CurrentHealth NetPolicy CP PHAR.294

Osimertinib (Tagrisso)

Defines medical necessity and prior authorization criteria for coverage of osimertinib (Tagrisso) for members with non-small cell lung cancer across Health Net lines of business (Commercial, HIM, Medicaid). Applies to prescribers requesting coverage under Centene-affiliated health plans.

Policy Summary

PayerHealth Net

PolicyOsimertinib (Tagrisso) coverage criteria

Policy CodePolicy CP PHAR.294

Change TypeNo material changes

Effective DateDec 1, 2016

Next Review Date

Key ActionProvider must submit clinical documentation (e.g., chart notes, lab results) demonstrating the member meets initial or continuation criteria for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

80 mg/daystandard dosing for NSCLC

40 mg, 80 mgproduct availability

12 moapproval duration (commercial)

6–12 moapproval duration (Medicaid/HIM)

FDA/NCCNindication basis

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Coverage Criteria for Osimertinib (Tagrisso)

Initial Therapy

Initial Therapy — Covered when ALL of the following are met (Initial Approval Criteria).

ALL of the following

Diagnosis of non-small cell lung cancer (NSCLC).
ANY of the following
- Completely resected stage IB-IIIB EGFR mutation–positive NSCLC who received previous adjuvant chemotherapy or are ineligible to receive platinum‑based chemotherapy (adjuvant setting).
- Recurrent, advanced, or metastatic NSCLC that is positive for one of the following: i) A sensitizing EGFR mutation (e.g., exon 19 deletion; exon 21 L858R, L861Q; exon 18 G719X; exon 20 S768I) when osimertinib is prescribed as indicated by FDA/NCCN guidance (as single agent or per recommended combination regimens). ii) T790M mutation with disease progression on or after prior EGFR tyrosine kinase inhibitor (e.g., erlotinib, gefitinib, afatinib).
ALL of the following
- Standard dose: 80 mg once daily (1 tablet daily).
- If co‑administered with a strong CYP3A4 inducer (e.g., phenytoin, rifampin, carbamazepine, St. John's wort), dose does not exceed 160 mg per day (2 tablets daily) only if supported by practice guidelines or peer‑reviewed literature and prescriber provides supporting evidence.
- Dose requested is supported by FDA labeling or NCCN recommendations; for non‑FDA labeled/off‑label dosing the prescriber must submit supporting peer‑reviewed evidence.
Member must use generic osimertinib if available unless contraindicated or if clinically significant adverse effects are experienced.
Prescribed regimen must be FDA‑approved or recommended by NCCN.
Authorization duration: Medicaid/HIM — 6 months; Commercial — 12 months or duration of request, whichever is less.

Continuation Therapy

Continuation Therapy — Continued Therapy (Renewal) — Covered when ALL of the following are met.

ALL of the following

Member is currently receiving osimertinib via the Centene benefit, or documentation supports the member has been receiving osimertinib for NSCLC for at least 30 days.
Diagnosis of non‑small cell lung cancer (NSCLC).
Member is responding positively to therapy, as documented in the chart (e.g., clinical benefit, radiographic response, or stabilization of disease).
If request is for a dose increase, new dose does not exceed 160 mg per day (2 tablets daily) unless supported by practice guidelines or peer‑reviewed literature and prescriber submits supporting evidence; if co‑administered with a strong CYP3A4 inducer, dosing adjustments must follow the same limits and supporting documentation requirements.

Prior Authorization

Requests for non‑FDA approved indications not addressed in the policy are not authorized unless sufficient documentation of efficacy and safety is provided per off‑label use policies (commercial: CP.CPA.09; Marketplace: HIM.PA.154; Medicaid: CP.PMN.53). Provider must submit clinical documentation such as office notes, pathology and molecular testing reports, prior therapy history, radiology reports, and rationale for off‑label use. Prior authorization is required for osimertinib; prescribers should include supporting evidence when seeking approval for non‑standard dosing or off‑label indications. Clinical judgment of the provider should be documented in the medical record and submitted with the PA request. Step therapy requirements (e.g., prior EGFR TKI trials) apply where governed by the member's specific plan policy.

Initial Authorization Criteria

Initial Therapy — Authorization Requirements and Limits

Initial authorization requirements and limits:

Initial authorization requirements and limits: 1) Diagnosis of NSCLC and age ≥ 18 years. 2) Documented qualifying EGFR mutation (sensitizing mutations or T790M as specified). 3) Indication aligns with covered scenarios (adjuvant for completely resected stage IB–IIIB EGFR mutation–positive disease, or recurrent/locally advanced/metastatic disease with qualifying mutations as single-agent or appropriate combination per eligibility). 4) Prescribed regimen must be FDA-approved or NCCN-recommended. 5) Use generic osimertinib if available unless contraindicated or clinically significant adverse effects occur. 6) Dose limits: do not exceed 80 mg/day (1 tablet/day); if co-administered with a strong CYP3A4 inducer (e.g., phenytoin, rifampin, carbamazepine, St. John's wort), do not exceed 160 mg/day (2 tablets/day). 7) Any off-label dosing must be supported by practice guidelines or peer-reviewed literature and supporting evidence must be submitted by the prescriber. 8) Approval duration varies by line of business (Commercial up to 12 months or duration requested; Medicaid/HIM typically 6 months).all conditions required

Prescriber must submit supporting evidence for off-label regimens; prior authorization may be required for EGFR TKI therapies.

Continuation / Reauthorization Criteria

Continuation/Reauthorization

Criteria for continued coverage:

Continued use nodes: 1) Member currently receiving osimertinib via the benefit or has documentation of at least 30 days of therapy. 2) Documented clinical benefit/positive response to therapy. 3) Dosing remains within allowed limits (≤80 mg/day or ≤160 mg/day if co-administered with a strong CYP3A4 inducer). 4) Any requested dose increase is supported by practice guidelines or peer-reviewed literature and prescriber provides supporting evidence. 5) Generic osimertinib should be used if available unless contraindicated or clinically significant adverse effects occur.all required

Continuation/reauthorization requests must include clinical documentation demonstrating benefit; approvals follow plan-specific duration guidance.

Provider Responsibilities and Actions

Prior Authorization

Prior authorization required for Tagrisso

Tagrisso (osimertinib) is subject to prior authorization; the provider must demonstrate the member meets the policy’s initial or continuation criteria (diagnosis, qualifying EGFR mutation status, dosing limits, prior therapy when required).

Demonstrate diagnosis of NSCLC and qualifying EGFR mutation.
Confirm dosing does not exceed 80 mg/day (or 160 mg/day when co‑administered with a strong CYP3A4 inducer) and other criteria in the policy.

Prior Authorization

Health Plan clinical policy governs prior authorization

Coverage determinations for osimertinib are governed by the Health Plan’s clinical policy and administrative processes; prior authorization requirements apply per the Health Plan’s procedures.

The Health Plan may require administrative prior authorization consistent with this clinical policy.

Note

Alternatives (other EGFR TKIs) may require authorization

Therapeutic alternatives (other EGFR TKIs such as afatinib, gefitinib, erlotinib, dacomitinib) are listed in Appendix B and may require authorization per formulary status.

Appendix B lists alternatives (e.g., Gilotrif/afatinib, Iressa/gefitinib, Tarceva/erlotinib, Vizimpro/dacomitinib).
These alternatives may not be formulary agents for all lines of business and may require authorization.

Step Therapy

Step therapy governed by Health Plan policy

Step therapy specifics and any plan‑level requirements are governed by the Health Plan; the Health Plan may change, amend, or withdraw this clinical policy and adopt additional policies that affect step therapy pathways.

Plan‑level administrative policies determine step therapy requirements and any changes to coverage pathways.

Documentation Required

Submit clinical documentation with authorization requests

Providers must submit supporting clinical documentation (e.g., office chart notes, laboratory results, or other clinical information) demonstrating that the member meets all approval criteria when requesting authorization.

Include documentation of diagnosis, mutation testing, prior therapies, and response to therapy as applicable.

Documentation Required

Policy is guidance — providers must use clinical judgment and document care

This clinical policy is guidance; providers must exercise professional medical judgment and are responsible for the medical advice and treatment of members. The policy does not replace required documentation for coverage decisions.

Providers remain responsible for independent clinical judgment and documentation when treating members.

Denial Risk

Denial risk if member’s coverage terms/exclusions are not met

Coverage decisions are subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents (e.g., evidence of coverage, certificate of coverage, policy/contract). Failure to meet those contractual terms may result in denial of coverage.

Verify member’s benefit terms and exclusions; contractual limits can supersede policy coverage guidance.

Therapeutic alternative (Appendix B)	Typical dosing (listed indication)	Dose limit / maximum
Gilotrif (afatinib)	Metastatic NSCLC: 40 mg PO QD	40 mg/day (note: 50 mg/day when on chronic concomitant therapy with a P-gp inducer)
Iressa (gefitinib)	Metastatic NSCLC: 250 mg PO QD	250 mg/day (500 mg/day when used with a strong CYP3A4 inducer)
Tarceva (erlotinib)	Metastatic NSCLC: 150 mg PO QD	150 mg/day (450 mg/day with a strong CYP3A4 inducer or 300 mg/day with a moderate CYP1A2 inducer)
Vizimpro (dacomitinib)	Metastatic NSCLC: 45 mg PO QD	45 mg/day

Definitions and Abbreviations

Definition — EGFR

TermEGFR = epidermal growth factor receptor

ContextReceptor targeted by EGFR tyrosine kinase inhibitors used in NSCLC treatment

Source appendixDefined in Appendix A: Abbreviation/Acronym Key

Definition — NSCLC

TermNSCLC = non-small cell lung cancer

Typical dosing contextOsimertinib NSCLC dosing regimen: 80 mg PO QD

Indication examplesIncludes resected stage IB–IIIB EGFR mutation-positive disease and recurrent/advanced/metastatic disease with qualifying EGFR mutations

Definition — Health Plan

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 any of such health plan's affiliates

RoleHealth Plan-level administrative policies and procedures govern coverage determinations and prior authorization processes

Coverage limitation noteCoverage decisions are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents

OpenPayer

Osimertinib (Tagrisso)

Coverage Criteria for Osimertinib (Tagrisso)

Initial Authorization Criteria

Continuation / Reauthorization Criteria

Provider Responsibilities and Actions

Step Therapy and Therapeutic Alternatives

Quantity Limits and Dosing

Definitions and Abbreviations

Background on Osimertinib (Tagrisso)