ModifiedAnthemPolicy CC-0174

Medical Drug Clinical Criteria - Kesimpta (ofatumumab)

Clinical criteria for medical-benefit coverage and prior authorization of Kesimpta (ofatumumab) for treatment of relapsing multiple sclerosis in adults, including quantity limits, step therapy, exclusions and applicable HCPCS/diagnosis codes.

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria - Kesimpta (ofatumumab)

Policy CodePolicy CC-0174

Change TypeRevised (step therapy, coding updates)

Effective DateDec 22, 2025

Next Review Date

Key ActionSubmit documentation demonstrating RMS diagnosis, ambulation >=100 meters, and applicable relapse/MRI history or prior therapy trials per step therapy requirements.

SourceLink

POLICY UPDATE CHANGES

11/14/2025 Annual Review: Update step therapy to allow override after a trial of any multiple sclerosis disease modifying therapy; step therapy table updates; coding reviewed and ICD-10-CM G35.A, G35.C1, G37.9 added; HCPCS NOC J3490 removed.

07/23/2025 - Step therapy table updates.

11/15/2024 - Annual Review: Add Ocrevus Zunovo and Tyruko to exclusion for concurrent use with other disease modifying therapy criteria.

03/01/2024 - Administrative update to add documentation.

1Quantity limit (pens per 28 days)

100Ambulation requirement (meters)

>=2

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Relapses in prior 2 years (approval pathway)

>=9T2 lesions for high disease activity

Coverage Summary & Stance

Coverage stance: covered_with_criteria. Scope: Clinical criteria for medical-benefit coverage and prior authorization of Kesimpta (ofatumumab) for treatment of relapsing multiple sclerosis in adults, including quantity limits, step therapy, exclusions and applicable HCPCS/diagnosis codes. Background: Kesimpta (ofatumumab) is an FDA-approved subcutaneous disease-modifying therapy for relapsing forms of multiple sclerosis in adults. Effective date: 2025-12-22. Last review: 2025-11-14.

Quick facts & thresholds

Ambulation requirement>= 100 meters

Relapses in prior 2 years (initiation pathway)>= 2 relapses

Relapses in prior 1 year (initiation pathway)>= 1 relapse

Gadolinium-enhancing T1 lesion (initiation pathway)>= 1 lesion in prior 1 year

High disease activity (step therapy - must meet all A-C)A: >=1 relapse in prior 1 year while on therapy; B: >=9 T2-hyperintense lesions; C: >=1 Gd-enhancing lesion

Quantity limit (routine)1 prefilled pen/syringe (20 mg/0.4 mL) per 28 days

Quantity limit (initiation allowance)May approve up to two additional pens/syringes during the first month of treatment

Step Therapy, Continuation & High Disease Activity

Step Therapy Approval Criteria

Covered when any of the following step therapy pathways are met:

{

"operator":"any",

"children":[

{

"text":"Individual is currently on Kesimpta (ofatumumab)."

Not Approved / Exclusions

Requests for Kesimpta may be approved under step therapy when criteria below are met:

ANY of the following

Documentation is provided that individual has been on Kesimpta
Documentation has been provided that individual has had a trial and inadequate response (including but not limited to clinical relapse, new or enlarged lesions on MRI or disability progression) or intolerance to a preferred agent
Documentation is provided that individual has high disease activity despite treatment with a disease modifying drug (examples listed)
High disease activity defined below

Definition of High Disease Activity (must meet all A-C)

Prior Authorization, Billing & Quantity Limits

Prior Authorization

Prior authorization required with clinical criteria

Submit prior authorization with documentation demonstrating the individual has relapsing multiple sclerosis (RMS), can ambulate at least 100 meters, and the applicable relapse and/or MRI history or prior therapy trials per step therapy requirements.

Billing/coding (informational): J3590
Billing/coding (informational): C9399

Billing Rule

Quantity limit

Limit = 1 prefilled pen/syringe (20 mg/0.4 mL) per 28 days. During initiation of therapy, may approve two additional pens/syringes during the first month of treatment.

Applicable Codes

HCPCS / billing codes (informational)HCPCS

J3590	Unclassified biologics (when specified as [Kesimpta]) (ofatumumab)
C9399	Unclassified drugs or biologicals (when specified as [Kesimpta]) (ofatumumab)
J3490	Removed from coding list per document history

Evidence & Guidelines

1,882 participantsPhase III trials enrolled

0.10-0.11 vs 0.22-0.25Primary endpoint - annualized relapse rate (Kesimpta vs Aubagio), p<0.001

The AAN 2018 guideline suggests initiating disease-modifying therapy in individuals with relapsing MS who have recent clinical relapses or MRI activity. Kesimpta is administered via monthly subcutaneous self-injection and phase III trials showed superior reduction in annualized relapse rate versus teriflunomide (Kesimpta ARR 0.10–0.11 vs teriflunomide 0.22–0.25, p<0.001).

Background and Definitions

Kesimpta (ofatumumab) is FDA-approved as a subcutaneous disease-modifying therapy for relapsing forms of multiple sclerosis in adults and is administered as a monthly subcutaneous self-injection. Phase III randomized, double-blind trials enrolling 1,882 participants demonstrated superior efficacy with annualized relapse rates of 0.10–0.11 for Kesimpta versus 0.22–0.25 for teriflunomide (p<0.001).

Term	Definition
Relapsing multiple sclerosis (RMS)
Includes clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease
Preferred agent
Agents deemed clinically comparable in the class but preferred based on clinical evidence and cost effectiveness

Policy Revision History

11/14/2025revisedLatest

07/23/2025revised

07/23/2025 - Step therapy table updates.

11/15/2024revised

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria - Kesimpta (ofatumumab)

Policy CodePolicy CC-0174

Change TypeRevised (step therapy, coding updates)

Effective DateDec 22, 2025

Next Review Date

Key ActionSubmit documentation demonstrating RMS diagnosis, ambulation >=100 meters, and applicable relapse/MRI history or prior therapy trials per step therapy requirements.

SourceLink

On This Page

"text":"Documentation has been provided that the individual has had a trial and inadequate response or intolerance to a preferred agent."

"note":"Inadequate response may include clinical relapse, new or enlarged lesions on MRI, or disability progression."

"label":"Definition of High Disease Activity",

"text":"At least one relapse in the previous year while on therapy.","threshold":">=1 relapse on therapy"

"text":"At least 9 T2-hyperintense lesions on cranial MRI.","threshold":">=9 T2 lesions"

"text":"At least one gadolinium-enhancing (Gd+) lesion on MRI.","threshold":">=1 Gd lesion"

Step Therapy

Step therapy override criteria

Kesimpta may be approved via step therapy override when the provider documents that the member meets one of the approval pathways above. Approval requires clear documentation of prior therapy trials, inadequate response or intolerance, and evidence of high disease activity when applicable. Note that Kesimpta is not approved in combination with other disease-modifying therapies.

Submit medical records documenting prior DMT trial(s) and reason for discontinuation (inadequate response or intolerance).
Provide MRI reports and clinical relapse history to support high disease activity when applicable (see Definition of High Disease Activity).
Concurrent use with other MS disease modifying therapies is excluded; list of excluded agents includes, but is not limited to: Aubagio, Avonex, Bafiertam, Betaseron, Briumvi, Copaxone/Glatiramer/Glatopa, Extavia, Gilenya, Lemtrada, Mavenclad, Mayzent, Ocrevus, Ocrevus Zunovo, Plegridy, Ponvory, Rebif, Tascenso ODT, Tecfidera, Tyruko, Tysabri, Vumerity and Zeposia.
When initiating Kesimpta, quantity limits allow up to two additional pens/syringes during the first month of treatment per the quantity limit policy.

Documentation Required

Documentation of prior therapy and disease activity

Providers must supply documentation demonstrating prior therapies and disease activity to support step therapy approval or continuation.

List of prior DMTs tried, dates of therapy, and reason for discontinuation (inadequate response or intolerance).
Clinical documentation of inadequate response: relapse descriptions, disability progression, or treatment-related intolerance.
MRI reports with dates showing number of T2 lesions and presence/absence of gadolinium-enhancing lesions to substantiate high disease activity.
Do not provide documentation indicating concurrent use of Kesimpta with other MS disease-modifying agents; concurrent DMT use is excluded and will result in non-approval.

At least one relapse in the previous year while on therapy>= 1 relapse in prior 1 year while on therapy

B: At least 9 T2-hyperintense lesions in cranial MRI>= 9 T2 lesions

C: At least one Gadolinium-enhancing lesion>= 1 Gd-enhancing lesion

Denial Risk

Infection at initiation

Do not initiate Kesimpta in individuals with active hepatitis B or another active infection; such cases may be denied at initiation.

Active hepatitis B or other active infection at initiation is an exclusion to approval.

Step Therapy

Step therapy override criteria

Kesimpta may be approved under step therapy when the patient is already receiving Kesimpta OR has trialed a preferred agent and had an inadequate response or intolerance, and the patient meets the defined high disease activity criteria. Documentation must show prior DMT trial(s) and inadequate response/intolerance as described (clinical relapse, new/enlarged MRI lesions, or disability progression).

Override allowed if patient already on Kesimpta.
Override allowed after trial and inadequate response or intolerance to a preferred agent, plus meeting high disease activity criteria.

11/15/2024 - Annual Review: Add Ocrevus Zunovo and Tyruko to exclusion for concurrent use with other disease modifying therapy criteria.

03/01/2024administrative

03/01/2024 - Administrative update to add documentation.