Multiple Sclerosis (MS) Agents — Prior Authorization Coverage Criteria
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Requirements for initial and renewal prior authorization of disease-modifying therapies for multiple sclerosis, including FDA age and dosing limits and prescribing/therapeutic prerequisites affecting prescribers and patients seeking coverage.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Authorization Criteria
Covered for initial prior authorization when ALL of the following are met:
Must meet all listed
Prescriber rationale required if requesting Vumerity or Bafiertam instead of dimethyl fumarate
Prescriber rationale required if requesting Tascenso ODT instead of fingolimod
Renewal Authorization Criteria
Covered for renewal prior authorization when ALL of the following are met:
Must meet all listed
Applies to renewal approvals for Lemtrada
Agents listed in Table 2 are not to be used concurrently. Concurrent therapy with two or more disease-modifying therapies (DMTs) in Table 2 will not meet authorization and should be avoided when requesting prior authorization.
Lemtrada (alemtuzumab) is generally reserved for patients who have had an inadequate response to two or more medications indicated for the treatment of multiple sclerosis. Subsequent treatment courses (12 mg IV daily for 3 consecutive days; total 36 mg) may be given if necessary, with courses administered no earlier than 12 months after the prior treatment cycle.
Coding and Agent List
| Ocrelizumab (Ocrevus®) | Indications: PPMS, CIS, RRMS, SPMS; Age ≥ 18 years; Dosing limits as listed |
| Ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo ™) | Indications: PPMS, CIS, RRMS, SPMS; Age ≥ 18 years; Dosing limits as listed |
| Ofatumumab (Kesimpta®) | Indications: CIS, RRMS, SPMS; Age ≥ 18 years; Dosing limits as listed |
| Ublituximab (Briumvi®) | Indications: CIS, RRMS, SPMS; Age ≥ 18 years; Dosing limits as listed |
| Alemtuzumab (Lemtrada®) | Indications: RRMS, SPMS; Age ≥ 18 years; Dosing limits as listed |
| Dimethyl Fumarate (Tecfidera®) | Indications: CIS, RRMS, SPMS; Age ≥ 18 years; 240 mg orally twice daily |
| Diroximel Fumarate (Vumerity®) | Indications: CIS, RRMS, SPMS; Age ≥ 18 years; 462 mg orally twice daily |
| Monomethyl Fumarate (Bafiertam®) | Indications: CIS, RRMS, SPMS; Age ≥ 18 years; 190 mg orally twice daily |
| Interferon Beta-1a (Avonex®, Rebif®) | Indications: CIS, RRMS, SPMS; Age and dosing per Table 1 |
| Interferon Beta-1b (Betaseron®, Extavia®) | Indications: CIS, RRMS, SPMS; Age ≥ 18 years; dosing per Table 1 |
Provider Actions and Requirements
Prior authorization required; meet indication, age, dosing, neurologist involvement
Prior authorization is required for all current and future dose forms of the MS agents listed in Table 1; approval requires that the medication is approved for the requested indication and age, does not exceed dosing limits in Table 1, and is prescribed by or in consultation with a neurologist.
- Medication must be approved for the indication, age, and not exceed dosing limits listed in Table 1.
- Medication must be prescribed by or in consultation with a neurologist.
Required ≥90-day trial of alternative fumarate or fingolimod before select agents
An adequate trial of the preferred fumarate or fingolimod is required before certain agents: at least 90 consecutive days of dimethyl fumarate is required prior to Vumerity or Bafiertam; at least 90 consecutive days of fingolimod is required prior to Tascenso ODT, unless a compelling rationale is provided.
- Adequate trial length defined as at least 90 consecutive days.
- Compelling rationale from prescriber required if requesting the alternative without the trial.
Prescriber attestation and benefit attestation at renewal
Prescriber must attest that the medication is prescribed by or in consultation with a neurologist; for renewal, the prescriber must attest that the patient has received clinical benefit from continuous treatment with the requested medication.
- Initial requests must document neurologist prescribing or consultation.
- Renewal requests require attestation of clinical benefit from continuous treatment.
Document indication, patient age, and dosing per Table 1
Documentation submitted with the PA request must support the requested agent's FDA-approved indication, the patient's age, and that dosing does not exceed the limits listed in Table 1.
- Provide evidence the requested agent matches the indication listed in Table 1.
- Include patient age to confirm it meets the Table 1 minimum.
- Document dosing regimen to show it does not exceed Table 1 dosing limits.
Concurrent DMTs prohibited
Concurrent therapy with another disease‑modifying MS agent listed in Table 2 is not allowed and will prevent authorization.
- Patient must not be on concurrent therapy with another DMT listed in Table 2 for initial or renewal authorization.
≥90-day dimethyl fumarate trial required before Vumerity/Bafiertam
If the patient has not completed an adequate trial of dimethyl fumarate (≥90 consecutive days), approval for Vumerity or Bafiertam will be precluded unless the prescriber provides a compelling rationale explaining why the alternative is necessary.
- Adequate trial of dimethyl fumarate defined as at least 90 consecutive days.
- Gastrointestinal side effects alone are explicitly not accepted as a compelling rationale.
≥90-day fingolimod trial required before Tascenso ODT
If the patient has not completed an adequate trial of fingolimod (≥90 consecutive days), approval for Tascenso ODT will be precluded unless the prescriber provides a compelling rationale explaining why Tascenso ODT is required instead of generic fingolimod.
- Adequate trial of fingolimod defined as at least 90 consecutive days.
- Prescriber must provide a compelling rationale when requesting Tascenso ODT without prior fingolimod trial.
Background
This policy governs coverage and prior authorization requirements for disease-modifying therapies (DMTs) used to treat multiple sclerosis phenotypes, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and primary progressive MS (PPMS). It lists the FDA-approved indications, age limits, and dosing constraints for each DMT and establishes that approval requires meeting indication, age, and dosing limits in Table 1 and that therapy must not be given concurrently with another DMT listed in Table 2.
Table 2 enumerates the DMT agents that should not be used at the same time; requests for authorization must document that the patient is not receiving any other agent from that table. The policy also includes agent-specific notes and limits (for example, reservation of Lemtrada for patients with inadequate response to ≥2 prior MS medications and dosing/course timing requirements for certain agents).
Definitions
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