Multiple Sclerosis medications (brand selection) including Lemtrada, Ocrevus, Mitoxantrone, IV steroids
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This policy governs medical and pharmacy utilization management (precertification and coverage criteria) for multiple sclerosis (MS) therapies for Curative Health Plan members and participating providers.
No material clinical or coverage changes in this revision.
Coverage Criteria for Multiple Sclerosis Therapies
Alemtuzumab (Lemtrada) Initial Therapy
Covered when ALL of the following are met:
Alemtuzumab (Lemtrada) Subsequent Courses
Covered when ALL of the following are met:
Mitoxantrone Initial Therapy
Covered when ALL of the following are met:
Mitoxantrone Continuation of Therapy
Covered when ALL of the following are met:
Ocrelizumab (Ocrevus) Initial Therapy
Covered when ANY of the following indications are met:
Ocrelizumab (Ocrevus) Continuation of Therapy
Covered when ALL of the following are met:
Intravenous Steroid Therapy
Covered when ANY of the following clinical conditions are present:
Continuation — Ocrevus
Continuation Therapy — Ocrelizumab (Ocrevus)
Continuation — Briumvi
Continuation Therapy — Ublituximab-xiiy (Briumvi)
Concomitant use with other DMTs is considered experimental/investigational and is not permitted.
Initial — Briumvi
Initial Approval Criteria — Ublituximab-xiiy (Briumvi)
All other indications considered experimental/investigational.
Plasmapheresis — acute severe MS after steroids fail
Plasma Exchange / Plasmapheresis
Not indicated as maintenance therapy for chronic or secondary progressive MS.
Curative considers all other indications not explicitly listed for specific agents (for example, alemtuzumab/Lemtrada, ocrelizumab/Ocrevus, mitoxantrone) to be experimental and investigational. Authorization for uses outside the covered indications should not be expected unless specifically addressed in the Experimental and Investigational section of the policy.
Members must not receive these agents for indications not enumerated in the policy because such uses are classified as investigational and therefore not covered under the medical necessity criteria.
Curative considers ublituximab-xiiy (Briumvi) medically necessary only for the listed indications: treatment of relapsing forms of multiple sclerosis (including relapsing‑remitting and secondary progressive disease with continued relapses) or for clinically isolated syndrome (CIS). All other indications for Briumvi are considered experimental and investigational.
The policy specifically lists a broad set of interventions and tests that are considered experimental or investigational in MS (examples include: various biologics and immunotherapies other than approved agents, cannabinoids, dietary interventions, IVIG for MS, mesenchymal stem cell therapies, plasmapheresis as maintenance for chronic/secondary progressive MS, retinal nerve scanning, and multiple biomarker assays). These listed items exemplify the types of therapies and diagnostics that will be denied when proposed for MS outside of established, covered indications.
Alemtuzumab (Lemtrada) is considered medically necessary only when the member meets the specified coverage criteria and has a contraindication, intolerance, or ineffective response to an adequate trial of Tysabri. Intolerance is defined as intolerable side effects despite optimized management strategies; failure of an adequate trial is defined by criteria such as increasing relapses (≥2 in a year or one severe relapse with poor recovery or MRI lesion progression) or sustained worsening disability.
Use of alemtuzumab (Lemtrada), ocrelizumab (Ocrevus), ublituximab (Briumvi) or other disease‑modifying multiple sclerosis agents concomitantly with additional disease‑modifying MS therapies is considered experimental and investigational and therefore not medically necessary. Ampyra and Nuedexta are explicitly noted as not being disease‑modifying agents and are not included in this restriction.
Providers should ensure that a member is not receiving overlapping DMTs when requesting authorization; simultaneous prescribing of two or more DMTs may result in denial of coverage.
Provider Requirements, Prior Authorization, and Documentation
Precertification required; Lemtrada initial/subsequent approval conditions
Precertification (prior authorization) is required for multiple sclerosis medications. Initial approval for alemtuzumab (Lemtrada) requires documentation that the member has had an inadequate response to two or more drugs indicated for MS (for first course) or completed at least one prior course with the next course starting ≥12 months after the prior dose (for subsequent courses).
- Precertification required for all MS medications.
- Alemtuzumab initial course: inadequate response to two or more MS drugs required.
- Alemtuzumab subsequent courses: completed ≥1 prior course and next course ≥12 months after prior dose.
Prior authorization required for Briumvi initiation
Prior authorization is required to initiate ublituximab-xiiy (Briumvi). The request must document the diagnosis of a relapsing form of multiple sclerosis or clinically isolated syndrome and meet the stated indication criteria; pediatric authorization may be considered when benefits outweigh risks.
- Document diagnosis: relapsing MS or clinically isolated syndrome (CIS).
- Pediatric authorization (<18 years) may be granted when benefits outweigh risks.
Step therapy: Lemtrada requires prior treatment failures
Alemtuzumab (Lemtrada) is covered only after inadequate response to other MS therapies — specifically an inadequate response to two or more drugs indicated for MS prior to first-course approval.
- First-course coverage requires prior inadequate response to ≥2 MS drugs.
Definition of failure of prior MS therapy
Failure of an adequate trial of prior therapy is defined as increasing relapses (two or more relapses in a year, or one severe relapse with poor recovery or MRI lesion progression), lesion progression by MRI (increase in number or volume of gadolinium‑enhancing, T2 hyperintense, or T1 hypointense lesions), or worsening disability (sustained worsening of EDSS score or neurological exam findings).
- ≥2 relapses in a year, or one severe relapse with poor recovery or MRI progression.
- MRI lesion progression (gadolinium‑enhancing, T2, or T1 lesion increases).
- Sustained worsening of EDSS score or neurologic exam findings.
Document neurological impairment to justify IV steroids for acute exacerbations
To justify intravenous steroid therapy for acute MS exacerbations, document that the relapse is characterized by functionally disabling symptoms with evidence of neurological impairment; prior response to steroids increases likelihood of benefit. For severe neurologic deficits requiring hospitalization, document the specific severe manifestations (e.g., acute cerebral symptoms with loss of intellectual capacity, seizures, fulminant MS, pseudobulbar palsy, quadriplegia, acute transverse myelitis, or acute visual loss).
- Document functionally disabling symptoms and objective neurological impairment.
- If inpatient, document severe deficits (list of severe clinical presentations as policy defines).
- Note prior steroid responsiveness when available.
Prescriber specialty and required documentation of benefit
Medications must be prescribed by, or in consultation with, a neurologist. Authorization requests should include documentation supporting the diagnosis (relapsing forms of MS or CIS as applicable) and, for continuation approvals, evidence of disease stability or improvement on therapy.
- Prescriber is a neurologist or request must document neurologist consultation.
- Include documentation of diagnosis: relapsing MS or CIS where applicable.
- For continuation, include evidence of disease stability or improvement on the agent.
Denial risk: lack of precertification
Failure to obtain required precertification/authorization for multiple sclerosis medications may result in denial of coverage.
- Obtain precertification for all MS medications to avoid denial.
Concomitant DMTs with Ocrevus/Briumvi is considered experimental
Use of Ocrevus (ocrelizumab) or Briumvi (ublituximab‑xiiy) concurrently with other disease‑modifying multiple sclerosis agents is considered experimental and investigational and may result in denial of authorization.
- Do not prescribe Ocrevus or Briumvi concomitantly with other DMTs; such use is considered experimental/investigational.
- Ampyra and Nuedexta are explicitly not disease‑modifying and are exceptions to the DMT list.
Definitions Used in This Policy
Background and Scope
Multiple sclerosis (MS) is managed primarily with disease‑modifying therapies (DMTs) that aim to reduce the frequency of relapses and slow disease progression. This policy defines when selected higher‑cost or higher‑risk agents (for example, alemtuzumab, ocrelizumab, mitoxantrone, and IV steroids for acute severe relapses) are considered medically necessary versus experimental/investigational and describes utilization management requirements such as precertification and prescriber specialty expectations.
Clinical use is guided by specific coverage criteria: some agents are limited to particular forms of MS (e.g., relapsing forms or clinically isolated syndrome), others require prior therapy failure or intolerance (for example, Lemtrada after inadequate response to specified prior therapies), and certain therapies (e.g., plasmapheresis) are reserved for acute, severe deficits that fail high‑dose glucocorticoids.
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