GILOTRIF, Afatinib Dimaleate Form

Afatinib (Gilotrif®) is a kinase inhibitor. FDA Approved Indication(s) Gilotrif is indicated for: • First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
• Treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.
Limitation(s) of Use: The safety and efficacy of Gilotrif have not been established in patients whose tumors have resistant EGFR mutations. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Gilotrif is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Non-Small Cell Lung Cancer (must meet all):

1. Diagnosis of recurrent, advanced or metastatic NSCLC;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Member meets one of the following (a or b): a. 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); b. Squamous cell carcinoma histology with progression after platinum-based chemotherapy (e.g., cisplatin, carboplatin);

2. One of the following (a or b): a. Prescribed as a single agent; Page 1 of 6

   CLINICAL POLICY Afatinib b. Prescribed in combination with Erbitux® and all of the following (i, ii, and iii); i. 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) ii. Prescribed as subsequent therapy; iii. Member has progressed on EGFR tyrosine kinase inhibitor therapy (e.g., Tarceva®, Vizimpro®, Iressa®, Tagrisso®);

3. For Gilotrif requests, member must use generic afatinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
4. Request meets one of the following (a or b): a. Dose does not exceed both (i and ii): i. 40 mg per day; ii. 1 tablet per day; b. 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
   Approval duration:
   Medicaid/HIM – 6 months
   Commercial – 12 months or duration of request, whichever is less
   B. Other diagnoses/indications (must meet 1 or 2):
5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Non-Small Cell Lung Cancer (must meet all):
7. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Gilotrif for a covered indication and has received this medication for at least 30 days;

8. Member is responding positively to therapy;

   3. For Gilotrif requests, member must use generic afatinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
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   CLINICAL POLICY Afatinib

9. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed both (i and ii): i. 40 mg per day; ii. 1 tablet per day; b. 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
   Approval duration:
   Medicaid/HIM – 12 months
   Commercial – 12 months or duration of request, whichever is less
   B. Other diagnoses/indications (must meet 1 or 2):
10. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

11. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key EGFR: epidermal growth factor receptor FDA: Food and Drug Administration NCCN: National Comprehensive Cancer Network NSCLC: non-small cell lung cancer Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Page 3 of 6

    CLINICAL POLICY Afatinib Drug Name Dosing Regimen Dose Limit/ Platinum-based chemotherapy (e.g., cisplatin, carboplatin) erlotinib (Tarceva®) Varies 150 mg PO QD Vizimpro® (dacomitinib) Iressa® (gefitinib) 45 mg PO QD 250 mg PO QD Tagrisso® (osimertinib) 80 mg PO QD Maximum Dose Varies 150 mg/day; 450 mg/day when used with a strong CYP3A4 inducer or 300 mg/day when used with a moderate CYP1A2 inducer 45 mg PO QD 250 mg/day; 500 mg/day when used with a strong CYP3A4 inducer 160 mg/day when used with a strong CYP3A4 inducer Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration
    Indication Dosing Regimen NSCLC 40 mg PO QD
    VI. Product Availability
    Tablets: 20 mg, 30 mg, 40 mg Maximum Dose 40 mg/day VII.