Overview

This document addresses the use of beta interferon agents and glatiramer acetate agents, injectable disease modifying therapies approved by the Food and Drug Administration (FDA) to treat relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease or active secondary progressive disease.

Interferon beta-1a agents:

• Avonex (interferon beta-1a)
• Plegridy (peginterferon beta-1a)
• Rebif (interferon beta-1a)

Interferon beta-1b agents:

• Betaseron (interferon beta-1b)
• Extavia (interferon beta-1b)

Glatiramer acetate agents:

• Copaxone (glatiramer acetate)
• Glatopa (glatiramer acetate)

Multiple sclerosis is an autoimmune inflammatory demyelinating disease of the central nervous system. Common symptoms of the disease include fatigue, numbness, coordination and balance problems, bowel and bladder dysfunction, emotional and cognitive changes, spasticity, vision problems, dizziness, sexual dysfunction and pain. Multiple sclerosis can be subdivided into four phenotypes: clinically isolated syndrome (CIS), relapsing remitting (RRMS), primary progressive (PPMS) and secondary progressive (SPMS). Relapsing multiple sclerosis (RMS) is a general term for all relapsing forms of multiple sclerosis including CIS, RRMS and active SPMS. The treatment goal for multiple sclerosis is to prevent relapses and progressive worsening of the disease. Currently available disease-modifying therapies (DMT) are most effective for the relapsing-remitting form of multiple sclerosis and less effective for secondary progressive decline. DMT include injectable agents, infusion therapies and oral agents. The American Academy of Neurology (AAN) guidelines suggest starting disease-modifying therapy in individuals with relapsing forms of multiple sclerosis with recent clinical relapses or MRI activity. The guidelines also suggest DMT for individuals who have experienced a single clinical demyelinating event and two or more brain lesions consistent with multiple sclerosis if the individual wishes to start therapy after a risks and benefits discussion. The guidelines do not recommend one DMT over another.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Beta Interferons [Avonex, Plegridy, Rebif (interferon beta-1a); Betaseron, Extavia (interferon beta-1b)]

Requests for beta interferons [Avonex, Plegridy, Rebif (interferon beta-1a); Betaseron, Extavia (interferon beta-1b)] may be approved if the following criteria are met:

1. Individual has a diagnosis of relapsing multiple sclerosis (RMS) (including clinically isolated syndrome, relapsing-remitting disease or active secondary progressive disease).

• Individual is using to treat primary progressive multiple sclerosis (PPMS); OR
• Individual is using to treat non-active secondary progressive multiple sclerosis (SPMS); OR

Beta interferons [Avonex, Plegridy, Rebif (interferon beta-1a); Betaseron, Extavia (interferon beta-1b)] may not be approved for the following:

1. Use in combination with other MS disease modifying agents (including Aubagio, Avonex, Bafiertam, Betaseron, Briumvi, Copaxone/Glatiramer/Glatopa, Extavia, Gilenya, Kesimpta, Lemtrada, Mavenclad, Mayzent, Ocrevus, Plegridy, Ponvory, Rebif, Tascenso ODT, Tecfidera, Tysabri, Vumerity and Zeposia); OR

May not be approved when the above criteria are not met and for all other indications.

Glatiramer acetate (Copaxone, Glatopa)

Requests for glatiramer acetate (Copaxone, Glatopa) may be approved if the following criteria are met:

1. Individual has a diagnosis of relapsing multiple sclerosis (RMS) (including clinically isolated syndrome, relapsing-remitting disease or active secondary progressive disease).

Glatiramer acetate (Copaxone, Glatopa) may not be approved for the following:

• Individual is using to treat primary progressive multiple sclerosis (PPMS); OR
• Individual is using to treat non-active secondary progressive multiple sclerosis (SPMS); OR
• Use in combination with other MS disease modifying agents (including Aubagio, Avonex, Bafiertam, Betaseron, Briumvi, Extavia, Gilenya, Kesimpta, Lemtrada, Mavenclad, Mayzent, Ocrevus, Plegridy, Ponvory, Rebif, Tascenso ODT, Tecfidera, Tysabri, Vumerity and Zeposia); OR
• May not be approved when the above criteria are not met and for all other indications.

Quantity Limits

Beta Interferons and Glatiramer Acetate Quantity Limits

Drug

• Avonex (interferon beta-1a) Administration Dose Pack 30 mcg/0.5 mL prefilled autoinjector pen
• Avonex (interferon beta-1a) Administration Dose Pack 30 mcg/0.5 mL prefilled syringe
• Betaseron (interferon beta-1b) 0.3 mg vial
• Copaxone (glatiramer acetate) 20 mg/mL prefilled syringe
• Copaxone (glatiramer acetate) 40 mg/mL prefilled syringe
• Extavia (interferon beta-1b) 0.3 mg vial
• Glatopa (glatiramer acetate) 20 mg/mL prefilled syringe
• Glatopa (glatiramer acetate) 40 mg/mL prefilled syringe
• Plegridy (peginterferon beta-1a) Starter Pack (prefilled autoinjector pen, prefilled syringe)
• Plegridy (peginterferon beta-1a) Titration Kit (prefilled syringe)
• Plegridy (peginterferon beta-1a) 125 mcg/0.5 mL prefilled autoinjector pen/syringe
• Rebif/Rebidose (interferon beta-1a) 22 mcg/0.5 mL, 44 mcg/0.5 mL prefilled syringe/autoinjector
• Rebif/Rebidose (interferon beta-1a) Titration Pack (prefilled syringe, prefilled syringe autoinjector)

Limit

• 4 pens (1 pack) per 28 days
• 4 syringes (1 pack) per 28 days
• 15 single-use vials per 30 days
• 1 syringe per day
• 12 syringes per 28 days
• 15 single-use vials per 30 days
• 1 syringe per day
• 12 syringes per 28 days
• 1 pack (1 mL) per fill, one time fill (28 day supply)
• 1 pack per fill, one time fill (28 day supply)
• 2 pens/syringes per 28 days
• 12 syringes/autoinjectors per 28 days
• 1 pack (4.2 mL) per fill, one time fill (28 day supply)

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

• C9399
• J1595

Unclassified drugs or biologicals [Plegridy] (Hospital Outpatient Use ONLY)

Injection, glatiramer acetate, 20 mg [Copaxone, Glatopa]

1. 2

• J1826
• J1830
• J3590
• Q3027
• Q3028
• S9559

ICD-10 Diagnosis

• G35

T50.995A- T50.995S

Document History

Injection, interferon beta-1a, 30 mcg [Avonex, Rebif]

Injection, interferon beta-1b, 0.25 mg [Betaseron, Extavia]

Unclassified drugs [when specified as peginterferon beta-1a Plegridy]

Injection, interferon beta-1a, 1 mcg for intramuscular use [Avonex]

Injection, interferon beta-1a, 1 mcg for subcutaneous use [Rebif]

Home injectable therapy, interferon, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment; per diem

Multiple sclerosis

Adverse effect of other drugs, medicaments and biological substances

Revised: 11/17/2023