CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Gilotrif (afatinib) coverage policy

Defines accepted indications, continuation rules, exclusions, and coding for Gilotrif (afatinib) for Evolent-managed medication requests across applicable lines of business (Commercial, Exchange/Marketplace, Medicaid). Includes FDA-approved and selected off-label uses supported by recognized compendia or peer-reviewed literature.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGilotrif (afatinib) coverage policy

Policy CodePolicy N/A

Change TypeTemplate conversionadministrative wording update

Effective Date

Next Review Date

Key ActionRequests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature meeting CMS manual standards.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1258 Gilotrif (afatinib)

Updated NCH verbiage to Evolent

1Covered primary indication (NSCLC)

1Excluded indication (Head & Neck single agent)

3Lines of Business applicable

Coverage Summary

Scope: This guideline defines accepted indications, continuation rules, exclusions, coding, and dose/quantity limits for Gilotrif (afatinib) for Evolent-managed medication requests across applicable lines of business: Commercial, Exchange/Marketplace, and Medicaid.

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Coverage stance: The policy takes a mixed coverage stance — afatinib is accepted for specified uses in advanced/recurrent/metastatic NSCLC (including selected first-line EGFR-mutant and second-line/post-platinum settings) and continuation under specified conditions, but it is excluded for certain situations (e.g., disease progression on afatinib, T790M or Exon 20 insertion positive NSCLC, concurrent anti-cancer therapy, exceeding dose or monthly tablet limits, and investigational/off-label uses lacking sufficient evidence).

Covered indication - Non-Small Cell Lung Cancer (NSCLC)

Gilotrif (afatinib) may be used as monotherapy in members with advanced/recurrent/metastatic (stage IIIb or IV) NSCLC when ANY of the following are met:

ANY of the following

As first line therapy in members with EGFR positive mutation (e.g., exon 19 deletions, exon 21 L858R, S768I, L861Q, G719X) that is negative for T790M mutation or Exon 20 insertion mutation
As second line/subsequent therapy following first line treatment with platinum containing chemotherapy, regardless of EGFR mutation status

Continuation Therapy Criteria

Continuation criteria

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
Additional medication(s) are not being added to the continuation request

Not Supported / Exclusion Criteria

Not supported / Exclusion criteria

Use of Gilotrif (afatinib) is excluded when ANY of the following apply:

ANY of the following

Disease progression while taking Gilotrif (afatinib)
Use in a member with advanced/metastatic NSCLC that is positive for the T790M mutation or EGFR Exon 20 insertion mutation
Concurrent use with other anti-cancer therapies
Dosing exceeds single dose limit of Gilotrif (afatinib) 40 mg40 mg
Treatment exceeds the maximum limit of 30 (20 mg), 30 (30 mg), or 30 (40 mg) tablets per month30 (20 mg), 30 (30 mg), 30 (40 mg)
Investigational use - insufficient evidence
- Whether the clinical characteristics of the patient and the cancer are adequately represented in the published evidence
- Whether the administered chemotherapy/biologic therapy/immune therapy/targeted therapy/other oncologic therapy regimen is adequately represented in the published evidence
- Whether the reported study outcomes represent clinically meaningful outcomes experienced by patients (e.g., ASCO definitions: Hazard Ratio < 0.80 or recommended survival benefit for OS and PFS of at least 3 months)HR < 0.80; survival benefit >= 3 months
- Whether the experimental design is appropriate to address the investigative question
  Examples: randomization, blinding, controls as appropriate
- That case reports and meeting abstracts without full peer-reviewed articles are insufficient as sole evidence

Head and Neck Cancers

Policy position:

Single agent Gilotrif (afatinib) is not supported by Evolent Policy for the treatment of advanced head and neck cancers due to lack of Level 1 evidence

Provider Actions & Billing Rules

Prior Authorization

Evolent authorization required

Evolent processes all medication requests for Gilotrif (afatinib). Authorization from Evolent is required; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Documentation Required

Support medication request with accepted evidence

Requests must be supported by one of the following evidence sources: FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Denial Risk

Exclusions that will lead to non-coverage

Claims may be denied when any of the following exclusion conditions apply: disease progression while taking Gilotrif; NSCLC positive for T790M mutation or EGFR Exon 20 insertion mutation; concurrent use with other anti-cancer therapies; dosing that exceeds the single dose limit of 40 mg; monthly tablet limits exceeded; or investigational/off‑label use lacking sufficient supporting evidence per policy criteria.

Disease progression while taking Gilotrif (afatinib)
NSCLC positive for T790M mutation or EGFR Exon 20 insertion mutation
Concurrent use with other anti-cancer therapies
Single dose exceeds 40 mg
Monthly tablet limits exceeded (see policy for strength-specific limits)
Investigational/off-label use without sufficient evidence (per CMS compendia or peer-reviewed standards)

Billing Rule

Dose and quantity limits

Do not exceed a single dose of 40 mg of Gilotrif (afatinib). Monthly tablet limits are 30 tablets per month for each available strength (20 mg, 30 mg, or 40 mg). Use HCPCS code J8999 for afatinib where applicable.

Maximum single dose: 40 mg
Maximum tablets per month: 30 (20 mg), 30 (30 mg), or 30 (40 mg)
Coding: J8999 - afatinib

Clinical Evidence

Key evidence cited: randomized trials from the LUX program (including LUX-Lung and LUX-Head & Neck trials published in Lancet Oncology 2012–2015) and the Gilotrif prescribing information are listed as primary supporting evidence.

Evidence standards: The policy references ASCO definitions for clinically meaningful outcomes (e.g., hazard ratio < 0.80 and recommended survival benefit for OS and PFS of at least 3 months) and requires supporting evidence from FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS manual standards.

Dose, quantity limits and ASCO clinically meaningful outcome definition

Maximum single dose40 mg

Maximum tablets per month30 (20 mg), 30 (30 mg), or 30 (40 mg)

Clinically meaningful outcomes (ASCO) definitionExamples include hazard ratio < 0.80 and recommended survival benefit for OS and PFS of at least 3 months