TECFIDERA (dimethyl fumarate)

TECFIDERA (dimethyl fumarate)

SELF ADMINISTRATION - ORAL

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 relapsing Multiple Sclerosis (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
• Prescribed by or in consultation with a neurologist AND
• Not used in combination with another disease-modifying therapy for MS, AND
• For Tecfidera only:
  • Trial and failure or intolerance to generic dimethyl fumarate

Reauthorization Criteria:

For diagnosis of relapsing MS:

• Patient has a documented diagnosis of relapsing forms of multiple sclerosis (MS), AND
• Prescribed by or in consultation with a neurologist AND
• For Tecfidera only:
  • Trial and failure or intolerance to generic dimethyl fumarate

Dosing:

For diagnosis of relapsing MS:

• Starting dose: 120 mg capsule twice a day for 7 days
• Maintenance dose: 240 mg capsule twice a 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 for: anaphylaxis and angioedema, Progressive Multifocal Leukoencephalopathy, herpes zoster and other serious opportunistic infections, lymphopenia, liver injury, flushing
• Pregnancy: There are no adequate data on the developmental risk associated with the use of Tecfidera in
  pregnant women
• Lactation: There are no data on the presence of DMF or MMF in human milk. The effects on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Tecfidera and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
• Safety and effectiveness in pediatric patients have not been established

Review History:

• 05/28/2013 - New policy
• 11/14/2019 - No changes
• 09/24/2020 - Annual review, indication updated, format updated
• 11/17/20- Class review, criteria updated
• 6/1/2024 (policy effective date)- RRT MS update, added generic ST (P&T 5/20/2024) (P&T Meeting May)  

References:

1. Tecfidera [package insert]. Cambridge, MA: Biogen; revised 02/2020.
2. Level B, Level A, 2018. Practice Guideline: Disease-modifying Therapies for Adults with Multiple Sclerosis.
3. OptumRX Therapeutic Class Overview – Multiple Sclerosis Agents.  Publication Date:  June 22, 2020.
4. Tecfidera. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed April 15, 2024. http://www.micromedexsolutions.com.