Kesimpta (ofatumumab) Letter of Medical Necessity
Kesimpta (ofatumumab) is a self-administered subcutaneous anti-CD20 for MS. PAs may require step therapy through preferred DMTs.
FDA-Approved Indications
- ● relapsing forms of multiple sclerosis
Why Kesimpta Prior Authorization Gets Denied
The most common denial reasons across major payers:
- 1. Step therapy through other DMTs
- 2. Hepatitis B screening missing
- 3. Disease activity documentation insufficient
What to Include in a Kesimpta Letter of Medical Necessity
Document MS diagnosis, disease activity, MRI findings, prior DMTs, hepatitis B screening, immunoglobulin levels, and rationale for self-administered anti-CD20.
Key clinical evidence to cite:
- ✓ ASCLEPIOS I and II trials
Relevant guidelines:
- 📖 AAN MS Guidelines
Kesimpta Prior Authorization Criteria
Standard criteria across major US payers for Kesimpta. Specific criteria vary by plan — RxCheckUp tailors each LMN to your patient's exact payer policy.
Typical step therapy requirements:
- → Step therapy through other DMTs
Required documentation:
- ✓ ICD-10 diagnosis code with specificity
- ✓ Prior therapy history with dates, doses, and discontinuation reasons
- ✓ Specialist evaluation (where applicable)
- ✓ Baseline disease activity or biomarker results
- ✓ Clinical rationale citing FDA labeling or guidelines
Approval details:
Initial approval: typically 6 months. Renewal: 12 months with documented clinical response.
Payers Covering Kesimpta
RxCheckUp tailors each LMN to the specific payer's medical policy and step therapy requirements:
Kesimpta Prior Authorization FAQ
Why was my Kesimpta prior authorization denied?
The most common denial reasons for Kesimpta are: Step therapy through other DMTs; Hepatitis B screening missing; Disease activity documentation insufficient.
What should a Kesimpta Letter of Medical Necessity include?
Document MS diagnosis, disease activity, MRI findings, prior DMTs, hepatitis B screening, immunoglobulin levels, and rationale for self-administered anti-CD20.
Which payers cover Kesimpta?
Kesimpta is covered by major US payers including UnitedHealthcare, Aetna, Cigna, BCBS, Medicare Part D, though formulary tier and prior authorization criteria vary.