CurrentmhnPolicy CP.PHAR.74

Erlotinib (Tarceva) clinical coverage policy

Defines medical necessity, approval criteria, and authorization limits for erlotinib (Tarceva) for commercial, HIM, and Medicaid lines of business; applies to providers requesting coverage for members receiving erlotinib.

Policy Summary

Payermhn

PolicyErlotinib (Tarceva) clinical coverage policy

Policy CodePolicy CP.PHAR.74

Change TypeNo material change

Effective Date09.01.11

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria for the requested indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

150 mgstandard NSCLC daily dose

100 mgstandard pancreatic cancer daily dose

450 mg/daymaximum dose listed

25/100/150 mgproduct strengths

05.25references updated through

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Initial Therapy - NSCLC

Initial Approval Criteria for Non-Small Cell Lung Cancer (must meet all):

NSCLC initial: 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 (e.g., exon 19 deletion or insertion; exon 21 point mutation - L858R, L861Q; exon 18 point mutation - G719X; exon 20 point mutation - S768I). 5. Tarceva is prescribed in one of the following ways: a) as a single agent; b) in combination with Cyramza (ramucirumab); or c) in combination with bevacizumab for non-squamous histology. 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 (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy - Pancreatic Cancer

Initial Approval Criteria for Pancreatic Cancer (must meet all):

Pancreatic initial: 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 (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy - Bone Cancer (Chordoma)

Initial Approval Criteria for Recurrent Chordoma (off-label) (must meet all):

Chordoma initial: 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 (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy - Renal Cell Carcinoma

Initial Approval Criteria for Renal Cell Carcinoma (off-label) (must meet all):

RCC initial: 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 is prescribed in one of the following ways: a) as a single agent; or b) 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 (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Continuation Therapy

Continuation/Repeat Criteria (All Indications in Section I must meet all):

Continuation: 1. Member is currently receiving medication via the Centene benefit, or documentation supports that the member has received Tarceva for a covered indication 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, the new dose must either: a) not exceed both i) 450 mg per day and ii) 3 tablets per day; or b) be supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Requests for use of erlotinib (Tarceva) for non‑FDA approved indications that are not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or the member’s evidence of coverage documents.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage requirements that may supersede this policy.

Covered Regimens and Dosing

Regimen	Dose (standard)	Dose adjustments	Maximum
Erlotinib as a single agent (NSCLC)
150 mg PO once daily
Increase up to 300 mg/day with concurrent tobacco smoking; increase up to 450 mg/day if taken with a CYP3A4 inducer
450 mg/day (also limited to 3 tablets per day)

Regimen	Dose (standard)	Dose adjustments	Maximum
Erlotinib in combination with gemcitabine (Pancreatic cancer)
100 mg PO once daily
Increase up to 300 mg/day with concurrent tobacco smoking; increase up to 450 mg/day if taken with a CYP3A4 inducer
450 mg/day (also limited to 3 tablets per day)

Regimen / Indication	Allowed use	Supporting requirement	Coverage stance
Single-agent erlotinib for recurrent chordoma
Use as single agent per clinician judgment
Prescribed regimen must be FDA-approved or recommended by NCCN; dose must be within FDA maximum or supported by practice guidelines/peer-reviewed literature (prescriber must submit supporting evidence)
Covered when criteria met (off-label)

Regimen / Indication	Allowed use	Supporting requirement	Coverage stance
Erlotinib as single agent or in combination with bevacizumab for non-clear cell renal cell carcinoma
Single agent or combined with bevacizumab per NCCN Compendium guidance
Prescribed regimen must be FDA-approved or recommended by NCCN; dose must be within FDA maximum or supported by practice guidelines/peer-reviewed literature (prescriber must submit supporting evidence)
Covered when criteria met (off-label)

Indication	Standard dose	Smoking-related adjustment	CYP3A4 inducer adjustment / Maximum
NSCLC (sensitizing EGFR mutation)
150 mg PO once daily
May increase up to 300 mg/day with concurrent tobacco smoking
May increase up to 450 mg/day if taken with a CYP3A4 inducer; maximum 450 mg/day (also limited to 3 tablets/day)

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must demonstrate the member and the requested use meet the indication-specific criteria listed in the Policy/Criteria (Initial Approval and Continuation sections). Provider must submit documentation (e.g., office chart notes, diagnostic test results, pathology or molecular testing confirming EGFR mutation when required, treatment history, and lab results) supporting that the member has met all approval criteria.

PA required with indication-specific criteria: prior authorization will be approved only when the submitted information confirms all criteria for the specific indication in Section I (Initial Approval Criteria) or Section III (Continuation) are met.
Required documentation: include office chart notes, lab results, pathology/molecular testing reports, prior treatment history, and any literature supporting off‑label dosing if applicable.
Generic preferred: member must use generic erlotinib for Tarceva requests unless contraindicated or clinically significant adverse effects are documented.

Note

Prior Authorization Applicability

Prior authorization requirements in this policy apply to Tarceva and generic erlotinib as specified. This policy was updated to explicitly include erlotinib in the Policy/Criteria applicability; prior authorization applicability follows the clinical criteria and approval durations stated (Medicaid/HIM - 6 months; Commercial - 12 months or duration of request, whichever is less).

PA applicability: applies to all indications covered in Section I and to continuation requests meeting Section III criteria.
Approval durations: Medicaid/HIM = 6 months; Commercial = 12 months or duration of request, whichever is less.

Denial Risk

Non‑FDA/Off‑Label Indications — Risk of Denial

Requests for indications that are non‑FDA approved and not addressed in this policy may be denied unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (Commercial: CP.CPA.09; HIM: HIM.PA.154; Medicaid: CP.PMN.53) or evidence of coverage documents. Off‑label requests must include supporting peer‑reviewed literature or practice guideline recommendations.

Non‑covered indications risk: absence of adequate supporting evidence for non‑FDA approved uses may result in denial per off‑label policies.
When approving off‑label uses, prescriber must submit supporting evidence and the prescribed regimen should be FDA‑approved for another indication or recommended by NCCN.

Note

Coverage Decisions and Administration of Benefits

Coverage decisions and the administration of benefits are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable state and federal requirements. This clinical policy is a guide to medical necessity and does not guarantee payment; the Health Plan retains the right to change or withdraw the policy.

Coverage administration: decisions are subject to evidence of coverage, certificate of coverage, policy/contract, and Health Plan administrative rules.
Policy governance: the policy may be updated and the effective posting date may differ from the Health Plan's effective date; legal/regulatory requirements govern if discrepancies exist.

Documentation Required

Reference Guidance

Clinical references that support the criteria and prior authorization rationale include the Tarceva (erlotinib) Prescribing Information and the NCCN Drugs & Biologics Compendium. Providers may cite these sources when submitting requests, particularly for dose exceptions or off‑label uses.

Tarceva Prescribing Information (OSI Pharmaceuticals): prescribing, dosing limits, and safety information.
NCCN Drugs & Biologics Compendium: guideline recommendations for indicated and select off‑label uses.

Definitions

inv-19: epidermal growth factor receptor — define EGFR.

TermEGFR = epidermal growth factor receptor

RelevanceEGFR is the molecular target for erlotinib (Tarceva) and is referenced in FDA indications and policy criteria

AbbreviationUsed throughout the policy and appendices as EGFR

inv-20: sensitizing EGFR mutation — define sensitizing mutations including exon 19 deletions and specific point mutations.

DefinitionSensitizing EGFR mutation = EGFR alterations associated with clinical sensitivity to EGFR inhibitors (examples listed by policy)

Examples included in policyExon 19 deletions/insertions; Exon 21 point mutations L858R and L861Q; Exon 18 G719X; Exon 20 S768I

Clinical implicationRequired for NSCLC coverage determinations in this policy (must be documented)

inv-21: Maximum Dose — definition/label for maximum dose.

DefinitionMaximum Dose = the highest total daily amount of medication allowed by the policy (450 mg/day for erlotinib)

Policy usageDose increases above the maximum require supporting practice guidelines or peer‑reviewed literature and prescriber documentation

Applies toReferenced for initial and continuation requests across all indications in the policy

inv-22: Dosing Regimen — definition/label for dosing regimen.

DefinitionDosing Regimen = specified daily dose and schedule for an indication (e.g., NSCLC: 150 mg PO QD; Pancreatic: 100 mg PO QD)

Adjustment guidanceRegimen may be adjusted for concurrent tobacco smoking (up to 300 mg/day) or CYP3A4 inducers (up to 450 mg/day)

RequirementPrescribed regimen must be FDA‑approved or recommended by NCCN per policy

inv-25: EGFR mutation (sensitizing) repeated key_value for definition cross-reference.

Cross-reference definitionEGFR mutation (sensitizing) — refers to EGFR alterations that predict response to EGFR inhibitors; examples: exon 19 deletions/insertions; exon 21 L858R, L861Q; exon 18 G719X; exon 20 S768I

Use in policyPresence of a sensitizing EGFR mutation is a required biomarker for NSCLC coverage under this policy

Testing noteMutations should be identified by appropriate molecular testing consistent with FDA labeling and NCCN recommendations

OpenPayer

Erlotinib (Tarceva) clinical coverage policy

Coverage Criteria

Covered Regimens and Dosing

Coding and Dose Limits

Provider Actions and Prior Authorization

Line of Therapy

Biomarker and Testing Requirements

Definitions

Quick Provider Summary

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