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), Extavia (interferon beta-1b), 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), 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, Brand Copaxone 40mg/mL, Generic glatiramer acetate, Glatopa, Kesimpta*, Mayzent, Generic Teriflunomide, 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
• 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 and failure (of a minimum 4-week supply), or intolerance to generic teriflunomide

Brand Copaxone 20mg/mL

If patient meets criteria above, please approve at GPI-14

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
• 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 and failure (of a minimum 4-week supply), or intolerance to generic glatiramer acetate

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
• Trial and failure (of a minimum 4-week supply), 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)
• Copaxone/Glatopa (glatiramer acetate)
• Dimethyl fumarate
• Fingolimod
• Kesimpta (ofatumumab)
• Vumerity (diroximel fumarate)
• Mayzent (siponimod)
• Zeposia (ozanimod)
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 (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
• Patient is 10 years of age or older
AND
• One of the following:
• Both of the following:
• Patient is 18 years of age or older
AND
• One of the following:
• For continuation of therapy
OR
• Trial and failure (of a minimum 4-week supply), 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)
• Copaxone/Glatopa (glatiramer acetate)
• Kesimpta (ofatumumab)
• Dimethyl fumarate
• Fingolimod
• Mayzent (siponimod)
• Vumerity (diroximel fumarate)
• Zeposia (ozanimod)
OR
• Both of the following:
• Patient is younger than 18 years of age
AND
• One of the following:
• Both of the following:
• Patient weighs greater than or equal to 40kg
• Trial and failure (of a minimum 4-week supply) or intolerance to generic fingolimod
OR
• Both of the following:
• Patient weighs less than 40kg
• Trial and failure (of a minimum 4-week supply) or intolerance to Gilenya (fingolimod)
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
• Patient is unable to take oral tablets

Brand Aubagio, Avonex, Bafiertam, Betaseron, Brand Copaxone 40mg/mL, Extavia, Generic glatiramer acetate, Glatopa, Kesimpta, Mayzent, Plegridy, Ponvory, Rebif, Tascenso ODT, Generic Teriflunomide, 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
• 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 and failure (of a minimum 4-week supply), or intolerance to generic teriflunomide

Brand Copaxone 20mg/mL

If patient meets criteria above, please approve at GPI-14

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
• 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 and failure (of a minimum 4-week supply), or intolerance to generic glatiramer acetate

Extavia, 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 for continuation of 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 two of the following disease-modifying therapies for MS:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Bafiertam (monomethyl fumarate)
• Copaxone/Glatopa (glatiramer acetate)
• Dimethyl fumarate
• Fingolimod
• Kesimpta (ofatumumab)
• Mayzent (siponimod)
• Vumerity (diroximel fumarate)
• Zeposia (ozanimod)
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
• Patient is 10 years of age or older
AND
• One of the following:
• Both of the following:
• Patient is 18 years of age or older
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 for continuation of 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 two of the following disease-modifying therapies for MS:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Bafiertam (monomethyl fumarate)
• Copaxone/Glatopa (glatiramer acetate)
• Dimethyl fumarate
• Fingolimod
• Kesimpta (ofatumumab)
• Vumerity (diroximel fumarate)
• Mayzent (siponimod)
• Zeposia (ozanimod)
OR
• Both of the following:
• Patient is younger than 18 years of age
AND
• One of the following:
• All of the following:
• Patient weighs greater than or equal to 40kg
AND
• Submission of medical records (e.g., chart notes) confirming lack of adequate clinical response (with related symptoms) with generic fingolimod
AND
• Submission of medical records confirming generic fingolimod has not been effective AND valid clinical justification provided explaining how the Tascenso ODT is expected to provide benefit when generic fingolimod has not been shown to be effective despite having the same active ingredient
OR
• All of the following:
• Patient weighs les than 40kg
AND
• Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) to Gilenya 0.25mg (fingolimod)
AND
• Submission of medical records confirming generic fingolimod has not been effective AND valid clinical justification provided explaining how the Tascenso ODT is expected to provide benefit when Gilenya 0.25mg (fingolimod) has not been shown to be effective despite having the same active ingredient
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
• Patient is unable to take oral tablets

Briumvi

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]
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])
OR
• For continuation of prior 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
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone)
AND
• Prescribed by or in consultation with a neurologist

Briumvi

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
• 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
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone)
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
• 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])
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

Mavenclad

Prior Authorization

Length of Approval: 2 Month(s) [H]

• 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])
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 (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:
• 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])
OR
• For continuation of prior 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
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone)
AND
• Prescribed by or in consultation with a neurologist

Ocrevus, Ocrevus Zunovo

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 [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
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone)
AND
• Prescribed by or in consultation with a neurologist

Ocrevus, Ocrevus Zunovo

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 [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
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone)
AND
• Prescribed by or in consultation with a neurologist

Ocrevus, Ocrevus Zunovo

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 [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
• Not used in combination with another lymphocyte trafficking blocker (e.g., alemtuzumab [Lemtrada], mitoxantrone)
AND
• Prescribed by or in consultation with a neurologist

Ocrevus Zunovo

Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming 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)
AND
• One of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming a 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])
OR
• Both of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy for continuation of therapy
AND
• Patient demonstrates positive clinical response to 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])
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 Zunovo

Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming 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
• 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

2024-11-26, 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. July 2023.
3. Copaxone Prescribing Information. Teva Pharmaceuticals. North Wales, PA. November 2023.
4. Extavia Prescribing Information. Novartis. East Hanover, NJ. July 2023.
5. Rebif Prescribing Information. Serono Inc. Rockland, MA. July 2023..
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 April 5, 2024
8. Per clinical consultation with MS specialist, December 29, 2010.
9. Plegridy Prescribing Information. Biogen Idec Inc. Cambridge, MA. July 2023.
10. Aubagio Prescribing Information. Genzyme Corporation. Cambridge, MA. December 2023.
11. Lemtrada Prescribing Information. Genzyme Corporation. Cambridge, MA. February 2024.
12. Glatopa Prescribing Information. Sandoz Inc. Princeton, NJ. November 2023.
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. September 2024.
15. Mayzent Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. August 2024.
16. Mavenclad Prescribing Information. EMD Serono, Inc. Rockland, MA. February 2024.
17. Vumerity Prescribing Information. Biogen Inc. Cambridge, MA. December 2023.
18. Bafiertam Prescribing Information. Banner Life Sciences. High Point, NC. December 2023.
19. Kesimpta Prescribing Information. Novartis Pharmaceuticals Corporation. East NJ. April 2024.
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. August 2023.
22. Wingerchuk, D., & Carter, J. (2014). Multiple Sclerosis: Current and Emerging Disease-Modifying Therapies and Treatment Strategies. Mayo Clinic Proceedings, 89(2), 225-240.
23. 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.
24. Tascenso ODT Prescribing Information. Cycle Pharmaceuticals Ltd. Cambridge, United Kingdom. December 2022.
25. Briumvi Prescribing Information. TG Therapeutics, Inc. Morrisville, NC. December 2022.

---

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. [11]
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. [16]
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. [22, 23]
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. [16]

---

Revision History

• 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.

---