Tagrisso (osimertinib) Letter of Medical Necessity
Tagrisso (osimertinib) requires confirmed EGFR mutation status. The LMN should include the specific mutation, testing methodology, and line of therapy.
FDA-Approved Indications
- ● EGFR mutation-positive NSCLC (1st line, adjuvant, T790M-positive after progression)
Why Tagrisso Prior Authorization Gets Denied
The most common denial reasons across major payers:
- 1. EGFR mutation testing not documented
- 2. Line of therapy not specified
- 3. T790M status missing for second-line use
What to Include in a Tagrisso Letter of Medical Necessity
Document NSCLC histology, stage, EGFR mutation type (exon 19 deletion, L858R, T790M), testing platform (tissue NGS, liquid biopsy), line of therapy, and ECOG status.
Key clinical evidence to cite:
- ✓ FLAURA
- ✓ AURA3
- ✓ ADAURA for adjuvant
Relevant guidelines:
- 📖 NCCN NSCLC Guidelines
Tagrisso Prior Authorization Criteria
Standard criteria across major US payers for Tagrisso. Specific criteria vary by plan — RxCheckUp tailors each LMN to your patient's exact payer policy.
Typical step therapy requirements:
- → Documented failure or contraindication to formulary alternatives
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 Tagrisso
RxCheckUp tailors each LMN to the specific payer's medical policy and step therapy requirements:
Tagrisso Prior Authorization FAQ
Why was my Tagrisso prior authorization denied?
The most common denial reasons for Tagrisso are: EGFR mutation testing not documented; Line of therapy not specified; T790M status missing for second-line use.
What should a Tagrisso Letter of Medical Necessity include?
Document NSCLC histology, stage, EGFR mutation type (exon 19 deletion, L858R, T790M), testing platform (tissue NGS, liquid biopsy), line of therapy, and ECOG status.
Which payers cover Tagrisso?
Tagrisso is covered by major US payers including UnitedHealthcare, Aetna, Cigna, BCBS, Medicare Part D, though formulary tier and prior authorization criteria vary.