KESIMPTA (ofatumumab)

KESIMPTA (ofatumumab)

SELF ADMINISTRATION—INJECTABLE

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

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
• For Kesimpta, there is a QL Override (For new starts only): Please enter 2 PAs as follows with the same start date: First PA: Approve 3 syringes or pens per 28 days for the first month (Loading dose has a MDD of 0.05); Second PA: Approve 1 syringe or pen per 28 days (no overrides needed) for 12 months. (Kesimpta is hard-coded with a quantity of 1 syringe or pen per 28 days; 0.4 mL per 20 mg pen or syringe. Maintenance dose has a MDD of 0.02)

Reauthorization Criteria:

For diagnosis of Multiple Sclerosis:

• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression) AND

• Not used in combination with another disease-modifying therapy for MS AND
• Prescribed by or in consultation with a neurologist

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
• 6/1/2024 (policy effective date)- RRT MS update, added criteria point to not use in combination (P&T 5/20/2024) (P&T Meeting May)

References: 

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