CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Kesimpta (ofatumumab) — Coverage Criteria for Relapsing Multiple Sclerosis

Policy governs coverage and authorization criteria for Kesimpta for treating relapsing forms of multiple sclerosis for members in the payer's Medicaid scope; applies to prescribing clinicians and reviewers evaluating prior authorization requests.

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 DateN/A

Key ActionObtain prior authorization with documentation of relapsing MS diagnosis, neurologist involvement, and prior trial or intolerance/contraindication to specified anti‑CD20 agents.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization

12 monthscontinuation authorization

1 pen/28dquantity limit

3 dosesinitial dosing

Coverage Criteria for Kesimpta (ofatumumab)

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Initial authorization — FDA‑approved relapsing MS indications

Covered when ALL of the following are met:

Indication — relapsing forms of MS: Member has documentation of being diagnosed with a relapsing form of multiple sclerosis (includes relapsing‑remitting disease and active secondary progressive disease with ongoing relapse).

Indication — clinically isolated syndrome: OR member has documentation of being diagnosed with clinically isolated syndrome.

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

Prior therapy / step requirement: Documentation that the member has had failure, intolerance, or contraindication to Ocrevus (ocrelizumab) or Briumvi (ublituximab).

Continuation of therapy

Covered when ALL of the following are met:

Prior approval: Member met the initial criteria for Kesimpta initiation.

Clinical response: Member is experiencing disease stability or improvement while receiving Kesimpta.

All indications for Kesimpta (ofatumumab) other than the FDA‑approved relapsing forms of multiple sclerosis — which include clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease in adults — are considered experimental/investigational and not medically necessary.

Kesimpta must not be used concomitantly with other disease‑modifying multiple sclerosis (DMT) agents. Note that Ampyra and Nuedexta are not classed as disease‑modifying agents and are not included in this DMT exclusion.

Use of Kesimpta for indications that are not included in the FDA‑approved relapsing forms of multiple sclerosis is not medically necessary.

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals may be granted for up to 6 months; continuation approvals may be granted for up to 12 months when continuation criteria are met.

Initial authorization duration: up to 6 months
Continuation authorization duration: up to 12 months

Step Therapy

Step Therapy Requirement

Documentation of failure, intolerance, or contraindication to specified comparator agents is required prior to approval. Requests must include evidence that the member has failed, is intolerant of, or has a contraindication to Ocrevus (ocrelizumab) or Briumvi (ublituximab).

Required step: failure, intolerance, or contraindication to Ocrevus (ocrelizumab) or Briumvi (ublituximab)

Documentation Required

Required Clinical Documentation

Provide clinical documentation with the prior authorization request, including diagnosis, prescriber specialty, prior therapies tried (with dates and reasons for discontinuation), and evidence of treatment response for continuation requests.

Diagnosis documentation (relapsing MS or clinically isolated syndrome)
Prescriber: neurologist or consultation with a neurologist
Prior therapy documentation: failure/intolerance/contraindication to Ocrevus or Briumvi
For continuation: documentation of disease stability or improvement while on Kesimpta

Denial Risk

Indication Limits

Use is limited to FDA‑approved relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS). All other indications are considered experimental/investigational and are not medically necessary.

Indication limit: FDA‑approved relapsing forms of MS only
Exclusions: all non‑FDA‑approved indications are not medically necessary

Denial Risk

Concomitant Disease‑Modifying Therapy Exclusion

Requests for concomitant use of Kesimpta with other disease‑modifying multiple sclerosis agents will be denied. (Note: Ampyra and Nuedexta are not disease‑modifying agents.)

Concomitant DMT use: not allowed — deny requests for concurrent disease‑modifying MS therapies
Clarification: Ampyra and Nuedexta are not considered disease‑modifying agents