KESIMPTA (ofatumumab)

KESIMPTA (ofatumumab)

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, 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™)

Dosing:

• Recommended adult dose: 20 mg at Weeks 0, 1, and 2, followed by 20 mg once monthly starting at Week 4
• Kesimpta is contraindicated in patients with active HBV infection

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:

• Kesimpta is contraindicated in patients with active HBV infection
• Infections: An increased risk of infections has been observed with other anti-CD20 B-cell depleting therapies. There is a possible increased risk of immunosuppressant effects with other immunosuppressants. There were no reports of HBV reactivation in patients with MS treated with Kesimpta. However, HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients being treated with ofatumumab for chronic lymphocytic leukemia (CLL) and in patients treated with other anti-CD20 antibodies. Kesimpta is contraindicated in patients with active hepatitis B disease. Although no cases of PML have been reported for Kesimpta in the RMS clinical studies, PML resulting in death has occurred in patients being treated with ofatumumab for CLL
• Additional warnings for injection-related reactions, reduction in immunoglobulins, fetal risk
• Pregnancy: There are no adequate data on the developmental risk associated with the use of KESIMPTA in pregnant women. Ofatumumab may cross the placenta and cause fetal B-cell depletion based on findings from animal studies
• Lactation: There are no data on the presence of ofatumumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Human IgG is excreted in human milk, and the potential for absorption of ofatumumab to lead to B-cell depletion in the infant is unknown
• Females of childbearing potential should use effective contraception while receiving Kesimpta and for 6 months after the last treatment of Kesimpta
• Safety and effectiveness in pediatric patients have not been established

Review History:

• 11/17/20- Class review, new policy

References: 

• Kesimpta [package insert]. East Hanover (NJ): Novartis Pharmaceuticals Corporation; 2020.
• OptumRX Therapeutic Class Overview – Multiple Sclerosis Agents.  Publication Date:  June 22, 2020.