TARCEVA, Erlotinib HCl Form

Erlotinib (Tarceva®) is a kinase inhibitor. FDA Approved Indication(s) Tarceva is indicated for the treatment of patients with: • Metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. • Locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine as first-line. Limitation(s) of use:
• Safety and efficacy of Tarceva have not been established in patients with NSCLC whose tumors have other EGFR mutations.
• Tarceva is not recommended for use in combination with platinum-based chemotherapy. Policy/Criteria Provider must submit documentation (including 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 Tarceva 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. 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);
2. Tarceva may be prescribed as a single agent, in combination with Cyramza®, or in combination with bevacizumab;

3. For use in combination with bevacizumab: Disease histology is nonsquamous NSCLC; Page 1 of 7

   CLINICAL POLICY Erlotinib

4. For Tarceva requests, member must use generic erlotinib, unless contraindicated or clinically significant adverse effects are experienced;
5. Request meets one of the following (a or b): a. Dose does not exceed both (i and ii): i. 450 mg per day; ii. 3 tablets 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. Pancreatic Cancer (must meet all):
6. Diagnosis of locally advanced, unresectable or metastatic pancreatic cancer;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Prescribed in combination with gemcitabine;
   5. For Tarceva requests, member must use generic erlotinib, unless contraindicated or clinically significant adverse effects are experienced;
7. Request meets one of the following (a or b): a. Dose does not exceed both (i and ii): i. 450 mg per day; ii. 3 tablets 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
   C. Bone Cancer (off-label) (must meet all):
   
   1. Diagnosis of recurrent chordoma;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Prescribed as a single agent;
   5. For Tarceva requests, member must use generic erlotinib, unless contraindicated or clinically significant adverse effects are experienced;

8. Dose is within FDA maximum limit for any FDA-approved indication or 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
   Page 2 of 7

   CLINICAL POLICY Erlotinib D. Renal Cell Carcinoma (off-label) (must meet all):

9. Diagnosis of relapsed or stage IV (unresectable or metastatic) renal cell carcinoma;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Histology is non-clear cell;
   5. Tarceva may be prescribed as a single agent or in combination with bevacizumab;
   6. For Tarceva requests, member must use generic erlotinib, unless contraindicated or clinically significant adverse effects are experienced;
10. Dose is within FDA maximum limit for any FDA-approved indication or 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
    E. Other diagnoses/indications (must meet 1 or 2):
11. 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
12. 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. All Indications in Section I (must meet all):
13. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Tarceva for a covered indication and has received this medication for at least 30 days;
14. Member is responding positively to therapy;
    3. For Tarceva requests, member must use generic erlotinib, unless contraindicated or clinically significant adverse effects are experienced;

15. 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. 450 mg per day; ii. 3 tablets per day; Page 3 of 7

    CLINICAL POLICY Erlotinib 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):

16. 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

17. 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 FDA: Food and Drug Administration EGFR: epidermal growth factor receptor NSCLC: non-small cell lung cancer Appendix B: Therapeutic Alternatives
    Not applicable Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration
    Indication NSCLC Dosing Regimen 150 mg PO QD Page 4 of 7 Maximum Dose 450 mg/day

    CLINICAL POLICY Erlotinib Indication Pancreatic cancer Dosing Regimen Up to 300 mg/day with concurrent tobacco smoking
    Up to 450 mg/day if taken with a CYP3A4 inducer
    100 mg PO QD Up to 300 mg/day with concurrent tobacco smoking Up to 450 mg/day if taken with a CYP3A4 inducer
    Maximum Dose 450 mg/day VI. Product Availability
    Tablets: 25 mg, 100 mg, 150 mg VII.