Interferon beta-1b (Betaseron, Extavia)

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

SELF ADMINISTRATION—INJECTABLE

Indication for Prior Authorization:

• 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:

• Patient has a documented diagnosis of relapsing forms of multiple sclerosis (MS), AND
• Prescribed by or in consultation with a neurologist, AND
• For Extavia® requests only:
  • Patient has experienced an inadequate response, contraindication, or intolerable side effect to two different preferred agents (e.g., Avonex®, Betaseron®, dimethyl fumarate [Tecfidera®], Gilenya®, glatiramer/Glatopa® [Copaxone®], Plegridy®, Rebif®/Rebif® Rebidose®, Vumerity™)

Dosing:

• 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:

• 11/17/20- Class review, criteria updated
• 12/1/14- Annual review

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.