Pharmacy Policy Bulletin
Androgen Receptor Inhibitors – Commercial and Healthcare Reform
Number: J-201 Category: Prior Authorization
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Commercial (1.):

  1. Miscellaneous Specialty Drugs Oral = Yes w/ Prior Authorization

Healthcare Reform: Not Applicable
Region(s):

All
Delaware
Pennsylvania
West Virginia

Additional Restriction(s):

None


Drugs Products
  • Erleada (apalutamide)
  • Nubeqa (darolutamide)
  • Xtandi (enzalutamide)
FDA-Approved Indications:
  • Erleada is indicated for the treatment of non-metastatic castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer.
  • Nubeqa is indicated for the treatment of non-metastatic castration-resistant prostate cancer.
  • Xtandi is indicated for the treatment of castration-resistant prostate cancer.


Background:
  • Erleada, Nubeqa, and Xtandi are androgen receptor inhibitors which bind to the androgen receptor (AR) in order to inhibit AR nuclear translocation and DNA binding to impede AR-mediated transcription. This in turn decreases tumor cell proliferation and growth.
  • Prescribing Considerations:
    • Erleada, Nubeqa, and Xtandi should be prescribed under the supervision of an oncologist.
    • Patients should receive a gonadotropin-releasing hormone (GnRH) analog (e.g. Zoladex [goserelin acetate], Lupron [leuprolide acetate], Vantas [histrelin], etc.) concurrently with Erleada, Nubeqa, or Xtandi, or should have had bilateral orchiectomy.
    • Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for three months after the last dose of Xtandi and Erleada, and one week after the last dose of Nubeqa.
    • Patients should be evaluated for fracture and fall risk when taking Erleada or Xtandi.
    • Advise patients of the risk of developing a seizure while receiving Xtandi or Erleada.
    • Dosage reduction below 300 mg twice daily is not recommended for Nubeqa.


Approval Criteria

I. Initial Authorization
    A. Erleada
        When a benefit, coverage of Erleada may be approved when all of the following criteria are met (1. and 2.):
        1. The member meets one (1) of the following criteria (a. or b.):
            a. The member has a diagnosis of non-metastatic castration-resistant prostate cancer.
            b. The member has a diagnosis of metastatic castration-sensitive prostate cancer.
        2. The member meets one of the following criteria (a. or b.):
            a. Erleada is being used in combination with a GnRH analog.
            b. The member has had a bilateral orchiectomy.

    B. Nubeqa
    When a benefit, coverage of Nubeqa may be approved when all of the following criteria are met (1. and 2.):
    1. The member has a diagnosis of non-metastatic castration-resistant prostate cancer.
    2. The member meets one of the following criteria (a. or b.):
        a. Nubeqa is being used in combination with a GnRH analog.
        b. The member has had a bilateral orchiectomy.

    C. Xtandi
    When a benefit, coverage of Xtandi may be approved when all of the following criteria are met (1. and 2.): 
     1. The member has a diagnosis of castration-resistant prostate cancer.
     2. The member meets one (1) of the following criteria (a. or b.):
         a. Xtandi is being used in combination with a GnRH analog.
         b. The member has had a bilateral orchiectomy.

II. Reauthorization
     When a benefit, reauthorization of an androgen receptor inhibitor may be approved when the following criterion is met (A.):
      A. The prescriber attests that the member is tolerating therapy and has experience a therapeutic response defined as either one of the following (1. or 2.):
          1. Disease improvement
          2. Delayed disease progression

III. For Commercial and Healthcare Reform members enrolled in a Delaware plan, an exception to select criteria within this policy may be made based on Policy J-651 – Delaware—Cancer Chemotherapy Override Exception—Commercial and Healthcare Reform.


Limitations of Coverage

I. Coverage of an androgen receptor inhibitor for disease states outside of its FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.
II. For Commercial or HCR members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.


Authorization Duration
  • Commercial and HCR Plans: If approved, up to a 2 year authorization may be granted.


Automatic Approval Criteria

 None


Version: J-201-001
Effective Date Begin: 12/10/2019
Effective End Begin: 02/12/2020
Original Date: 11/06/2019
Review Date: 11/06/2019


References:

  1. Erleada [package insert]. Horsham, PA: Janssen Pharmaceutical Companies; February 2018.
  2. Nubeqa [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; July 2019.
  3. Xtandi [package insert]. New York, NY. Pfizer, Inc; July 2018.
  4. Smith M, Saad F, Chowdhury S, et al. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. New England Journal of Medicine. 2018;378:1408-18.




Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.