Medical Policy

Effective Date:08/04/2010 Title:Tarceva (Erlotinib)
Revision Date:06/01/2014 Document:BI279:00
CPT Code(s):None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1.    Tarceva (Erlotinib) requires pre-authorization

2.    Tarceva (Erlotinib) is an oral medication used to treat different forms of cancer.

3.    Tarceva is considered a specialty drug and must be obtained through the contracted specialty pharmacy.

Medical Statement

1.    Tarceva (Erlotinib) is considered medically necessary in the treatment of advanced non small cell cancer of the lung without EGFR mutation that:

    1. Is locally advanced or metastatic and
    2. There has been failure of at least one other chemotherapy regimen.

2.    Tarceva (Erlotinib) is approved for first-line therapy of advanced non-small cell lung cancer with EGFR mutation.

3.    Tarceva (Erlotinib) is considered medically necessary in the treatment of pancreatic cancer in combination with gemcitabine that is:

    1. Locally advanced or metastatic and:
    2. Is unresectable.

4.  Tarceva (Erlotinib) is considered medically necessary as single-agent therapy for the treatment of recurrent bone cancer – Chordoma. 

5.  Tarceva (Erlotinib) is considered medically necessary as palliative therapy for patients with Esophageal and Esophagogastric Junction Cancers with:

            a. Karnofsky performance score >60% AND

b. ECOG performance score <2

6.  Tarceva (Erlotinib) is considered medically necessary as first-line therapy as a single-agent for patients with kidney cancer that is:

            a. relapsed or medically unresectable AND

            b. Stage IV disease with non-clear cell histology


As a specialty drug, Tarceva is limited to a maximum 30 day supply per fill.


1.    Tarceva Product Information.  Genentech/Astellas.  June 2011.

2.    Tarceva (Erlotinib). Clinical Pharmacology.  Accessed online April 2012.

3.    National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2012 Non-Small Cell Lung Cancer.  Accessed April 2012.

4.    NCCN Drugs & Biologic Compendium.  Accessed online May 2014.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.