Centene Osimertinib (Tagrisso) Coverage

Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met:

Primary criteria: 1) Diagnosis of non-small cell lung cancer (NSCLC); 2) Patient is an adult (>= 18 years); 3) Tumor is EGFR mutation–positive as detected by an FDA‑approved test (examples: exon 19 deletion, exon 21 L858R, other sensitizing mutations such as exon 18 G719X, exon 20 S768I, L861Q, or T790M where applicable); 4) Request corresponds to an allowed clinical scenario: a) adjuvant therapy after complete resection for stage IB-IIIB EGFR mutation–positive NSCLC (patients who received prior adjuvant chemotherapy or are ineligible for platinum‑based chemotherapy), b) locally advanced unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum‑based chemoradiation, c) first‑line treatment of metastatic NSCLC with sensitizing EGFR exon 19 deletion or exon 21 L858R mutation (including in combination with pemetrexed plus platinum when indicated), or d) treatment of metastatic EGFR T790M mutation–positive NSCLC after progression on or after prior EGFR TKI therapy; 5) Prescribed dose does not exceed policy limits (standard 80 mg orally once daily; see dose adjustments below); 6) Generic osimertinib should be used if available unless contraindicated or clinically significant adverse effects are experienced.all

Dose limits: usual 80 mg/day; if co‑administered with a strong CYP3A4 inducer (e.g., phenytoin, rifampin, carbamazepine, St. John's wort) dosing may be increased per policy but must not exceed 160 mg/day (2 tablets) and must be supported by practice guidelines or peer‑reviewed literature for any off‑label dosing.

inv-02: Continuation Therapy

Continuation Therapy – Covered when ALL of the following are met:

Continuation criteria: 1) Member is currently receiving Tagrisso via the Centene benefit or documentation shows the member has received Tagrisso for at least 30 days; 2) Member is demonstrating a positive clinical response to therapy; 3) Generic osimertinib should be used if available unless contraindicated or clinically significant adverse effects are experienced; 4) Any requested dose increase meets the policy dose limits and is supported by practice guidelines or peer‑reviewed literature when used off‑label.all

Dose limits on renewal: new dose must not exceed standard 80 mg/day (1 tablet/day) unless co‑administered with a strong CYP3A4 inducer, in which case the new dose must not exceed 160 mg/day (2 tablets/day); dose increases for off‑label uses require supporting evidence.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation demonstrating efficacy and safety. Such requests must follow the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or be supported by the member’s evidence of coverage documents.

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid provisions take precedence. Providers should refer to the applicable state Medicaid manual for specific coverage requirements and follow those provisions in lieu of this policy where a conflict exists.

Uses not listed in this policy or uses that are not supported by the referenced off‑label use policies are considered not authorized and may be denied. Providers seeking coverage for off‑label indications must submit evidence per the off‑label use policies named in this document or as required by the member’s coverage documents.

Coding and Dosing

NDC / Drug codesNDC

No codes listed

inv-07: Dose limit — Maximum 80 mg/day

Dose limitMaximum 80 mg/day

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Tagrisso (osimertinib) is considered medically necessary only when the member meets the clinical criteria in this policy and a prior authorization request is submitted and approved before coverage is provided.

Prior authorization required for Tagrisso per this clinical policy and the Health Plan's authorization procedures.
Dose limits, indication, and clinical-history requirements in the Policy/Criteria must be documented on the authorization request.

Denial Risk

Non‑Covered Indications

Requests for indications that are not FDA‑approved and are not specifically addressed in this policy may be denied. Off‑label uses will only be considered when sufficient supporting documentation is provided showing efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid), or the member's evidence of coverage document.

Background

Osimertinib (Tagrisso) is an EGFR tyrosine kinase inhibitor (EGFR TKI) indicated for several epidermal growth factor receptor (EGFR)–mutated non‑small cell lung cancer (NSCLC) scenarios. Indications include adjuvant therapy after complete resection for tumors with EGFR exon 19 deletions or exon 21 L858R mutations, treatment of unresectable stage III disease following chemoradiation, first‑line therapy for metastatic disease in patients with sensitizing EGFR mutations (including specified combination regimens), and treatment of metastatic disease with the EGFR T790M resistance mutation after progression on prior EGFR TKIs. Dosing is typically 80 mg orally once daily, and prescribing should follow FDA‑approved labeling or recognized guidelines.

Definitions

inv-17: EGFR definition and mutation examples

TermEGFR (epidermal growth factor receptor)

Common sensitizing mutationsExon 19 deletions or insertions; exon 21 L858R; exon 18 G719X; exon 20 S768I; L861Q

Resistance mutation exampleT790M (EGFR T790M mutation-positive disease)

inv-18: Health Plan definition

DefinitionHealth Plan: a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or its affiliates.

Policy governanceThis clinical policy is effective as of the date determined by the Health Plan; the Health Plan may change, amend, or withdraw this policy and prior authorization requirements are governed by the Health Plan.

Initial Therapy Criteria

inv-19: Initial Therapy

Initial authorization criteria

Initial therapy nodes: 1) Diagnosis of NSCLC; 2) Patient age >= 18 years; 3) Tumor is EGFR mutation–positive as determined by an FDA‑approved test (examples include exon 19 deletion, exon 21 L858R, and other sensitizing mutations); 4) Request aligns with one of the approved clinical indications: a) adjuvant therapy after complete resection for stage IB–IIIB EGFR mutation–positive NSCLC, b) locally advanced unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum‑based chemoradiation, c) first‑line treatment of metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R mutation (including use in combination with pemetrexed plus platinum where indicated), or d) metastatic EGFR T790M mutation–positive NSCLC after progression on or after prior EGFR TKI therapy; 5) Requested dose does not exceed policy limits (standard 80 mg PO once daily; higher dosing only per policy for concomitant strong CYP3A4 inducers up to 160 mg/day); 6) Generic osimertinib is used if available unless contraindicated.

Continuation / Renewal Criteria

inv-20: Continuation Therapy

Continuation/renewal conditions

Continuation: 1) Member is currently receiving Tagrisso via the Centene benefit or has documentation showing at least 30 days of therapy; 2) Member is responding positively to therapy as evidenced by clinical assessment; 3) Generic osimertinib should be used if available unless contraindicated or clinically significant adverse effects are experienced; 4) Any requested dose changes comply with policy limits and, for off‑label dosing, are supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Step Therapy

Step	Therapeutic alternatives / guidance
1	Therapeutic alternatives: afatinib (Gilotrif), gefitinib (Iressa), erlotinib (Tarceva), dacomitinib (Vizimpro). Use of listed alternatives is guided by the health plan formulary and may require prior authorization; drugs listed may not be formulary for all lines of business and may require authorization per plan.

Quantity Limits

inv-22: Osimertinib quantity limit — 80 (units / daily dose shorthand)

Quantity limit (daily)80 mg per day (standard dosing for NSCLC)

Dosage form examplesTablets available: 40 mg and 80 mg

Maximum per policyNSCLC maximum dose = 80 mg/day (higher dosing up to 160 mg/day allowed only when co‑administered with a strong CYP3A4 inducer as specified)

OpenPayer

Osimertinib (Tagrisso) coverage