CurrentmhnPolicy CP.PHAR.298

Afatinib (Gilotrif) coverage for NSCLC

Defines medical necessity, prior authorization and coverage criteria for afatinib (Gilotrif) for members across Commercial, HIM/ICHRA and Medicaid lines of business; applies to prescribing oncologists and pharmacy/specialty drug benefit administrators.

Policy Summary

Payermhn

PolicyAfatinib (Gilotrif) coverage for NSCLC

Policy CodePolicy CP.PHAR.298

Change TypeNo material changes

Effective DateJan 1, 2017

Next Review Date

Key ActionSubmit chart notes, lab results or other clinical documentation to demonstrate the member meets all approval criteria, and obtain prior authorization as required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12Typical approval duration (Medicaid/HIM/ICHRA & Commercial limit)

18+Minimum member age for coverage

40Standard maximum daily dose

3Product availability (20, 30, 40 mg)

Afatinib (Gilotrif) — Coverage Conditions

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ALL of the following

Diagnosis of recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC).
Prescribed by or in consultation with an oncologist.
Member age is greater than or equal to 18 years.>= 18 years
Disease subtype (one of):
- Tumor positive for a sensitizing EGFR mutation (examples: exon 19 deletion/insertion; exon 21 point mutations L858R, L861Q; exon 18 G719X; exon 20 S768I).
- Squamous cell carcinoma histology with progression after platinum-based chemotherapy (e.g., cisplatin, carboplatin).
Prescribing regimen (one of):
- Prescribed as a single agent.
- Combination with Erbitux (all required):
  - Prescribed in combination with Erbitux (cetuximab).
  - Disease is positive for a sensitizing EGFR mutation (examples listed above).
  - Prescribed as subsequent therapy.
  - Member has progressed on prior EGFR tyrosine kinase inhibitor therapy (examples: erlotinib, dacomitinib, gefitinib, osimertinib).
Member must use generic afatinib, if available, unless contraindicated or clinically significant adverse effects are experienced.
Dose limits (one of):
- Standard dose limit (both required):
  - Dose does not exceed 40 mg per day.<= 40 mg/day
  - Dose does not exceed 1 tablet per day.<= 1 tablet/day
- 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.

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title”: “Initial Approval — Non-Small Cell Lung Cancer”

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Continued Therapy — Non-Small Cell Lung Cancer

Continued coverage when ALL of the following are met:

ALL of the following

Member is currently receiving medication via Centene benefit, or documentation supports current use of Gilotrif for a covered indication for at least 30 days.>= 30 days
Member is responding positively to therapy (clinical response documented).
Member must use generic afatinib, if available, unless contraindicated or clinically significant adverse effects are experienced.
Dose increase (one of):
- New dose limit (both required):
  - New dose does not exceed 40 mg per day.<= 40 mg/day
  - New dose does not exceed 1 tablet per day.<= 1 tablet/day
- 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.

ref”: “b0_1

title”:

Not Authorized / Not Covered Indications

Coverage is NOT authorized for:

ANY of the following

Non‑FDA approved indications not addressed in this policy unless sufficient documentation of efficacy and safety per the off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents is provided.

ref”: “b0_2

title”:

Special label-change handling

If drug label recently changed within last 6 months:

ANY of the following

Refer to the appropriate no coverage or non‑formulary policy for the relevant line of business if label change not yet reflected in this policy (see related_policies list).
See related policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16

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title”:

What Providers Must Do

Prior Authorization

Prior authorization required

Prior authorization is required for Gilotrif (afatinib); approval duration varies by line of business (typically 12 months). When requesting off‑label dosing, the prescriber must justify the dose with practice guidelines or peer‑reviewed literature as supporting evidence.

Approval duration: Medicaid/HIM/ICHRA — 12 months; Commercial — 12 months or duration of request, whichever is less.
Prescriber must submit supporting evidence when dose exceeds standard limits or is for an off‑label use.

Documentation Required

Submit supporting documentation

Submit chart notes, laboratory results, and other clinical information that document the member meets all approval criteria, including diagnosis, EGFR mutation status, prior therapies, and response to therapy for continuation requests.

Examples of documentation: office chart notes, lab results, mutation testing reports, prior treatment records, and clinical response documentation.
Documentation must support initial criteria (diagnosis, prescriber specialty, age, mutation or histology, regimen) or continued therapy criteria (≥30 days of therapy and positive response).

Step Therapy

Use of generic when available

Member must use generic afatinib if available; if prescribing brand or substituting is not possible, the prescriber must document a contraindication or clinically significant adverse effect to the generic.

Requirement applies to both initial and continued therapy requests.
Prescriber documentation must state the contraindication or intolerance to support exemption from generic use.

Denial Risk

Denial risk for non‑listed indications

Requests for non‑FDA approved indications that are not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided in accordance with the off‑label use policies referenced by line of business.

Off‑label documentation must follow CP.CPA.09 (commercial), HIM.PA.154 (HIM/ICHRA), or CP.PMN.53 (Medicaid) as applicable.
Coverage is not authorized for non‑FDA approved indications unless these requirements are met.

Clinical Background

Afatinib (Gilotrif) is an irreversible ErbB family blocker/kinase inhibitor used in the treatment of non‑small cell lung cancer (NSCLC). It is indicated as first‑line therapy for metastatic NSCLC when tumors harbor non‑resistant (sensitizing) EGFR mutations as detected by an FDA‑approved test, and as treatment for metastatic squamous NSCLC that has progressed following platinum‑based chemotherapy. The FDA labeling includes a specific limitation noting that the safety and efficacy have not been established for tumors with resistant EGFR mutations.

The product is available in tablet strengths of 20 mg, 30 mg, and 40 mg and is typically managed under prior authorization with requirements to document diagnosis, mutation status, prior therapies, and clinical response as applicable.

Policy Summary

Payermhn

PolicyAfatinib (Gilotrif) coverage for NSCLC

Policy CodePolicy CP.PHAR.298

Change TypeNo material changes

Effective DateJan 1, 2017

Next Review Date

Key ActionSubmit chart notes, lab results or other clinical documentation to demonstrate the member meets all approval criteria, and obtain prior authorization as required.

SourceLink

On This Page

OpenPayer

Afatinib (Gilotrif) coverage for NSCLC

Afatinib (Gilotrif) — Coverage Conditions

Product Strengths and Coding

What Providers Must Do

Clinical Background

Clinical & Dosing Thresholds

Terms Defined

20 mg	Tablet strength
30 mg	Tablet strength
40 mg	Tablet strength

Afatinib (Gilotrif) coverage for NSCLC

Afatinib (Gilotrif) — Coverage Conditions

Product Strengths and Coding

What Providers Must Do

Clinical Background

Clinical & Dosing Thresholds

Terms Defined

Policies to Read With This One