COPAXONE (glatiramer/glatopa)

COPAXONE (glatiramer/glatopa)

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 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
• Prescribed by or in consultation with a neurologist AND
• Not used in combination with another disease-modifying therapy for MS

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 Dose: 20 mg once per day OR 40 mg three times per week, at least 48 hours apart, preferably on the same 3 days each week
• The 20 mg per mL formulation and the 40 mg per mL formulation are not interchangeable

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 and precautions include: immediate post-injection reaction, chest pain, lipoatrophy and skin necrosis, potential effects on immune response, and hepatic injury
• Lactation: There are no data on the presence of glatiramer acetate in human milk, the effects on breastfed infants, or the effects on milk production
• The safety and effectiveness of Copaxone have not been established in patients under 18 years of age

Review History:

• 11/17/20- Class review, format and criteria updated
• 1/3/20- Annual review, no changes
• 6/1/2024 (policy effective date)- RRT MS update, added criteria point to not use in combination (P&T 5/20/2024) (P&T Meeting May)

References:

• Copaxone [package insert]. Parsippany (NJ): Teva Neuroscience, Inc.; 2020.
• OptumRX Therapeutic Class Overview – Multiple Sclerosis Agents.  Publication Date:  June 22, 2020.