Pharmacy Prior Authorization Criteria

Multiple Sclerosis (MS) Agents - PA, NF

Indications for Prior Authorization

Aubagio (teriflunomide), Avonex (interferon beta-1a), Bafiertam (monomethyl fumarate), Betaseron (interferon beta-1b), Briumvi (ublituximab-xiiy), Copaxone (glatiramer acetate), Glatopa (glatiramer acetate)

• For diagnosis of Relapsing forms of multiple sclerosis (MS)
  Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Kesimpta (ofatumumab), Mayzent (siponimod), Plegridy (peginterferon beta-1a), Ponvory (ponesimod), Rebif (interferon beta-1a), Vumerity (diroximel fumarate)

• For diagnosis of Relapsing forms of multiple sclerosis (MS)
  Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Lemtrada (alemtuzumab)

• For diagnosis of Relapsing forms of MS
  Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

  Limitations of Use: Lemtrada is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

Mavenclad (cladribine)

• For diagnosis of Relapsing forms of MS
  Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS.

  Limitations of Use: Mavenclad is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

Ocrevus (ocrelizumab)

• For diagnosis of Relapsing forms of MS
  Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

• For diagnosis of Primary Progressive Forms of Multiple Sclerosis (PPMS)
  Indicated for the treatment of primary progressive MS, in adults.

• For diagnosis of Relapsing-remitting MS
  Indicated for the treatment of relapsing-remitting MS in pediatric patients 10 years of age and older who weigh 25 kg or more.

Ocrevus Zunovo (ocrelizumab)

• For diagnosis of Relapsing forms of MS
  Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

• For diagnosis of Primary Progressive Forms of Multiple Sclerosis (PPMS)
  Indicated for the treatment of primary progressive MS, in adults.

Tascenso ODT (fingolimod)

• For diagnosis of Relapsing forms of MS
  Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.

Criteria

Brand Aubagio, Avonex, Bafiertam, Betaseron, Generic glatiramer acetate*, Glatopa, Kesimpta, Mayzent, Generic Teriflunomide*, Vumerity

Prior Authorization

Length of Approval: When approved; no reauthorization required

• Diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A-D]
AND
• Not used in combination with another disease-modifying therapy for MS [G, 22, 23]
AND
• Prescribed by or in consultation with a neurologist
AND
• For Brand Aubagio, trial (of a minimum 4-week supply), or intolerance to generic teriflunomide^

Brand Copaxone

Prior Authorization

Length of Approval: When approved; no reauthorization required

• Diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A-D]
AND
• Not used in combination with another disease-modifying therapy for MS [G, 22, 23]
AND
• Prescribed by or in consultation with a neurologist
AND
• Trial (of a minimum 4-week supply), or intolerance to generic glatiramer acetate^

Brand Copaxone

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming a diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A-D]
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy
AND
• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression)
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure (of a minimum 4-week supply), contraindication, or intolerance to at least three disease-modifying therapies for MS (e.g., Kesimpta [Ofatumumab], Mavenclad [Cladribine], Avonex [Interferon beta-1a], Betaseron [Interferon beta-1b], Mayzent [Siponimod], Zeposia [ozanimod], Vumerity [diroximel fumarate], Bafiertam [monomethyl fumarate], Copaxone [glatiramer acetate])
AND
• One of the following
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of 4-week trial of generic glatiramer acetate^
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to generic glatiramer acetate
OR
• Submission of medical records (e.g., chart notes) documenting ONE of the following:
• An adverse event (e.g., cellulitis) due to treatment with generic glatiramer acetate
• Potential for an allergic reaction due to a non-active ingredient that is contained in generic glatiramer acetate but not included in the requested product
AND
• Not used in combination with another disease-modifying therapy for MS [G, 22, 23]
AND
• Prescribed by or in consultation with a neurologist

Plegridy, Ponvory, Rebif

Prior Authorization

Length of Approval: When approved; no reauthorization required

• Diagnosis of a relapsing form of MS (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A]
AND
• One of the following:
• For continuation of therapy defined as no more than a 45-day gap in therapy
OR
• Trial and failure (of a minimum 4-week supply), contraindication, or intolerance to two disease-modifying therapies for MS (e.g., Kesimpta [Ofatumumab], Mavenclad [Cladribine], Avonex [Interferon beta-1a], Betaseron [Interferon beta-1b], Mayzent [Siponimod], Zeposia [ozanimod], Vumerity [diroximel fumarate], Bafiertam [monomethyl fumarate], Copaxone [glatiramer acetate])
AND
• Not used in combination with another disease-modifying therapy for MS [G, 22, 23]
AND
• Prescribed by or in consultation with a neurologist

Plegridy, Ponvory, Rebif

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming a diagnosis of a relapsing form of MS (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A]
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy
AND
• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression)
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure (of a minimum 4-week supply), contraindication, or intolerance to at least three disease-modifying therapies for MS (e.g., Kesimpta [Ofatumumab], Mavenclad [Cladribine], Avonex [Interferon beta-1a], Betaseron [Interferon beta-1b], Mayzent [Siponimod], Zeposia [ozanimod], Vumerity [diroximel fumarate], Bafiertam [monomethyl fumarate], Copaxone [glatiramer acetate])
AND
• Not used in combination with another disease-modifying therapy for MS [G, 22, 23]
AND
• Prescribed by or in consultation with a neurologist

Tascenso ODT

Prior Authorization

Length of Approval: When approved; no reauthorization required

• Diagnosis of a relapsing form of MS (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A]
AND
• One of the following:
• All of the following:
• Patient is 18 years of age or older
AND
• One of the following:
• Trial and failure (of a minimum 4-week supply), contraindication, or intolerance to two disease-modifying therapies for MS (e.g., Kesimpta [Ofatumumab], Mavenclad [Cladribine], Avonex [Interferon beta-1a], Betaseron [Interferon beta-1b], Mayzent [Siponimod], Zeposia [ozanimod], Vumerity [diroximel fumarate], Bafiertam [monomethyl fumarate], Copaxone [glatiramer acetate])
OR
• For continuation of therapy defined as no more than a 45-day gap in therapy
AND
• Patient is unable to swallow solid oral dosage forms (e.g., oral tablet, capsule) due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube
OR
• Both of the following:
• Patient is at least 10 years of age to less than 18 years of age
AND
• One of the following:
• Both of the following:
• Patient weighs greater than or equal to 40kg
• Trial (of a minimum 4-week supply) or intolerance to generic fingolimod
OR
• Both of the following:
• Patient weighs less than 40kg
• Trial (of a minimum 4-week supply) or intolerance to Brand Gilenya (fingolimod)
OR
• Patient is unable to swallow solid oral dosage forms (e.g., oral tablet, capsule) due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube
AND
• Not used in combination with another disease-modifying therapy for MS [G, 22, 23]
AND
• Prescribed by or in consultation with a neurologist

Tascenso ODT

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming a diagnosis of a relapsing form of MS (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A]
AND
• One of the following:
• All of the following:
• Patient is 18 years of age or older
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure (of a minimum 4-week supply), contraindication, or intolerance to at least two of the following disease-modifying therapies for MS (e.g., Kesimpta [Ofatumumab], Mavenclad [Cladribine], Avonex [Interferon beta-1a], Betaseron [Interferon beta-1b], Mayzent [Siponimod], Zeposia [ozanimod], Vumerity [diroximel fumarate], Bafiertam [monomethyl fumarate], Copaxone [glatiramer acetate])
OR
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy
AND
• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression)
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of 4-week trial of generic fingolimod
• Submission of medical records documenting objective information indicating a lack of adequate clinical response to generic fingolimod
OR
• Submission of medical records (e.g., chart notes) documenting ONE of the following:
• An adverse event (e.g., cellulitis) due to treatment with generic fingolimod
• Potential for an allergic reaction due to a non-active ingredient that is contained in generic fingolimod but not included in the requested product
OR
• Submission of medical records confirming patient is unable to swallow solid oral dosage forms (e.g., oral tablet, capsule) due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube
OR
• Both of the following:
• Patient is at least 10 years of age to less than 18 years of age
AND
• One of the following:
• Both of the following:
• Patient weighs greater than or equal to 40kg
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of 4-week trial of generic fingolimod
• Submission of medical records documenting objective information indicating a lack of adequate clinical response to generic fingolimod
OR
• Submission of medical records (e.g., chart notes) documenting ONE of the following:
• An adverse event (e.g., cellulitis) due to treatment with generic fingolimod
• Potential for an allergic reaction due to a non-active ingredient that is contained in generic fingolimod but not included in the requested product
OR
• Both of the following:
• Patient weighs less than 40kg
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of 4-week trial of Brand Gilenya 0.25mg (fingolimod)
• Submission of medical records documenting objective information indicating a lack of adequate clinical response to Brand Gilenya 0.25mg (fingolimod)
OR
• Submission of medical records (e.g., chart notes) documenting ONE of the following:
• An adverse event (e.g., cellulitis) due to treatment with Brand Gilenya 0.25mg (fingolimod)
• Potential for an allergic reaction due to a non-active ingredient that is contained in Brand Gilenya 0.25mg (fingolimod) but not included in the requested product
OR
• Submission of medical records confirming patient is unable to swallow solid oral dosage forms (e.g., oral tablet, capsule) due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube
AND
• Not used in combination with another disease-modifying therapy for MS [G, 22, 23]
AND
• Prescribed by or in consultation with a neurologist

Briumvi

Prior Authorization

Length of Approval: When approved; no reauthorization required

• Diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A]
AND
• One of the following:
• Trial and failure (of a minimum 4-week supply), contraindication, or intolerance to two disease-modifying therapies for MS (e.g., Kesimpta [Ofatumumab], Mavenclad [Cladribine], Avonex [Interferon beta-1a], Betaseron [Interferon beta-1b], Mayzent [Siponimod], Zeposia [ozanimod], Vumerity [diroximel fumarate], Bafiertam [monomethyl fumarate], Copaxone [glatiramer acetate])
OR
• For continuation of prior therapy defined as no more than a 45-day gap in therapy
AND
• Not used in combination with another disease-modifying therapy for MS [G, 22, 23]
AND
• Not used in combination with another B-cell targeted therapy (e.g., rituximab [Rituxan], belimumab [Benlysta], ofatumumab [Arzerra, Kesimpta]) [16]
AND
• Prescribed by or in consultation with a neurologist

Lemtrada

Prior Authorization

Length of Approval: When approved; no reauthorization required

• Diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A]
AND
• One of the following:
• Both of the following:
• Patient has not been previously treated with alemtuzumab
AND
• Trial and failure (of a minimum 4-week supply), contraindication, or intolerance to two disease-modifying therapies for MS (e.g., Kesimpta [Ofatumumab], Mavenclad [Cladribine], Avonex [Interferon beta-1a], Betaseron [Interferon beta-1b], Mayzent [Siponimod], Zeposia [ozanimod], Vumerity [diroximel fumarate], Bafiertam [monomethyl fumarate], Copaxone [glatiramer acetate])
OR
• Both of the following: [E]
• Patient has previously received treatment with alemtuzumab
AND
• At least 12 months have or will have elapsed since the most recent treatment course with alemtuzumab
AND
• Not used in combination with another disease-modifying therapy for MS [G, 22, 23]
AND
• Prescribed by or in consultation with a neurologist

Brand Mavenclad, generic cladribine

Prior Authorization

Length of Approval: When approved; no reauthorization required

• Diagnosis of a relapsing form of MS (e.g., relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A]
AND
• One of the following:
• Both of the following:
• Patient has not been previously treated with cladribine
AND
• Trial and failure (of a minimum 4-week supply), contraindication, or intolerance to one disease-modifying therapy for MS (e.g., Kesimpta [Ofatumumab], Avonex [Interferon beta-1a], Betaseron [Interferon beta-1b], Mayzent [Siponimod], Zeposia [ozanimod], Vumerity [diroximel fumarate], Bafiertam [monomethyl fumarate], Copaxone [glatiramer acetate])
OR
• Both of the following:
• Patient has previously received treatment with cladribine
AND
• Patient has not already received the FDA-recommended lifetime limit of 2 treatment courses (or 4 treatment cycles total) of cladribine
AND
• Not used in combination with another disease-modifying therapy for MS [G, 22, 23]
AND
• Prescribed by or in consultation with a neurologist

Ocrevus, Ocrevus Zunovo

Prior Authorization

Length of Approval: When approved; no reauthorization required
For diagnosis of Relapsing Forms of MS

• Diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A]
AND
• One of the following:
• Both of the following (applies to Ocrevus only):
• Patient is at least 10 years of age to less than 18 years of age
AND
• Patient weighs greater than or equal to 25kg
OR
• Both of the following (applies to Ocrevus and Ocrevus Zunovo):
• Patient is 18 years of age or older
AND
• One of the following:
• Trial and failure (of a minimum 4-week supply), contraindication, or intolerance to one disease-modifying therapy for MS (e.g., Kesimpta [Ofatumumab], Mavenclad [Cladribine], Avonex [Interferon beta-1a], Betaseron [Interferon beta-1b], Mayzent [Siponimod], Zeposia [ozanimod], Vumerity [diroximel fumarate], Bafiertam [monomethyl fumarate], Copaxone [glatiramer acetate])
OR
• For continuation of prior therapy defined as no more than a 45-day gap in therapy
AND
• Not used in combination with another disease-modifying therapy for MS [G, 22, 23]
AND
• Not used in combination with another B-cell targeted therapy (e.g., rituximab [Rituxan], belimumab [Benlysta], ofatumumab [Arzerra, Kesimpta]) [14]
AND
• Prescribed by or in consultation with a neurologist

Ocrevus, Ocrevus Zunovo

Prior Authorization

Length of Approval: When approved; no reauthorization required
For diagnosis of Primary Progressive Multiple Sclerosis (PPMS)

• Diagnosis of Primary Progressive Multiple Sclerosis (PPMS)
AND
• Not used in combination with another disease-modifying therapy for MS [G, 22, 23]
AND
• Not used in combination with another B-cell targeted therapy (e.g., rituximab [Rituxan], belimumab [Benlysta], ofatumumab [Arzerra, Kesimpta]) [14]
AND
• Prescribed by or in consultation with a neurologist

P & T Revisions

1970-01-01, 2026-06-29, 2026-05-22, 2026-01-23, 2026-01-06, 2025-12-26, 2025-12-18, 2025-10-29, 2025-08-28, 2025-07-25, 2025-05-29, 2025-05-09, 2025-05-01, 2025-04-30, 2025-03-24, 2025-02-04, 2024-11-26, 2024-11-26, 2024-11-07, 2024-09-05, 2024-05-21, 2023-10-30, 2023-10-30, 2023-10-27, 2023-09-29, 2023-09-12, 2023-05-23, 2023-04-28, 2023-04-20, 2023-04-04, 2023-03-01, 2023-01-30, 2022-11-30, 2022-11-02, 2022-05-05, 2022-04-04, 2022-03-03, 2021-12-02, 2021-11-08, 2021-09-07, 2021-08-09, 2021-06-29, 2021-05-27, 2021-05-10, 2021-03-02, 2021-01-08, 2020-12-11, 2020-11-06, 2020-08-31, 2020-07-27, 2020-07-17, 2020-06-29, 2020-04-13, 2020-02-19, 2019-12-19, 2019-11-05, 2019-09-03

References

1. Avonex Prescribing Information. Biogen Inc. Cambridge, MA. July 2023.
2. Betaseron Prescribing Information. Bayer. Whippany, NJ. September 2025.
3. Copaxone Prescribing Information. Teva Pharmaceuticals. North Wales, PA. January 2025.
4. Rebif Prescribing Information. Serono Inc. Rockland, MA. July 2023.
5. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline: Disease-modifying therapies for adults with multiple sclerosis. Neurology 2018;90:777-788.
6. National Multiple Sclerosis Society. Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed April 5, 2024
7. Per clinical consultation with MS specialist, December 29, 2010.
8. Plegridy Prescribing Information. Biogen Idec Inc. Cambridge, MA. November 2024.
9. Aubagio Prescribing Information. Genzyme Corporation. Cambridge, MA. February 2026.
10. Lemtrada Prescribing Information. Genzyme Corporation. Cambridge, MA. May 2024.
11. Glatopa Prescribing Information. Sandoz Inc. Princeton, NJ. February 2025.
12. Hawker K, O'Connor P, Freedman MS, et al. Rituximab in patients with primary progressive multiple sclerosis: results of a randomized double-blind placebo-controlled multicenter trial. Ann Neurol. 2009; Oct;66(4):460-71.
13. Ocrevus Prescribing Information. Genentech, Inc. San Francisco, CA. May 2026.
14. Mayzent Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. August 2025.
15. Mavenclad Prescribing Information. EMD Serono, Inc. Boston, MA. May 2024.
16. Vumerity Prescribing Information. Biogen Inc. Cambridge, MA. November 2024.
17. Bafiertam Prescribing Information. Banner Life Sciences. High Point, NC. June 2025.
18. Kesimpta Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. April 2026.
19. Hauser S, Bar-Or A, Cohen J et al. Ofatumumab versus Teriflunomide in Multiple Sclerosis. New England Journal of Medicine. 2020;383(6):546-557.
20. Ponvory Prescribing Information. Janssen Pharmaceuticals Inc. Titusville, NJ. August 2024.
21. Wingerchuk, D., & Carter, J. (2014). Multiple Sclerosis: Current and Emerging Disease-Modifying Therapies and Treatment Strategies. Mayo Clinic Proceedings, 89(2), 225-240.
22. Sorensen, P., Lycke, J., Erälinna, J., Edland, A., Wu, X., & Frederiksen, J. et al. (2011). Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial. The Lancet Neurology, 10(8), 691-701.
23. Tascenso ODT Prescribing Information. Cycle Pharmaceuticals Ltd. Cambridge, United Kingdom. January 2026.
24. Briumvi Prescribing Information. TG Therapeutics, Inc. Morrisville, NC. February 2026.
25. Ocrevus Zunovo Prescribing Information. Genentech, Inc. San Francisco, CA. August 2025.
26. Fox RJ, Bar-Or A, Traboulsee A, Oreja-Guevara C, Giovannoni G, et al.; HERCULES Trial Group. Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis. N Engl J Med. 2025 May 15;392(19):1883-1892.

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End Notes

1. According to the National MS Society, of the four disease courses that have been identified in MS, relapsing-remitting MS (RRMS) is characterized primarily by relapses, and secondary-progressive MS (SPMS) has both relapsing and progressive characteristics. These two constitute “relapsing forms of MS” if they describe a disease course that is characterized by the occurrence of relapses. [6] The effectiveness of interferon beta in SPMS patients without relapses is uncertain. [5]
2. Initiation of treatment with an interferon beta medication or glatiramer acetate should be considered as soon as possible following a definite diagnosis of MS with active, relapsing disease, and may also be considered for selected patients with a first attack who are at high risk of MS. [5]
3. Based on several years of experience with glatiramer acetate and interferon beta 1a and 1b, it is the consensus of researchers and clinicians with expertise in MS that these agents are likely to reduce future disease activity and improve quality of life for many individuals with relapsing forms of MS, including those with secondary progressive disease who continue to have relapses. For those who are appropriate candidates for one of these drugs, treatment must be sustained for years. Cessation of treatment may result in a resumption of pre-treatment disease activity. [5]
4. MS specialists will use Copaxone in relapsing forms of disease, including SPMS with relapses. While there have been no trials of Copaxone in SPMS (so we have no evidenced-based data upon which to make decisions or recommendations), it's clear that where there are relapses, the injectable therapies are partially effective – they reduce relapses and new lesions on MRI. In SPMS, the trials suggest that the interferons work better in earlier, more inflammatory (i.e. those with relapses prior to the trial and with gadolinium-enhancing lesions, which is the MRI equivalent of active inflammation). Since Copaxone and the interferons appear to have rather similar efficacy in the head-to-head trials, most assume that Copaxone has a similar efficacy in SPMS: where there are relapses or active inflammation on MRI, it will likely have some benefit. Thus, most MS specialists will use Copaxone in patients with SPMS who have persistent relapses. [7]
5. According to Prescribing Information, the recommended dosage of Lemtrada is 12 mg/day administered by intravenous infusion for 2 treatment courses (first treatment course: 12 mg/day on 5 consecutive days; second treatment course: 12 mg/day on 3 consecutive days administered 12 months after the first treatment course). Following the second treatment course, subsequent treatment courses of 12 mg per day on 3 consecutive days (36 mg total dose) may be administered, as needed, at least 12 months after the last dose of any prior treatment courses. [10]
6. Not to exceed the FDA-recommended dosage of 2 treatment courses (with the second course administered 43 weeks following the last dose of the first course). According to Prescribing Information, the recommended cumulative dosage of Mavenclad is 3.5 mg per kg body weight administered orally and divided into 2 yearly treatment courses (1.75 mg per kg per treatment course). Each treatment course is divided into 2 treatment cycles with the second cycle of each course administered 23 to 27 days after the last dose of the first cycle. Following the administration of 2 treatment courses, do not administer additional Mavenclad treatment during the next 2 years. Treatment during these 2 years may further increase the risk of malignancy. The safety and efficacy of reinitiating Mavenclad more than 2 years after completing 2 treatment courses has not been studied. [15]
7. The advantage of using combination disease-modifying therapy (DMT) compared to monotherapy DMT use has not been demonstrated, but there are safety concerns, such as reduced efficacy or disease aggravation, with combination use. [21, 22]
8. Due to the unique dosing regimen of Mavenclad, a two-month PA approval length is implemented to ensure medication for the second cycle of the same treatment course is accessible to patients before the auth expires. [15]

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Revision History

• 2026-06-29: Update to guideline for Ocrevus’ expanded age indication.
• 2026-05-22: 2026 Annual Review. (1) Removed obsolete product Extavia from guideline. (2) Updated operational notes for generic teriflunomide and Brand Copaxone. (3) Updated the Tascenso ODT criteria. (4) Addition of Brand Copaxone NF criteria. (5) For Briumvi, Ocrevus, Ocrevus Zunovo, removed requirement “Not used in combination with another lymphocyte trafficking blocker.” (6) Remove NF criteria for Ocrevus Zunovo. (7) Updated end notes and references
• 2026-01-23: Clean up product list.
• 2026-01-06: Addition of new generic cladribine to mirror Brand Mavenclad criteria.
• 2025-12-26: Remove prospective tolebrutinib criteria.
• 2025-12-18: no criteria changes, added IL statute operational note
• 2025-10-29: Update to require a trial of generic glatiramer acetate for Copaxone 40mg.
• 2025-08-28: Add note for generic glatiramer acetate: *If patient meets criteria above, please approve at GPI-12 level and with a MSC Y.
• 2025-07-25: Updated verbiage within Tascenso ODT NF criteria to remove ambiguity on trial of Gilenya 0.25mg. NO change to clinical intent.
• 2025-05-29: 2025 Annual Review: Updated embedded trial to be consistent across the guideline, with examples of DMTs instead of a list, which was previously in place for some criteria buckets. Additionally, formatting update to Tascenso ODT PA and NF criteria, to include a bypass to the embedded step for those who cannot swallow, using the standard verbiage for non-solid oral dosage froms. Further updates to the Tascenso ODT NF criteria, to also require a trial of generic for adults. References also updated.
• 2025-05-09: updating typo in Tascenso ODT NF criteria.
• 2025-05-01: Approval length updated to "Approved- no reauthorization required"
• 2025-04-30: Note and approval lenght updated from 2099 to 2039.
• 2025-03-24: Removing reauthorization requirement as part of extended reauthorization program
• 2025-02-04: Update to Kesimpta; removal of drug specific QL note & replacing it with coding to allow a loading dose bypass.
• 2024-11-26: Updated Mavenclad trial examples to removed cladribine, for clinical clarity.
• 2024-11-26: Correction to NF for Ocrevus Zunovo, replacing 'AND' with 'OR' to ensure clinical intent is clear
• 2024-11-07: Added Ocrevus Zunovo as target to guideline (PA & NF).
• 2024-09-05: Updated NF criteria for Extavia, Plegridy, Ponvory, Rebif and Tascenso ODT.
• 2024-05-21: 2024 Annual Review. Background updates. Criteria formatting changes to consolidate clinically driven t/f step within guideline to have examples only.
• 2023-10-30: GPI cleanup
• 2023-10-30: Addition of drug specific NF guideline for Tascenso ODT
• 2023-10-27: Addition of t/f/i to generic glatiramer acetate for Brand Copaxone 20mg/mL for initial and reauth
• 2023-09-29: Removed Avonex GPI 62403060456420
• 2023-09-12: GPI updates
• 2023-05-23: For brand Aubagio, requiring trial and failure or intolerance of generic teriflunomide
• 2023-04-28: Added generic Aubagio to guideline
• 2023-04-20: 2023 UM Annual Review. No criteria changes. Updated references
• 2023-04-04: No changes to criteria. Extended Mavenclad PA approval length.
• 2023-03-01: Addition of new product, Briumvi
• 2023-01-30: Addition of new product, Tascenso ODT
• 2022-11-30: Removed brand and generic Gilenya
• 2022-11-02: Addition of new generic fingolimod
• 2022-05-05: Update to Kesimpta operational note - fill count no longer needed in First PA
• 2022-04-04: Addition of two new formulations of Mayzent
• 2022-03-03: 2022 UM Annual Review.
• 2021-12-02: Updated criteria to add Non-Formulary criteria for Rebif, Rebif Rebidose, Extavia, Plegridy, Ponvory.
• 2021-11-08: Per PA team request, add operational note for Kesimpta QL with no changes to clinical criteria.
• 2021-09-07: Removed EHB formulary from guideline as EHB has its MS specific guideline now (GL-87782). Will make August P&T updates on EHB guideline.
• 2021-08-09: Removed Zeposia from guideline as Zeposia will have its own guideline.
• 2021-06-29: Reattaching EHB formulary. No changes to clinical intent.
• 2021-05-27: Removed brand Tecfidera/generic dimethyl fumarate and their associated criteria from this guideline as products will have their own PA, NF guideline effective 7/1.
• 2021-05-10: Added new product, Ponvory, to guideline.
• 2021-03-02: 2021 UM annual review.
• 2021-01-08: Per formulary strategy, added Kesimpta as a t/f option to non-preferred agents (ie, Extavia, Plegridy, Rebif), Lemtrada, Mavenclad, and Ocrevus (RRMS indication).
• 2020-12-11: Moved Kesimpta to preferred criteria to only require a diagnosis and prescriber requirement.
• 2020-11-06: Added criteria for new product, Kesimpta. Moved Zeposia to preferred criteria, only requiring diagnosis and specialist requirements.
• 2020-08-31: Added new product, generic dimethyl fumarate, to guideline and mirrored criteria to brand Tecfidera.
• 2020-07-27: Added new product, Bafiertam, to guideline.
• 2020-07-17: Added new product Zeposia to guideline. General program updates were made.
• 2020-06-29: Added new product Zeposia to guideline. General program updates were made.
• 2020-04-13: 2020 UM Annual Review. No changes to criteria.
• 2020-02-19: Per formulary strategy, removed embedded steps for Mayzent. Removed Zinbryta from guideline as product discontinued.
• 2019-12-19: Included new criteria for Vumerity and updated indications and references for MS agents. Pending Jan 2020 P&T Decision.
• 2019-11-05: Updated Mavenclad approval duration to 1 month (instead of 1 treatment course) to provide more clarity.
• 2019-09-03: Updated Mavenclad approval duration to 1 month (instead of 1 treatment course) to provide more clarity.

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