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Pharmacy Medical Policy Multiple Sclerosis Prior Auth Policy Table of Contents • Related Polices

• Prior Authorization Information

• Summary • Policy

• Provider Documentation

• Individual Consideration • Policy History

• Forms

• References Policy Number: 839 BCBSA Reference Number: N/A Related Policies • Quality Care Dosing guidelines may apply and can be found in Medical Policy #621B • Medical Utilization Management (MED UM) & Pharmacy Prior Authorization Policy #033 • Immune Modulating Drugs Policy #004

Prior Authorization Information

Policy ☒ Prior Authorization ☐ Step Therapy ☒ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 3/15/2026 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☐ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage
Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason. We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.
See Appendix for additional information.

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Summary This is a comprehensive policy covering step therapy, prior authorization and quantity limit requirements for medications used to treat Multiple Sclerosis.
This policy applies to members utilizing the below medications for the treatment of Multiple Sclerosis. Coverage of medications listed below that are FDA approved for other indications can be found in the related Medical Polices listed above.
Policy Prior Use Criteria The plan uses prescription claim records to support criteria for prior use within previous 130 days or the trial and failure of formulary alternatives when available. Additional documentation will be required from the provider when historic prescription claim data is either not available or the medication fill history fails to establish criteria for prior use or trial and failure of formulary alternatives. Documentation will also be required to support any clinical reasons preventing the trial and failure of formulary alternatives. Please see the section on documentation requirements for more information.
Prior Authorization Requirements Length of Approval 12 months Formulary Status All requests must meet the PA requirement and for non-covered medications, the member must also have had a previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient.
Member cost share consideration A higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non-covered drug.

Prior authorization is required for the following medications for Multiple Sclerosis: Drug Formulary Status (BCBSMA Commercial Plan) Requirement Aubagio ® (teriflunomide) PA PA Required
Avonex ® (interferon beta-1a) PA, QCD PA Required Bafiertam ® (monomethyl fumarate) PA, NFNC PA Required Betaseron ® (interferon beta-1b) PA, QCD PA Required Cladribine PA PA Required Copaxone ® (glatiramer) PA, NFNC PA Required Extavia ®# (interferon beta-1b) PA PA Required Gilenya ® (fingolimod) PA PA Required Kesimpta ® (ofatumumab) PA PA Required Mavenclad ® (cladribine) PA PA Required Mayzent ® (siponimod) PA PA Required
Plegridy ® (peginterferon beta-1a) PA, QCD PA Required Ponvory ™ (ponesimod) PA, NFNC PA Required Rebif ® (interferon beta-1a) PA, QCD PA Required Tascenso ODT ™ (fingolimod) PA, NFNC PA Required Tecfidera ®# (dimethyl fumarate) PA, NFNC PA Required Vumerity ™ (diroximel fumarate) PA, QCD PA Required Zeposia ® (ozanimod) PA PA Required

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QCD - Quality Care Dosing (quantity limits policy #621B); PA – Prior Authorization; NFNC – Non-Formulary, Non- Covered

Avonex ®, Betaseron ®, Extavia ®, Kesimpta ®, Mayzent ®, Plegridy ®, Rebif ®, Vumerity ™, and Zeposia ®
Avonex ® (interferon beta-1a), Betaseron ® (interferon beta-1b), Extavia ® (interferon beta-1b), Kesimpta ® (ofatumumab), Mayzent (siponimod), Plegridy ® (peginterferon beta-1a), Rebif ® (interferon beta-1a), Vumerity (diroximel fumarate) or Zeposia (ozanimod) may be covered when ALL of the following criteria are met:

1. Confirmed diagnosis of relapsing forms of multiple sclerosis (MS) – including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease; AND

2. Age 18 years or older; AND

3. The medication is prescribed by a board-certified or board eligible Neurologist.

   Aubagio ® Aubagio (teriflunomide) may be covered when ALL of the following criteria are met:

4. Confirmed diagnosis of relapsing forms of multiple sclerosis (MS) – including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive; AND

5. Age 18 years or older; AND

6. The medication is prescribed by a board-certified or board eligible Neurologist; AND

7. Previous trial of teriflunomide or clinical rational for being unable to use.

   Bafiertam ®, Copaxone ®, Ponvory ™, Tascenso ODT ™, Tecfidera ® Bafiertam ®# (monomethyl fumarate), Copaxone ®# (glatiramer), Ponvory ™# (ponesimod), Tascenso ODT ™#(fingolimod), Tecfidera ®# (dimethyl fumarate), may be covered when ALL of the following criteria are met:

8. Confirmed diagnosis of relapsing forms of multiple sclerosis (MS) – including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive; AND

9. Age 18 years or older; AND

10. The medication is prescribed by a board-certified or board eligible Neurologist; AND

11. Previous trial of TWO (2) of the following: Avonex ® (interferon beta-1a), Betaseron ® (interferon beta-1b), Extavia ® (interferon beta-1b), Kesimpta ® (ofatumumab), Plegridy ® (peginterferon beta- 1a), Rebif ® (interferon beta-1a) or clinical rational for being unable to use TWO (2).

    These medications are Non-Formulary, Non-Covered (NFNC).

    Gilenya ®

    Gilenya (fingolimod) may be covered when ALL of the following criteria are met:

12. Confirmed diagnosis of relapsing forms of multiple sclerosis (MS) – including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive; AND

13. Age 10 years or older; AND

14. The medication is prescribed by a board-certified or board eligible Neurologist.

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4. Previous trial of fingolimod or clinical rational for being unable to use fingolimod.

   Mavenclad (cladribine), Cladribine Mavenclad (cladribine) and generic cladribine may be covered when ALL of the following criteria are met:

5. Confirmed diagnosis of relapsing forms of multiple sclerosis (MS) – including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease; AND
6. Age 18 years or older; AND
7. The medication is prescribed by a board-certified or board eligible Neurologist; AND

8. Previous trial of ONE (1) of the following medications: Aubagio, Avonex, Betaseron, dimethyl fumarate, fingolimod, Gilenya, glatiramer, Glatopa, Kesimpta, Mayzent, Plegridy, Rebif, teriflunomide, or Vumerity.

   Provider Documentation Requirements
   Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason.
   Individual Consideration (For Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
   If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
   Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
   To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines.

   Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to:

   Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
   Phone: 1-800-366-7778 Fax: 1-800-583-6289

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We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met.

Policy History

Date Action 3/15/2026 Added generic cladribine to the policy. 11/2025 Annual Review: updated Prior Authorization box and references. 4/2024 Clarified coding for Gilenya. 1/2024 Updated to change policy to a Prior Authorization policy. 9/2023 Reformatted Policy. Updated IC section to align with 118E MGL § 51A. 7/2023 Reformatted Policy. 4/2023 Add teriflunomide to the policy at Step 1 and update Aubagio criteria to include teriflunomide. 1/2023 Updated Policy name with addition of Prior Auth required for Aubagio ®, Gilenya ®, Mavenclad ®, Mayzent ®, Vumerity ™, and Zeposia ®. 8/2022 Updated to add Tascenso ODT ™ to step 3 of the policy. 1/1/2022 Implement new step policy for Multiple Sclerosis.

Forms

To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below:

Massachusetts Standard Form for Medication Prior Authorization Requests #434

To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below:
http://www.bluecrossma.org/medical- policies/sites/g/files/csphws2091/files/acquiadamassets/023%20E%20Form%20medication%20prior%20 auth%20instruction%20prn.pdf

References

1. Aubagio ® [package insert]. Cambridge, MA: Genzyme Corporation.: 6/2024.
2. Zeposia ® [package insert]. Summit, NJ: Celgene Corporation: 8/2024.
3. Avonex ® [package insert]. Cambridge, MA: Biogen Inc.: 7/2023.
4. Bafiertam ™ [package insert]. High Point, NC: Banner Life Sciences LLC.: 9/2024.
5. Betaseron ® [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.: 3/2021.
6. Gilenya ® [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.: 6/2024.
7. Kesimpta ® [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.: 8/2025.
8. Mavenclad ® [package insert]. Rockland, MA: EMD Serono, Inc.: 5/2024.
9. Mayzent ® [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.: 6/2024.
10. Plegridy ® [package insert]. Cambridge, MA: Biogen Inc.: 7/2023.
11. Rebif ® [package insert]. Rockland, MA: EMD Serono, Inc.: 7/2023.
12. Zeposia ® [package insert]. Summit, NJ: Celgene Corporation: 8/2024.
13. Copaxone ® [package insert]. Parsippany, NJ: Teva Neuroscience, Inc: 1/2025.
14. Extavia ® [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.: 9/2021.

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15. Tecfidera ® [package insert]. Cambridge, MA: Biogen Inc.: 3/2024
16. Ponvory ™ [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.: 10/2024
17. Vumerity ™ [package insert]. Cambridge, MA: Biogen Inc.: 9/2024.
18. Tascenso ™ [package insert]. San Jose, CA: Handa Neuroscience, LL.: 12/2021