Utilization Management Policy Name: Agents for Prostate Cancer – NC Standard

Restricted Product(s):

Restriction applies to brand and generic

• Erleada® (apalutamide)
• NubeqaTM (darolutamide)
• Xtandi® (enzalutamide)
• Yonsa® (abiraterone)
• Zytiga® (abiraterone)

FDA Approved Use:

Erleada

• For the treatment of patients with non-metastatic castration-resistant prostate cancer.
• For the treatment of patients with metastatic castration-sensitive prostate cancer.

Nubeqa

• For the treatment of patients with nonmetastatic castration-resistant prostate cancer.
• For the treatment of patients with metastatic hormone-sensitive prostate cancer in combination with docetaxel.

Xtandi

• For the treatment of patients with castration-resistant prostate cancer.
• For the treatment of patients with metastatic castration-sensitive prostate cancer.
• For the treatment of patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

Yonsa

• For the treatment of patients with metastatic castration-resistant prostate cancer, in combination with methylprednisolone.

Zytiga

• For the treatment of patients with metastatic castration-resistant prostate cancer (CRPC), in combination with prednisone.
• For the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC), in combination with prednisone.

Criteria for Approval of Restricted Product(s):

    1. The patient is currently taking the requested medication for a cancer diagnosis; AND

        a. The patient will utilize the generic formulation of this product (if available); AND

        b. If the request is for generic abiraterone (Zytiga), the patient will utilize generic abiraterone 250 mg tablets; OR

            i. The provider submits a written rationale why utilizing the generic 250 mg tablets would cause harm/or lack efficacy based on the patient specific clinical scenario; OR

    2. The patient is 18 years of age or older; AND

    3. The patient is being managed by or in consultation with an oncologist or urologist; AND

    4. If the request is for brand medication,

        a. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic medication if available (medical record documentation required); AND

    5. The request is for the coverage of Zytiga; AND

        a. The patient will use prednisone in combination with Zytiga; AND

        b. The patient will utilize generic abiraterone 250 mg tablets; OR

            i. The provider submits a written rationale why utilizing the generic 250 mg tablets would cause harm/or lack efficacy based on the patient specific clinical scenario; AND

        c. The patient has a diagnosis of metastatic castration-resistant prostate cancer; OR

        d. The patient has a diagnosis of metastatic high-risk castration-sensitive prostate cancer; OR

    6. The request is for the coverage of Yonsa; AND

        a. The patient will use methylprednisolone in combination with Yonsa; AND

        b. The patient has a diagnosis of metastatic castration-resistant prostate cancer; OR

    7. The request is for the coverage of Xtandi; AND

        a. The patient has a diagnosis of castration-resistant prostate cancer; OR

        b. The patient has a diagnosis of metastatic castration-sensitive prostate cancer; OR

        c. The patient has a diagnosis of non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis; OR

    8. The request is for the coverage of Nubeqa; AND

        a. The patient has a diagnosis of non-metastatic castration-resistant prostate cancer; OR

        b. The patient has a diagnosis of metastatic hormone-sensitive prostate cancer; AND

            i. Nubeqa will be used in combination with docetaxel; OR

    9. The request is for the coverage of Erleada; AND

        a. The patient has a diagnosis of non-metastatic castration-resistant prostate cancer; OR

        b. The patient has a diagnosis of metastatic castration-sensitive prostate cancer; AND

        c. The patient will be concurrently receiving a gonadotropin-releasing hormone (GnRH) analog; OR

        d. The patient has undergone a bilateral orchiectomy; OR

    10. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. [Medical records and references / evidence must be provided]; AND

    11. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval:

365 days (1 year)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval:

365 days (1 year)

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

January 2024: Criteria change: Added preference of abiraterone 250mg tablets to criteria point one to require for all reviews. Added P&T review statement.

November 2023: Criteria update: Added new indication for Xtandi for use in patients with non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

March 2023: Criteria update: Added new Erleada (apalutamide) 240 mg tablet to the policy.

January 2023: Criteria change: Changed Xtandi 40 mg tablet QL to 4 tablets per day to match Xtandi 40 mg capsule QL.

August 2022: Criteria update: Added expanded indication for Nubeqa for the treatment of metastatic hormone-sensitive prostate cancer in combination with docetaxel.

July 2022: Criteria change: Require usage of generic medication unless patient has tried and failed, is intolerant to, or has a clinical contraindication to generic medication.

Sept 2021: Criteria change: Changed Xtandi 40mg capsule QL back to 4 capsules per day

July 2021: Criteria change: Reduced Xtandi 40mg capsule quantity limit from 4 capsules per day to 3 capsules per day.

April 2021: Criteria change: Requests for Zytiga required to use generic abiraterone 250mg tablets.

March 2021: Criteria update: Added new tablet Xtandi dosage forms and strength to the policy.

January 2021: Criteria update: Added new abiraterone 500mg (generic Zytiga) to the policy.

July 2020: Criteria update: Allow for approval if currently taking the requested agent for a cancer diagnosis and utilizing the generic formulation (if available).

April 2020: Criteria update: Added new to market Nubeqa to policy.

December 2019: Criteria update: Added expanded indication for Xtandi of metastatic castration-sensitive prostate cancer.

October 2019: Criteria Change: Removed criteria which gave preference to Zytiga over Xtandi in metastatic disease; Erleada policy merged into policy; allowance for urologist management; preference of generic abiraterone over brand added to policy; continuation of stablished therapy statement added.

Nov 2018: Updated to include expanded indication for Xtandi

Jun 2018: Updated to include new to market Yonsa.

Feb 2018: Updated criteria in accord with FDA expanded indication for high-risk castration-sensitive prostate cancer with Zytiga; Erleada policy implemented

May 2017: New to market Zytiga 500 mg strength added.

Apr 2017: Quantity limits added

Jan 2017: Reviewed for ASO Net Results and Essential formularies.

Sep 2014: Historical Update.