CurrentNeighborhood Health Plan of Rhode IslandPolicy 1663-A

osimertinib (Tagrisso) for EGFR‑mutant non‑small cell lung cancer (NSCLC)

Covers use of Tagrisso (osimertinib) for FDA‑approved and compendial indications in patients with EGFR mutation–positive non‑small cell lung cancer (NSCLC); applies to members of Neighborhood Health Plan of Rhode Island as indicated in the document.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policyosimertinib (Tagrisso) for EGFR‑mutant non‑small cell lung cancer (NSCLC)

Policy CodePolicy 1663-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit EGFR mutation testing results to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical initial authorization duration

up to 3 yearsmaximum adjuvant reauth

exon19 / L858Rfirst‑line biomarkers

T790Mresistance mutation

brain, leptomeningeal, adjuvantcompendial uses

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Covered Indications and Criteria

Covered when ALL of the following are met for the specific indication group:

First-line metastatic NSCLC: Patient is an adult with metastatic or locally advanced NSCLC whose tumor harbors an EGFR exon 19 deletion or exon 21 L858R mutation as detected by an FDA‑approved test; Tagrisso (osimertinib) is being used as first‑line monotherapy or in combination with pemetrexed and platinum‑based chemotherapy where indicated.

See FDA‑approved first‑line indications (chunk 3).

T790M‑positive metastatic NSCLC after prior EGFR TKI: Patient is an adult with metastatic NSCLC whose tumor harbors an EGFR T790M mutation as detected by an FDA‑approved test and disease has progressed on or after prior EGFR tyrosine kinase inhibitor (TKI) therapy; Tagrisso is being used for treatment of T790M‑positive disease.

See FDA‑approved T790M indication (chunk 3).

Adjuvant therapy after resection: Patient is an adult with completely resected NSCLC (including node‑positive disease) whose tumor harbors an EGFR exon 19 deletion or exon 21 L858R mutation as detected by an FDA‑approved test; Tagrisso is being used as adjuvant therapy following tumor resection.

See FDA‑approved adjuvant indication (chunk 3).

Unresectable stage III consolidation: Patient has locally advanced, unresectable (stage III) NSCLC that has not progressed during or following concurrent or sequential platinum‑based chemoradiation therapy and whose tumor harbors an EGFR exon 19 deletion or exon 21 L858R mutation as detected by an FDA‑approved test; Tagrisso is being used as consolidation therapy.

See FDA‑approved consolidation indication (chunk 3).

Compendial uses: Includes EGFR mutation‑positive recurrent, advanced or metastatic NSCLC; adjuvant treatment of completely resected stage IB‑IIIB EGFR‑mutation positive NSCLC; brain metastases; and leptomeningeal metastases from EGFR mutation‑positive NSCLC.

Listed compendial uses (chunk 4).

All indications for osimertinib (Tagrisso) that are not listed as FDA‑approved or in accepted compendia are considered experimental/investigational and not medically necessary.

Use of Tagrisso (osimertinib) for indications outside the FDA‑approved and the listed compendial uses is considered not medically necessary.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Typical initial and reauthorization approvals are for 12 months; initial authorization may be granted for NSCLC indications including adjuvant, recurrent/advanced/metastatic disease, brain or leptomeningeal metastases, and consolidation therapy after chemoradiation. Reauthorization may be granted for up to 12 months (and for adjuvant therapy up to a maximum of 3 years total) when there is no evidence of unacceptable toxicity or disease recurrence while on the current regimen.

Authorization duration: 12 months (initial and reauthorization).
Adjuvant reauthorization: up to a maximum duration of 3 years total when criteria met.

Denial Risk

Experimental / Investigational Exclusions

Use for indications not listed in the FDA‑approved indications or accepted compendial uses (e.g., any indication other than the listed EGFR mutation-positive NSCLC settings and compendial uses) is considered experimental/investigational and not medically necessary.

Compendial/approved uses include: EGFR mutation-positive recurrent/advanced/metastatic NSCLC; adjuvant treatment of completely resected stage IB-IIIB EGFR‑mutation positive NSCLC; brain or leptomeningeal metastases from EGFR-sensitizing mutation-positive NSCLC.

Step Therapy

No explicit step therapy sequence is required or described in this policy.

Documentation Required

Required Documentation

Submit EGFR mutation testing results to initiate prior authorization review.

Required documentation: EGFR mutation testing results.

Background on Osimertinib

Osimertinib (Tagrisso) is an EGFR‑directed tyrosine kinase inhibitor approved for multiple clinical settings in EGFR‑mutation positive non‑small cell lung cancer (NSCLC). Documented approved and compendial uses include first‑line treatment for tumors with EGFR sensitizing mutations (exon 19 deletions or exon 21 L858R), treatment of EGFR T790M mutation–positive disease after progression on prior EGFR TKIs, adjuvant therapy after complete tumor resection, consolidation after chemoradiation for unresectable stage II–III disease, and management of central nervous system involvement such as brain and leptomeningeal metastases. Compendial listings specifically cite: EGFR mutation‑positive recurrent, advanced or metastatic NSCLC; adjuvant treatment of completely resected stage IB–IIIB EGFR‑mutation positive NSCLC; brain metastases from EGFR‑sensitizing mutation‑positive NSCLC; and leptomeningeal metastases from EGFR mutation‑positive NSCLC.

Definitions and Biomarkers

inv-09: EGFR‑sensitizing mutation — Definition and relevance

DefinitionTumor EGFR alterations such as exon 19 deletions or exon 21 L858R mutations that confer sensitivity to EGFR tyrosine kinase inhibitors (EGFR‑TKIs).

Clinical relevanceThese EGFR‑sensitizing mutations are FDA‑recognized first‑line biomarkers for use of osimertinib (Tagrisso) in metastatic NSCLC.

Typical settingsDetected in patients with metastatic, locally advanced unresectable, or resected NSCLC where osimertinib is indicated (first‑line, adjuvant, consolidation).

Related compendial usesPresence of sensitizing EGFR mutations supports compendial indications including recurrent/advanced disease, brain metastases, and leptomeningeal metastases.

Line of Therapy Criteria

first-line

First-line: Member has metastatic or locally advanced NSCLC with documented EGFR exon 19 deletion or exon 21 L858R mutation detected by an FDA‑approved test, and Tagrisso is prescribed as first‑line therapy (monotherapy or in combination with pemetrexed + platinum chemotherapy where indicated).

First‑line FDA approvals (chunk 3); typical initial authorization duration 12 months (chunk 6).

second-line

Second-line (after progression on EGFR TKI): Member has metastatic NSCLC with documented EGFR T790M mutation detected by an FDA‑approved test and disease progression on or after prior EGFR TKI therapy; Tagrisso is prescribed for treatment of T790M‑positive disease.

FDA‑approved T790M indication (chunk 3); typical initial authorization duration 12 months (chunk 6).

salvage

Adjuvant/Salvage: Member has completely resected (including node‑positive) or unresectable stage II‑III NSCLC with an EGFR exon 19 deletion or exon 21 L858R mutation detected by an FDA‑approved test and Tagrisso is prescribed as adjuvant therapy after resection or as consolidation after chemoradiation when there is no disease progression.

Adjuvant and consolidation indications (chunks 3 and 4); authorization typically 12 months with reauthorization up to 3 years for adjuvant treatment if no recurrence or unacceptable toxicity (chunk 7).

Required Biomarker Testing

inv-13: EGFR exon 19 deletion or exon 21 L858R — Requirements

Required biomarkerEGFR exon 19 deletion or exon 21 L858R mutation.

Detection methodMust be detected by an FDA‑approved test.

Indications tied to this markerFirst‑line metastatic NSCLC (monotherapy or with pemetrexed+platinum), adjuvant therapy after resection, and consolidation for unresectable stage III when criteria met.

Documentation for PASubmit EGFR mutation testing results to initiate prior authorization review.

inv-14: EGFR T790M — Requirements

Required biomarkerEGFR T790M mutation.