CurrentmhnPolicy CP.PHAR.306

Ofatumumab (Arzerra, Kesimpta) coverage

Defines medical necessity, prior authorization, and coverage criteria for ofatumumab products (Arzerra for CLL; Kesimpta for relapsing MS) across Commercial, HIM, and Medicaid lines of business for Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyOfatumumab (Arzerra, Kesimpta) coverage

Policy CodePolicy CP.PHAR.306

Change TypeNo material change

Effective DateFeb 1, 2017

Next Review Date

Key ActionProvider must submit documentation (chart notes, labs, other clinical information) supporting that the member meets all approval criteria and request prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2brand indications

6 monthstypical approval duration

20 mgKesimpta dose

NCapplicable state

J9302,J3590,C9399codes listed

Coverage Criteria

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Initial Therapy - CLL (Arzerra)

Covered when ALL of the following are met

CLL initial criteria: 1. Diagnosis of chronic lymphocytic leukemia (CLL); 2. Request is for Arzerra (ofatumumab intravenous formulation); 3. Prescribed by or in consultation with an oncologist or hematologist; 4. Age ≥ 18 years; 5. One of the following (a, b, c, or d): a) Prescribed as first-line therapy in combination with chlorambucil AND fludarabine-based therapy is considered inappropriate; b) Prescribed in combination with fludarabine and cyclophosphamide for relapsed disease; c) Member is in complete or partial response after at least two lines of therapy for recurrent or progressive disease; d) Disease is refractory to fludarabine and alemtuzumab; 6. Dose does not exceed the maximums in Section V OR the requested dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence); 7. Prescribed regimen is FDA‑approved or recommended by NCCN.

Initial Therapy - MS (Kesimpta)

Covered when ALL of the following are met

MS initial criteria: 1. Diagnosis of one of: clinically isolated syndrome, relapsing‑remitting MS, or secondary progressive MS; 2. Request is for Kesimpta (ofatumumab subcutaneous formulation); 3. Prescribed by or in consultation with a neurologist; 4. Age ≥ 18 years; 5. Kesimpta is not prescribed concurrently with other disease‑modifying therapies for MS; 6. At the time of request, member does not have active hepatitis B infection (negative hepatitis B surface antigen and anti‑hepatitis B virus tests); 7. Dose within limits: initiation 20 mg SC at day 0, then 20 mg SC at weeks 1 and 2; maintenance 20 mg SC every 4 weeks; 8. Prescribed regimen is FDA‑approved or recommended by NCCN; 9. Where applicable, step therapy requirements (failure, contraindication, or intolerance to specified oral and injectable DMTs) have been met per policy and line of business.

Continuation Therapy - CLL

Covered when ALL of the following are met

CLL continued therapy: 1. Member is currently receiving Arzerra via the Centene benefit, or documentation supports that the member has been receiving Arzerra for a covered indication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, the new dose does not exceed the maximums in Section V OR the new dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 4. Prescribed regimen is FDA‑approved or recommended by NCCN.

Continuation Therapy - MS

Covered when ALL of the following are met

MS continued therapy: 1. Member currently receiving Kesimpta via the Centene benefit OR member has previously met initial approval criteria or continuity of care applies; 2. Member is responding positively to therapy; 3. Kesimpta is not prescribed concurrently with other disease‑modifying therapies for MS; 4. If request is for a dose increase, the new dose does not exceed 20 mg every 4 weeks.

Other Indications / Off-label

Covered when ONE of the following is met

Other indications handling: 1. If the drug has undergone a recent label change (within the last 6 months) not yet reflected in this policy, follow the applicable formulary/no‑coverage or non‑formulary policy for the relevant line of business as specified in the policy (see policy references); 2. If the requested use (diagnosis, age, dosing) is not listed under section III and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

Dosing regimens by indication

Dosing regimens and maximum duration by indication (informational for coverage determinations):

Arzerra - Previously untreated CLL: 300 mg IV on Day 1, followed by 1,000 mg IV on Day 8 (Cycle 1); then 1,000 mg IV on Day 1 of subsequent 28‑day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles.max 12 cycles

Arzerra - Relapsed CLL: 300 mg IV on Day 1, followed by 1,000 mg IV on Day 8 (Cycle 1); then 1,000 mg IV on Day 1 of subsequent 28‑day cycles for a maximum of 6 cycles.max 6 cycles

Arzerra - Extended treatment in CLL: 300 mg on Day 1 followed by 1,000 mg on Day 8, then 1,000 mg seven weeks later and every 8 weeks thereafter for up to a maximum of 2 years.max 2 years

Coverage for ofatumumab (Kesimpta) does not include primary progressive multiple sclerosis. Requests for this diagnosis are not authorized under this policy.

Policy maintenance updates removed several previously listed off‑label indications for Arzerra, including criteria for B‑cell lymphoma and small lymphocytic lymphoma (SLL), and in a later review removed Waldenström's macroglobulinemia/lymphoplasmacytic lymphoma as an off‑label use. These removals reflect updated NCCN guidance and limited commercial availability.

Non‑FDA approved indications that are not specifically addressed in this policy are not covered unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, or CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Per the policy's most recent reviews, off‑label uses of Arzerra for certain CLL‑related and B‑cell malignancy indications (including some prior CLL off‑label uses, SLL, and B‑cell lymphoma indications) were removed based on updated NCCN recommendations; such uses are no longer supported by this clinical policy.

Covered Regimens and Dosing

Indication	Regimen	Coverage
Previously untreated CLL in combination with chlorambucil	300 mg IV on Day 1 followed by 1,000 mg IV on Day 8 (Cycle 1); then 1,000 mg IV on Day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles.	Covered when initial CLL criteria are met (see policy); maximum 12 cycles.

Indication	Regimen	Coverage
Relapsed CLL in combination with fludarabine and cyclophosphamide	300 mg IV on Day 1 followed by 1,000 mg IV on Day 8 (Cycle 1); then 1,000 mg IV on Day 1 of subsequent 28-day cycles for a maximum of 6 cycles.	Covered when CLL relapsed criteria are met (see policy); maximum 6 cycles.

Indication	Regimen	Coverage
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Indication	Regimen	Coverage
Refractory CLL	300 mg initial dose, followed 1 week later by 2,000 mg weekly for 7 doses, then 4 weeks later by 2,000 mg every 4 weeks for 4 doses (maximum 12 doses).	Covered for refractory disease when criteria met; maximum 12 doses.

Indication	Regimen	Coverage
Relapsing forms of multiple sclerosis (Kesimpta)	20 mg subcutaneously at weeks 0, 1, and 2, then 20 mg SC monthly starting at week 4.	Covered when MS initial or continuation criteria are met; maintenance dosing 20 mg every 4 weeks.

Indication	Regimens summary	Coverage
Arzerra (ofatumumab) CLL indications	Multiple IV dosing schedules described by indication: previously untreated (300 mg Day 1; 1,000 mg Day 8; then 1,000 mg Day 1 q28d; min 3 cycles, max 12), relapsed (same initial dosing; max 6 cycles), extended treatment (300 mg Day 1; 1,000 mg Day 8; then 1,000 mg at 7 weeks and q8w up to 2 years), refractory (300 mg then 2,000 mg weekly x7, then 2,000 mg q4w x4; max 12 doses).	Covered when applicable CLL criteria are met; follow regimen-specific maximums as stated.

Product	Supply/Presentation	Regimen summary
Kesimpta (ofatumumab)	Supplied as single-dose prefilled Sensoready pen or prefilled syringe: 20 mg/0.4 mL.	Initiation: 20 mg SC at weeks 0, 1, and 2; maintenance: 20 mg SC every 4 weeks starting at week 4.

Provider Actions and Authorization

Prior Authorization

Prior authorization required

Prior authorization is required. The provider must document the diagnosis, prescriber specialty, age, and prior therapies/appropriateness per indication (e.g., CLL) or prior MS therapies and hepatitis B testing (Kesimpta) to demonstrate that the request meets the policy criteria.

CLL: diagnosis of CLL, request for Arzerra, prescribed by/with oncologist or hematologist, age ≥ 18, and line-specific prior therapy rationale per section I.A.
MS (Kesimpta): diagnosis per section I.B, prescribed by/with neurologist, age ≥ 18, not concurrent with other DMTs, and negative hepatitis B testing.

Prior Authorization

Prior authorization required using listed codes

Prior authorization must be requested using the applicable HCPCS/J-code and the request is subject to the clinical policy's coding and coverage guidance.

Referenced codes: J9302 (ofatumumab, Arzerra), J3590 or C9399 (Kesimpta).
Authorization requests must meet the plan's documented medical necessity criteria.

Step Therapy

MS step therapy requirements

For Kesimpta requests in MS, step therapy requires failure, contraindication, or intolerance to the specified oral and injectable disease-modifying therapies prior to approval, unless state-specific exceptions apply.

Required failures include agents such as dimethyl fumarate, teriflunomide, fingolimod, and an interferon-beta agent or glatiramer at maximally indicated doses unless contraindicated or not tolerated.
Illinois HIM: step therapy requirements do not apply per IL HB 5395 for applicable requests (see policy notes).

Step Therapy

Step therapy and redirections per plan edits

Template and plan edits have added step therapy rules, product redirections, and step therapy bypasses for certain lines of business; follow the specific plan's step-therapy rules when processing requests.

Template changes applied to continued therapy and other diagnoses/indications.
A step therapy bypass was added for Illinois HIM per IL HB 5395.

Documentation Required

Submit required clinical documentation

Providers must submit clinical documentation (e.g., office chart notes, lab results, or other clinical information) that supports the member has met all approval criteria.

Documentation should substantiate diagnosis, prior therapies, response to therapy, and any other criteria relevant to the requested indication.

Documentation Required

Follow plan-specific documentation requirements

Follow the plan's current, line-of-business specific documentation requirements; policy maintenance notes reflect changes to required documentation for specific indications (for example, baseline relapses/EDSS and measures of response for MS).

Documentation expectations and continued approval durations have been updated across reviews—confirm the plan appendix and recent edits for exact requirements.

Denial Risk

Denial triggers for non‑covered indications

Requests for uses that are not FDA‑approved and are not covered by this policy may be denied unless supported by the applicable off-label use policy and sufficient evidence of efficacy and safety; primary progressive MS is not authorized.

Off-label requests must include supporting evidence per CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) as applicable.
Primary progressive MS is specifically excluded from coverage.

Definitions

CLL — Chronic lymphocytic leukemia

TermCLL = chronic lymphocytic leukemia

Typical prescriber specialtyOncologist or hematologist for Arzerra (CLL) requests

Coverage contextArzerra (ofatumumab) dosing and coverage criteria for multiple CLL settings (untreated, relapsed, extended, refractory) are defined in the policy.

MS — Multiple sclerosis

TermMS = multiple sclerosis

Covered MS typesClinically isolated syndrome, relapsing‑remitting MS, secondary progressive MS (policy excludes primary progressive MS).

Kesimpta roleKesimpta (ofatumumab) is the subcutaneous CD20‑directed therapy for relapsing forms of MS with initiation and monthly maintenance dosing.

Arzerra (ofatumumab) — Intravenous ofatumumab formulations used for CLL with indication-specific dosing schedules

ProductArzerra (ofatumumab) — intravenous formulation for CLL

Key IV vial presentationsSingle‑use vials: 100 mg/5 mL and 1,000 mg/50 mL (Arzerra).

Indication-specific dosingMultiple IV schedules described: previously untreated, relapsed, extended treatment, and refractory CLL with distinct maximum cycles/doses per regimen.

Kesimpta (ofatumumab) — Subcutaneous ofatumumab formulation (20 mg) for MS administered via single-dose prefilled pen or syringe

ProductKesimpta (ofatumumab) — subcutaneous formulation (20 mg)

Administration devicesSupplied as single‑dose prefilled Sensoready pen or prefilled syringe (20 mg/0.4 mL).

Dosing summaryInitiation: 20 mg SC at weeks 0, 1, and 2; Maintenance: 20 mg SC every 4 weeks starting at week 4.

OpenPayer

Ofatumumab (Arzerra, Kesimpta) coverage

Coverage Criteria

Covered Regimens and Dosing

Coding

Provider Actions and Authorization

Line of Therapy

Definitions

Background

J9302	Injection, ofatumumab, 10 mg (Arzerra)
J3590	Unclassified biologics (Kesimpta)
C9399	Unclassified drugs or biologicals (Kesimpta)