VUMERITY (diroximel fumarate)

VUMERITY (diroximel 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 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 Multiple Sclerosis:

• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic 
• disease activity, clinical relapses, disease progressions) AND
• Not used in combination with another disease-modifying therapy for MS AND
• Prescribed by or in consultation with a neurologist 
   

Dosing:

• Starting dose for adults: 231 mg twice a day for 7 days
• Maintenance dose for adults: 462 mg (administered as two 231 mg capsules) twice a day
• Contraindications: use with dimethyl fumarate and known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of Vumerity
• Not recommended in patients with moderate or severe renal impairment

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Policy Updates:

• 2/18/20- Original review
• 11/17/20- Class review, criteria updated
• 6/1/2024 (policy effective date)- RRT MS update, addition of combination DMT use 
• (P&T 5/20/2024) (P&T Meeting May) 

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 to treatment include: use with dimethyl fumarate and known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of Vumerity
• The following blood tests should be obtained prior to  the initiation of Vumerity: serum aminotransferase, alkaline phosphatase, total bilirubin levels, and complete blood cell count (CBC), including lymphocyte count
• Warnings include: anaphylaxis and angioedema, progressive multifocal leukoencephalopathy, herpes zoster and other serious opportunistic infections, lymphopenia, liver injury, and flushing
• Pregnancy: There are no adequate data on the developmental risk associated with the use of Vumerity or dimethyl fumarate (which has the same active metabolite as Vumerity) in pregnant women
• Lactation: There are no data on the presence of diroximel fumarate or metabolites (MMF, HES) 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:

• 11/17/20- Class review, criteria updated
• 2/18/20- Original review

References:

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