Pharmacy Prior Authorization Criteria

Multiple Sclerosis (MS) Agents - PA, NF

Indications for Prior Authorization

Aubagio (teriflunomide)

• 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.

Avonex (interferon beta-1a)

• 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.

Bafiertam (monomethyl fumarate)

• 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.

Betaseron (interferon beta-1b)

• 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.

Copaxone (glatiramer acetate), Glatopa (glatiramer acetate)

• 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.

Extavia (interferon beta-1b)

• 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.

Kesimpta (ofatumumab)

• 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.

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.

Mayzent (siponimod)

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

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.

Plegridy (peginterferon beta-1a)

• 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.

Ponvory (ponesimod)

• 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.

Rebif (interferon beta-1a)

• 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.

Vumerity (diroximel fumarate)

• 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.

Criteria

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

*For Kesimpta, there is a QL Override (For new starts only): Please enter 2 PAs as follows with the same start date: First PA: Approve 3 syringes or pens per 28 days for the first month (Loading dose has a MDD of 0.05); Second PA: Approve 1 syringe or pen per 28 days (no overrides needed) for 12 months. (Kesimpta is hard-coded with a quantity of 1 syringe or pen per 28 days; 0.4 mL per 20 mg pen or syringe. Maintenance dose has a MDD of 0.02)

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• 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
• Prescribed by or in consultation with a neurologist

Aubagio, Vumerity

Non Formulary

Length of Approval: 12 Month(s)

• 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
• Prescribed by or in consultation with a neurologist

Extavia, Plegridy, Ponvory, Rebif

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• 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
OR
• Failure after a trial of at least 4 weeks, contraindication, or intolerance to at least two of the following disease-modifying therapies for MS:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Bafiertam (monomethyl fumarate)
• Glatopa (glatiramer acetate)
• Kesimpta (ofatumumab)
• Dimethyl fumarate
AND
• Prescribed by or in consultation with a neurologist

Extavia, Plegridy, Ponvory, Rebif

Non Formulary

Length of Approval: 12 Month(s)

• 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:
• 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
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming failure after a trial of at least 4 weeks, contraindication, or intolerance to at least two of the following disease-modifying therapies for MS:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Bafiertam (monomethyl fumarate)
• Glatopa (glatiramer acetate)
• Dimethyl fumarate
AND
• Prescribed by or in consultation with a neurologist

Aubagio, Avonex, Bafiertam, Betaseron, Brand Copaxone, Extavia, Generic glatiramer acetate, Glatopa, Kesimpta, Mayzent, Plegridy, Ponvory, Rebif, Vumerity

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression)
AND
• Prescribed by or in consultation with a neurologist

Lemtrada

Prior Authorization

Length of Approval: 12 Month(s)

• 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
• Failure after a trial of at least 4 weeks, contraindication, or intolerance to two of the following disease-modifying therapies for MS:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Kesimpta (ofatumumab)
• Tysabri (natalizumab)
• Any one of the glatiramer acetate injections (e.g., Glatopa, generic glatiramer acetate)
• Any one of the oral fumarates (e.g., generic dimethyl fumarate)
• Any one of the Sphingosine 1-Phosphate (S1P) receptor modulators (e.g., Gilenya, Mayzent)
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
AND
• Prescribed by or in consultation with a neurologist

Lemtrada

Non Formulary

Length of Approval: 12 Month(s)

• 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
• Paid claims or submission of medical records (e.g., chart notes) confirming failure after a trial of at least 4 weeks, contraindication, or intolerance to two of the following disease-modifying therapies for MS:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Tysabri (natalizumab)
• Any one of the glatiramer acetate injections (e.g., Glatopa, generic glatiramer acetate)
• Any one of the oral fumarates (e.g., generic dimethyl fumarate)
• Any one of the Sphingosine 1-Phosphate (S1P) receptor modulators (e.g., Gilenya, Mayzent)
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
AND
• Prescribed by or in consultation with a neurologist

Mavenclad

Prior Authorization

Length of Approval: 1 Month(s)

• 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
• Failure after a trial of at least 4 weeks, contraindication, or intolerance to one of the following disease-modifying therapies for MS:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Kesimpta (ofatumumab)
• Tysabri (natalizumab)
• Any one of the glatiramer acetate injections (e.g., Glatopa, generic glatiramer acetate)
• Any one of the oral fumarates (e.g., generic dimethyl fumarate)
• Any one of the Sphingosine 1-Phosphate (S1P) receptor modulators (e.g., Gilenya, Mayzent)
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
AND
• Prescribed by or in consultation with a neurologist

Mavenclad

Non Formulary

Length of Approval: 1 Month(s)

• 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
• Paid claims or submission of medical records (e.g., chart notes) confirming failure after a trial of at least 4 weeks, contraindication, or intolerance to one of the following disease-modifying therapies for MS:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Tysabri (natalizumab)
• Any one of the glatiramer acetate injections (e.g., Glatopa, generic glatiramer acetate)
• Any one of the oral fumarates (e.g., generic dimethyl fumarate)
• Any one of the Sphingosine 1-Phosphate (S1P) receptor modulators (e.g., Gilenya, Mayzent)
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
AND
• Prescribed by or in consultation with a neurologist

Ocrevus

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
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:
• Failure after a trial of at least 4 weeks, contraindication, or intolerance to one of the following disease-modifying therapies for MS:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Kesimpta (ofatumumab)
• Tysabri (natalizumab)
• Any one of the glatiramer acetate injections (e.g., Glatopa, generic glatiramer acetate)
• Any one of the oral fumarates (e.g., generic dimethyl fumarate)
• Any one of the Sphingosine 1-Phosphate (S1P) receptor modulators (e.g., Gilenya, Mayzent)
OR
• For continuation of prior therapy
AND
• Not used in combination with another disease-modifying therapy for MS
AND
• Not used in combination with another B-cell targeted therapy (e.g., rituximab [Rituxan], belimumab [Benlysta], ofatumumab [Arzerra, Kesimpta]) [16]
AND
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone)
AND
• Prescribed by or in consultation with a neurologist

Ocrevus

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Relapsing Forms of MS

• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression)
AND
• Not used in combination with another disease-modifying therapy for MS
AND
• Not used in combination with another B-cell targeted therapy (e.g., rituximab [Rituxan], belimumab [Benlysta], ofatumumab [Arzerra, Kesimpta]) [16]
AND
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone)
AND
• Prescribed by or in consultation with a neurologist

Ocrevus

Non Formulary

Length of Approval: 12 Month(s)
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:
• Paid claims or submission of medical records (e.g., chart notes) confirming failure after a trial of at least 4 weeks, contraindication, or intolerance to one of the following disease-modifying therapies for MS:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Tysabri (natalizumab)
• Any one of the glatiramer acetate injections (e.g., Glatopa, generic glatiramer acetate)
• Any one of the oral fumarates (e.g., generic dimethyl fumarate)
• Any one of the Sphingosine 1-Phosphate (S1P) receptor modulators (e.g., Gilenya, Mayzent)
OR
• 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
• Not used in combination with another disease-modifying therapy for MS
AND
• Not used in combination with another B-cell targeted therapy (e.g., rituximab [Rituxan], belimumab [Benlysta], ofatumumab [Arzerra, Kesimpta]) [16]
AND
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone)
AND
• Prescribed by or in consultation with a neurologist

Ocrevus

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
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
AND
• Not used in combination with another B-cell targeted therapy (e.g., rituximab [Rituxan], belimumab [Benlysta], ofatumumab [Arzerra, Kesimpta]) [16]
AND
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone)
AND
• Prescribed by or in consultation with a neurologist

Ocrevus

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Primary Progressive Multiple Sclerosis (PPMS)

• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression)
AND
• Not used in combination with another disease-modifying therapy for MS
AND
• Not used in combination with another B-cell targeted therapy (e.g., rituximab [Rituxan], belimumab [Benlysta], ofatumumab [Arzerra, Kesimpta]) [16]
AND
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone)
AND
• Prescribed by or in consultation with a neurologist

Ocrevus

Non Formulary

Length of Approval: 12 Month(s)
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
AND
• Not used in combination with another B-cell targeted therapy (e.g., rituximab [Rituxan], belimumab [Benlysta], ofatumumab [Arzerra, Kesimpta]) [16]
AND
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone)
AND
• Prescribed by or in consultation with a neurologist

P & T Revisions

2024-11-01, 2023-10-30, 2023-09-29, 2023-09-12, 2023-08-22, 2022-11-30, 2022-05-05, 2021-12-02, 2021-11-08, 2021-09-08, 2021-06-01, 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. March 2020.
2. Betaseron Prescribing Information. Bayer. Whippany, NJ. October 2020.
3. Copaxone Prescribing Information. Teva Pharmaceuticals. North Wales, PA. July 2020.
4. Extavia Prescribing Information. Novartis. East Hanover, NJ. October 2020.
5. Rebif Prescribing Information. Serono Inc. Rockland, MA. October 2020.
6. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline: Disease-modifying therapies for adults with multiple sclerosis. Neurology 2018;90:777-788.
7. National Multiple Sclerosis Society. Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed March 29, 2019.
8. Per clinical consultation with MS specialist, December 29, 2010.
9. Plegridy Prescribing Information. Biogen Idec Inc. Cambridge, MA. January 2021.
10. Aubagio Prescribing Information. Genzyme Corporation. Cambridge, MA. November 2020.
11. Lemtrada Prescribing Information. Genzyme Corporation. Cambridge, MA. September 2020.
12. Glatopa Prescribing Information. Sandoz Inc. Princeton, NJ. January 2020.
13. 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.
14. Ocrevus Prescribing Information. Genentech, Inc. San Francisco, CA. December 2020.
15. Mayzent Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. January 2021.
16. Mavenclad Prescribing Information. EMD Serono, Inc. Rockland, MA. April 2019.
17. Vumerity Prescribing Information. Biogen Inc. Cambridge, MA. January 2021.
18. Bafiertam Prescribing Information. Banner Life Sciences. High Point, NC. April 2020.
19. Kesimpta Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. August 2020.
20. 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.
21. Ponvory Prescribing Information. Janssen Pharmaceuticals Inc. Titusville, NJ. March 2021.

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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. [7] The effectiveness of interferon beta in SPMS patients without relapses is uncertain. [6]
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. [6]
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. [6]
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. [8]
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. [13]
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. [19]

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Revision History

• 2024-11-01: Removal of Kesimpta from Non-formulary section
• 2023-10-30: target drugs that have "Copaxone/Glatopa (glatiramer acetate)" listed as a trial option, revised to say "Glatopa (glatiramer acetate).
• 2023-09-29: Removed Avonex GPI 62403060456420
• 2023-09-12: GPI cleanup
• 2023-08-22: GPI clean up
• 2022-11-30: Removed Gilenya
• 2022-05-05: Update to Kesimpta operational note - fill count no longer needed
• 2021-12-02: Added non-formulary criteria for drugs excluded on EHB (i.e., Aubagio, Kesimpta, Vumerity, Extavia, Plegridy, Ponvory, Rebif, Lemtrada, Mavenclad, Ocrevus).
• 2021-11-08: Per PA team request, add operational note for Kesimpta QL with no changes to clinical criteria.
• 2021-09-08: Removed Zeposia from the general MS guideline as it gained a new indication for ulcerative colitis.
• 2021-06-01: New guideline for EHB formulary.
• 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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