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Oncology Agents, Prostate Cancer Oncology Oral, Prostate Cancer Therapeutic Class Review (TCR) December 23, 2019 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. Oncology Oral, Prostate Review – December 2019 Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2010-2019 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Manufacturer Indication(s) abiraterone acetate generic, Janssen . In combination with prednisone for the treatment of patients with (Zytiga®)1 metastatic castration-resistant prostate cancer (mCRPC) or metastatic high-risk castration-sensitive prostate cancer (mCSPC) abiraterone acetate Sun . In combination with methylprednisolone for the treatment of (Yonsa®)2 patients with mCRPC apalutamide Janssen . Treatment of patients with non-metastatic castration-resistant (Erleada®)3 prostate cancer (NM-CRPC) . Treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) bicalutamide generic, Ani . In combination therapy with a luteinizing hormone-releasing (Casodex®)4 hormone (LHRH) analog for the treatment of stage D2 metastatic carcinoma of the prostate* darolutamide Bayer . Treatment of non-metastatic castration resistant prostate cancer (Nubeqa®)5 (NM-CRPC) enzalutamide Astellas . Treatment of patients with CRPC (Xtandi®)6 . Treatment of patients with mCSPC estramustine Pfizer . Palliative treatment of metastatic and/or progressive carcinoma of (Emcyt®)7 the prostate flutamide8 generic . In combination with LHRH agonists for the management of locally confined stage B2-C and stage D2 metastatic carcinoma of the prostate nilutamide generic, Concordia . In combination with surgical castration for the treatment of 9 † (Nilandron®) metastatic prostate cancer (stage D2) * Bicalutamide is not approved for use alone or with treatments other than LHRH analogs. † For maximum benefit, treatment with nilutamide tablets must begin on the same day as or on the day after surgical castration. OVERVIEW In the United States (US), prostate cancer is the most commonly diagnosed cancer in men (excluding non-melanoma skin cancers), with an estimated 191,930 cases projected to be diagnosed in 2020.10 While prostate cancer accounts for the largest percentage of diagnosed cases in US males (20%), it only accounts for about 10% of all cancer deaths in this population, far behind the leading cause of cancer death, which is lung cancer, accounting for 24% of US male cancer deaths.11,12 There has been a decreasing incidence of prostate cancer diagnoses since the early 1990s, and from 2011 to 2015, the incidence of prostate cancer declined approximately 7% per year. This decreased incidence in the diagnosis of prostate cancer was likely secondary to a change in practice during that time which saw a decreased rate of routine prostate-specific antigen (PSA) screening. This decrease in routine PSA screening was based on prior recommendations against routine PSA screening from the US Preventive Services Task Force (USPSTF). These recommendations were subsequently revised in early 2018 when the USPSTF recommended that the decision of whether or not to perform PSA testing should be individualized for men ages 55 to 69 years of age based on a discussion with a clinician regarding the potential benefits and harms associated with screening (Grade C recommendation).13 The benefits include a small chance of reducing the odds of dying of prostate cancer, while the potential harms include possible false-positive results requiring additional testing and possible unnecessary prostate Oncology Oral, Prostate Review – December 2019 Page 2 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2010-2019 Magellan Rx Management. All Rights Reserved. biopsy. Other potential harms include over-diagnosis and over-treatment with potential treatment complications, such as incontinence and impotence. The 2018 USPSTF statement also recommends against PSA-based screening for men ages 70 years or older (Grade D). The National Comprehensive Cancer Network (NCCN) guideline for Prostate Cancer Early Detection supports the continued discussion and use of baseline PSA testing in informed, healthy men ages 45 to 75 years.14 The NCCN guidelines also note that due to a higher incidence of prostate cancer and increased prostate cancer mortality seen in African American men, shared decision making about PSA screening may be considered earlier, beginning at age 40, for this population. Likewise, men with known germline BRCA1/2 mutations may consider shared decision making about PSA screening beginning at age 40 years and both groups may consider screening at annual intervals rather than every other year.15 Similarly, the American Cancer Society (ACS) recommends men should receive information about the uncertainties, risks, and potential benefits of prostate cancer screening prior to making an informed choice and that screening should not be conducted unless men have received this information. The age at which to begin these discussions varies depending on the individual risk level based on race and family history.16 The 2013 American Urological Association (AUA) guideline for the early detection of prostate cancer was reviewed and validity confirmed by the AUA in 2018; it recommends average risk men ages 55 to 69 years participate in a shared decision making process with their provider to determine their desire for PSA screening (Evidence Strength Grade B).17 According to a 2012 American Society of Clinical Oncology (ASCO) Provisional Clinical Opinion, the role of PSA testing should be discussed with all men with a life expectancy of > 10 years. ASCO notes that although PSA testing is a useful marker for detecting prostate cancer at early stages, it may also be associated with complications resulting from potentially unnecessary biopsy, surgery, or radiation treatment.18 Prostate cancer is rare in men under the age of 40 years, but the risk increases with each subsequent decade of life. Overall, 1 in 9 US men will develop prostate cancer during their lifetime.19 Aside from age, the risk factors most strongly associated with development of prostate cancer include race/ethnicity and family history. Prostate cancer mortality in non-Hispanic African Americans is more than twice that seen in the US Caucasian population.20 Androgens (specifically testosterone) are a known growth signal for prostate cancer, and the majority of prostate cancers are hormonally dependent. Due to the hormone responsiveness of the tumor, androgen deprivation therapy (ADT) is a cornerstone of prostate cancer treatment. ADT is utilized as the backbone of therapy in advanced or metastatic disease as well as in combination with radiation therapy for locally-advanced prostate cancer. ADT can be accomplished by utilizing either a surgical approach (bilateral orchiectomy) or a medical approach with the administration of a luteinizing hormone-releasing hormone (LHRH) agonist or a LHRH antagonist, to suppress serum testosterone concentrations to castrate levels (< 50 ng/dL). The prognosis of patients diagnosed with prostate cancer is determined by several factors, including the tumor size, histologic grade (reported as a Gleason score), PSA level, and disease stage. While early stage disease is highly curable, advanced, metastatic disease is currently considered incurable. In addition to the treatment approaches discussed in this review, other pharmaceutical treatment modalities exist. Intravenous chemotherapy options, such as docetaxel and cabazitaxel (Jevtana®), as well as immunotherapy options for certain patients, including sipuleucel-T (Provenge®) or pembrolizumab (Keytruda®), and a radiopharmaceutical option, radium-223 (Xofigo®), may also be utilized in the treatment of metastatic prostate cancer. The use of docetaxel, cabazitaxel, sipuleucel-T, Oncology Oral, Prostate Review – December 2019 Page 3 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2010-2019 Magellan Rx Management. All Rights Reserved. pembrolizumab and radium-223 for the management of metastatic
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