ofatumumab
Marketed as KESIMPTA.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| BLA125326 | KESIMPTA | 2009-10-26 | NOVARTIS |
Manufacturers
NOVARTIS
Common denial patterns
- Step therapy requiring oral DMT first
- Step therapy requiring ocrelizumab first within anti-CD20 class
- Self-administration concerns
- Specialty pharmacy network restriction
Specific notes
Brand: Kesimpta. Anti-CD20 monoclonal antibody for relapsing MS. Self-administered monthly subQ — distinct positioning vs ocrelizumab (IV every 6 months).
Novartis Patient Assistance Foundation: https://www.kesimpta.com/savings-support
Frequently asked questions
Why does insurance commonly deny ofatumumab?
Step therapy requiring oral DMT first; Step therapy requiring ocrelizumab first within anti-CD20 class; Self-administration concerns; Specialty pharmacy network restriction.
When was ofatumumab FDA approved?
Earliest FDA approval on record: 2009-10-26.
What brand names are sold as ofatumumab?
KESIMPTA.
Is there a patient assistance program for ofatumumab?
Yes — Novartis Patient Assistance Foundation at https://www.kesimpta.com/savings-support.
What's specific to ofatumumab?
Brand: Kesimpta. Anti-CD20 monoclonal antibody for relapsing MS. Self-administered monthly subQ — distinct positioning vs ocrelizumab (IV every 6 months).
Related
Sources
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