PLEGRIDY (peginterferon beta-1a)

PLEGRIDY (peginterferon beta-1a)

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

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:

• Treatment initiation:
  • Day 1: 63 micrograms
  • Day 15: 94 micrograms
  • Day 29 and every 14 days thereafter: full dose (125 micrograms) every 14 days
• Recommended adult dose: 125 micrograms every 14 days

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:

• Monitor for adverse reactions due to increased drug exposure in patients with severe renal impairment
• Warnings include: hepatic injury, depression and suicide, seizures, anaphylaxis and other allergic reactions, injection site reactions, congestive heart failure, decreased peripheral blood counts, thrombotic microangiopathy, autoimmune disorders
• Pregnancy: The majority of observational studies reporting on pregnancies exposed to interferon beta products did not identify an association between the use of interferon beta products during early pregnancy and an increased risk of major birth defects
• Lactation: Limited published literature has described the presence of interferon beta-1a products in human milk at low levels. There are no data on the effects of interferon beta-1a on milk production
• Safety and effectiveness in pediatric patients have not been established

Review History:

• 12/2/14-Original review
• 11/17/20- Annual review, format updated
• 6/1/2024 (policy effective date) –RRT MS update, addition of reauthorization criteria (P&T 5/21/2024) (P&T Meeting May)  

References:

• OptumRX Therapeutic Class Overview – Multiple Sclerosis Agents.  Publication Date:  June 22, 2020.
• Plegridy [package insert]. Cambridge (MA): Biogen Inc.; 2020.