Interferon beta-1b (Betaseron, Extavia)

Interferon beta-1b (Betaseron®, Extavia®)

SELF ADMINISTRATION—INJECTABLE

Indication for Prior Authorization:

• 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

Coverage Criteria:

For diagnosis of MS:

• Patient has a documented diagnosis of relapsing forms of multiple sclerosis (MS), (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) AND
• Not used in combination with another disease-modifying therapy for MS AND 
• Prescribed by or in consultation with a neurologist, AND
• For Extavia® requests only:
  • Patient has experienced an inadequate response, contraindication, or intolerance to at least TWO of the following disease-modifying therapies for MS:
    • Avonex (interferon beta-1a)
    • Betaseron (interferon beta-1a)
    • Copaxone/Glatopa (glatiramer acetate)
    • Dimethyl Fumarate
    • Vumerity 
    • Plegridy®
    • Rebif®/Rebif Rebidose®
    • Kesimpta (ofatumumab) OR
  • For continuation of therapy, defined as no more than 45-day gap in therapy 

Reauthorization Criteria:

For diagnosis 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
• Prescribed by or in consultation with a neurologist

Dosing:

For diagnosis of MS:

• Recommended adult dose: 0.25 mg every other day
• Schedule for Dose Titration:
  • Weeks 1-2: 0.0625 mg every other day
  • Weeks 3-4: 0.125 mg every other day
  • Weeks 5-6: 0.1875 mg every other day
  • Week 7 and thereafter: 0.25 mg every other day

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Warnings include: severe hepatic injury, anaphylaxis and other allergic reactions, depression and suicide, congestive heart failure, injection site necrosis and reactions, leukopenia, thrombotic microangiopathy, flu-like symptom complex, seizures, drug-induced lupus erythematosus, and monitoring for laboratory abnormalities
• Pregnancy: Although there have been no well-controlled studies in pregnant women, available data, which include prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy
• Lactation: There are no data on the presence of interferon beta-1b in human milk, the effects on the breastfed infant, or the effects of the drug on milk production
• Safety and effectiveness in pediatric patients have not been established

Review History:

• 12/1/14- Annual review
• 11/17/20- Class review, criteria updated
• 6/1/2024 (policy effective date)- RRT MS update, removal of embedded DSE (P&T 5/20/2024) (P&T Meeting May) 

References: 

• Betaseron [package insert]. Whippany (NJ): Bayer HealthCare Pharmaceuticals Inc.; 2020.
• Extavia [package insert]. East Hanover (NJ): Novartis Pharmaceuticals Corporation; 2020.
• OptumRX Therapeutic Class Overview – Multiple Sclerosis Agents.  Publication Date:  June 22, 2020.