State and School Employees' Health Insurance Plan - Multiple Sclerosis

POLICY NUMBER

S.5.01.452

Briumvi (ublituximab-xiiy)

Lemtrada (alemtuzumab)

Ocrevus (ocrelizumab)

Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq)

Tysabri (natalizumab)

DESCRIPTION

Multiple sclerosis (MS) is a chronic, potentially debilitating disease that affects the central nervous system. It is thought to be an autoimmune disease in which the body incorrectly directs antibodies and white blood cells against proteins in the myelin sheath. This causes inflammation and injury to the sheath and ultimately to the nerves that it surrounds. The result may be multiple areas of scarring (sclerosis). Eventually, this damage can slow or block the nerve signals that control muscle coordination, strength, sensation, and vision. Treatments available can modify the course of the disease and relieve symptoms.

There are four basic MS disease courses that have been defined:

1. Clinically isolated syndrome (CIS) is a first episode of neurologic symptoms caused by inflammation and demyelination in the central nervous system lasting for at least 24 hours.

2. Relapsing-remitting multiple sclerosis (RRMS), the most common type of MS, is characterized by clearly defined attacks of new or increasing neurologic symptoms. These attacks are followed by periods of partial or complete recovery.

3. Secondary progressive multiple sclerosis (SPMS) follows an initial RRMS course and there is a progressive worsening of neurologic function over time.

4. Primary progressive multiple sclerosis (PPMS) is characterized by worsening neurologic function from the onset of symptoms, without early relapses or remissions.

POLICY

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. 

Initial Evaluation

The requested agent may be considered medically necessary when ALL of the following criteria are met:

1. The individual is 18 years of age or older;

2. ONE of the following:

   1. Individual has a diagnosis of relapsing multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease; OR

   2. Individual has a diagnosis of primary progressive multiple sclerosis, and the request is for Ocrevus or Ocrevus Zunovo;

3. The prescriber is a specialist in the area of the individual’s diagnosis (i.e., neurologist) or has consulted with a specialist in the area of the individual’s diagnosis;

4. ONE of the following:

   1. The request is for Ocrevus, Ocrevus Zunovo, or Tysabri and ONE of the following:

      1. The individual has tried and failed (see definition of Medication Failure in Policy Guidelines section) ONE of the following generic agents:

         1. Diemthyl fumarate;

         2. Fingolimod;

         3. Glatiramer; OR

         4. Teriflunomide; OR

      2. The individual has signs or symptoms of highly active disease with documentation of at least ONE of the following:

         1. Spinal cord involvement;

         2. Significant increase in T2 lesion load compared with a previous MRI;

         3. One or more gadolinium-enhancing lesions on brain MRI; OR

         4. Two or more disabling relapses in 1 year;

   2. The request is for Ocrevus or Ocrevus Zunovo, and the individual has a diagnosis of PPMS; AND

   3. The request is for Lemtrada, and the individual has tried and failed (see definition of Medication Failure in Policy Guidelines section) TWO of the following:

      1. Avonex;

      2. Betaseron;

      3. Diemthyl fumarate;

      4. Fingolimod;

      5. Glatiramer;

      6. Kesimpta;

      7. Plegridy;

      8. Rebif;

      9. Teriflunomide; OR

      10. Zeposia

5. Individual is not being treated with another biologic immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti IgE antibody, etc.);

6. ONE of the following:

   1. Individual is NOT currently being treated with another disease modifying agent (DMA) for MS; OR

   2. Individual is currently being treated with another DMA for MS and the DMA will be discontinued before starting the requested agent;

7. Individual does not have any contraindication(s) to therapy with the requested agent; AND

8. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

Renewal Evaluation

The requested agent may be approved for RENEWAL when ALL of the following criteria are met:

1. Individual has been previously approved for the requested agent through the BCBSMS review process;

2. Individual has documented clinical improvement (i.e., slowing of disease progression, decrease in symptom severity and/or frequency, etc.);

3. Individual does not have any contraindication(s) to therapy with the requested agent; AND

4. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

Briumvi (ublituximab-xiiy) is considered not medically necessary on all Blue Cross & Blue Shield of Mississippi formularies as there are other formulary alternatives available.

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

Medical Policy Manual coverage guidelines should not be used in lieu of the Participant's specific benefit plan language outlined in the Mississippi's State and School Employees’ Life and Health Insurance Plan.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Participant's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Participant's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Participant, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to the Participant. When applied to the care of an Inpatient, it further means that services for the Participant's medical symptoms or conditions require that the services cannot be safely provided to the Participant as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

Medication Failure

Medication failure is defined as documented disease progression (i.e., new lesions, enhancement, etc. on MRI), frequent exacerbations, or symptoms despite adherence to generally accepted doses of current regimen. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested based on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

07/01/2023: New policy added.

06/03/2025: Policy reviewed by Pharmacy & Therapeutics (P&T) Committee; no changes.

10/01/2025: Policy updated to add Briumvi (ublituximab-xiiy) and Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) to the list of drugs. Policy section updated to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary criteria updated regarding prescriber requirements and requests for Ocrevus, Ocrevus Zunovo, Tysabri, and Lemtrada. Added statement that Briumvi (ublituximab-xiiy) is considered not medically necessary on all Blue Cross & Blue Shield of Mississippi formularies as there are other formulary alternatives available. Sources updated. Code Reference section updated to add HCPCS code J2351 to the Medically Necessary Codes table. Added J2329 to the Not Medically Necessary Codes table. Added new ICD-10 diagnosis codes G35.A, G35.B0, G35.B1, G35.C0, G35.C1, and G35.D.

SOURCE(S)

1. Briumvi prescribing information. TG Therapeutics, Inc. August 2025. Last accessed September 2025.

2. Lemtrada prescribing information. Genzyme Corporation. May 2024. Last accessed March 2025.

3. Ocrevus prescribing information. Genentech, Inc. November 2024. Last accessed March 2025.

4. Ocrevus Zunovo prescribing information. Genentech, Inc. November 2024. Last accessed June 2025.

5. Types of MS. National Multiple Sclerosis Society.

   https://www.nationalmssociety.org/What-is-MS/Types-of-MS

6. Tysabri prescribing information. Biogen Inc. March 2025. Last accessed March 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes        

Not Medically Necessary Codes

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