CurrentCignaPolicy N/A

Kesimpta (ofatumumab) prior authorization for multiple sclerosis — Coverage Criteria

Defines prior authorization requirements and coverage criteria for Kesimpta (ofatumumab subcutaneous injection) for treatment of relapsing forms of multiple sclerosis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyKesimpta (ofatumumab) prior authorization for multiple sclerosis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJul 23, 2025

Key ActionObtain prior authorization for Kesimpta; approvals are issued for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearapproval duration

≥18min patient age

relapsing formsrequired disease course

prohibitedconcurrent DMTs

Coverage and Medical Necessity Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

FDA-Approved Indication: Approve for the duration noted below if the patient meets ONE of the following (A or B)

A) Initial Therapy: Approve for 1 year if the patient meets ALL of the following (i, ii, and iii)

A.i: Patient is ≥ 18 years of age

chunk_indices: [8]

A.ii: Patient has a relapsing form of multiple sclerosis (examples: clinically isolated syndrome, relapsing-remitting disease, active secondary progressive disease)

chunk_indices: [8]

A.iii: Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

chunk_indices: [8]

B.i: Patient has a relapsing form of multiple sclerosis (examples: clinically isolated syndrome, relapsing-remitting disease, active secondary progressive disease)

chunk_indices: [8,9]

B.ii: Patient meets ONE of the following:

B.ii.a: Patient experienced a beneficial clinical response when assessed by at least one objective measure (examples: MRI lesion reduction or stabilization such as absence or decrease in gadolinium-enhancing lesions or fewer new/enlarging T2 lesions; stabilization or reduced worsening on EDSS; achievement of NEDA-3 or NEDA-4; reduction in relapses; improvement or maintenance on functional measures such as six-minute walk, 12-Item MS Walking Scale, MSFC; attenuation of brain volume loss)

chunk_indices: [8]

B.ii.b: Patient experienced stabilization, slowed progression, or improvement in at least one symptom (examples: motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, pain/numbness/tingling)

chunk_indices: [9]

B.iii: Patient is ≥ 18 years of age

chunk_indices: [9]

B.iv: Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

chunk_indices: [9]

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Kesimpta. Approvals are issued for 1 year when the criteria are met.

Approval duration: 1 year

Note

Provider Action / Alert

Provider action: Ensure prior authorization is obtained and that the prescribing clinician is a neurologist or a physician who specializes in the treatment of multiple sclerosis, or that treatment is in consultation with such a specialist.

Documentation Required

Prescriber and Clinical Documentation Requirements

Prescription must be by or in consultation with a neurologist or an MS specialist. Documentation in the medical record should support the patient is ≥ 18 years of age and include clinical details such as diagnosis of a relapsing form of multiple sclerosis, objective measures of response or stabilization (for continuation), and relevant assessment data (e.g., MRI findings, EDSS score, relapse history, or functional measures).

Must document age ≥ 18 years
Document relapsing form of MS (examples: clinically isolated syndrome, relapsing–remitting, active secondary progressive)
For continuation: document beneficial clinical response or stabilization (e.g., MRI, EDSS, NEDA criteria, relapse reduction, functional measures)

Denial Risk

Concurrent Therapy Exclusion

Use of Kesimpta concurrently with other disease-modifying multiple sclerosis agents is considered not medically necessary and will be denied.

Concurrent use with other disease-modifying MS agents = Not medically necessary

Key Definitions

Relapsing forms of MS — scope and examples

DefinitionRelapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Examples providedClinically isolated syndrome; relapsing‑remitting MS; active secondary progressive MS.

Relevant age group (context)Indication specified for adults (policy references adult patients).

Treatment implicationKesimpta is indicated for these relapsing forms of MS and coverage criteria apply to these disease courses.

Policy Summary

PayerCigna

PolicyKesimpta (ofatumumab) prior authorization for multiple sclerosis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJul 23, 2025

Key ActionObtain prior authorization for Kesimpta; approvals are issued for 1 year when criteria are met.

SourceLink

On This Page

OpenPayer

Kesimpta (ofatumumab) prior authorization for multiple sclerosis — Coverage Criteria

Coverage and Medical Necessity Criteria

Prior Authorization and Provider Requirements

Key Definitions

Background