CurrentCignaPolicy N/A

POLICY: Oncology (Oral - Epidermal Growth Factor Receptor Inhibitor) - Erlotinib Prior Authorization Policy

Policy Summary

PayerCigna

PolicyPOLICY: Oncology (Oral - Epidermal Growth Factor Receptor Inhibitor) - Erlotinib Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria and administrative revisions

Effective Date

Next Review DateApr 21, 2025

Key ActionObtain prior authorization and document that approvals meet the specific indication-based criteria; for NSCLC document EGFR mutation-positive status and for pancreatic or HLRCC-associated RCC document required combination therapy.

SourceLink

POLICY UPDATE CHANGES

Deleted the word 'sensitizing' while referring to EGFR mutations in NSCLC criteria and note.

Renal cell carcinoma criteria changed: disease qualifier changed from 'recurrent or advanced' to 'Stage IV or relapsed'; monotherapy for non-clear cell histology removed and requirement changed to combination with bevacizumab for HLRCC-associated disease.

Policy name changed to 'Oncology (Oral - Epidermal Growth Factor Receptor Inhibitor) - Erlotinib PA Policy'.

For NSCLC, removed requirement that the EGFR mutation was detected by an approved test.

Several previously listed 'Conditions Not Covered' (Breast Cancer, Advanced Colon Cancer, Glioblastoma Multiforme, Head and Neck Cancer, Advanced Hepatocellular Carcinoma) were deleted from the policy.

2FDA-approved indications covered

Coverage Summary & Indications

Defines prior authorization criteria for coverage of oral erlotinib (Tarceva) for FDA-approved indications and other uses with supportive evidence across Cigna health benefit plans; covered with criteria. FDA‑approved uses include EGFR mutation‑positive non‑small cell lung cancer (NSCLC) and combination therapy with gemcitabine for pancreatic cancer. Other supported indications with evidence and guideline support (see policy) include chordoma, select non‑clear cell renal cell carcinoma subtypes including HLRCC‑associated disease (when given with bevacizumab), and vulvar cancer. All approvals are provided for a duration of 1 year.

Approval Duration

ALL of the following

All approvals are provided for a duration of 1 year

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of erlotinib. Approvals are provided for a duration of 1 year and are contingent on meeting the specific indication-based criteria listed in the policy.

Approval duration: 1 year

Documentation Required

Document EGFR mutation status for NSCLC

For approvals in non‑small cell lung cancer (NSCLC), document that the patient has EGFR mutation‑positive disease. Examples of EGFR mutations listed in the policy include exon 19 deletions, exon 21 (L858R) substitution mutations, L861Q, G719X, and S768I.

Exon 19 deletions
Exon 21 (L858R) substitution mutations
L861Q
G719X
S768I

Documentation Required

Document combination therapy where required

When required by the indication, document the concomitant use of erlotinib with the specified partner agent: for pancreatic cancer, document use in combination with gemcitabine; for HLRCC‑associated (advanced papillary) renal cell carcinoma, document use in combination with bevacizumab.

Pancreatic cancer: combination with gemcitabine
HLRCC-associated renal cell carcinoma: combination with bevacizumab

Applicable Codes

Drug (NDC) / productNDC

No codes listed

Evidence & Guidelines Referenced

NCCN guidance is referenced across multiple guideline versions supporting indications and recommendations for erlotinib, including NSCLC, pancreatic cancer, bone (chordoma), kidney (non‑clear cell RCC including HLRCC‑associated disease), and vulvar cancer. The policy cites specific NCCN guideline versions and categories that support these uses.

Background & Definitions

Erlotinib is a tyrosine kinase inhibitor indicated for NSCLC in patients whose tumors have certain EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) and for pancreatic cancer in combination with gemcitabine. NCCN guidelines provide additional recommendations for other tumor types such as chordoma, select non‑clear cell renal cell carcinoma subtypes including HLRCC‑associated disease (in combination with bevacizumab), and vulvar cancer. This policy defines prior authorization criteria for these FDA‑approved and other supported uses across Cigna plans.

EGFR mutation‑positive: examples include exon 19 deletions, exon 21 (L858R) substitution mutations, L861Q, G719X, and S768I. The policy notes removal of the word 'sensitizing' when referring to EGFR mutations. HLRCC: defined as hereditary leiomyomatosis and renal cell carcinoma‑associated renal cell carcinoma.

Not-Covered Conditions & Exclusions

Several previously listed 'Conditions Not Covered' were deleted during annual revisions: Breast Cancer, Advanced Colon Cancer, Glioblastoma Multiforme, Head and Neck Cancer, and Advanced Hepatocellular Carcinoma. The policy's Conditions Not Covered section now retains only items explicitly listed (for example, advanced clear‑cell renal cell carcinoma is noted as not covered); the removed conditions listed above were deleted.

Policy Revision History

2024-02-07material_change

Deleted the word 'sensitizing' while referring to EGFR mutations in NSCLC criteria and note. (Summary of changes from Annual Revision.)

2024-02-07material_change

Renal cell carcinoma criteria changed: disease qualifier changed from 'recurrent or advanced' to 'Stage IV or relapsed'; the logical operator linking the Stage IV/relapsed description and HLRCC criterion was changed from OR to AND; added 'advanced papillary disease including HLRCC-associated renal cell carcinoma'; and erlotinib monotherapy for non-clear cell histology was removed in favor of combination with bevacizumab for HLRCC-associated disease. (Summary of changes from Annual Revision.)

2025-04-21administrative_update