COPAXONE (glatiramer/glatopa)

COPAXONE (glatiramer/glatopa)

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

Dosing:

• Recommended Dose: 20 mg once per day OR 40 mg three times per 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
• Pregnancy: There are no adequate and well-controlled studies of Copaxone in pregnant women. The available postmarketing reports, case series, and small cohort studies do not provide sufficient information to support conclusions about drug-associated risk for major birth defects and miscarriage
• 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

References:

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