CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Kesimpta (ofatumumab) — Coverage Criteria for Relapsing Multiple Sclerosis

Defines coverage criteria, quantity limits, and continuation requirements for Kesimpta for Medicaid members when prescribed for approved relapsing forms of multiple sclerosis and clinically isolated syndrome.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKesimpta (ofatumumab) — Coverage Criteria for Relapsing Multiple Sclerosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2021

Next Review Date2025-06

Key ActionObtain prior authorization with documentation of diagnosis, neurologist involvement, and prior failure/intolerance/contraindication to ocrelizumab or ublituximab.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization

12 monthscontinuation authorization

3 dosesinitial quantity limit

1 pen / 28dmaintenance quantity

Medicaidpayer population

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Coverage Criteria

Initial coverage criteria — Relapsing forms of MS

Covered when ALL of the following are met

Relapsing MS diagnosis: Member has documentation of a diagnosis of a relapsing form of multiple sclerosis (including relapsing‑remitting disease and active secondary progressive disease)

Authorization of 6 months may be granted when criteria are met

Prescriber requirement: Medication is prescribed by or in consultation with a neurologist

Step therapy requirement: Documentation of prior failure, intolerance, or contraindication to ocrelizumab (Ocrevus) or ublituximab (Briumvi)

Initial coverage criteria — Clinically isolated syndrome

Covered when ALL of the following are met

Clinically isolated syndrome diagnosis: Documentation of a diagnosis of clinically isolated syndrome

Authorization of 6 months may be granted when criteria are met

Prescriber requirement: Medication is prescribed by or in consultation with a neurologist

Step therapy requirement: Documentation of prior failure, intolerance, or contraindication to ocrelizumab (Ocrevus) or ublituximab (Briumvi)

Continuation of therapy

Continuation criteria

Continuation requirement: Member met initial criteria and is experiencing disease stability or improvement while receiving Kesimpta

Authorization of 12 months may be granted

Coverage is limited to the FDA‑approved and compendium‑recognized indications. Kesimpta (ofatumumab) is indicated for treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease. All other indications are considered experimental/investigational and are not medically necessary.

Members must not receive Kesimpta concomitantly with other disease‑modifying multiple sclerosis agents. (Note: agents such as Ampyra and Nuedexta are not considered disease‑modifying therapies.)

Use of Kesimpta for any indication outside the approved relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease) is considered not medically necessary because these uses are experimental/investigational.

Coding and Dosing Limits

Quantity-limited products/dosingmixedCovered

Kesimpta 20mg/0.4ml	Quantity limit: 1 pen every 28 days
initial dosing	Quantity limit exception for 3 weekly doses initially for first month (daily dose of 0.043)

inv-08: Initial dosing — 3 weekly doses for first month

Initial dosing regimenThree weekly doses during the first month (quantity limit exception for 3 weekly doses)

Daily dose noteInitial dosing corresponds to a daily dose of 0.043 (per policy quantity-limit description)

Authorization periodInitial authorization may be granted for 6 months when criteria are met

inv-09: Maintenance dosing — 1 pen every 28 days

Maintenance dosingKesimpta 20 mg/0.4 mL: quantity limit of 1 pen every 28 days

Daily dose noteMaintenance dosing corresponds to a daily dose of 0.015 (per policy quantity-limit description)

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required for initial therapy

Prior authorization is required for initial Kesimpta therapy; approval may be granted for 6 months when all initial criteria are met, including documented diagnosis, neurologist prescribing or consultation, and documentation of prior failure, intolerance, or contraindication to Ocrevus (ocrelizumab) or Briumvi (ublituximab).

Step Therapy

Step requirement vs other anti‑CD20 agents

Kesimpta requires step verification versus other anti‑CD20 agents: provide documentation of prior failure, intolerance, or contraindication to Ocrevus (ocrelizumab) or Briumvi (ublituximab) before authorization will be granted.

Documentation Required

Background

Kesimpta (ofatumumab) is a B‑cell‑targeting therapy indicated for the treatment of relapsing forms of multiple sclerosis in adults, which the manufacturer and regulatory authorities specify includes clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease.

Definitions

inv-16: Relapsing forms of multiple sclerosis

DefinitionRelapsing forms of multiple sclerosis include relapsing-remitting disease and active secondary progressive disease (Kesimpta indicated for relapsing forms of MS)

Covered indicationKesimpta is indicated for treatment of relapsing forms of MS in adults

ExclusionsAll other indications are considered experimental/investigational and not medically necessary

inv-17: Clinically isolated syndrome

DefinitionClinically isolated syndrome is an FDA‑recognized relapsing indication for Kesimpta (member must have documentation of diagnosis)

Prescriber requirementMedication must be prescribed by or in consultation with a neurologist