CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Iressa (gefitinib) — Coverage Criteria for NSCLC

Defines accepted indications, coverage criteria, and administrative requirements for gefitinib (Iressa) treatment requests for network members; applies to medications processed by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIressa (gefitinib) — Coverage Criteria for NSCLC

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent for gefitinib (J8565) and include supporting evidence such as FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

EGFR exon19/21primary covered biomarker for NSCLC

J8565HCPCS code for gefitinib

250 mgsingle dose limit

30/momaximum monthly limit

Coverage Criteria for Gefitinib (Iressa)

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Initial Therapy

Covered when ALL of the following are met

NSCLC initial therapy with EGFR sensitizing mutation: Member has advanced or metastatic non-small cell lung cancer AND tumor harbors a known EGFR exon 19 deletion OR exon 21 (L858R) sensitizing mutation AND gefitinib is requested as single-agent initial therapy

References include prescribing information and pivotal clinical trials (see References).

Iressa (gefitinib) is excluded from coverage when used in members with advanced or metastatic non-small cell lung cancer that is positive for the T790M mutation or an EGFR exon 20 insertion mutation. Coverage is also excluded for concurrent use with other anti-cancer therapies, use after documented disease progression on the same gefitinib regimen, dosing that exceeds the single-dose limit of 250 mg, or treatment that exceeds the maximum of 30 (250 mg) tablets per month.

Investigational or off-label use of Iressa (gefitinib) that lacks sufficient supporting evidence or is not generally accepted by the medical community is considered not medically necessary. The policy defines sufficient evidence as support from CMS‑recognized compendia, acceptable peer‑reviewed literature, or studies whose patient and regimen characteristics and outcomes are clinically meaningful. Case reports, meeting abstracts without full peer‑reviewed publication, and other uncontrolled anecdotal reports are not adequate to establish accepted use.

Billing and Coding

Drug HCPCS CodeHCPCSCovered

J8565

gefitinib

Single dose limit — 250 mg

Single dose limit250 mg

Applies to dosing requestsRequests where dosing exceeds 250 mg may be denied

Related exclusionDosing above this limit is listed under Exclusion Criteria

Maximum monthly supply — 30 (250 mg) tablets per month

Maximum monthly supply30 (250 mg) tablets per month

Denial triggerTreatment exceeding 30 (250 mg) tablets/month may be denied

Coding implicationMonthly quantity limits apply to dispensed tablets

Provider Requirements and Authorization

Prior Authorization

Prior authorization required for gefitinib (J8565)

Prior authorization/medication request processing is required by Evolent for gefitinib (HCPCS J8565). Continuation requests may be allowed without re-review when specified continuity conditions (see continuation exemption) are met; providers must submit a prior authorization request to Evolent for initial therapy or changes in therapy.

Drug HCPCS code: J8565

Step Therapy

Continuation exemption conditions for non‑approvable medications

Continuation requests for a medication that would otherwise be non‑approvable are exempt from re-review only if all of the following are met: no disease progression on the requested medication, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the continuation request.

Documentation Required

Acceptable supporting evidence for gefitinib requests

Support for use must be provided by one of the following: FDA‑approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the standards in the CMS Medicare Benefit Policy Manual Chapter 15; references cited in those guidelines may be used as supporting documentation.

Denial Risk

Denial triggers and non‑covered scenarios

Requests may be denied for any of the following: dosing that exceeds the single‑dose limit of 250 mg; treatment that exceeds 30 (250 mg) tablets per month; concurrent use with other anti‑cancer therapies; use after disease progression on the same regimen; use in members with EGFR T790M or exon 20 insertion mutations; or investigational/off‑label indications without sufficient supporting evidence.

Regimens — Included and Excluded Uses

Regimen	Indication	Coverage
Gefitinib 250 mg orally daily (single agent)	Initial (first-line) therapy for advanced or metastatic non-small cell lung cancer when tumor harbors a known EGFR exon 19 deletion or exon 21 (L858R) sensitizing mutation	Covered with criteria

Context / Use	Reason for Exclusion	Coverage
Use in members with EGFR T790M mutation	Policy excludes use for members positive for the T790M mutation	Not covered
Use in members with EGFR exon 20 insertion mutation	Policy excludes use for members positive for EGFR exon 20 insertion mutations	Not covered
Concurrent use with other anti-cancer therapies	Policy excludes concurrent use with other anti-cancer therapies	Not covered

Background

Gefitinib (Iressa) is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor indicated for use in non‑small cell lung cancer with EGFR sensitizing mutations. The policy references pivotal clinical literature and standard drug references to support approved and accepted uses, and explicitly excludes uses lacking adequate evidence or for mutation contexts (T790M, exon 20 insertion) where gefitinib is not considered appropriate.