NUBEQA, Darolutamide Form

Darolutamide (Nubeqa®) is an androgen receptor inhibitor. FDA Approved Indication(s) Nubeqa is indicated for the treatment of adult patients with:
• Non-metastatic castration-resistant prostate cancer (nmCRPC) • Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel 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 Nubeqa is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Prostate Cancer (must meet all):

1. Diagnosis of nmCRPC or mHSPC;
   2. Prescribed by or in consultation with an oncologist or urologist;
   3. Age ≥ 18 years;
   4. Member will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy;
2. If request is for mHSPC, Nubeqa is prescribed in combination with docetaxel;
   6. For Nubeqa requests, member must use darolutamide, if available, unless contraindicated or clinically significant adverse effects are experienced;

3. Request meets one of the following (a or b): a. Dose does not exceed 1,200 mg (4 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 – 12 months Commercial – 12 months or duration of request, whichever is less Page 1 of 5

   CLINICAL POLICY Darolutamide 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: 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: 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: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Prostate Cancer (must meet all):
5. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Nubeqa for nmCRPC or mHSPC and has received this medication for at least 30 days;
6. Member is responding positively to therapy;
   3. For Nubeqa requests, member must use darolutamide, if available, unless contraindicated or clinically significant adverse effects are experienced;
   4. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 1,200 mg (4 tablets) 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):

7. 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 Page 2 of 5

   CLINICAL POLICY Darolutamide

8. 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 CRPC: castration-resistant prostate cancer FDA: Food and Drug Administration GnRH: gonadotropin-releasing hormone LHRH: luteinizing-hormone releasing- hormone
   Appendix B: Therapeutic Alternatives
   Not applicable NCCN: National Comprehensive Cancer Network mHSPC: metastatic hormone-sensitive prostate cancer
   nm: non-metastatic
   Appendix C: Contraindications/Boxed Warnings None reported
   Appendix D: General Information
   • CRPC is prostate cancer that progresses clinically, radiographically, or biochemically despite castrate levels of serum testosterone (< 50 ng/dL). • Examples of androgen deprivation therapy for non-metastatic, castration-naïve prostate cancer include: o Orchiectomy (surgical castration) o Luteinizing-hormone releasing-hormone (LHRH) agonist given with or without a first-generation anti-androgen:
    LHRH agonists: Zoladex® (goserelin), Vantas® (histrelin), leuprolide (Lupron Depot® or Eligard®), and Trelstar® (triptorelin)  Anti-androgens: bicalutamide (Casodex®), flutamide, and nilutamide (Nilandron®) o LHRH antagonist: Firmagon® (degarelix) V. Dosage and Administration
   Indication nmCRPC, mHSPC Dosing Regimen 600 mg PO BID Maximum Dose 1,200 mg/day VI. Product Availability
   Tablet: 300 mg Page 3 of 5

   CLINICAL POLICY Darolutamide VII.