Neighborhood Health Plan RI Imaavy Coverage Update

Coverage Criteria for Imaavy (nipocalimab)

Initial Approval Criteria

Covered when ALL of the following are met for initial approval

Universal eligibility: Member is at least 12 years of age; prescribed by, or in consultation with, a neurologist; will not use the requested agent in combination with other immunomodulatory biologic therapies; no FDA-labeled contraindications to the requested agent

Diagnosis and objective findings: Submission of medical records to support diagnosis of generalized myasthenia gravis (gMG); MGFA Clinical Classification II to IVb; positive anti-AChR or anti-MuSK antibody; baseline neurological exam documenting objective weakness and fatiguability (e.g., QMG); baseline MG-ADL total score >= 6MG-ADL >= 6

Prior therapy requirement (one of): At least ONE of the following: inadequate response to at least one conventional agent (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide); OR intolerance/hypersensitivity to one conventional agent; OR FDA-labeled contraindication to all conventional agents; OR required chronic IVIG; OR required chronic plasmapheresis/plasma exchange

Medication review and step therapy: Current medications assessed and any drugs known to exacerbate myasthenia gravis discontinued if appropriate; for adult anti-AChR Ab+ members, inadequate response or contraindication to Vyvgart (efgartigimod) or Vyvgart Hytrulo required; members who require maintenance dose every 2 weeks requiring 2 vials (>1200 mg) must have inadequate response or contraindication to rozanolixizumab (Rystiggo) or eculizumab; prescribed dose must be provided and in accordance with FDA-approved labeling based on current documented weight

Renewal Criteria

Renewal covered when ALL of the following are met

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; not used with other immunomodulatory biologic therapies; no FDA-labeled contraindications; prescribed dose provided and in accordance with FDA-approved labeling based on current documented weight

Clinical response: Member has had improvement of at least 2 points from baseline in MG-ADL total score sustained for at least 4 weeks OR improvement of at least 3 points from baseline in QMG total score sustained for at least 4 weeks; improvement in muscle strength testing with fatigue maneuvers compared to baselineMG-ADL >=2-point reduction (sustained 4 weeks) or QMG >=3-point reduction (sustained 4 weeks)

General coverage criteria / Rationale

Neighborhood adopted clinical coverage criteria to align use of Imaavy with FDA labeling and clinical literature and to promote cost-effective use.

Plan-level coverage rationale: Use must align with FDA-approved labeling and/or relevant clinical literature; criteria are intended to minimize adverse effects and ensure cost-effective options are used first when applicable

For Medicare members, these criteria apply only in the absence of a National Coverage Determination (NCD) or Local Coverage Determination (LCD); Neighborhood will give individual consideration to each request based on submitted information

Use of Imaavy (nipocalimab) in combination with other immunomodulatory biologic therapies is not permitted. Examples of biologic agents that must not be used concurrently with Imaavy include, but are not limited to, Rystiggo (rozanolixizumab), Vyvgart (efgartigimod), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase), Soliris/Epysqli/Bkemv (eculizumab), Ultomiris (ravulizumab), and Zilbrysq (zilucoplan).

For Medicare members, Neighborhood's clinical coverage criteria for Imaavy will only be applied in the absence of an applicable National Coverage Determination (NCD) or Local Coverage Determination (LCD). If an NCD or LCD exists and prescribes different coverage, those Medicare determinations take precedence; Neighborhood will consider individual requests in the context of any applicable NCD/LCD.

Requests for Imaavy will be considered not medically necessary when the patient does not meet the policy's explicit eligibility requirements. Specifically, coverage is not supported if the member is younger than 12 years, the drug is not prescribed by or in consultation with a neurologist, documentation does not support a diagnosis of generalized myasthenia gravis with required objective findings, the baseline MG-ADL total score is less than 6, serologic testing is not positive for anti-AChR or anti-MuSK antibodies, or the member has not met the prior therapy requirements (e.g., inadequate trial or intolerance to conventional agents or other listed exceptions).

Coding and Clinical Thresholds

HCPCS CodeHCPCSCovered

C9305

Injection, nipocalimab-aahu, 3 mg; 1 billable unit = 3 mg

NDC(s)NDC

57894-0800-xx	Imaavy 300 mg/1.62 mL solution in a single-dose vial
57894-0801-xx	Imaavy 1,200 mg/6.5 mL solution in a single-dose vial

Covered Diagnosis Codes (ICD-10)ICD-10Covered

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

Medicare Part B Covered Diagnosis CodesICD-10

N/A	Medicare Part B Covered Diagnosis Codes

Medicare Part B MAC Jurisdictions and Contractors (group A-N)mixed

MAC jurisdictions list	CA, HI, NV, AS, GU, CNMI; Contractor: Noridian Healthcare Solutions, LLC
MAC jurisdictions list	AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ; Contractor: Noridian Healthcare Solutions, LLC
MAC jurisdictions list	KS, NE, IA, MO; Contractor: Wisconsin Physicians Service Insurance Corp (WPS)
MAC jurisdictions list	MN, WI, IL; Contractor: National Government Services, Inc. (NGS)
MAC jurisdictions list	LA, AR, MS, TX, OK, CO, NM; Contractor: Novitas Solutions, Inc.
MAC jurisdictions list	MI, IN; Contractor: Wisconsin Physicians Service Insurance Corp (WPS)
MAC jurisdictions list	FL, PR, VI; Contractor: First Coast Service Options, Inc.

Medicare Part B MAC Jurisdictions and Contractors (group J-15)mixed

MAC jurisdictions list	TN, GA, AL; Contractor: Palmetto GBA
MAC jurisdictions list	NC, SC, WV, VA; Contractor: Palmetto GBA
MAC jurisdictions list	DE, MD, PA, NJ, DC; Contractor: Novitas Solutions, Inc.
MAC jurisdictions list	NY, CT, MA, RI, VT, ME, NH; Contractor: National Government Services, Inc. (NGS)
MAC jurisdictions list	KY, OH; Contractor: CGS Administrators, LLC

Medicare Part B MAC Jurisdictions and Contractors (group A-N)mixed

MAC jurisdictions list	CA, HI, NV, AS, GU, CNMI; Contractor: Noridian Healthcare Solutions, LLC
MAC jurisdictions list	AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ; Contractor: Noridian Healthcare Solutions, LLC
MAC jurisdictions list	KS, NE, IA, MO; Contractor: Wisconsin Physicians Service Insurance Corp (WPS)
MAC jurisdictions list	MN, WI, IL; Contractor: National Government Services, Inc. (NGS)
MAC jurisdictions list	LA, AR, MS, TX, OK, CO, NM; Contractor: Novitas Solutions, Inc.
MAC jurisdictions list	MI, IN; Contractor: Wisconsin Physicians Service Insurance Corp (WPS)
MAC jurisdictions list	FL, PR, VI; Contractor: First Coast Service Options, Inc.

Medicare Part B MAC Jurisdictions and Contractors (group J-15)mixed

MAC jurisdictions list	TN, GA, AL; Contractor: Palmetto GBA
MAC jurisdictions list	NC, SC, WV, VA; Contractor: Palmetto GBA
MAC jurisdictions list	DE, MD, PA, NJ, DC; Contractor: Novitas Solutions, Inc.
MAC jurisdictions list	NY, CT, MA, RI, VT, ME, NH; Contractor: National Government Services, Inc. (NGS)
MAC jurisdictions list	KY, OH; Contractor: CGS Administrators, LLC

inv-13: Baseline MG-ADL — baseline requirement

Baseline MG-ADL requirementMember must have a baseline Myasthenia Gravis–Activities of Daily Living (MG-ADL) total score of at least 6

Supporting diagnostic requirementsBaseline MG-ADL must accompany documentation of MGFA clinical classification II–IVb and objective neurological exam (e.g., QMG) showing weakness/fatiguability

Age prespecificationBaseline MG-ADL requirement applies for members ≥12 years of age as part of initial eligibility

Purpose of baseline scoreUsed to establish functional impairment severity and eligibility for initiation of nipocalimab (Imaavy)

inv-14: Renewal MG-ADL improvement — required improvement thresholds for renewal

Prior Authorization, Step Therapy, and Documentation

Prior Authorization

Prior Authorization Required

Initial prior authorization is required. Medicare members who have received the medication within the past 365 days are exempt from step therapy requirements.

Prior authorization required before initial use
Medicare members with prior receipt within 365 days exempt from Step Therapy

Note

Coverage Criteria and Cost-effective Options Preferred

Coverage will follow the clinical criteria adopted by the plan to align use with FDA labeling and current clinical literature and to promote use of cost-effective options first when appropriate.

Criteria ensure therapy is for medically accepted indications and minimize risk of adverse effects
Cost-effective treatment options are preferred when clinically appropriate

Background and Rationale

Imaavy (nipocalimab) is a neonatal fragment crystallizable (FcRn) receptor blocker approved for the treatment of generalized myasthenia gravis (gMG) in patients aged 12 years and older who are anti-AChR or anti-MuSK antibody positive. Neighborhood reviewed Imaavy through its Pharmacy & Therapeutics committee and adopted coverage criteria to align use with FDA-approved labeling and relevant clinical literature. The approval is based on randomized clinical trial data demonstrating improvements in patient-reported and objective measures of gMG; common adverse reactions include respiratory tract infections, peripheral edema, and muscle spasms.

Definitions and Clinical Scales

inv-24: MG-ADL — Myasthenia Gravis Activities of Daily Living scale; baseline score requirement and interpretation

DefinitionMyasthenia Gravis Activities of Daily Living (MG-ADL) is a patient-reported scale with possible scores 0–24; higher scores indicate greater impairment

Baseline score interpretationA baseline MG-ADL total score of ≥6 indicates sufficient functional impairment to meet policy initiation criteria

Use in trials and licensingVG3 trial population had median MG-ADL of 9; MG-ADL was the primary functional outcome used to assess treatment response

Role in monitoringMG-ADL is used to measure clinical response for renewal (≥2-point reduction sustained 4 weeks) or as complement to QMG testing

inv-25: Ab+ gMG — Generalized myasthenia gravis with positive serologic test for anti-AChR or anti-MuSK

Ab+ gMG definition

OpenPayer

Imaavy (nipocalimab) for generalized myasthenia gravis — coverage criteria

Coverage Criteria for Imaavy (nipocalimab)

Coding and Clinical Thresholds

Prior Authorization, Step Therapy, and Documentation

Background and Rationale

Definitions and Clinical Scales