be denied when the member is not currently receiving the requested product and the submitted request fails to demonstrate that all listed clinical and documentation requirements are satisfied.

Key Clinical Thresholds and Coding-Related Values

Hemoglobin (Hb)

Hemoglobin threshold<10 g/dL

Timing requirementHemoglobin value dated within the last 60 days

Associated indicationApplies to Enjaymo (sutimlimab-jome) for cold agglutinin disease (CAD)

Age requirement for Syfovre

Age requirement> 50 years of age

Associated agentSyfovre (pegcetacoplan) for geographic atrophy (GA) secondary to AMD

Prescriber requirement

Required Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization (PA) is required for these products. For members new to the plan, authorization may be granted only if the member is currently receiving the requested product and documentation shows active treatment with that product (authorizations will not be granted for medications obtained solely as samples or through manufacturer's patient assistance programs). Authorizations may be denied if the member is not currently receiving the product or if required specialist documentation or other supporting records are not provided.

PA required for products managed through the medical benefit per policy review (e.g., Soliris, Vyvgart, Uplizna, Enjaymo, Rystiggo, Vyvgart Hytrulo as indicated in review history).
Members new to plan: authorization may be granted only when currently receiving the product and adequate documentation is submitted; samples or patient assistance program supply alone are not sufficient.

Denial Risk

Denial Risk — Insufficient Criteria / Documentation

Policy Background and Drug List Overview

This policy covers multiple complement inhibitors and related immunomodulatory biologics used across hematologic, neurologic, ophthalmologic, and rare genetic disease indications. Included agents described in the policy window include complement inhibitors such as eculizumab (Soliris) and pegcetacoplan (Syfovre), neonatal Fc receptor–targeting agents such as rozanolixizumab (Rystiggo) and FcRn modulators (Vyvgart/Vyvgart Hytrulo), and other specialized biologics such as sutimlimab (Enjaymo) for cold agglutinin disease. Coverage criteria tie each agent to indication‑specific requirements including diagnosis confirmation, specialist prescriber or consult notes, age limits, serologic or laboratory thresholds, and prior‑therapy trials where applicable.

Drug Definitions and Reference Ranges

Enjaymo (sutimlimab-jome) — key facts

Agent class and indicationEnjaymo (sutimlimab-jome) — IgG4 monoclonal antibody indicated to decrease need for RBC transfusion due to hemolysis in adults with cold agglutinin disease (CAD)

Coverage linkageCovered when CAD diagnosis, hematology prescriber or consult, age ≥18, Hb <10 g/dL within 60 days, and appropriate dosing are documented

PrescriberHematologist preferred or specialist consult notes required per criteria

Rystiggo (rozanolixizumab-noli) — key facts

Agent class and mechanismRystiggo (rozanolixizumab-noli) — neonatal Fc receptor (FcRn) blocker

IndicationIndicated for treatment of generalized myasthenia gravis (gMG) in adult patients who are anti‑AChR or anti‑MuSK antibody positive

Policy Changes and Effective Date

2025-02-18material_changeLatest

Policy updated to remove Tavneos from the medical benefit (moved to pharmacy), removed the vaccination requirement, expanded myasthenia gravis criteria to include disease severity and requirement for trial with IVIG or plasmapheresis plus glucocorticoids, and added CIDP indication for Vyvgart Hytrulo.

2024-05-06material_change

Added criteria for Soliris for the off‑label diagnosis of PLE/CHAPLE and created an appendix with age‑adjusted serum IgG reference ranges; Syfovre age criterion changed from >60 to >50 years.

2024-03-04material_change

Policy Summary

PayerMass General Brigham Health Plan

PolicyComplement Inhibitors and Miscellaneous Immunosuppressive Agents

Policy CodePolicy N/A

Change TypeMultiple material revisions (agent additions, criteria updates, durations)

Effective Date02/18/2025

Next Review DateN/A

Key ActionObtain prior authorization and submit required specialist documentation and recent labs (e.g., Hb, antibody or IgG results) per the specific agent criteria.

SourceLink

On This Page

Prescriber must be an ophthalmologist (per Syfovre criteria)

Best-corrected visual acuity (BCVA)

BCVA thresholdNormal luminance best corrected visual acuity (BCVA) ≥24 letters

Snellen equivalenceEquivalent to 20/320 Snellen

ContextRequired for Syfovre (pegcetacoplan) coverage for GA secondary to AMD

Age and recertification for PLE/CHAPLE

Recertification requirementRecertification for PLE/CHAPLE requires documentation of clinical improvement or stabilization and laboratory IgG/albumin changes per appendix age-adjusted ranges

Minimum age at initiation noted in criteriaMember is ≥2 months of age for initial PLE/CHAPLE therapy

Specialist requirementPrescriber must be a specialist in rare genetic or hematologic diseases or consult notes provided

Age‑Adjusted Serum IgG Reference Ranges (appendix)

1–3 months176–601 mg/dL

4–6 months172–814 mg/dL

7–12 months217–1213 mg/dL

13–24 months424–1051 mg/dL

25–36 months441–1135 mg/dL

3–5 years441–1236 mg/dL

6–8 years633–1280 mg/dL

9–11 years608–1572 mg/dL

12–16 years1066–1218 mg/dL

16–18 years1188–1458 mg/dL

≥18 years639–1349 mg/dL

NoteLaboratory‑specified age-adjusted reference ranges in submitted records may be accepted in place of the table values

Denial Risk for Insufficient Criteria or Documentation — Requests lacking required clinical information or not meeting the policy's stated clinical criteria, duration thresholds, or specialist prescriber/consultation requirements are at high risk for denial.

Missing specialist prescriber or consult notes (hematology, nephrology, neurology, ophthalmology, or other specialist as specified) increases denial risk.
Failure to document required diagnosis, antibody/serologic testing (e.g., AChR, MuSK, AQP4), age, lab values (e.g., Hb for CAD, age-adjusted serum IgG for CHAPLE), prior trial history (pyridostigmine, IVIG, plasmapheresis with glucocorticoids, specified immunosuppressants), or appropriate dosing may result in denial.
Requests that do not meet required trial or step-therapy requirements (including required trials with IVIG or plasmapheresis plus glucocorticoids for myasthenia gravis where specified) or that do not meet the policy's duration limits for initial approval are at risk for denial.

Documentation Required

Required Clinical Documentation

Required Clinical Documentation — Submit complete supporting documentation with PA requests: diagnosis, specialist prescriber or consult notes, required laboratory or serologic test results (with lab reference ranges when applicable), documentation of prior therapies and treatment response or contraindications, and dosing information.

Diagnosis and indication-specific data (e.g., CAD, generalized MG, NMOSD, PNH, PLE/CHAPLE, GA secondary to AMD, CIDP).
Specialist prescriber or consult notes from an appropriate specialist (hematologist, nephrologist, neurologist, ophthalmologist, or rare disease specialist) as specified per indication.
Relevant lab results: Hb within 60 days for CAD; antibody/serologic confirmation (AChR, MuSK, AQP4) where required; age-adjusted serum IgG levels for CHAPLE/PLE requests with lab-specified reference ranges preferred.
Prior therapy history: documentation of trials, inadequate response, adverse reactions, or contraindications to required agents (e.g., pyridostigmine, IVIG, plasmapheresis with glucocorticoids, azathioprine, cyclosporine, mycophenolate, tacrolimus, glucocorticoids).
Appropriate weight- or indication-based dosing information.

Step Therapy

Step Therapy and Required Prior Trials

Step Therapy and Trial Requirements — Many myasthenia gravis and other neuromuscular indications require documented prior trials before approval. For generalized myasthenia gravis, requests generally require documentation of inadequate response, adverse reaction, or contraindication to pyridostigmine and specified immunosuppressant trials; where indicated, a trial or contraindication to IVIG or plasmapheresis with glucocorticoids is required prior to some agents. Follow the indication-specific criteria for acceptable step therapy trials.

Generalized MG: documentation of inadequate response/adverse reaction/contraindication to pyridostigmine AND required immunosuppressant trials (or contraindications).
MG trial requirement update: where specified, a trial with IVIG or plasmapheresis combined with glucocorticoids is required (or documentation of contraindication) before certain agents.
CIDP and other indications: follow the agent-specific step requirements listed in the policy (e.g., inadequate response or contraindication to immune globulin, plasma exchange, or glucocorticoids as applicable).

Prior Authorization

Medical‑Benefit Prior Authorization Required

Medical‑Benefit Prior Authorization Required — Certain agents are managed through the medical benefit and require PA under medical billing. Ensure requests are submitted under the correct benefit and include all medical documentation.

Examples of agents managed via medical benefit per review history: Soliris (eculizumab), Vyvgart (efgartigimod alfa-fcab), Uplizna (inebilizumab-cdon), Enjaymo (sutimlimab-jome), Rystiggo (rozanolixizumab-noli), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) where specified.
If a product is designated MB, submit PA with medical documentation (specialist notes, infusion setting, dosing, labs) consistent with medical benefit processing.

Coverage linkageCovered when gMG diagnosis, neurologist prescriber or consult, antibody positivity, age ≥18, and required prior trials or contraindications are documented

IgG age‑adjusted ranges — appendix pointer

ReferenceSee appendix for age‑adjusted serum IgG concentration ranges used for recertification or submit laboratory‑specified reference ranges in the medical record

Use caseApplied for Soliris (eculizumab) requests for CHAPLE disease recertification

LocationAppendix table titled 'age‑adjusted serum immunoglobulin G (IgG) concentration reference ranges' in policy appendix

Added Rystiggo and Vyvgart Hytrulo to the policy requiring prior authorization through the medical benefit (did not include a preferred product requirement).

2023-06-30material_change

Removed preferred product requirement from Enjaymo, Uplizna, and Soliris for requests reviewed under the medical benefit.

2023-04-01administrative

Policy created and reviewed for Feb P&T to match MassHealth UPPL criteria; effective date noted as 04/01/2023.