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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

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.

National Clinical Advisory Board of the National Multiple Sclerosis (MS) Society. MS Disease Management Consensus Statement1  

  • Initiation of treatment with an interferon (IFN) or glatiramer should be considered as soon as possible following a definite diagnosis of MS with active, relapsing disease.
  • Initiation of treatment with an IFN or glatiramer may also be considered for selected patients with a first attack who are at high risk of MS.
  • Access to medication should not be limited by the frequency of relapses, age, or level of disability.
  • Therapy should be continued indefinitely, except for the following circumstances: clear lack of benefit, intolerable side effects, or availability of better therapy.
  • The most appropriate agent should be selected on an individual basis.
  • Transition from one disease-modifying agent to another should occur only for medically appropriate reasons.

Siponimod  

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

 

1National Clinical Advisory Board of the National Multiple Sclerosis Society. MS Disease Management Consensus Statement. 2007 [cited 2010 Nov 10]. Available from www.nationalmssociety.org.

 

 Multiple Sclerosis Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

alemtuzumab 12 mg Lemtrada ^ PA  
dalfampridine Ampyra PA  
dimethyl fumarate Tecfidera PA  
fingolimod Gilenya BP PA  
glatiramer 20 mg Copaxone BP test  
glatiramer 40 mg Copaxone # test  
natalizumab Tysabri test  
ocrelizumab Ocrevus PA  
siponimod Mayzent PA  
teriflunomide Aubagio PA  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization 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.
 
^ This drug is available through the health care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy.
 

II. Therapeutic Uses

FDA-approved, for example: 

  • Active secondary-progressive MS
  • Clinically isolated syndrome
  • Relapsing-remitting MS
  • 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.
  • 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 the member’s condition and requested medication (see below).

 

Aubagio, Gilenya, and Tecfidera

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • requesting prescriber is a neurologist or documents a consultation with a neurologist; and
    • requested quantity is ≤ 30 units/30 days (Aubagio and Gilenya) or ≤ 60 units/30 days (Tecfidera); and
    • for Gilenya, one of the following:
      • request is for the 0.5 mg strength and member weight is ≥ 40 kg; or
      • request is for the 0.25 mg strength and member weight is < 40 kg. 

 

dalfampridine

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • requesting prescriber is a neurologist or documents a consultation with a neurologist; and
    • requested quantity is ≤ 60 units/30 days.

 

Extavia

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • requesting prescriber is a neurologist or documents a consultation with a neurologist; and
    • medical necessity for use instead of Betaseron (interferon beta-1b).

  

Lemtrada

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • requesting prescriber is a neurologist or documents a consultation with a neurologist; 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 disease-modifying MS agents: Aubagio, Gilenya, glatiramer acetate therapy, interferon therapy, Ocrevus, Tecfidera, Tysabri. 

   

Mayzent

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • requesting prescriber is a neurologist or documents a consultation with a neurologist; 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
    • inadequate response or adverse reaction to two or contraindication to all of the following disease-modifying MS agents: Aubagio, Gilenya, glatiramer acetate therapy, interferon therapy, Ocrevus, Tecfidera. 

  

Ocrevus

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • requesting prescriber is a neurologist or documents a consultation with a neurologist; and
    • requested dose is 600 mg every six months. 

 

Plegridy

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • requesting prescriber is a neurologist or documents a consultation with a neurologist; and
    • medical necessity for use instead of Avonex or Rebif (interferon beta-1a); and
    • requested dose does not exceed two units/28 days; and
    • one of the following:
      • inadequate response or adverse reaction to one of the following non-interferon disease-modifying MS agents: Aubagio, Gilenya, glatiramer acetate therapy, Lemtrada, Ocrevus, Tecfidera, Tysabri; or
      • contraindication to the use of all other disease-modifying agents for the treatment of MS.


Original Effective Date: 02/2011

Last Revised Date: 08/2019


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Last updated 08/29/19