Neighborhood Health Plan RI Ultomiris Coverage Update

Coverage Criteria for Ultomiris (ravulizumab)

Initial Approval — Coverage is provided when ALL of the applicable universal criteria AND the indication-specific criteria below are met.

Coverage is provided when ALL of the applicable universal criteria AND the indication‑specific criteria below are met.

Universal Criteria: Member is ≥18 years of age; will not be used in combination with other immunomodulatory biologic therapies; member does NOT have any FDA‑labeled contraindications to the requested agent; requested quantity (dose) is within FDA‑labeled dosing for the requested indication.

From Universal Criteria

gMG indication-specific: Diagnosis of generalized myasthenia gravis (gMG) supported by submission of medical records; prescribed by or in consultation with a neurologist; MGFA clinical class II–IVb; positive serologic test for anti‑acetylcholine receptor (AChR) antibodies; baseline objective neurological weakness and fatigability documented (e.g., QMG); review and discontinuation of medications known to exacerbate MG when appropriate; AND member has either tried and had an inadequate response to at least ONE conventional agent for MG (e.g., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) OR has intolerance/hypersensitivity to at least ONE such conventional agent; AND must have inadequate response/intolerance/contraindication to efgartigimod and inebilizumab unless not expected with the requested agent (documentation required).

See chunk 8

NMOSD indication-specific: Diagnosis of neuromyelitis optica spectrum disorder (NMOSD) confirmed by a neurologist with submission of medical records; member is AQP4 antibody positive; diagnosis confirmed by at least one qualifying clinical syndrome (optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic diencephalic or cerebral syndrome); at least one discrete clinical attack; alternative diagnoses ruled out; prescribed by or in consultation with a neurologist; AND member must have experienced failure, contraindication, or intolerance to Enspryng (satralizumab) AND Uplizna (inebilizumab) (this requirement applies to Medicaid members only).

See chunk 11

Renewal Criteria — Coverage may be renewed when ALL renewal requirements are met.

Coverage may be renewed when ALL renewal requirements are met.

Renewal - general: Member was previously approved through the plan's Medical Drug Review; prescribed by or in consultation with a neurologist; not used in combination with other immunomodulatory biologic therapies; member does NOT have any FDA‑labeled contraindications to the requested agent; requested quantity (dose) is within FDA‑labeled dosing for the requested indication.

See chunk 12

Renewal - gMG specific: Submission of medical records demonstrating positive clinical response from baseline: improvement and/or maintenance of at least a 3‑point reduction from pre‑treatment baseline in the MG‑ADL total score sustained for at least 4 weeks AND improvement in muscle strength testing with fatigue maneuvers compared to baseline. (May substitute ≥4‑point improvement in QMG sustained ≥4 weeks if available).MG‑ADL ≥3 improvement sustained ≥4 weeks or QMG ≥4 improvement sustained ≥4 weeks

See chunk 12

Renewal - NMOSD specific:

Dosage/Administration — Dosing and administration must follow body-weight based loading and maintenance schedule.

Dosing and administration must follow body‑weight based loading and maintenance schedule.

Dosing: Administer intravenous doses based on body weight: loading dose on Day 0, a dose on Day 14, then maintenance dosing every 8 weeks thereafter. Specific mg dosing is mapped to body‑weight ranges (e.g., 40–<60 kg, 60–<100 kg, ≥100 kg) with corresponding loading and maintenance mg amounts per FDA label; maximum units: 300 units on Day 0 and 360 units on Day 14 and every 8 weeks thereafter (1 unit = 10 mg).Max units: 300 units Day 0; 360 units Day 14 and every 8 weeks thereafter (1 unit = 10 mg)

See chunks 14,15,3

General Coverage Criteria — Coverage granted when requests align with FDA labeling and relevant clinical literature; individual consideration described.

Coverage is granted when requests align with FDA‑approved labeling and relevant clinical literature; individual consideration is given based on prescriber‑submitted information.

General coverage conditions: Use consistent with FDA labeling or relevant clinical literature; prescriber justification should document prior therapies or rationale when more cost‑effective alternatives exist; Neighborhood will give individual consideration to each request based on submitted clinical information.

Policy rationale and references

Requests for ravulizumab (Ultomiris) must adhere to the policy's universal criteria, which include a prohibition on concomitant use with other immunomodulatory biologic therapies. Specifically, Ultomiris will not be used in combination with other immunomodulatory biologic therapies (examples listed in policy include rituximab, eculizumab, pegcetacoplan, satralizumab, inebilizumab, efgartigimod products, rozanolixizumab, nipocalimab, and others).

Incomplete requests lacking essential supporting documentation may be considered not medically necessary. Required documentation includes medical records supporting the diagnosis (e.g., chart notes and laboratory values), positive antibody testing where applicable (anti-AChR for gMG; AQP4 for NMOSD), and evidence of neurologist involvement (prescribing clinician or documented consultation). For indication-specific criteria, the request must also include baseline neurologic assessment (e.g., QMG) and documentation of prior therapy trials, intolerances, or contraindications as specified in the policy.

For Medicare members, coverage determinations for outpatient (Part B) drugs must comply with any applicable Centers for Medicare & Medicaid Services policies. Applicable National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs) take precedence over the plan's non‑Medicare coverage criteria when those Medicare policies exist.

Situations where Medicare NCDs or LCDs disallow coverage for a given indication, or where the information submitted does not support FDA‑labeled or literature‑supported use, should be handled in accordance with Medicare policy. If an applicable NCD/LCD or Medicare benefit manual guidance precludes coverage, the request may be considered not medically necessary for the Medicare benefit and denied per those Medicare rules.

Provider Responsibilities, Prior Authorization, and Documentation

Prior Authorization

Prior authorization and review

Prior authorization is required for the requested agent. Requests will be reviewed by the plan and given individual consideration based on clinical information submitted by the prescriber and other information available to the plan. For Medicare members, any applicable National Coverage Determination (NCD) or Local Coverage Determination (LCD) takes precedence over these criteria; prescribers must ensure compliance with relevant NCD/LCD guidance and submit documentation demonstrating applicability if relying on an NCD/LCD.

Medicare NCD/LCDs supersede plan criteria where applicable; use https://www.cms.gov/medicare-coverage-database/search.aspx to locate documents.
Provide copies or references to any relevant NCD/LCD when submitting requests for Medicare members.

Step Therapy

Step therapy expectation

Step therapy requirements are intended to ensure cost-effective treatment sequencing. Prescribers should document clinical rationale when requesting an exception, including why recommended alternatives are inappropriate or ineffective for the member. Members who previously received the medication within the past 365 days are not subject to step therapy requirements.

Billing Codes and Unit Limits

Covered HCPCS CodesHCPCSCovered

J1303

Injection, ravulizumab-cwvz, 10 mg; 1 billable unit = 10 mg

NDCsNDC

25682-0025-xx	Ultomiris 300 mg/3 mL single-dose vial for injection: 25682-0025-xx
25682-0028-xx	Ultomiris 1,100 mg/11 mL single-dose vial for injection: 25682-0028-xx

Covered ICD-10 CodesICD-10Covered

G36.0	Neuromyelitis optica [Devic]
G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation

Max units per dosing schedule

Maximum units — Day 0300 units (1 unit = 10 mg)

Maximum units — Day 14360 units (1 unit = 10 mg)

Maintenance schedule360 units every 8 weeks after Day 14 (1 unit = 10 mg)

Definitions, REMS, and Safety Requirements

REMS / meningococcal vaccination

REMS requirementUltomiris is available only through a REMS program

Meningococcal vaccinationPatients must receive meningococcal vaccination prior to initiation of therapy and be monitored for signs of infection

Infection risk rationaleRisk due to increased likelihood of life‑threatening meningococcal infections with C5 inhibition

G36.0

ICD-10 codeG36.0

DescriptionNeuromyelitis optica [Devic]

Usage

Background on Ravulizumab (Ultomiris)

Ravulizumab (Ultomiris) is a terminal complement C5 inhibitor approved for adult patients with AChR‑antibody positive generalized myasthenia gravis (gMG) and for adult patients with AQP4‑antibody positive neuromyelitis optica spectrum disorder (NMOSD). The agent works by preventing formation of the terminal complement complex (C5b‑9), thereby reducing complement‑mediated tissue damage; clinical efficacy was demonstrated in randomized and open‑label studies for these indications. Because C5 inhibition increases the risk of life‑threatening meningococcal infections, vaccination and enrollment in the drug's REMS program are required per the product labeling.

OpenPayer

Intravenous ravulizumab (Ultomiris) — coverage criteria for gMG and NMOSD

Coverage Criteria for Ultomiris (ravulizumab)

Provider Responsibilities, Prior Authorization, and Documentation

Billing Codes and Unit Limits

Definitions, REMS, and Safety Requirements

Background on Ravulizumab (Ultomiris)