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Table 52: Multiple Sclerosis Agents


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Drug Category: Central Nervous System (CNS)

Medication Class/Individual Agents: Multiple Sclerosis Agents

I. Prior-Authorization Requirements

 Multiple Sclerosis Agents – Interferons

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

interferon beta-1a-Avonex Avonex test  
interferon beta-1a-Rebif Rebif test  
interferon beta-1b-Betaseron Betaseron test  
interferon beta-1b-Extavia Extavia PA  
peginterferon beta-1a Plegridy PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

 

Siponimod  

  • Genetic testing of CYP2C9 variants is required prior to initiation.
 

 Multiple Sclerosis Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

alemtuzumab 12 mg Lemtrada PA   MB
cladribine tablet Mavenclad PA  
dalfampridine Ampyra PA   - > 2 units/day # , A90
dimethyl fumarate Tecfidera PA   - > 2 units/day # , A90
diroximel fumarate Vumerity PA  
fingolimod capsule Gilenya PA   - > 1 unit/day # , A90
fingolimod orally disintegrating tablet Tascenso ODT PA  
glatiramer Copaxone test   BP
monomethyl fumarate Bafiertam PA  
natalizumab Tysabri test  
ocrelizumab Ocrevus PA  
ofatumumab prefilled syringe Kesimpta PA  
ozanimod for multiple sclerosis Zeposia PA  
ponesimod Ponvory PA  
siponimod Mayzent PA  
teriflunomide Aubagio PA   - > 1 unit/day # , A90
ublituximab-xiiy Briumvi PA  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example: 

  • Active secondary-progressive MS (SPMS)
  • Clinically isolated syndrome (CIS)
  • Relapsing-remitting MS (RRMS)
  • Primary-progressive MS (Ocrevus)
  • To improve walking in patients with MS (dalfampridine)

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

  

Bafiertam

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • medical necessity for Bafiertam instead of dimethyl fumarate and Vumerity; and
    • requested quantity is ≤ four units/day.

 

Briumvi

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • requested dose is 450 mg every 24 weeks.

 

dalfampridine and dimethyl fumarate > two units/day

  • Documentation of all of the following is required:
    • appropriate diagnosis; and 
    • medical necessity for exceeding the quantity limits.

 

Extavia

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • medical necessity for Extavia instead of Betaseron (interferon beta-1b).

 

fingolimod capsule and teriflunomide > one unit/day

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for exceeding the quantity limits.

 

Kesimpta

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • inadequate response or adverse reaction to two or contraindication to all of the following: Briumvi or Ocrevus, dimethyl fumarate or Vumerity, fingolimod capsule, glatiramer acetate therapy, interferon therapy, teriflunomide, Tysabri; and
    • requested dose is 20 mg at weeks 0, 1, 2, 4 and then every month.

   

Lemtrada

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • requested dose is 12 mg daily for five days in first year of therapy or 12 mg daily for three days in second year of therapy; and
    • inadequate response or adverse reaction to two or contraindication to all of the following: Briumvi or Ocrevus, dimethyl fumarate or Vumerity, fingolimod capsule, glatiramer acetate therapy, interferon therapy, teriflunomide, Tysabri. 

   

Mavenclad

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • inadequate response or adverse reaction to three or contraindication to all of the following: Briumvi or Ocrevus, dimethyl fumarate or Vumerity, fingolimod capsule or Mayzent, glatiramer acetate therapy, interferon therapy, teriflunomide, Tysabri; and
    • requested dose is 3.5 mg/kg divided into two yearly treatment courses (1.75 mg/kg per course).

  

Mayzent

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • requested dose is appropriate based on CYP2C9 genotype; and
    • genetic testing for CYP2C9 genotype showing the member does not have a CYP2C9 *3/*3 genotype; and
    • medical necessity for Mayzent instead of fingolimod capsule; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: Briumvi or Ocrevus, dimethyl fumarate or Vumerity, glatiramer acetate therapy, interferon therapy, teriflunomide. 

  

Ocrevus

  • Documentation of all of the following is required for a diagnosis of primary progressive MS: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • requested dose is 600 mg every six months. 
  • Documentation of all of the following is required for a diagnosis of CIS, RRMS, and active SPMS: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • inadequate response, adverse reaction, or contraindication to Briumvi; and
    • requested dose is 600 mg every six months. 

 

Plegridy

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • medical necessity for Plegridy instead of Avonex or Rebif (interferon beta-1a); and
    • requested dose is ≤ two units/28 days; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: Briumvi or Ocrevus, dimethyl fumarate or Vumerity, fingolimod capsule, glatiramer acetate therapy, Lemtrada, teriflunomide, Tysabri.

  

Ponvory and Zeposia

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • medical necessity for the requested agent instead of fingolimod capsule; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: Briumvi or Ocrevus, dimethyl fumarate or Vumerity, glatiramer acetate therapy, interferon therapy, teriflunomide; and
    • requested quantity is ≤ one unit/day. 

 

Tascenso ODT

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • member is ≥ 10 years of age; and
    • one of the following:
      • for the 0.25 mg ODT, member weight is ≤ 40 kg; or
      • for the 0.5 mg ODT, member weight is > 40 kg; and
    • medical necessity for Tascenso ODT instead of fingolimod capsule; and
    • requested quantity is ≤ one unit/day.

 

Vumerity

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurology office are provided; and
    • medical necessity for Vumerity instead of dimethyl fumarate; and
    • requested quantity is ≤ four capsules/day.


Original Effective Date: 02/2011

Last Revised Date: 03/2024


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Last updated 05/16/24

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