Multiple Sclerosis

POLICY NUMBER

L.5.01.452

Ampyra (dalfampridine)

Aubagio (teriflunomide)

Avonex (interferon beta-1a)

Bafiertam (monomethyl fumarate)

Betaseron (interferon beta-1b)

Briumvi (ublituximab-xiiy)

Copaxone (glatiramer acetate)

Dimethyl fumarate

Gilenya (fingolimod)

Glatiramer acetate

Glatopa (glatiramer acetate)

Kesimpta (ofatumumab)

Lemtrada (alemtuzumab)

Mavenclad (cladribine)

Mayzent (siponimod)

Ocrevus (ocrelizumab)

Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq)

Plegridy (peginterferon beta-1a)

Ponvory (ponesimod)

Rebif (interferon beta-1a)

Tascenso ODT (fingolimod lauryl sulfate)

Tecfidera (dimethyl fumarate)

Tysabri (natalizumab)

Vumerity (diroximel fumarate)

Zeposia (ozanimod)

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:

• 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.

• 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.

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

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

Table 1: Pharmacy Preferred / Non-Preferred Agents

Table 2: Medical Covered Agents

¹Lemtrada: One drug trial/failure must include a Step 1 agent.²Ocrevus. Ocrevus Zunovo: Trial/Failure requirements do not apply for PPMS.

POLICY

Prior authorization is required.

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

Bafiertam (monomethyl fumarate), Briumvi (ublituximab-xiiy), Copaxone (glatiramer acetate), Mavenclad (cladribine), Mayzent (siponimod), Ponvory (ponesimod), Tascenso ODT (fingolimod lauryl sulfate), Tecfidera (dimethyl fumarate), and Vumerity (diroximel fumarate) are considered not medically necessary on all Blue Cross & Blue Shield of Mississippi formularies as there are other formulary alternatives available.

Initial Evaluation

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

1. ONE of the following:

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

   2. The individual is 10 years of age or older and request is for fingolimod;

2. ONE of the following:

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

   2. The 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. If request is for a Step 2 Agent (See Table 1), then ONE of the following:

   1. The individual's medication history indicates trial and failure (see definition of Medication Failure in Policy Guidelines section) of the required number of preferred agent(s) as indicated in Table 1, unless there is an FDA-labeled contraindication or hypersensitivity to ALL of the step therapy agents listed; OR

   2. BOTH of the following:

      1. 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; AND

      2. The request is for Kesimpta;

5. If request is for a medical covered agent (see Table 2), then BOTH of the following:

   1. ONE of the following:

      1. The individual has tried and failed (see definition of Medication Failure in Policy Guidelines section) the required number of preferred agent(s) as indicated in Table 2;

      2. The individual has a diagnosis of

         PPMS, and the request is for Ocrevus or Ocrevus Zunovo; OR

      3. BOTH of the following:

         1. 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; AND

         2. The request is for Ocrevus, Ocrevus Zunovo, or Tysabri; AND

   2. The 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. The individual is NOT currently being treated with another disease modifying agent (DMA) for MS; OR

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

7. The 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. The individual has been previously approved for the requested agent through the BCBSMS PA process;

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

3. The 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

Initial Evaluation for Ampyra (dalfampridine)

Ampyra (dalfampridine) may be considered medically necessary when ALL of the following criteria are met:

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

2. The individual has a diagnosis of multiple sclerosis;

3. The individual's ambulatory status has been documented AND has a baseline Timed 25-foot Walk (T25FW) of 8-45 seconds;

4. The individual does not have any contraindication(s) to therapy with the requested agent; AND

5. The prescribed dosage is within the program quantity limit based on FDA approved labeled dosage.

Length of Approval: 6 months

 Renewal Evaluation for Ampyra (dalfampridine)

Ampyra (dalfampridine) may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved for the requested agent through the BCBSMS PA process;

2. The individual has documented stabilization or improvement from baseline timed walking speed;

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

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

Length of Approval: 12 months

Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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 Member'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 Member'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 Member, his or her Provider; and

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

7/1997: Approved by Medical Policy Advisory Committee (MPAC), CPT code 90782, 99204 added, ICD-9 procedure code 99.29 added, HCPCS J1825, J1830 added.

2/1999: Reviewed and updated by Pharmacy & Therapeutics Committee.

1/30/2002: Prior authorization added.

2/14/2002: Investigational definition added.

5/1/2002: Type of Service and Place of Service deleted.

11/6/2002: Nova Factor new telephone and fax numbers added. Telephone # 1-800-235-8498 and fax # 1-888-355-6652 deleted.

3/17/2003: Code Reference section updated, HCPCS Q3025, Q3026 added.

3/25/2003: FDA Approved Indications and Policy section expanded to include Avonex coverage for early treatment of MS.

8/15/2005: Code Reference section updated, CPT code 90782, 99204 deleted.

10/27/2005: Title of policy expanded to include Multiple Sclerosis, Rebif® and Glatiramer acetate (Copaxone®). Description section updated with information about Multiple Sclerosis (MS), Rebif® and glatiramer acetate (Copaxone®). FDA approved indications and identification information revised. "Off-Label" uses deleted. Policy section updated: changed preferred provider to Accredo, changed telephone # from 1-866-591-9075 to 1-866-240-3373, changed fax # from 1-866-591-9094 to 1-800-464-2107; added CuraScript as another preferred provider; added Rebif® and glatiramer acetate (Copaxone®); deleted disease states considered investigational.  Sources updated with Rebif®, Avonex®, Betaseron® and Copaxone® added.

11/2005: Approved by Pharmacy & Therapeutics (P&T) Committee.

6/29/2006: CuraScript fax number changed from 1-877-462-6234 to 1-866-239-5502.

8/24/2006: Tysabri® added to policy.

11/28/2006: Code Reference section updated; added HCPCS Q4079.

7/9/2007: Code Reference section updated; HCPCS J1595 added.

12/19/2007: Coding updated per 2008 CPT/HCPCS revisions.

01/01/2009: Accredo and CuraScript preferred provider information removed. BCBSMS information added.

10/7/2009: Extavia® Prescribing Information added to policy description and policy statement sections. HCPC code Q4079 deleted from covered table due code was deleted as of 12-31-2007.

02/22/2010: Policy section updated to add Dalfampridine (Ampyra®). Dalfampridime (Ampyra®) is considered medically necessary to improve walking in patients with Multiple Sclerosis. After six months of therapy, documentation of patient's improvement in walking must be submitted for continuation of treatment. Added HCPCS Code J8499 to Covered Codes Table for Ampyra®.

07/15/2010: Policy description unchanged. Policy statement regarding Dalfampridine (Ampyra®) revised to state that a baseline Timed 25-foot Walk (T25FW), creatinine clearance value, and documentation of ambulatory status must be provided for initial approval. The time frame to evaluate for continuation of treatment was changed from six months to twelve weeks, with a follow-up T25FW being required at that time.

02/28/2011: Added new HCPCS code J1826 to the Code Reference section.

09/19/2011: Policy revised to add coverage criteria for Gilenya®. Added Gilenya® to the HCPCS description of J8499.

09/28/2011: Policy statement revised to state that effective 10/01/11, failure of Betaseron®, Rebif®, or Copaxone® is required for new starts before receiving Avonex®, Extavia®, Tysabri®, or Gilenya®.

03/06/2013: Policy updated to add coverage criteria for Teriflunomide (Aubagio®), which is considered medically necessary for the treatment of patients with relapsing forms of multiple sclerosis as monotherapy after documentation of failure with Avonex®, Rebif®, Betaseron®, Copaxone®, Extavia®, or Tysabri®. Prior to initiating therapy, a TB skin test must be performed. Transaminase, bilirubin levels, and a CBC must be obtained within six months before initiation of therapy. Further CBC monitoring should be based on signs and symptoms of infection. ALT levels must be monitored at least monthly for six months after starting treatment. Blood pressure must be checked before the start of therapy and periodically thereafter. Pregnancy must be excluded before the initiation of treatment and prevented thereafter in female patients and female partners of male patients. Dosage should not exceed 14mg/day and must be prescribed by a board certified neurologist.

10/01/2013: Policy updated to add coverage criteria for Dimethyl fumarate (Tecfidera®), which is considered medically necessary in patients with relapsing forms of multiple sclerosis. A CBC within 6 months is required before initiation of therapy and should be completed annually. Documentation of failure with Betaseron, Rebif, Copaxone is required before starting Tecfidera®. Dosage should not exceed 240 mg twice daily.

01/22/2014: Policy statement revised to state that effective 01/01/2014, failure of two of the following Betaseron®, Rebif®, Copaxone®, or Tecfidera® are required before receiving Avonex®, Extavia®, Tysabri®, Gilenya®, or Aubagio®. Policy statement for Dimethyl fumarate (Tecfidera®) revised to delete "Documentation of failure with Betaseron, Rebif, Copaxone is required before starting Tecfidera." Starter dosing information added. Also for Fingolimod (Gilenya®), deleted "after failure of at least one other Multiple Sclerosis therapy (Copaxone®, Rebif®, Avonex®, Betaseron®, Extavia®, or Tysabri®)." For Natalizumab (Tysabri®), deleted "after failure of at least one other Multiple Sclerosis therapy (Copaxone®, Rebif®, Avonex®, Betaseron® Extavia®, Gilenya®, or Novantrone®)." For Teriflunomide (Aubagio®), deleted "as monotherapy after documentation of failure with Avonex®, Rebif®, Betaseron®, Copaxone®, Extavia®, or Tysabri®." Added the following to the Policy Exceptions section: State Health Plan (State and School Employees):  Prior authorization is not required for State Health Plan members.  However, these biologic drugs will be reviewed for medical necessity based on medical policy guidelines. Added the following new 2014 CPT code(s) to the Code Reference section: Q3027 and Q3028.

01/05/2015: Policy updated to add coverage criteria for Peginterferon beta-1a (Plegridy™). Policy statement revised to state that effective 01/01/2015, failure of one of the following Betaseron®, Rebif®, Copaxone®, Plegridy™, or Tecfidera® are required before receiving Avonex®, Extavia®, Tysabri®, Gilenya®, or Aubagio®. Added the following policy statement: Peginterferon beta-1a (Plegridy™) is considered medically necessary for the treatment of patients with relapsing forms of multiple sclerosis. Treatment should be started with 63 micrograms on Day 1, 94 micrograms on Day 15, and 125 micrograms on Day 29. The full 125 micrograms should be continued every 14 days thereafter. Sources section updated to add Plegridy® prescribing information. Removed the following deleted HCPCS Codes from the Code Reference section: Q3025 and Q3026.

05/28/2015: Policy updated to add coverage for Alemtuzumab (Lemtrada™), which is considered medically necessary for the treatment of patients with relapsing forms of multiple sclerosis after failure with at least two or more drugs indicated for the treatment of multiple sclerosis. At least one of the two drugs must include Betaseron®, Rebif®, Copaxone®, Plegridy™, or Tecfidera®. Only two treatment courses will be approved with the first course consisting of 5 consecutive days and the second course 3 consecutive days administered 12 months after the first treatment course.

08/26/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 procedure code 99.29 from the Code Reference section.

02/02/2016: Approved by Pharmacy & Therapeutics (P&T) Committee. Policy guidelines updated to add medically necessary and investigative definitions.

05/27/2016: Policy number L.5.01.452 added.

11/22/2016: Policy statement regarding Dalfampridime (Ampyra®) updated to add that after 6 months of therapy, documentation of stabilization or improvement from the baseline timed walking speed is required for continuation of treatment. It previously stated: After twelve weeks of therapy, documentation of patient's improvement in walking as seen by an increase in walking speed during a follow-up T25FW must be submitted for continuation of treatment.

01/01/2017: Policy updated to add coverage criteria for Daclizumab (Zinbryta™), which is considered medically necessary for the treatment of adult patients with relapsing forms of multiple sclerosis in patients who have had an inadequate response to two or more drugs indicated for the treatment of multiple sclerosis. At least one of the two drugs must include Betaseron®, Rebif®, Copaxone®, Plegridy™, Tecfidera®, Avonex®, Gilenya®, or Aubagio®. Policy statement revised to state that effective 01/01/2017, failure of one of the following Betaseron®, Rebif®, Copaxone®, Plegridy™, Tecfidera®, Avonex®, Gilenya®, or Aubagio® is required before receiving Tysabri®. Extavia® will only be considered for coverage after failure of both Betaseron® and Rebif®. Sources updated.

02/07/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

05/31/2017: Policy section updated to remove failure of Rebif® as an indication for coverage of Extavia®. It previously stated: Extavia® will only be considered for coverage after failure of both Betaseron® and Rebif®. Effective 01/01/2017.

08/29/2017: Policy description updated to add indications for Ocrelizumab (Ocrevus™). Added the following policy statements: 1) Ocrelizumab (Ocrevus™) is considered medically necessary for the treatment of adult patients with primary progressive forms of multiple sclerosis. 2) Ocrelizumab (Ocrevus™) is considered medically necessary for the treatment of adult patients with relapsing forms of multiple sclerosis in patients who have had failure of one of the following: Betaseron®, Rebif®, Copaxone®, Plegridy™, Tecfidera®, Avonex®, Gilenya®, or Aubagio®. Sources updated.

01/01/2018: Policy section updated to add that effective 01/01/2018, failure of one of the following Betaseron®, Rebif®, Copaxone®, Glatiramer, Plegridy™, Tecfidera®, Avonex®, Gilenya®, or Aubagio® is required before receiving Extavia® or Tysabri®. Medically necessary statement for Ocrevus for relapsing forms of multiple sclerosis updated to change the number of prerequisites required from "failure of one" to "failure of two" and to include "Glatiramer." Code Reference section updated to add new 2018 HCPCS code J2350.

02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

07/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding FDA Approved indications. Policy statements regarding Ocrelizumab (Ocrevus™) updated to change "treatment of adult patients" to "treatment of patients." Policy statement revised to state that Fingolimod (Gilenya®) is considered medically necessary for patients 10 years of age or older with relapsing forms of multiple sclerosis as monotherapy. Policy statement revised to state that Dalfampridine (Ampyra®) is considered medically necessary to improve walking in adult patients with Multiple Sclerosis. Sources updated.

02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy updated to remove indications and coverage criteria for Zinbryta (daclizumab). Policy description updated regarding FDA approved indications. Added policy statement that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Policy statement for Ocrevus updated to clarify that the treatment is for adult patients. Policy statement requiring failure of listed drugs moved to individual policy statements for Extavia and Tysabri. Sources section updated. Code Reference section updated to add HCPCS codes C9399, J0202, and J3590. Effective 01/01/2019.

05/14/2019: Code Reference section updated to remove deleted HCPCS code J1825.

10/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description revised. Added policy statement that Glatopa (glatiramer acetate) is currently not covered. Policy statement for Ocrevus updated regarding dosing information. Policy statements regarding Avonex, Rebif, Betaseron, Copaxone, and Tysabri revised. Added separate medically necessary statement for Extavia. Policy statement regarding Ampyra updated regarding therapy and dosing information. Sources updated.

10/14/2019: Policy updated to add that Mavenclad and Mayzent are currently non-covered on all Blue Cross & Blue Shield of Mississippi formularies.

05/01/2020: Policy description extensively revised to add FDA approved indications for the drugs listed in this policy. Added policy statement to state that Glatopa, Mavenclad, Mayzent, and Vumerity are considered not medically necessary on all Blue Cross & Blue Shield of Mississippi formularies as there are other alternatives covered by the plan. Revised policy statements regarding Betaseron, Extavia, Copaxone, Gilenya, and Tysabri. Sources updated.

08/18/2020: Policy updated to add Zeposia (ozanimod) to the policy. Zeposia (ozanimod) may be considered medically necessary as monotherapy for Relapsing forms of Multiple Sclerosis (clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease) in adult patients. Failure of Copaxone (glatiramer acetate) must be documented prior to consideration of coverage of Zeposia. Sources updated.

02/18/2021: Added Bafiertam (monomethyl fumarate), Dimethyl fumarate, Glatiramer acetate, and Kesimpta (ofatumumab) to the top of the policy. Policy description updated regarding four basic MS disease courses and to add tables for pharmacy preferred/non preferred and medical covered agents. Added Bafiertam (monomethyl fumarate) and Kesimpta (ofatumumab) as not medically necessary. Policy section extensively revised to list initial and renewal evaluation criteria for requested agents. Added initial and renewal evaluation criteria for Ampyra (dalfampridine). Added statement that services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary. Policy Guidelines updated regarding BCBSMS request for medical records and to define medication failure. Sources updated. Code Reference section updated to add HCPCS code J9065.

08/17/2021: Added Ponvory (ponesimod) to the top of the policy. Policy statement updated to include Ponvory (ponesimod) as 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 J9302.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

02/20/2023: Policy description updated to revise Table 2 step therapy requirements for Ocrevus and Tysabri. Policy statements unchanged.

04/03/2023: Policy statement updated to add Tascenso ODT (fingolimod lauryl sulfate) as not medically necessary on all Blue Cross & Blue Shield of Mississippi formularies as there are other formulary alternatives available. Sources updated.

06/01/2023: Code Reference section updated to remove HCPCS code J9065.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.

03/06/2024: Policy updated to add fingolimod and teriflunomide as Step 1 Preferred Agents. Removed Aubagio and Gilenya as Step 2 Preferred Agents and added Kesimpta. Removed Kesimpta (ofatumumab) from the not medically necessary policy statement. Medically necessary criteria updated to remove "Gilenya." Code Reference section updated to move HCPCS code J9302 from Not Medically Necessary to Medically Necessary.

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

08/01/2025: Effective 10/01/2025 - Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy updated to add Briumvi (ublituximab-xiiy) and Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) to the list of drugs. Removed Extavia (interferon beta-1b) from the policy. Table 1 in Policy Description revised to remove the Step 3 program requirement and to clarify generic and brand name preferred agents. Table 2 updated to add Ocrevus Zunovo as a medical covered agent. Footnote updated. 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. Policy statement updated to remove Glatopa and add Briumvi (ublituximab-xiiy), Copaxone (glatiramer acetate), and Tecfidera (dimethyl fumarate) as not medically necessary on all Blue Cross & Blue Shield of Mississippi formularies as there are other formulary alternatives available. Initial evaluation criteria updated regarding prescriber requirement, requests for Step 2 Agents, and requests for medical covered agents. All other statements updated to change "member" to "individual." Sources updated. Code Reference section updated to add HCPCS code J2351 to the Medically Necessary Codes table. Added HCPCS code J2329 to the Not Medically Necessary Codes table. Policy update effective 10/01/2025.

10/01/2025: Code Reference section updated to add new ICD-10 diagnosis codes G35.A, G35.B0, G35.B1, G35.C0, G35.C1, and G35.D.

SOURCE(S)

1. Ampyra prescribing information. Merz Pharmaceuticals, LLC. December 2024. Last accessed March 2025.

2. Aubagio prescribing information. Genzyme Corporation. June 2024. Last accessed March 2025.

3. Avonex prescribing information. Biogen, Inc. November 2024. Last accessed March 2025.

4. Bafiertam prescribing information. Banner Life Sciences LLC. March 2024. Last accessed March 2025.

5. Betaseron prescribing information. Bayer HealthCare Pharmaceuticals Inc. July 2023. Last accessed March 2025.

6. Copaxone prescribing information. Teva Neuroscience, Inc. January 2025. Last accessed March 2025.

7. Gilenya prescribing information. Novartis Pharmaceuticals Corporation. July 2024. Last accessed March 2025.

8. Glatopa prescribing information. Sandoz Inc. February 2025. Last accessed March 2025.

9. Kesimpta prescribing information. Novartis Pharmaceuticals Corporation. April 2024. Last accessed March 2025.

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

11. Mayzent prescribing information. Novartis Pharmaceuticals Corporation. July 2024. Last accessed March 2025.

12. Mavenclad prescribing information. EMD Serono, Inc. May 2024. Last accessed March 2025.

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

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

15. Olek MJ, Mowry E. Initial disease-modifying therapy for relapsing-remitting multiple sclerosis in adults. In: UpToDate, Connor RF (Ed), Wolters Kluwer.  https://www.uptodate.com/contents/initial-disease-modifying-therapy-for-relapsing-remitting-multiple-sclerosis-in-adults (Accessed on March 28, 2025)

16. Plegridy prescribing information. Biogen Inc. November 2024. Last accessed March 2025.

17. Ponvory prescribing information. Janssen Pharmaceuticals, Inc. August 2024. Last accessed March 2025.

18. Rebif prescribing information. EMD Serono, Inc. August 2023. Last accessed March 2025.

19. Tascenso ODT prescribing information. Cycle Pharmaceuticals Ltd. January 2025. Last accessed March 2025.

20. Tecfidera prescribing information. Biogen Inc. March 2024. Last accessed March 2025.

21. Types of MS. National Multiple Sclerosis Society. https://www.nationalmssociety.org/What-is-MS/Types-of-MS

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

23. Vumerity prescribing information. Biogen Inc. November 2024. Last accessed March 2025.

24. Zeposia prescribing information. Celgene Corporation. August 2024. 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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