Blue Cross Blue Shield - Iowa MS DMT Coverage Update

Coverage and Medical Necessity Criteria

inv-01: Initial Approval — multiple listed agents

Covered when ALL of the following are met for listed agents:

General initial coverage for listed DMTs: Member diagnosed with a relapsing form of multiple sclerosis (including relapsing-remitting and secondary progressive disease for those who continue to experience relapse) or clinically isolated syndrome where specified; specific listed agents may be considered medically necessary.

Approval will be for 12 months.

inv-02: Initial Approval — Mavenclad

Mavenclad specific initial criteria — ALL must be met:

Mavenclad initial approval: Member has had an inadequate response to or is unable to tolerate an alternative drug indicated for the treatment of multiple sclerosis; member does not have clinically isolated syndrome (CIS); member has obtained a recent complete blood count (CBC) and lymphocytes are within normal limits; member has been screened for tuberculosis, hepatitis B, and hepatitis C; member has not received 2 courses (i.e., 4 cycles) of Mavenclad; members will not use Mavenclad concomitantly with other medications used for the treatment of multiple sclerosis (excluding Ampyra and Nuedexta).

Approval will be for 90 days.

inv-03: Initial Approval — Lemtrada (first course)

Lemtrada first-course criteria:

Lemtrada first course: Member has had an inadequate response to two or more drugs indicated for multiple sclerosis.

Approval will be for 30 days (5 doses).

inv-04: Initial Approval — Ocrevus / Ocrevus Zunovo

Ocrevus initial coverage:

Ocrevus initial approval: Member diagnosed with a relapsing form of multiple sclerosis (including relapsing-remitting and secondary progressive disease for those who continue to experience relapse), clinically isolated syndrome, or primary progressive multiple sclerosis as specified; Ocrevus and Ocrevus Zunovo may be considered medically necessary for these indications.

Approval will be for 12 months.

inv-05: Continuation of Therapy — general

Continuation criteria — covered when ALL requirements below are met:

General continuation: Member meets the Criteria for Initial Approval for the requested medication and is experiencing disease stability or improvement while receiving the requested medication.

Approval will be for 12 months.

inv-06: Continuation of Therapy — Mavenclad

Mavenclad continuation — ALL must be met:

Mavenclad continuation: Member meets initial criteria for Mavenclad and has not received 2 courses (i.e., 4 cycles) of Mavenclad; member has obtained a complete blood count (CBC) with differential including lymphocyte count and lymphocytes are at least 800 cells/µL; member has not received Mavenclad in the last 43 weeks.lymphocytes >= 800 cells/µL

Approval will be for 90 days.

inv-07: Continuation of Therapy — Lemtrada subsequent courses

Lemtrada subsequent course criteria — ALL must be met:

Lemtrada subsequent courses: Member has completed at least one previous course of Lemtrada; member received the last dose of the prior treatment course at least 12 months prior to the planned date of the first dose of the subsequent Lemtrada course.

Approval will be for 30 days (3 doses).

Members must not use the requested medication concomitantly with other disease‑modifying multiple sclerosis agents. Ampyra and Nuedexta are exceptions because they are not disease‑modifying therapies. This concomitant‑use exclusion also applies to members receiving samples or manufacturer patient‑assistance program product—those members must meet the criteria for initial approval just like other members.

Certain chunks of the source document do not state additional clinical exclusions but instead list specific quantity limits and initiation/maintenance dosing schedules for individual agents (for example, aubagio = 30 tablets per 30 days; Kesimpta initiation = 3 pens per 15 days, maintenance = 1 pen per 28 days). These numeric limits and schedules should be used to evaluate dosing and quantity rather than interpreted as new clinical contraindications.

When a member does not meet the approval criteria outlined in this policy (for example, required prior therapy trials, timing between courses, or laboratory thresholds where specified), the requested disease‑modifying therapy is considered not medically necessary and is not covered.

The quantity‑limit and dosing‑schedule sections list numeric limits and initiation/maintenance regimens for many drugs but do not themselves contain separate, explicit statements listing additional 'not medically necessary' conditions beyond the general policy language. Coverage determinations should reference the criteria sets and not solely the dosing/quantity tables when assessing medical necessity.

Procedure, Billing Codes and Quantity Limits

Procedure/Billing codes for injectable DMTs and unclassified biologicsHCPCS

J0202	Injection, alemtuzumab, 1 mg
J2323	Injection, natalizumab, 1 mg
J2350	Injection, ocrelizumab, 1mg
J2351	Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq (effective 4/1/2025)
J2329	Injection, ublituximab-xiiy, 1 mg
Q5134	Inj, tyruko, 1 mg
J3590	Unclassified biologicals
C9399	Unclassified drugs or biologicals

Drug quantity limits and dosing schedulesmixed

Aubagio (teriflunomide)	Quantity Limit = 30 tablets per 30 days
Avonex (interferon beta-1α)	Quantity Limit = 4 vials, syringes, or pens per 28 days
Betaseron (interferon beta-1β)	Quantity Limit = 14 vials/syringes per 28 days
Bafiertam (monomethyl fumarate)	Quantity Limit = 120 capsules per 30 days
Briumvi (ublituximab-xiiy)	Initiation: 150 mg day 1; Maintenance: 450 mg day 15, then 450 mg every 6 months
Copaxone/Gl 40mg (glatiramer acetate 40mg)	Quantity Limit = 12 syringes per 28 days
Copaxone/Gl 20mg (glatiramer acetate 20mg)	Quantity Limit = 30 syringes per 30 days
Extavia (interferon beta-1β)	Quantity Limit = 15 vials/syringes per 30 days
Gilenya (fingolimod)	Quantity Limit = 30 capsules per 30 days
Kesimpta (ofatumumab)	Initiation: 3 pens per 15 days; Maintenance: 1 pen per 28 days

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Quantity and dosing thresholds — per-drug limits and schedules

Aubagio (teriflunomide)Quantity limit = 30 tablets per 30 days

Kesimpta (ofatumumab)Initiation: 3 pens per 15 days; Maintenance: 1 pen per 28 days

Mavenclad (cladribine)Quantity limit = 20 tablets per 9 months

Ocrevus (ocrelizumab)Initiation: 300 mg infusion day 1 and 15; Maintenance: 600 mg every 6 months

Briumvi (ublituximab-xiiy)Initiation: 150 mg day 1; Maintenance: 450 mg day 15, then 450 mg every 6 months

Prior Authorization, Prescriber Requirements, and Documentation

Prior Authorization

Prescriber Requirements

Medication must be prescribed by or in consultation with a neurologist or other prescriber specializing in the treatment of multiple sclerosis.

Step Therapy

Preferred Product Sequencing (Step Therapy)

The plan requires use of the health plan's preferred products before targeted products unless clinical circumstances exclude their use. Preferred products include Avonex, Betaseron, generic dimethyl fumarate, generic fingolimod, glatiramer acetate, Glatopa, Kesimpta, Mayzent, Plegridy, Ponvory, Rebif, generic teriflunomide, Vumerity, and Zeposia; Briumvi, Ocrevus, Ocrevus Zunovo, and Tyruko are also considered preferred and must be tried before Lemtrada or Tysabri. Exceptions apply when documented clinical reasons prevent use of preferred products or the member is already receiving the non-preferred product with a positive therapeutic outcome.

Policy Scope and Background

This policy governs the use of disease‑modifying therapies for relapsing forms of multiple sclerosis, including relapsing‑remitting disease and secondary progressive disease in patients who continue to experience relapses, and it also addresses treatment of clinically isolated syndrome for many agents. The policy establishes prior authorization requirements, medical necessity criteria, preferred product sequencing, and quantity/dosing limits to guide appropriate selection and continuation of therapy.

Key Definitions

Relapsing forms of multiple sclerosis

DefinitionRelapsing forms of multiple sclerosis include relapsing-remitting disease and secondary progressive disease for those who continue to experience relapse.

Condition scopeAlso includes clinically isolated syndrome for many agents when specified in individual criteria.

Approval implicationDrugs listed for relapsing forms are generally eligible for approval when the member has this diagnosis; typical approval duration is 12 months for most agents.

Non‑Formulary Exception process

PurposeAllows coverage of a non‑formulary drug when the Criteria for Approval are met and additional non‑formulary exception requirements are satisfied.

Required indication support

OpenPayer

Multiple sclerosis disease‑modifying therapies (drug policy)

Coverage and Medical Necessity Criteria

Procedure, Billing Codes and Quantity Limits

Prior Authorization, Prescriber Requirements, and Documentation

Policy Scope and Background

Key Definitions