CurrentCignaPolicy N/A

Drug Quantity Management Policy — Kesimpta (ofatumumab)

Defines quantity limits and exception criteria for Kesimpta (ofatumumab) subcutaneous injection for Cigna-administered benefit plans; applies to providers and pharmacists submitting coverage/authorization requests.

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy — Kesimpta (ofatumumab)

Policy CodePolicy N/A

Change TypeClarified one-time override durationupdated home delivery limits

Effective DateMay 2, 2025

Next Review DateMay 2, 2025

Key ActionRequest a one-time induction override when initiating Kesimpta to allow 4 pens (retail, 28 days) or 6 pens (home delivery, 84 days) for induction; overrides are valid for 30 days.

SourceLink

POLICY UPDATE CHANGES

Policy Statement was updated to clarify that 'one-time' overrides are provided for 30 days in duration.

Updated to reflect the existing quantity limits when a product is obtained via home delivery.

1 pen/28dRetail maximum quantity

3 pens/84dHome delivery maximum quantity

4 or 6 pensInduction override

30 daysOverride duration

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Drug Quantity Limits and Induction Override

Quantity limits apply; exceptions covered as medically necessary when the criteria below are met.

Default quantity limits: Retail maximum = 1 pen per 28 days; Home delivery maximum = 3 pens per 84 days.

See Drug Quantity Limits for Kesimpta (ofatumumab) 20 mg/0.4 mL Sensoready pen.

Exception - Initiating treatment or requiring additional induction dosing: If the patient is initiating treatment or requires additional induction dosing, approve a one-time override: 4 pens as a 28-day supply at retail OR 6 pens as an 84-day supply at home delivery.

Override sufficient for Weeks 0,1,2,4 (retail) or Weeks 0,1,2,4,8,12 (home delivery). One-time overrides are provided for 30 days in duration.

EXCEPTIONS TO THE QUANTITY LIMITS LISTED ABOVE ARE COVERED AS MEDICALLY NECESSARY WHEN THE SPECIFIED CRITERIA ARE MET. Any other exception is considered not medically necessary.

Exceptions to the quantity limits that are not the specified induction/initiation override are considered not medically necessary. The policy only authorizes the one-time induction/initiating-treatment override described in the criteria.

Coding and Dispensing Limits

No specific billing codes listed in policymixed

No codes listed

Retail maximum quantity per 28 days

Retail maximum quantity1 pen per 28 days

ProductKesimpta (ofatumumab) 20 mg/0.4 mL Sensoready pen

ScopeApplies to retail dispensing

Home delivery maximum quantity per 84 days

Home delivery maximum quantity3 pens per 84 days

ProductKesimpta (ofatumumab) 20 mg/0.4 mL Sensoready pen

ScopeApplies to home delivery dispensing

Provider Actions and Billing Guidance

Prior Authorization

Quantity Management Prior Authorization

This Drug Quantity Management program requires prior authorization when requested quantities exceed the quantity limits at point of sale. If the quantity management rule is not met for the requested medication at the point of service, coverage will be determined by the policy criteria. Approvals are provided for the duration noted in the policy; one-time overrides are limited to 30 days.

Retail max: 1 pen per 28 days
Home Delivery max: 3 pens per 84 days
One-time override: 30 days

Step Therapy

Step therapy

No step therapy requirements are specified for this drug policy.

Documentation Required

Billing and coding documentation

Providers must bill using the most appropriate diagnosis and procedure codes in effect on the date of submission. Claims submitted for services that are not accompanied by covered code(s) under the applicable coverage policy will be denied as not covered.

Denial Risk

Coding-based denial risk

Claims lacking covered procedure or diagnosis codes will be denied as not covered. Ensure submitted codes match the policy's covered codes and quantity-limit rules to avoid coding-based denials.

Background

Kesimpta (ofatumumab) is a 20 mg/0.4 mL Sensoready pen for subcutaneous injection used to treat relapsing forms of multiple sclerosis in adults. Quantity limits in this policy specify a retail maximum of 1 pen per 28 days and a home delivery maximum of 3 pens per 84 days. For patients initiating therapy or requiring additional induction dosing, a one-time override is permitted to cover induction doses: 4 pens as a 28-day retail supply or 6 pens as an 84-day home delivery supply, sufficient for the Weeks 0, 1, 2, and 4 doses (retail) or Weeks 0, 1, 2, 4, 8, and 12 (home delivery).

Initial Therapy / Induction Criteria

Initial therapy / induction

Induction dosing and allowed initial quantity override.

Induction dosing schedule: 20 mg subcutaneous injection at Weeks 0, 1, and 2, followed by 20 mg SC at Week 4; then once-monthly maintenance dosing.

Recommended dosing schedule for Kesimpta.

Induction quantity override: Approve one-time override: 4 pens (retail, 28 days) or 6 pens (home delivery, 84 days) to cover induction and early doses.

Override covers Weeks 0,1,2,4 (retail) or Weeks 0,1,2,4,8,12 (home delivery); one-time overrides provided for 30 days in duration.

Step	Requirement
0	No step therapy requirements specified in this policy.

Quantity Limits

Kesimpta quantity limits (site-specific)

ProductKesimpta (ofatumumab) 20 mg/0.4 mL Sensoready pen

Retail limit1 pen per 28 days

Home delivery limit3 pens per 84 days

Kesimpta induction override — allowed override quantities

One-time induction override (retail)4 pens as a 28-day supply (covers Weeks 0,1,2,4)

One-time induction override (home delivery)6 pens as an 84-day supply (covers Weeks 0,1,2,4,8,12)

DurationOne-time overrides provided for 30 days

Site of Care

Note

Different maximums for retail vs home delivery dispensing

Quantity maximums differ by dispensing channel: retail limits are set per 28 days and home delivery limits are set per 84 days; request quantities must conform to the applicable channel limit or meet exception criteria.

Retail maximum: 1 pen per 28 days.
Home delivery maximum: 3 pens per 84 days.
One-time induction override quantities differ by channel (see criteria for 4 pens retail vs 6 pens home delivery).

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy — Kesimpta (ofatumumab)

Policy CodePolicy N/A

Change TypeClarified one-time override durationupdated home delivery limits

Effective DateMay 2, 2025

Next Review DateMay 2, 2025

Key ActionRequest a one-time induction override when initiating Kesimpta to allow 4 pens (retail, 28 days) or 6 pens (home delivery, 84 days) for induction; overrides are valid for 30 days.

SourceLink

On This Page

OpenPayer

Drug Quantity Management Policy — Kesimpta (ofatumumab)

Coverage Criteria

Coding and Dispensing Limits

Provider Actions and Billing Guidance

Background

Definitions

Initial Therapy / Induction Criteria

Step Therapy

Quantity Limits

Site of Care