ABRAXANE, Paclitaxel Protein-Bound Particles Form

Protein-bound paclitaxel (Abraxane®) is microtubule inhibitor. FDA Approved Indication(s) Abraxane is indicated for the treatment of: • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. • Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. • Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. 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 Abraxane is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Breast Cancer (must meet all):

1. Diagnosis of breast cancer;
2. Disease is recurrent, metastatic, or unresponsive to preoperative systemic therapy;
3. Prescribed by or in consultation with an oncologist;
4. Age ≥ 18 years;

5. For Abraxane requests, member must use paclitaxel protein-bound particles, if available, unless contraindicated or clinically significant adverse effects are experienced;

   6. Request meets one of the following (a or b): a. Dose does not exceed 260 mg/m2 every 3 weeks; 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: 6 months Page 1 of 10

   CLINICAL POLICY
   Paclitaxel, Protein-Bound B. Non-Small Cell Lung Cancer (must meet all):

   1. Diagnosis of recurrent, advanced, or metastatic NSCLC;
6. Prescribed by or in consultation with an oncologist;
7. Age ≥ 18 years;
8. Member must use paclitaxel, unless contraindicated or clinically significant adverse effects are experienced;
   5. For Abraxane requests, member must use paclitaxel protein-bound particles, if available, unless contraindicated or clinically significant adverse effects are experienced;
   6. Request meets one of the following (a or b): a. Dose does not exceed 100 mg/m2 IV on Days 1, 8, and 15 of each 21-day cycle; 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: 6 months C. Adenocarcinoma of the Pancreas (must meet all):
9. Diagnosis of adenocarcinoma of the pancreas;
10. Prescribed by or in consultation with an oncologist;
11. Age ≥ 18 years;
12. Abraxane will be used in combination with gemcitabine; Gemcitabine may require prior authorization
    5. Disease is metastatic, unresectable, or borderline resectable;

13. For Abraxane requests, member must use paclitaxel protein-bound particles, if available, unless contraindicated or clinically significant adverse effects are experienced;

    7. Request meets one of the following (a or b): a. Dose does not exceed 125 mg/m2 on Days 1, 8 and 15 of each 28-day cycle; 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: 6 months D. Additional NCCN Recommended Uses (off-label) (must meet all):
    8. Prescribed for one of the following NCCN categories 1 and 2A supported indications (a - h): a. AIDS-related Kaposi sarcoma; b. Ampullary adenocarcinoma;
       c. Cutaneous or uveal melanoma, prescribed as a single agent; d. Cervical cancer;
       e. Endometrial carcinoma, prescribed as a single agent; f. Cholangiocarcinoma or gallbladder cancer, and member meets both of the following (i and ii): i. Disease is unresectable or metastatic; ii. Abraxane is prescribed in combination with gemcitabine; g. Relapsed ovarian cancer; h. Advanced or metastatic small bowel adenocarcinoma; Page 2 of 10

    CLINICAL POLICY
    Paclitaxel, Protein-Bound

    2. Prescribed by or in consultation with an oncologist;
14. Age ≥ 18 years;
15. For Abraxane requests, member must use paclitaxel protein-bound particles, if available, unless contraindicated or clinically significant adverse effects are experienced;
    5. 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: 6 months E. Other diagnoses/indications (must meet 1 or 2):
    6. 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
    7. 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):
    8. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Abraxane for a covered indication and has received this medication for at least 30 days;
    9. Member is responding positively to therapy;

16. For Abraxane requests, member must use paclitaxel protein-bound particles, if available, unless contraindicated or clinically significant adverse effects are experienced;

    4. If request is for a dose increase, meets one of the following (a or b): a. New dose does not exceed one of the following (i, ii, or iii): i. For breast cancer: 260 mg/m2 IV every 3 weeks; ii. For NSCLC: 100 mg/m2 IV on Days 1, 8, and 15 of each 21-day cycle; iii. For adenocarcinoma of the pancreas: 125 mg/m2 on Days 1, 8 and 15 of each 28-day cycle; 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 Page 3 of 10

    CLINICAL POLICY
    Paclitaxel, Protein-Bound Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

    1. 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
    2. 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 HER2: human epidermal growth factor receptor 2 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.
       Drug Name Dosing Regimen For breast cancer: Refer to prescribing information Dose Limit/ Maximum Dose Refer to prescribing information anthracyclines (e.g., doxorubicin, pegylated liposomal doxorubicin, epirubicin) paclitaxel (Taxol®) For NSCLC: Various combinations 250 mg/m2 every 3 weeks Page 4 of 10

    CLINICAL POLICY
    Paclitaxel, Protein-Bound Drug Name Dosing Regimen gemcitabine (Gemzar®) For adenocarcinoma of the pancreas:
    1,000 mg/m2 IV over 30 to 40 minutes on days 1, 8, and 15 preceded by nab-paclitaxel (125 mg/m2 IV over 30 to 40 minutes on days 1, 8, and 15) every 28 days 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. Dose Limit/ Maximum Dose 1000 mg/m2 once weekly for up to 7 consecutive weeks Appendix C: Contraindications/Boxed Warnings • Contraindication(s): neutrophil counts of < 1,500 cells/mm3, severe hypersensitivity • Boxed warning(s): severe myelosuppression
    V. Dosage and Administration
    Indication Metastatic breast cancer Non-small cell lung cancer
    Metastatic adenocarcinoma of the pancreas Dosing Regimen 260 mg/m2 IV every 3 weeks Maximum Dose 260 mg/m2 100 mg/m2 IV on days 1, 8, and 15 of each 21-day cycle 125 mg/m2 IV on days 1, 8 and 15 of each 28-day cycle 260 mg/m2 260 mg/m2 VI. Product Availability
    Injectable suspension: lyophilized powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-use vial for reconstitution VII.