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:

Prior Authorization (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:
    • Treatment of non-metastatic castration-resistant prostate cancer
    • Treatment of metastatic castration-sensitive prostate cancer.
  • Nubeqa
    • Treatment of non-metastatic castration-resistant prostate cancer.
  • Xtandi
    • Treatment of castration-resistant prostate cancer
    • Treatment of metastatic castration-sensitive prostate cancer.


Background:
  • Erleada, Nubeqa, and Xtandi are androgen receptor (AR) inhibitors which bind to the AR in order to inhibit AR nuclear translocation and DNA binding to impede AR-mediated transcription. This decreases tumor cell proliferation and growth.
  • Androgen-deprivation therapy, either bilateral orchiectomy or treatment with a gonadotropin-releasing hormone analogue agonist or antagonist, is the mainstay of treatment for metastatic prostate cancer.
  • Castrate-resistant prostate cancer is defined by disease progression despite androgen depletion therapy.
  • 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.
  • Prescribing Considerations:
    • Erleada, Nubeqa, and Xtandi should be prescribed under the supervision of an oncologist.
    • Male patients with female partners of reproductive potential should be advised 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.
    • Patients should be advised of the risk of developing a seizure while receiving Xtandi or Erleada.
    • Dosage reduction below 300 mg twice daily is not recommended for Nubeqa.
    • Patients receiving Erleada and Xtandi should be advised of ischemic cardiovascular events and monitored for signs and symptoms of ischemic heart disease.


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 metastatic castration-sensitive prostate cancer.

b.    The member has a diagnosis of non-metastatic castration-resistant prostate cancer.

2.     The member meets one (1) 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 (1) 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 meets one (1) of the following criteria (a. or b.):

a.     The member has a diagnosis of castration-resistant prostate cancer.

b.    The member has a diagnosis of metastatic castration-sensitive 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 Erleada, Nubeqa, or Xtandi  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 one (1) of the following (1. or 2.):

1.     Disease improvement

2.     Delayed disease progression

 

III.   An exception to some or all of the criteria above may be granted for select members and/or circumstances based on state and/or federal regulations.

 

IV.   Coverage of oncology medications listed in this policy may be approved on a case-by-case basis per indications supported in the most current NCCN guidelines.

 


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-201-003
Effective Date Begin: 11/28/2020
Effective End Begin: 12/15/2020
Original Date: 11/06/2019
Review Date: 10/07/2020


References:

  1. Erleada [package insert]. Horsham, PA: Janssen Pharmaceutical Companies; July 2020.
  2. Nubeqa [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; July 2019.
  3. Xtandi [package insert]. Northbrook, IL. Astellas; August 2020.
  4. Smith M, Saad F, Chowdhury S, et al. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. New England Journal of Medicine. 2018.
  5. Saad F, Hotte SJ. Guidelines for the management of castrate-resistant prostate cancer. Can Urol Assoc J. 2010.
  6. NCCN Guidelines. Prostate Cancer v.2.2020. National Comprehensive Cancer Network. Accessed August 10, 2020.

 




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.