CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Erlotinib (Tarceva) — Coverage Criteria

Defines coverage, prior authorization, and renewal criteria for erlotinib (Tarceva) for FDA-approved and compendial oncology indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyErlotinib (Tarceva) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit EGFR mutation testing results when applicable to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

EGFR exon19/21required tumor mutations

with gemcitabinepancreatic cancer

listedcompendial uses

Coverage Criteria for Erlotinib (Tarceva)

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NSCLC (FDA) initial therapy: Patient has metastatic non-small cell lung cancer (NSCLC) whose tumor harbors an EGFR exon 19 deletion OR exon 21 (L858R) substitution mutation detected by an FDA-approved test;

From FDA-approved indications (first-line, maintenance, or second-or-greater line).

NSCLC (FDA) line of therapy: Erlotinib will be used as first-line, maintenance, or second-or-greater line treatment after progression following at least one prior chemotherapy regimen as applicable to the patient’s clinical status.

Per FDA indication for EGFR exon 19 or exon 21 (L858R) mutation-positive metastatic NSCLC.

Combination restriction: Erlotinib is not used in combination with platinum-based chemotherapy (combination with platinum-based chemotherapy is not recommended).

Limitation of use per product labeling.

Pancreatic cancer (with gemcitabine)

Covered when ALL of the following are met for pancreatic cancer

Pancreatic cancer initial therapy: Patient has locally advanced, unresectable, or metastatic pancreatic cancer; AND erlotinib is prescribed in combination with gemcitabine.

Authorization of up to 12 months may be granted when criteria are met.

Compendial indications

Covered compendial uses when ALL criteria are met

Compendial oncology uses: Erlotinib use for listed compendial oncology indications including: recurrent/advanced/metastatic EGFR sensitizing mutation-positive NSCLC; recurrent chordoma; relapsed or stage IV non-clear cell renal cell carcinoma (single agent or with bevacizumab); brain metastases from EGFR sensitizing mutation-positive NSCLC; and recurrent pancreatic cancer.

Authorization of up to 12 months may be granted for the listed compendial uses.

Reauthorization / Continued therapy

Reauthorization criteria

NSCLC reauthorization: Continued treatment for EGFR-positive NSCLC may be authorized for 12 months when EITHER: 1) there is no evidence of unacceptable toxicity or disease progression while on the current regimen; OR 2) disease is EGFR T790M negative and there is no evidence of unacceptable toxicity.

Specific mention that T790M negative status supports continued authorization.

Other indications reauthorization: Continued treatment for other listed indications may be authorized for 12 months when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Per reauthorization provisions for all other indications listed in Section III.

Indication	Authorized Regimen	Coverage Status
Non‑Small Cell Lung Cancer (sensitizing EGFR mutation‑positive, including brain metastases)
Single‑agent erlotinib; erlotinib in combination with ramucirumab or bevacizumab
Pancreatic cancer (locally advanced, unresectable, recurrent or metastatic)
Erlotinib in combination with gemcitabine
Renal cell carcinoma (relapsed or stage IV, non‑clear cell histology)
Single‑agent erlotinib or erlotinib in combination with bevacizumab
Chordoma (recurrent)
Single‑agent erlotinib

Combination	Policy Statement	Coverage Status
Platinum‑based chemotherapy combined with erlotinib
Tarceva is not recommended for use in combination with platinum‑based chemotherapy (limitation of use).

The safety and efficacy of Tarceva have not been established for patients with NSCLC whose tumors harbor EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitutions. Use in those non‑exon 19/21 EGFR mutation settings is therefore not established and is not covered under the FDA‑approved indication criteria.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial and reauthorization approvals may be granted for up to 12 months when the applicable clinical criteria are met.

Authorization up to 12 months for NSCLC with sensitizing EGFR mutation-positive disease (single agent or with ramucirumab/bevacizumab)
Authorization up to 12 months for pancreatic cancer when used with gemcitabine
Authorization up to 12 months for relapsed or stage IV renal cell carcinoma with non-clear cell histology (single agent or with bevacizumab)
Authorization up to 12 months for recurrent chordoma (single agent)
Reauthorization for EGFR-positive NSCLC: no unacceptable toxicity or disease progression OR T790M negative with no unacceptable toxicity
Reauthorization for other listed indications: no unacceptable toxicity or disease progression

Prior Authorization

Indication-based Prior Authorization

Coverage is limited to FDA-approved indications and specified compendial uses. Tarceva is indicated for metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test, and for use in combination with gemcitabine for first-line treatment of locally advanced, unresectable or metastatic pancreatic cancer. Compendial uses include EGFR-sensitizing mutation–positive NSCLC (recurrent/advanced/metastatic), recurrent chordoma, relapsed or stage IV non-clear cell RCC, brain metastases from EGFR-sensitizing NSCLC, and recurrent pancreatic cancer. All other indications are considered experimental/investigational and not medically necessary.

Covered when FDA-approved or listed compendial uses are met
Not covered when indication is experimental/investigational

Denial Risk

Combination Restriction

Tarceva is not recommended for use in combination with platinum-based chemotherapy; safety and efficacy have not been established for NSCLC tumors with other EGFR mutations.

Do not combine with platinum-based chemotherapy for NSCLC
Safety/efficacy not established for non-sensitizing EGFR mutations

Documentation Required

Required Documentation

Submit EGFR mutation testing results when applicable to initiate prior authorization review. Lack of required documentation will prevent initiation of the prior authorization review and may result in denial.

EGFR mutation testing results required where applicable
Missing documentation will halt PA review and may trigger denial

Authorized Regimens and Combinations

Indication	Regimen Details	Coverage Status
NSCLC with sensitizing EGFR mutations (exon 19 deletion or exon 21 L858R)
Single‑agent erlotinib; may be authorized as single agent or in combination with ramucirumab or bevacizumab (including for brain metastases).
Pancreatic cancer (locally advanced, unresectable, recurrent or metastatic)
Erlotinib used in combination with gemcitabine.
Renal cell carcinoma (relapsed or stage IV, non‑clear cell histology)
Erlotinib as single agent or in combination with bevacizumab.

Regimen Combination	Recommendation	Coverage Status
Erlotinib plus platinum‑based chemotherapy
Tarceva is not recommended for use in combination with platinum‑based chemotherapy.

Biomarker and Testing Requirements

EGFR (exon 19 deletion or exon 21 L858R) — detected by an FDA-approved test

BiomarkerEGFR exon 19 deletion OR exon 21 (L858R) substitution

Detection methodDetected by an FDA-approved test

Indication relevanceRequired for FDA‑approved metastatic NSCLC indication (first‑line, maintenance, or second+ line)

EGFR T790M — T790M negative status cited for reauthorization

Reauthorization conditionDisease is T790M negative and there is no evidence of unacceptable toxicity — cited as a condition for continued NSCLC treatment

Alternate reauthorization conditionNo evidence of unacceptable toxicity or disease progression while on the current regimen

ContextApplies to members requesting reauthorization for EGFR‑positive NSCLC

Sensitizing EGFR mutations — exon 19 deletions or exon 21 (L858R)

DefinitionSensitizing EGFR mutations = EGFR exon 19 deletions OR exon 21 (L858R) substitution mutations

Clinical implicationSpecifies tumor mutation requirement for FDA‑approved metastatic NSCLC indication

Use casesDetermines eligibility for first‑line, maintenance, or second+ line erlotinib therapy in NSCLC

Line of Therapy Placement

first-line | second-line | maintenance

NSCLC lines: Erlotinib may be used as first-line therapy, as maintenance therapy, or as second-or-greater line therapy after progression following at least one prior chemotherapy regimen for patients with metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitutions.

Reflects FDA-approved line-of-therapy placement for sensitizing EGFR mutation-positive NSCLC.

Background and Indication Notes

Erlotinib (Tarceva) is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. It is indicated as monotherapy for patients with metastatic non‑small cell lung cancer (NSCLC) whose tumors have sensitizing EGFR mutations (exon 19 deletions or exon 21 L858R), and in combination with gemcitabine for the first‑line treatment of locally advanced, unresectable, or metastatic pancreatic cancer. The policy also recognizes several compendial oncology uses (for example, recurrent/advanced or metastatic sensitizing EGFR mutation‑positive NSCLC, recurrent chordoma, and relapsed or stage IV non‑clear cell renal cell carcinoma) when the specific criteria in this policy are met.

Definitions