CurrentCentenePolicy CP.PHAR.68

Gefitinib (Iressa) Coverage Policy

Defines medical necessity criteria, authorization requirements, dosing limits, and approval durations for gefitinib (Iressa) primarily for treatment of EGFR‑mutated metastatic non‑small cell lung cancer for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyGefitinib (Iressa) Coverage Policy

Policy CodePolicy CP.PHAR.68

Change TypeNo material change

Effective DateNov 16, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that the member meets all criteria (diagnosis, prescriber specialty, age, EGFR mutation status, dosing limits, and generic use when available).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

250 mg/dayStandard dose for NSCLC

500 mg/dayMax dose with CYP3A4 inducer

6 or 12 moApproval duration

≥18Minimum age

Coverage Criteria

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Initial NSCLC criteria: 1. Diagnosis of recurrent, advanced, or metastatic NSCLC; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Prescribed as a single agent; 5. 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); 6. Member must use generic gefitinib (Iressa), if available, unless contraindicated or clinically significant adverse effects are experienced; 7. Request meets one of the following: (a) dose does not exceed 250 mg (1 tablet) per day; (b) dose does not exceed 500 mg (2 tablets) per day if receiving a strong CYP3A4 inducer; (c) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-02: Continuation Therapy — Covered when ALL of the following are met for Continued Therapy (Non-Small Cell Lung Cancer).

Covered when ALL of the following are met for Continued Therapy (Non-Small Cell Lung Cancer):

Continued NSCLC criteria: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Iressa for NSCLC and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. Member must use generic gefitinib (Iressa), if available, 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 250 mg (1 tablet) per day; (b) new dose does not exceed 500 mg (2 tablets) per day if receiving a strong CYP3A4 inducer; (c) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN; continued therapy approvals per durations defined by line of business

Requests for use of gefitinib (Iressa) for non‑FDA approved indications that are not specifically addressed by this policy are excluded from coverage unless the provider submits sufficient documentation demonstrating efficacy and safety consistent with the applicable off‑label use policy. Supporting documentation should follow the referenced off‑label policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid).

Initial Therapy

inv-11: Initial Therapy — Initial approval criteria and durations for gefitinib.

Initial approval criteria and durations for gefitinib

Initial therapy nodes: See coverage.initial criteria: diagnosis of recurrent/advanced/metastatic NSCLC; prescribed by or in consultation with an oncologist; age ≥ 18 years; single-agent use; disease positive for a sensitizing EGFR mutation (examples: exon 19 deletion/insertion; exon 21 L858R, L861Q; exon 18 G719X; exon 20 S768I); member must use generic gefitinib if available unless contraindicated; dosing limits: standard dose ≤ 250 mg/day, or ≤ 500 mg/day if receiving a strong CYP3A4 inducer; off-label doses require supporting practice guideline or peer-reviewed literature.

Approval duration: Medicaid/HIM - 6 months; Commercial - 12 months or duration of request, whichever is less

Continuation Therapy

inv-12: Continuation Therapy — Criteria and approval durations for continuation therapy.

Criteria and approval durations for continuation therapy

Continued therapy nodes: See coverage.continuation criteria: currently receiving medication via Centene benefit or documentation of ≥30 days of therapy; member is responding positively to therapy; member must use generic gefitinib if available unless contraindicated; if dose increase requested, new dose must be ≤ 250 mg/day, or ≤ 500 mg/day if receiving a strong CYP3A4 inducer, or supported by practice guidelines/peer-reviewed literature (prescriber must submit evidence).

Approval duration: Medicaid/HIM - 12 months; Commercial - 12 months or duration of request, whichever is less

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization requires documentation that the member meets all criteria for initial or continued therapy per policy (diagnosis, prescriber specialty, age, mutation status, dosing limits, and regimen alignment with FDA or NCCN). Provider must submit supporting clinical records at the time of request (e.g., office chart notes, pathology or molecular testing results, lab reports, and prior treatment history).

Prior authorization required for Iressa (gefitinib) requests for NSCLC
Include molecular testing showing a sensitizing EGFR mutation (e.g., exon 19 deletion, exon 21 L858R, L861Q, exon 18 G719X, exon 20 S768I)
Prescriber documentation: oncologist or consult note confirming diagnosis and treatment plan

Documentation Required

Required Clinical Documentation

Provider must submit documentation (such as office chart notes, pathology/molecular testing results, lab reports, and other clinical information) that clearly supports the member has met all applicable approval criteria for initial or continued therapy. Lack of adequate documentation may result in denial or delay.

Examples: pathology report, EGFR mutation test result, treatment start date and response assessments, adverse event documentation if switching from branded product

Billing Rule

Generic Redirection (use generic gefitinib when available)

Policy requires use of generic gefitinib when available. Prescribers should document a clinical contraindication or prior clinically significant adverse effects to the generic formulation if requesting branded Iressa instead. Requests that do not justify branded product may be redirected to generic gefitinib.

If generic gefitinib is available, use is required unless contraindicated or not tolerated
If switching due to drug interaction (e.g., CYP3A4 inducers) or dosing concerns, include supporting documentation

Denial Risk

Non‑FDA Indications Risk

Requests for non‑FDA approved indications not addressed in this policy may be denied unless the provider supplies sufficient documentation per the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) demonstrating efficacy and safety. Prescriber must submit supporting peer‑reviewed literature or guideline recommendations for the specific off‑label use.

Off‑label requests must include rationale, literature or guideline support, and detailed clinical history
Non‑FDA indications not supported by documentation are not authorized

Step	Requirement	Applies to
1	Use of generic gefitinib is required if available unless contraindicated or clinically significant adverse effects occur.	Initial and continued therapy

Background

Gefitinib (Iressa) is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor indicated for the first‑line treatment of patients with metastatic non‑small cell lung cancer (NSCLC) whose tumors harbor sensitizing EGFR mutations. The standard dosing for NSCLC is 250 mg once daily; the policy recognizes a maximum of 500 mg/day when a patient is concurrently receiving a strong CYP3A4 inducer. Efficacy is established for tumors with EGFR exon 19 deletions or exon 21 (L858R) substitutions, with other qualifying EGFR point mutations noted in the policy as examples.