PROVENGE, Sipuleucel-T Form

Sipuleucel-T (Provenge®) is an autologous cellular immunotherapy.
FDA Approved Indication(s) Provenge is indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer (CRPC).
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 Provenge is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Prostate Cancer (must meet all):

1. Diagnosis of metastatic CRPC, as evidenced by disease progression despite bilateral orchiectomy or other androgen deprivation therapy (see Appendix D);
2. Member is asymptomatic or minimally symptomatic;
   3. Member does not have visceral disease (e.g., lung, liver, or brain metastases);
   4. Member has an estimated life expectancy of > 6 months;
   5. Member’s Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1;
3. Prescribed by or in consultation with an oncologist or urologist;
   7. Age ≥ 18 years;
   8. Member will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy;
4. Member has not received ≥ 3 doses (infusions) of Provenge. Approval duration: 6 months (up to a total of 3 doses) B. Other diagnoses/indications (must meet 1 or 2):

5. 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 and CP.PMN.255 for Medicaid; or Page 1 of 6

   CLINICAL POLICY Sipuleucel-T 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 and CP.PMN.16 for Medicaid; or

6. 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 and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Prostate Cancer (must meet all):
7. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Provenge for prostate cancer and has received this medication for at least 30 days;
8. Member is responding positively to therapy;
   3. Member continues to use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy;
9. Member has not received ≥ 3 doses (infusions) of Provenge. Approval duration: 6 months (up to a total of 3 doses) B. Other diagnoses/indications (must meet 1 or 2):
10. 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 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 and CP.PMN.16 for Medicaid; or

11. 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 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 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 CRPC: castration-resistant prostate cancer Page 2 of 6

    CLINICAL POLICY Sipuleucel-T Appendix B: Therapeutic Alternatives
    Not applicable 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). Per the NCCN, androgen deprivation therapy should be continued in the setting of CRPC while additional therapies are applied. • Examples of androgen deprivation therapy include: o Bilateral orchiectomy (surgical castration) o Luteinizing hormone-releasing hormone (LHRH) given with or without an anti- androgen:  LHRH agonists: Zoladex® (goserelin), leuprolide (Lupron Depot®, Eligard®), and Trelstar® (triptorelin)  Anti-androgens: bicalutamide (Casodex®), flutamide (Eulexin®), nilutamide (Nilandron®), Xtandi® (enzalutamide), Erleada® (apalutamide), Nubeqa® (darolutamide) o LHRH antagonist: Firmagon® (degarelix), Orgovyx™ (relugolix) V. Dosage and Administration
    Indication Metastatic CRPC Dosing Regimen One dose IV over 60 minutes given approximately every 2 weeks for 3 doses Each dose contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM- CSF, in 250 ml of Lactated Ringer’s Injection Maximum Dose 1 dose approximately every 2 weeks (max 3 doses) VI. Product Availability
    Suspension for injection: minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, in 250 ml of Lactated Ringer’s Injection VII.