BAFIERTAM (monomethyl fumarate)

BAFIERTAM (monomethyl fumarate)

SELF ADMINISTRATION- ORAL

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 is 18 years of age or older, AND
• Patient has a documented diagnosis of relapsing forms of multiple sclerosis (MS), AND
• Prescribed by or in consultation with a neurologist, AND
• 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™), AND
• Bafiertam will not be used in combination with any other disease-modifying therapy for MS, either oral or injectable, AND
• Patient does not have a contraindication to treatment:
  • Known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of Bafiertam. Reactions may include anaphylaxis or angioedema
  • Co-administration with dimethyl fumarate or diroximel fumarate, AND
• Patient is not currently pregnant 

Dosing:

• Starting adult dose: 95 mg twice a day for 7 days
• Maintenance dose: 190 mg (administered as two 95 mg capsules) 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:

• Contraindications:
  • Known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of Bafiertam. Reactions may include anaphylaxis or angioedema
  • Taking dimethyl fumarate or diroximel fumarate
    • Both dimethyl fumarate and diroximel fumarate are metabolized to monomethyl fumarate. Therefore, Bafiertam is contraindicated in patients currently taking dimethyl fumarate or diroximel fumarate
• Obtain the following prior to treatment with Bafiertam:
  • A complete blood cell count (CBC), including lymphocyte count
  • Serum aminotransferase, alkaline phosphatase, and total bilirubin levels
• Additional warnings for: anaphylaxis and angioedema, progressive multifocal leukoencephalopathy (PML), 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 Bafiertam or dimethyl fumarate (the prodrug of Bafiertam) in pregnant women. In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses
• 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
• Safety and effectiveness in pediatric patients have not been established

Review History:

• 4/20/21- Criteria updated
• 11/17/20- Class review, new policy

References: 

• Bafiertam [package insert]. High Point (NC): Banner Life Sciences LLC; 2020.
• OptumRX Therapeutic Class Overview – Multiple Sclerosis Agents.  Publication Date:  June 22, 2020.