FASLODEX, Fulvestrant Form

Fulvestrant (Faslodex® Injection) is an estrogen receptor antagonist. FDA Approved Indication(s) Faslodex is indicated for the treatment of: Monotherapy • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine 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 Faslodex Injection is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Breast Cancer (must meet all):

1. Diagnosis of advanced breast cancer (i.e., recurrent, stage III, or stage IV [metastatic]);

2. Prescribed by or in consultation with an oncologist;

   3. Age ≥ 18 years;
   4. Disease is HR-positive (i.e., estrogen or progesterone receptor [ER/PR]-positive);
   5. Request meets one of the following (a or b): a. Dose does not exceed 500 mg three times for the first month then once monthly; 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
      Page 1 of 8

   CLINICAL POLICY Fulvestrant Approval duration:
   Medicaid/HIM – 6 months Commercial – 6 months or to the member’s renewal date, whichever is longer B. Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (off-label) (must meet all):

3. Diagnosis of ovarian, fallopian tube, or primary peritoneal cancer;
   2. Prescribed by or in consultation with an oncologist;
   3. Disease is classified as low-grade serous carcinoma;
   4. 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 – 6 months or to the member’s renewal date, whichever is longer C. Endometrial Carcinoma (off-label) (must meet all):
4. Diagnosis of endometrial carcinoma;
   2. Prescribed by or in consultation with an oncologist;
   3. Disease is classified as grade 1 or 2 endometrioid carcinoma;
   4. Faslodex is prescribed in one of the following ways (a, b, c, or d): a. For recurrent or metastatic disease; b. For stage II disease, in combination with sequential external beam radiation therapy; c. For stage IIIA or higher disease; d. For disease not suitable for primary surgery;
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:
   Medicaid/HIM – 6 months Commercial – 6 months or to the member’s renewal date, whichever is longer D. Uterine Sarcoma (off-label) (must meet all):

6. Diagnosis of uterine sarcoma;

   2. Prescribed by or in consultation with an oncologist;
   3. Disease is classified in one of the following ways (a, b, or c): a. Low-grade endometrial stromal sarcoma; b. Adenosarcoma without sarcomatous overgrowth; c. HR-positive (i.e., ER/PR-positive) uterine leiomyosarcoma;
   4. Faslodex is prescribed in one of the following ways (a, b, c, or d): a. Following total hysterectomy; b. For vaginal or pelvic recurrence; c. For metastatic disease; d. For disease not suitable for primary surgery; Page 2 of 8

   CLINICAL POLICY Fulvestrant

7. 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 – 6 months or to the member’s renewal date, whichever is longer E. Other diagnoses/indications (must meet 1 or 2):
8. 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
9. 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):
10. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Faslodex for a covered indication and has received this medication for at least 30 days;
11. Member is responding positively to therapy;
    3. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 500 mg once monthly; 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 – 6 months or to the member’s renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):

12. 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: Page 3 of 8

    CLINICAL POLICY Fulvestrant 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

13. 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.
    LHRH: luteinizing hormone-releasing hormone NCCN: National Comprehensive Cancer Network
    PR: progesterone receptor IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ER: estrogen receptor
    FDA: Food and Drug Administration HER2: human epidermal growth factor receptor 2 HR: hormone receptor Appendix B: Therapeutic Alternatives
    Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity • Boxed warning(s): none reported V. Dosage and Administration
    Indication Dosing Regimen Maximum Dose Faslodex: 500 mg three times for first month then once monthly Faslodex: 500 mg IM into buttocks (gluteal area) slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29 and once monthly thereafter. Monotherapy • HR-positive, HER2- negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. • HR-positive advanced breast cancer in Page 4 of 8

    CLINICAL POLICY Fulvestrant Indication Dosing Regimen postmenopausal women with disease progression following endocrine therapy. Combination Therapy • HR-positive, HER2- negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. • HR-positive, HER2- negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
    Faslodex: 500 mg IM into buttocks (gluteal area) slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29 and once monthly thereafter.
    Ribociclib: 600 mg PO QD for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days.
    Palbociclib: 125 mg PO QD for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Abemaciclib: 150 mg PO BID. Pre/perimenopausal women treated with the combination of Faslodex plus palbociclib, abemaciclib, or ribociclib, should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards. Maximum Dose Faslodex: 500 mg three times for first month then once monthly Ribociclib: 600 mg/day Palbociclib: 125 mg/day Abemaciclib: 300 mg/day VI. Product Availability
    Two 5 mL glass barrels (syringes), each containing 250 mg/5 mL of Faslodex solution for IM injection. The syringes are presented in a tray with polystyrene plunger rod and safety needles (SafetyGlide™) for connection to the barrel.
    VII.