NUBEQA DAROLUTAMIDE Metastatic Hormone-Sensitive Prostate Cancer Instructions

NUBEQA DAROLUTAMIDE Metastatic Hormone-Sensitive Prostate Cancer Instructions

DAROLUTAMIDE

GUIDELINES FOR USE

INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

1. Does the patient have a diagnosis of non-metastatic castration resistant prostate cancer (nmCRPC) and meet ALL of the following criteria?

   • The patient is 18 years of age or older
   • The patient has high risk prostate cancer (i.e., rapidly increasing prostate specific antigen [PSA] levels)
     If yes, continue to #2.
     If no, do not approve.
     DENIAL TEXT: See the initial denial text at the end of the guideline.

2. Does the patient meet ONE of the following criteria?

   • The patient previously received a bilateral orchiectomy
   • The patient has a castrate level of testosterone (i.e., < 50 ng/dL)
   • The requested medication will be used concurrently with a gonadotropin releasing hormone (GnRH) analog (e.g., leuprolide, goserelin, histrelin, degarelix)
     If yes, approve for 12 months by HICL or GPI-10 with a quantity limit of #4 per day.
     If no, continue to #3.

3. Does the patient have a diagnosis of metastatic hormone-sensitive prostate cancer (mHSPC) and meet ALL of the following criteria?

   • The patient is 18 years of age or older
   • The requested medication will be used in combination with docetaxel

If yes, approve for 12 months by HICL or GPI-10 with a quantity limit of #4 per day.
If no, do not approve.
DENIAL TEXT: See the initial denial text at the end of the guideline.

INITIAL DENIAL TEXT: *Some terms are already pre-defined in parenthesis. Please use these definitions if the particular text you need to use does not already have definition(s) in it.

Our guideline named DAROLUTAMIDE (Nubeqa) requires the following rule(s) be met for approval:

A. You have ONE of the following diagnoses:

1. Non-metastatic castration resistant prostate cancer (mmCRPC: prostate cancer that has not spread to other parts of the body and does not respond to hormone therapy)
2. Metastatic hormone-sensitive prostate cancer (mHSPC: prostate cancer that has spread to other parts of the body and responds to hormone therapy).

B. If you have non-metastatic castration resistant prostate cancer, approval also requires:

1. You are 18 years of age or older
2. You have high risk prostate cancer (rapidly increasing prostate specific antigen [PSA: lab result that may indicate prostate cancer] levels)
3. You meet ONE of the following:
   a. You previously received a bilateral orchiectomy (both testicles have been surgically removed)
   b. You have a castrate level of testosterone (your blood testosterone levels are less than 50 ng/dL)
   c. The requested medication will be used together with a gonadotropin releasing hormone analog (such as leuprolide, goserelin, histrelin, degarelix)

C. If you have metastatic hormone-sensitive prostate cancer, approval also requires:

1. You are 18 years of age or older
2. The requested medication will be used in combination with docetaxel

Your doctor told us [INSERT PT SPECIFIC INFO PROVIDED]. We do not have information showing you [INSERT UNMET CRITERIA]. This is why your request is denied. Please work with your doctor to use a different medication or get us more information if it will allow us to approve this request.

RENEWAL CRITERIA

NOTE: For the diagnosis of metastatic hormone-sensitive prostate cancer (mHSPC), please refer to the Initial Criteria section.

Does the patient have a diagnosis of non-metastatic castration resistant prostate cancer (nmCRPC)?

If yes, approve for 12 months by HICL or GPI-10 with a quantity limit of #4 per day.
If no, do not approve.
RENEWAL DENIAL TEXT: *Some terms are already pre-defined in parenthesis. Please use these definitions if the particular text you need to use does not already have definition(s) in it.

Our guideline named DAROLUTAMIDE (Nubeqa) requires the following rule(s) be met for renewal:

A. You have non-metastatic castration resistant prostate cancer (mmCRPC: prostate cancer that has not spread to other parts of the body and does not respond to hormone therapy)

Your doctor told us [INSERT PT SPECIFIC INFO PROVIDED]. We do not have information showing you [INSERT UNMET CRITERIA]. This is why your request is denied. Please work with your doctor to use a different medication or get us more information if it will allow us to approve this request.

RATIONALE
For further information, please refer to the Prescribing Information and/or Drug Monograph for Nubeqa.

REFERENCES

Nubeqa [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; August 2022.

Part D Effective: N/A Created: 11/19
Commercial Effective: 09/12/22 Client Approval: 08/22 P&T Approval: 10/22

Copyright © 2022 MedImpact Healthcare Systems, Inc. All rights reserved. This document is proprietary to MedImpact. MedImpact maintains the sole and exclusive ownership, right, title, and interest in and to this document.

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