Multiple Sclerosis Drugs (Lemtrada, mitoxantrone)
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Defines prior authorization, coverage criteria, dosing limits, and continuation requirements for alemtuzumab (Lemtrada) and mitoxantrone for Arizona Complete Health (Arizona Medicaid) members.
Removed certain drugs (e.g., Tysabri, Ocrevus, Ponvory, Tascenso ODT) from this policy and redirected to AHCCCS FFS criteria where applicable.
Aligned preferred and non-preferred drug lists with AHCCCS FFS PA Guideline and removed references to Care1st and a retired off-label policy.
Specified limits on treatment courses for certain agents (Lemtrada: one course per authorization; Mavenclad: one course per authorization and two lifetime courses).
Coverage Criteria for Disease-Modifying Therapies
Initial Therapy
Covered when ALL of the following are met
Continuation Therapy
Covered when ALL of the following are met
Other Indications
Other diagnoses/indications
If member is currently receiving medication via Centene benefit and documentation supports a positive response to therapy, approval duration for other indications is the duration of the request or up to 6 months (whichever is less).
General coverage alignment and redirections
Policy-level coverage stance and operational criteria changes
Providers submitting requests for agents or indications removed from this policy should be redirected to AHCCCS FFS PA criteria; requests for certain non-covered indications (e.g., ocrelizumab for rheumatoid arthritis or lupus nephritis) may be denied if submitted under this policy.
Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the AHCCCS FFS Prior Authorization Guideline — Coverage of Off‑Label Non‑FDA Approved Indications (the off‑label use policy).
Ocrelizumab (Ocrevus) is not covered for the indications of rheumatoid arthritis and lupus nephritis/systemic lupus erythematosus due to safety concerns and because the policy has removed Ocrevus as a listed agent and redirected such requests to AHCCCS FFS criteria.
Use of Ocrevus for rheumatoid arthritis or lupus nephritis/systemic lupus erythematosus is not authorized under this policy and is considered not covered.
References to indications outside the approved multiple sclerosis diagnoses (for example, rheumatoid arthritis or lupus nephritis) are explicitly noted as not covered in this policy; requests for such indications should follow the off‑label use procedures or be referred to the AHCCCS FFS criteria as applicable.
Coding and Billing Implications
| No codes listed |
| J1826 | Injection, interferon beta-1a, 30 mcg. |
| Q3027 | Injection, interferon beta-1a, 1 mcg for intramuscular use. |
| Q3028 | Injection, interferon beta-1a, 1 mcg for subcutaneous use. |
| J1830 | Injection interferon beta-1b, 0.25 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered). |
| J1595 | Injection, glatiramer acetate, 20 mg. |
| J0202 | Injection, alemtuzumab, 1 mg. |
| J9293 | Injection, mitoxantrone HCl, per 5 mg. |
| J2323 | Injection, natalizumab, 1 mg. |
| J2350 | Injection, ocrelizumab, 1 mg. |
| J9302 | Injection, ofatumumab, 10 mg. |
Provider Requirements and Prior Authorization
Prior Authorization Required
Prior authorization is required for Lemtrada and mitoxantrone. Requests must include documentation elements listed in other callouts; failure to obtain PA may result in denial.
- Prior authorization required for Lemtrada and mitoxantrone
- PA must be obtained before dispensing/administration
Documentation Requirement
Providers must submit supporting documentation such as office chart notes, laboratory results, or claims history showing prior therapies, dates, and durations. Failure to submit required documentation may result in denial or delayed review.
- Office notes documenting diagnosis and neurologist consultation
- Lab results when applicable (e.g., baseline labs per product labeling)
- Claims history or medical records showing prior DMT name, start/stop dates, and duration
Continued Therapy Documentation
For continued therapy (re-authorization), include documentation of clinical benefit or positive response to therapy and evidence of ongoing need. For Lemtrada, note that only one treatment course may be approved per authorization; continued-therapy requests must reference prior course and dates. For mitoxantrone, include cumulative dose information and monitoring data.
- Documentation of positive clinical response (office notes, EDSS or other objective measures when available)
- For Lemtrada: prior treatment course date(s); continued approval typically limited to 12 months (1 treatment course only)
- For mitoxantrone: provide cumulative lifetime dose and monitoring (cardiac, labs); approval duration per policy
Step Therapy Requirement
Step therapy: prior to approval, member must have trial and failure (or documented contraindication/intolerance) to TWO listed disease-modifying therapies (document medication used, date, and duration).
- Trials must be at least 4 weeks each unless clinical rationale provided
- List of therapies to try includes (but is not limited to): Avonex, Copaxone, dalfampridine, dimethyl fumarate, fingolimod, Kesimpta, Ocrevus/Ocrevus Zunovo, Rebif, teriflunomide, Tysabri
- If member has contraindication or intolerance to required agents, provide supporting documentation
Denial Triggers and Redirections
Denial triggers and redirections: requests for non-covered diagnoses or indications will be denied or redirected per policy. For example, ocrelizumab (Ocrevus) requests for diagnoses such as rheumatoid arthritis or lupus nephritis are not covered under this MS-focused policy and should be redirected to the appropriate policy (e.g., Novantrone or AHCCCS FFS criteria) when applicable.
- Requests lacking required documentation of prior DMTs, dates, or durations may be denied
- Requests for non-covered diagnoses will be denied or redirected (e.g., RA or lupus nephritis requests for Ocrevus)
- Refer to AHCCCS FFS PA criteria for agents/indications removed from this policy
Background and Clinical Context
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system. Management includes disease‑modifying therapies (DMTs) intended to reduce relapse frequency and slow accumulation of disability. Certain agents (for example, alemtuzumab [Lemtrada] and mitoxantrone) are associated with significant safety risks and have specific prescribing, dosing, and monitoring requirements; therefore prior authorization with documentation of diagnosis, prescriber specialty, prior DMT trials, dosing within limits, and evidence of clinical benefit is required for covered agents.
Definitions and Abbreviations
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