CurrentCentenePolicy CP PHAR.298

Afatinib (Gilotrif) clinical coverage

Defines medical necessity and prior authorization criteria for afatinib (Gilotrif) for treatment of non-small cell lung cancer across Centene lines of business (Commercial, HIM, Medicaid). Applies to providers submitting authorization requests for this drug.

Policy Summary

PayerCentene

PolicyAfatinib (Gilotrif) clinical coverage

Policy CodePolicy CP PHAR.298

Change TypeNo material change

Effective DateJan 1, 2017

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria and request prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Adults onlyAge requirement

40 mg/dayMax dose

20/30/40 mgStrengths

6–12 moMedicaid/HIM duration

12 moCommercial duration

Coverage Criteria for Afatinib (Gilotrif)

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Initial Therapy — Covered when ALL of the following are met for initial therapy

Covered when ALL of the following are met for initial therapy:

Initial Approval Criteria: 1) Diagnosis of recurrent, advanced, or metastatic non‑small cell lung cancer (NSCLC).; 2) Prescribed by or in consultation with an oncologist.; 3) Age > 18 years.; 4) Disease is positive for a sensitizing EGFR mutation (examples include exon 19 deletion/insertion; exon 21 L858R, L861Q; exon 18 G719X; exon 20 S768I).; 5) Member meets one of the following: (a) prescribed as a single agent for EGFR‑mutant disease, OR (b) squamous cell carcinoma histology with progression after platinum‑based chemotherapy.; 6) If prescribed in combination with cetuximab (Erbitux), all of the following must be met: (i) disease is positive for a sensitizing EGFR mutation; (ii) prescribed as subsequent therapy; (iii) member has progressed on prior EGFR tyrosine kinase inhibitor therapy.; 7) Dose does not exceed both: (i) 40 mg per day and (ii) 1 tablet per day, unless dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence for off‑label dosing).; 8) Generic afatinib must be used if available unless contraindicated or clinically significant adverse effects are experienced.

Prescriber must submit supporting evidence for off‑label dosing or combinations when applicable.

Continuation Therapy — Covered when ALL of the following are met for continued therapy

Covered when ALL of the following are met for continued therapy:

Continued Therapy Criteria: 1) Member is currently receiving afatinib via the Centene benefit, or documentation supports the member has been receiving afatinib for a covered indication for at least 30 days.; 2) Member is responding positively to therapy.; 3) Generic afatinib must be used if available unless contraindicated or clinically significant adverse effects are experienced.; 4) If request is for a dose increase, the new dose must meet one of the following: (a) not exceed 40 mg per day and 1 tablet per day, OR (b) be supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Provider must document response and any rationale/evidence for dose changes.

Requests for afatinib (Gilotrif) for non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation supporting efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Use of afatinib for non‑FDA indications without adequate evidence or off‑label justification is not authorized. Providers seeking coverage for off‑label uses must submit documentation that meets the referenced off‑label use policy requirements; otherwise the request will be denied.

Provider Requirements and Authorization Steps

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document diagnosis, oncologist involvement, member age, EGFR mutation status, prior therapies (if applicable), dosing rationale, and any contraindications or adverse reactions. Submit supporting clinical documentation such as office chart notes, pathology or molecular testing results (EGFR mutation report), and relevant laboratory data.

Prior authorization required for Gilotrif (afatinib) requests
Prescriber must be an oncologist or consult with an oncologist
Age > 18 years required

Denial Risk

Non‑FDA Indications — Documentation Required

Requests for indications that are not FDA‑approved and not addressed by this policy will be denied unless the provider supplies sufficient clinical evidence of efficacy and safety per the plan's off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Marketplace, CPPMN.53 for Medicaid) or applicable evidence-of-coverage documents. When requesting coverage for a non‑FDA indication, include peer‑reviewed literature, guideline support, and a clear rationale for use.

Non‑FDA approved indications require robust off‑label documentation
Cite applicable off‑label policy: CP.CPA.09, HIM.PA.154, CPPMN.53

Step Therapy

Therapeutic Alternatives Guidance

Consider therapeutic alternatives before approval. Preferred alternatives and relevant chemotherapy options include platinum‑based chemotherapy (e.g., cisplatin, carboplatin) and other EGFR‑targeted agents such as erlotinib (Tarceva), gefitinib (Iressa), dacomitinib (Vizimpro), and osimertinib (Tagrisso). Dose regimens vary by agent and concomitant CYP3A4/CYP1A2 interactions — consult product labeling and formulary rules.

Platinum-based chemotherapy (cisplatin, carboplatin)
Erlotinib (Tarceva) — typical 150 mg PO QD
Gefitinib (Iressa) — typical 250 mg PO QD
Dacomitinib (Vizimpro) — typical 45 mg PO QD
Osimertinib (Tagrisso) — typical 80 mg PO QD

Documentation Required

Supportive Documentation Required

Provider must submit documentation (e.g., office chart notes, pathology/molecular testing reports confirming EGFR sensitizing mutation, lab results, prior treatment records) demonstrating that the member meets the approval criteria. If dose exceeds standard dosing or is for an off‑label regimen, include supporting practice guidelines or peer‑reviewed literature.

Office chart notes and clinical history
EGFR mutation test results (specify exon/mutation)
Records of prior therapies and response/progression
Supporting literature for off‑label dosing or indications

Definitions and Abbreviations

inv-12: Definition — epidermal growth factor receptor (EGFR)

TermEGFR (epidermal growth factor receptor)

DefinitionA cell-surface receptor tyrosine kinase involved in cell proliferation; tested to identify sensitizing mutations for afatinib use

Testing guidanceProviders should follow FDA-approved testing and NCCN recommendations for EGFR mutation status

inv-13: Definition — non‑small cell lung cancer (NSCLC)

TermNSCLC (non-small cell lung cancer)

DefinitionA category of lung cancer including adenocarcinoma and squamous cell carcinoma; indication for afatinib in metastatic disease with sensitizing EGFR mutations

Relevant clinical notePolicy specifies recurrent, advanced, or metastatic NSCLC as qualifying diagnoses for initial therapy

Initial Authorization Criteria

Initial authorization — initial authorization criteria and durations

Initial authorization criteria and durations:

Initial Authorization: See initial therapy criteria: diagnosis of recurrent/advanced/metastatic NSCLC; prescribed by or in consultation with an oncologist; age >18 years; sensitizing EGFR mutation positive; single‑agent use for EGFR‑mutant disease or squamous histology after platinum chemotherapy; combination use with cetuximab only per specified subcriteria; dose does not exceed 40 mg per day and 1 tablet per day unless supported by guidelines/literature; use generic afatinib if available unless contraindicated.

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

Continuation / Renewal Criteria

Continuation/renewal — continuation therapy requirements and durations

Continuation/renewal requirements and durations:

Continuation/Renewal: See continued therapy criteria: member must be on therapy ≥30 days or have Centene benefit documentation of current use; show clinical response; use generic if available unless contraindicated; dose increases must not exceed 40 mg per day and 1 tablet per day unless supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

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

Step	Requirement	Notes / Therapeutic alternatives
1	Consider formulary alternatives and NCCN recommendations prior to approval when applicable.	Therapeutic alternatives listed in Appendix B: erlotinib (Tarceva), gefitinib (Iressa), dacomitinib (Vizimpro), osimertinib (Tagrisso), and platinum‑based chemotherapy (cisplatin/carboplatin). These agents and dosing regimens are provided as preferred alternatives and may require authorization per formulary.

Policy Summary

PayerCentene

PolicyAfatinib (Gilotrif) clinical coverage

Policy CodePolicy CP PHAR.298

Change TypeNo material change

Effective DateJan 1, 2017

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria and request prior authorization.

SourceLink

On This Page

OpenPayer

Afatinib (Gilotrif) clinical coverage

Coverage Criteria for Afatinib (Gilotrif)

Coding and Dose Information

Provider Requirements and Authorization Steps

Background Information

Definitions and Abbreviations

Initial Authorization Criteria

Continuation / Renewal Criteria

Step Therapy Considerations

Quantity Limits and Dispensing

Site-of-Care Restrictions