Centene Tarceva (erlotinib) Coverage Update | OpenPayer

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Centene Tarceva (erlotinib) Coverage Update | OpenPayer

Coverage Criteria

Initial Therapy - Non-Small Cell Lung Cancer

Covered when ALL of the following are met:

NSCLC initial therapy criteria: 1. Diagnosis of recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC).; 2. Prescribed by or in consultation with an oncologist.; 3. Age ≥ 18 years.; 4. Disease is positive for a sensitizing EGFR mutation (examples: exon 19 deletion or insertion; exon 21 point mutations L858R, L861Q; exon 18 G719X; exon 20 S768I).; 5. Tarceva (erlotinib) is prescribed as one of the following: a) single agent; b) in combination with ramucirumab (Cyramza); or c) in combination with bevacizumab when histology is non-squamous NSCLC.; 6. Member must use generic erlotinib unless contraindicated or clinically significant adverse effects are experienced.; 7. Request meets one of the following: a) Dose does not exceed both i) 450 mg per day and ii) 3 tablets per day; or b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).age >= 18; dose <= 450 mg/day; tablets <= 3/day

Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy - Pancreatic Cancer (with gemcitabine)

Covered when ALL of the following are met:

Pancreatic cancer initial therapy criteria: 1. Diagnosis of locally advanced, unresectable, or metastatic pancreatic cancer.; 2. Prescribed by or in consultation with an oncologist.; 3. Age ≥ 18 years.; 4. Prescribed in combination with gemcitabine.; 5. Member must use generic erlotinib unless contraindicated or clinically significant adverse effects are experienced.; 6. Request meets one of the following: a) Dose does not exceed both i) 450 mg per day and ii) 3 tablets per day; or b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).age >= 18; dose <= 450 mg/day; tablets <= 3/day

Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy - Bone Cancer (Chordoma, off-label)

Covered when ALL of the following are met:

Chordoma initial therapy criteria: 1. Diagnosis of recurrent chordoma.; 2. Prescribed by or in consultation with an oncologist.; 3. Age ≥ 18 years.; 4. Prescribed as a single agent.; 5. Member must use generic erlotinib unless contraindicated or clinically significant adverse effects are experienced.; 6. Dose is within the FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).age >= 18; dose <= 450 mg/day unless guideline-supported

Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy - Renal Cell Carcinoma (off-label)

Covered when ALL of the following are met:

Renal cell carcinoma initial therapy criteria: 1. Diagnosis of relapsed or stage IV (unresectable or metastatic) renal cell carcinoma.; 2. Prescribed by or in consultation with an oncologist.; 3. Age ≥ 18 years.; 4. Histology is non-clear cell.; 5. Tarceva (erlotinib) is prescribed in combination with bevacizumab.; 6. Member must use generic erlotinib unless contraindicated or clinically significant adverse effects are experienced.; 7. Dose is within the FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).age >= 18; histology non-clear cell; dose <= 450 mg/day unless guideline-supported

Prescribed regimen must be FDA-approved or recommended by NCCN.

Continuation Therapy

Covered when ALL of the following are met:

Continuation criteria for all indications: 1. Member is currently receiving medication via the Centene benefit, or documentation supports that the member has been receiving Tarceva for at least 30 days.; 2. Member is responding positively to therapy.; 3. Member must use generic erlotinib unless contraindicated or clinically significant adverse effects are experienced.; 4. If request is for a dose increase, request meets one of the following: a) New dose does not exceed both i) 450 mg per day and ii) 3 tablets per day; or b) New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).>= 30 days prior therapy; response positive; dose <= 450 mg/day

Prescribed regimen must be FDA-approved or recommended by NCCN.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety. Supporting evidence should follow the applicable off‑label use policies (Commercial: CP.CPA.09; HIM/ICHRA: HIM.PA.154; Medicaid: CP.PMN.53) or other plan evidence of coverage.

Per the 2Q 2026 annual review, the single‑agent therapy option for kidney cancer was removed in accordance with NCCN recommendations. Requests for erlotinib in kidney cancer should follow the updated regimen options reflected in the policy and must meet any remaining coverage criteria and documentation requirements.

Use of Tarceva (erlotinib) for NSCLC tumors harboring non‑sensitizing or other EGFR mutations is not supported by established safety and efficacy data and therefore is not authorized. Similarly, requests for other non‑FDA approved indications without sufficient off‑label evidence will be denied unless the prescriber provides adequate documentation per the plan’s off‑label use policies.

Covered Regimens and Dosing

Regimen	Indication / Notes	Coverage Status
Erlotinib as a single agent
Indication: Recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC). Policy requires tumor positive for a sensitizing EGFR mutation and prescriber is or consulted with an oncologist. Single-agent use is permitted per NSCLC initial approval criteria.
Covered when criteria met (see NSCLC initial therapy criteria)

Dose	Indication / Adjustment	Maximum / Notes
150 mg PO once daily
Indication: NSCLC (recurrent, advanced, or metastatic). Dose adjustments: up to 300 mg/day with concurrent tobacco smoking; up to 450 mg/day if taken with a CYP3A4 inducer.
Maximum documented dose 450 mg/day (also limited to 3 tablets/day unless guideline-supported higher dosing).

Line of Therapy

first-line | second-line

NSCLC lines

approved lines: First-line, maintenance, or second or greater line after progression following at least one prior chemotherapy regimen for patients with EGFR exon 19 deletions or exon 21 L858R substitutions per FDA label (FDA-approved test required).

Pancreatic line

first-line: First-line in combination with gemcitabine for locally advanced, unresectable, or metastatic pancreatic cancer.

Biomarker Requirements

inv-25: EGFR mutation (sensitizing)

DefinitionSensitizing EGFR mutation refers to EGFR alterations associated with response to erlotinib; examples include exon 19 deletions and exon 21 (L858R) substitutions.

Additional qualifying point mutationsOther point mutations listed as qualifying include L861Q, G719X (exon 18), and S768I (exon 20).

Clinical relevancePresence of a sensitizing EGFR mutation is required for NSCLC coverage under this policy (FDA‑approved test required).

Coding and Dose Information

Policy Identifiermixed

CP.PHAR.74

Policy reference number for Erlotinib (Tarceva)

inv-10: Maximum daily dose

Maximum daily dose (policy)450 mg per day.

Tablet limit3 tablets per day (policy documents dose limits as both mg/day and tablet count).

Dose adjustments notedHigher daily totals (up to 300 mg/day or 450 mg/day) may be used in the context of tobacco smoking or concurrent CYP3A4 inducers per dosing guidance; prescriber must submit supporting evidence if exceeding standard dosing limits.

Provider Actions and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation demonstrating the member meets all applicable approval criteria for the requested indication.

Prior authorization required for Tarceva/erlotinib per policy criteria
Prescriber must be an oncologist or in consultation with an oncologist for oncology indications

Documentation Required

Required Documentation

Provider must submit supporting documentation (e.g., office chart notes, lab results, pathology or molecular testing reports) that member has met all approval criteria. Incomplete requests or those lacking required documentation may be denied.

Include EGFR mutation test report for NSCLC requests showing sensitizing mutation when applicable
Include evidence of current therapy and response for continuation requests (≥30 days of prior therapy and documentation of clinical benefit)

Background

Erlotinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. It is indicated for the treatment of patients with EGFR‑mutant metastatic non‑small cell lung cancer (NSCLC), where efficacy is established for tumors with sensitizing EGFR mutations, and it is indicated in combination with gemcitabine for the treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Definitions

inv-20: Sensitizing EGFR mutation

Core examplesExon 19 deletions and exon 21 (L858R) substitutions are primary examples of sensitizing EGFR mutations.

Other qualifying point mutationsPolicy also lists L861Q, G719X (exon 18), and S768I (exon 20) as qualifying sensitizing mutations.

Coverage requirementA documented sensitizing EGFR mutation (detected by an FDA‑approved test) is required for NSCLC coverage under this policy.

inv-21: Maximum Dose

Documented maximum doseMaximum documented dose is 450 mg/day as stated in the dosage table and approval criteria.

Tablet correspondencePolicy ties the 450 mg/day maximum to a limit of 3 tablets per day in the criteria and dosing table.

Overview and Revision History

Note

References and policy history (overview)

Policy references and history are recorded in the references section and annual review notes; see Tarceva PI, NCCN Drugs & Biologics Compendium, NCCN guidelines, and recorded P&T annual-review summaries.

Policy history entries include 2Q 2022, 2Q 2023, 2Q 2024, 2Q 2025, and 2Q 2026 reviews.