Tysabri (natalizumab) Letter of Medical Necessity
Tysabri (natalizumab) carries PML risk and requires JCV antibody monitoring under the TOUCH program. PAs require comprehensive risk documentation.
FDA-Approved Indications
- ● relapsing forms of multiple sclerosis
- ● Crohn's disease (TOUCH program)
Why Tysabri Prior Authorization Gets Denied
The most common denial reasons across major payers:
- 1. JCV antibody status not documented
- 2. TOUCH enrollment missing
- 3. Step therapy through other DMTs
What to Include in a Tysabri Letter of Medical Necessity
Document MS diagnosis, MRI findings, EDSS, prior DMTs and outcomes, JCV antibody status and index, TOUCH enrollment, and benefit-risk discussion.
Key clinical evidence to cite:
- ✓ AFFIRM, SENTINEL trials
Relevant guidelines:
- 📖 AAN MS Guidelines
- 📖 NMSS Treatment Guidelines
Tysabri Prior Authorization Criteria
Standard criteria across major US payers for Tysabri. 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 Tysabri
RxCheckUp tailors each LMN to the specific payer's medical policy and step therapy requirements:
Tysabri Prior Authorization FAQ
Why was my Tysabri prior authorization denied?
The most common denial reasons for Tysabri are: JCV antibody status not documented; TOUCH enrollment missing; Step therapy through other DMTs.
What should a Tysabri Letter of Medical Necessity include?
Document MS diagnosis, MRI findings, EDSS, prior DMTs and outcomes, JCV antibody status and index, TOUCH enrollment, and benefit-risk discussion.
Which payers cover Tysabri?
Tysabri is covered by major US payers including UnitedHealthcare, Aetna, Cigna, BCBS, Medicare Part B, though formulary tier and prior authorization criteria vary.