Osimertinib (Tagrisso) Form

Osimertinib (Tagrisso®) is a tyrosine kinase inhibitor. FDA Approved Indication(s) Tagrisso is indicated: • As adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
• For the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test • For the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy 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 Tagrisso 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 NSCLC;

   2. Age ≥ 18 years;
   3. Request is for one of the following (a or b): a. Completely resected stage IB–IIIB EGFR mutation-positive NSCLC who received previous adjuvant chemotherapy or are ineligible to receive platinum- based chemotherapy; b. Recurrent, advanced or metastatic NSCLC and disease is positive for either of the following (i or ii):
      i. 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. T790M mutation with progression on or after an EGFR TKI therapy (e.g., Tarceva®, Gilotrif®, Iressa®, Vizimpro®); *Prior authorization may be required for EGFR TKI therapies. Page 1 of 6

   CLINICAL POLICY Osimertinib

2. For Tagrisso requests, member must use generic osimertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
3. Prescribed as a single agent;
   6. Request meets one of the following (a, b or c): a. Dose does not exceed both (i and ii): i. 80 mg per day; ii. 1 tablet per day; b. If co-administered with a strong CYP3A4 inducer (e.g., phenytoin, rifampin, carbamazepine, St. John’s wort), dose does not exceed both (i and ii): i. 160 mg per day; ii. 2 tablets per day;
      c. 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):
4. 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
5. 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):
6. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Tagrisso for NSCLC and has received this medication for at least 30 days;

7. Member is responding positively to therapy;

   3. For Tagrisso requests, member must use generic osimertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
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   CLINICAL POLICY Osimertinib

8. If request is for a dose increase, request meets one of the following (a, b or c):
   a. New dose does not exceed both (i and ii): i. 80 mg per day; ii. 1 tablet per day; b. If co-administered with a strong CYP3A4 inducer (e.g., phenytoin, rifampin, carbamazepine, St. John’s wort), new dose does not exceed both (i and ii): i. 160 mg per day; ii. 2 tablets per day;
   c. 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):
9. 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

10. 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 NSCLC: non-small cell lung cancer
    TKI: tyrosine kinase inhibitor Page 3 of 6

    CLINICAL POLICY Osimertinib 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.
    Drug Name Dosing Regimen Gilotrif® (afatinib) Iressa® (gefitinib) Tarceva® (erlotinib) Metastatic NSCLC 40 mg PO QD Metastatic NSCLC 250 mg PO QD Metastatic NSCLC 150 mg PO QD Dose Limit/ Maximum Dose 40 mg/day 50 mg/day when on chronic concomitant therapy with a P-gp inducer 250 mg/day 500 mg/day when used with a strong CYP3A4 inducer 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/day Vizimpro® (dacomitinib) 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. Metastatic NSCLC 45 mg PO QD Appendix C: Contraindications/Boxed Warnings None reported. V. Dosage and Administration
    Indication Dosing Regimen Maximum Dose NSCLC 80 mg PO QD 80 mg/day 160 mg/day when used with a strong CYP3A4 inducer VI. Product Availability
    Tablets: 40 mg, 80 mg VII.