Orgovyx (relugolix)

Orgovyx (relugolix) is FDA-approved for the treatment of adult patients with advanced prostate cancer.

Treatment options for prostate cancer include:

• Observation (watching without treatment)
• Surgery radiation (using strong beams of energy)
• Medicines

Medicines used in the treatment can be chemotherapy that stops cancer cells from increasing, targeted therapy that kills cancer cells only, or hormone treatment that stops the body from making hormones that may help cancer cells grow. Orgovyx (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist that works by competitively binding to pituitary GnRH receptors, thereby, reducing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and consequently testosterone. Testosterone helps prostate cancer to grow until or unless cellular adaptation results in hormonal resistance.

NOTE: The Plan requires that members be unable to use, or have tried and failed preferred product(s) first. Requests for non-formulary medications are also subject to Medical Necessity Criteria for Non-Formulary Drugs (PG069).

Definitions

• Castration sensitive refers to a type of prostate cancer that is highly responsive to medical treatment.
• Gonadotropin releasing hormone (GnRH) refers to a neurohormone that is responsible for the production of sex hormones.
• Improvement in disease-related symptoms refers to a positive change in symptoms associated with prostate cancer. These symptoms could include pain reduction, improvement in urinary symptoms, or overall improvement in the quality of life.
• Metastatic disease is the spread of disease from the initial site to another part or parts of the body.
• PSA (prostate-specific antigen) refers to a protein produced by prostate cells that is often found at higher levels in most cancerous prostate cells. An elevated PSA can be indicative of a fast-growing tumor or a cancer that is more likely to spread to other parts of the body.
• Stable disease by imaging refers to the absence of disease progression as observed through imaging tests such as CT scans, MRI scans, or bone scans. This indicates that the cancer has not worsened since starting Orgovyx treatment.
• Testosterone is the primary sex hormone in males that is associated with the development of reproductive tissues such as the prostate.

Medical Necessity Criteria for Initial Authorization

The Plan considers Orgovyx (relugolix) medically necessary when ALL of the following criteria are met:

1. Orgovyx (relugolix) is being used to treat stage IV advanced, metastatic cancer [based upon applicable state regulations]; OR
2. The following criteria are met:
   1. The member is 18 years of age or older; AND
   2. The member has a diagnosis of androgen-sensitive advanced prostate cancer with ONE of the following:
      1. Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent (such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound); or
      2. Newly diagnosed androgen-sensitive metastatic disease; or
      3. Advanced localized disease not suitable for local primary surgical intervention with curative intent; AND
   3. The member meets ONE (1) of the following:
      1. is unable to use, or has tried and failed leuprolide injection; or
      2. has established cardiovascular disease (e.g., history of myocardial ischemia, coronary artery disease, myocardial infarction, cerebrovascular accident, angina pectoris, or coronary artery bypass) OR multiple cardiovascular risk factors (2 or more); AND
   4. Chart documentation and supporting laboratory test results are provided for review to substantiate the above listed requirements.
   If the above prior authorization criteria are met, Orgovyx (relugolix) will be approved for 6 months.

Medical Necessity Criteria for Reauthorization:

Reauthorization for 12 months will be granted if recent chart documentation (within the last 6 months) shows ONE of the following since starting Orgovyx (relugolix):

2. The member has demonstrated a clinically significant response to Orgovyx therapy as evidenced by ANY ONE of the following:
   1. ≥50% PSA decline from baseline; or
   2. Improvement in disease-related symptoms; or
   3. Stable disease by imaging.

Experimental or Investigational / Not Medically Necessary:

Orgovyx (relugolix) for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References

1. American Urological Association Guidelines 2020: Advanced Prostate Cancer. Available at: https://www.urotoday.com/conference-highlights/aua-2020/aua-2020-prostate-cancer/122475-aua-guidelines-2020-advanced-prostate-cancer.html. Accessed 23 Feb 2021.
2. Lee RJ, Smith ML. Initial systemic therapy for advanced, recurrent, and metastatic no cast rate (castration-sensitive) prostate cancer. Accessed at www.UpToDate.com. Updated 31 Jan 2022. Accessed 10 February 2022.
3. Levine GN, D’Amico AV, Berger P, et al; American Heart Association Council on Clinical Cardiology and Council on Epidemiology and Prevention, the American Cancer Society, and the American Urological Association. Androgen-deprivation therapy in prostate cancer and cardiovascular risk. A science advisory from the American Heart Association, American Cancer Society, and American Urological Association: endorsed by the American Society for Radiation Oncology. Circulation. 2010;121(6):833-840.
   doi:10.1161/CIRCULATIONAHA.109.192695[PubMed 20124128]
4. Lowrance WT et al: Advanced prostate cancer: AUA/ASTRO/SUO guideline part II. J Urol. 205(1):22-9, 2021
5. Lyon AR, López-Fernández T, Couch LS, et al; ESC Scientific Document Group. 2022 ESC guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022;43(41):4229-4361. doi:10.1093/eurheartj/ehac244[PubMed 36017568]
6. Merriam-Webster.com Dictionary. Merriam-Webster. Available at: https://www.merriam-webster.com/dictionary. Accessed 23 Feb 2021.
7. National Comprehensive Cancer Network: NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Prostate Cancer. Version 1.2023. NCCN website. Updated September 16, 2022. Accessed November 2022. https://www.nccn.org/
8. National Comprehensive Cancer Network. (2022). Prostate cancer (version 3.2022). Retrieved from https://www.nccn.org/professionals/physician_gls/pdf/prostate_blocks.pdf. Accessed 10 Feb 2022.
9. Orgovyx (relugolix) [prescribing information]. Brisbane, CA: Myovant Sciences Inc; March 2023.
10. Shore ND, Saad F, Cookson MS, et al. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. The New England Journal of Medicine. (2020): 2187-2196.
    doi:10.1056/NEJMoa2004325doi:10.1056/NEJMoa2004325
11. Virgo KS, Rumble RB, de Wit R, et al. Initial Management of Noncastrate Advanced, Recurrent, or Metastatic Prostate Cancer: ASCO Guideline Update. J Clin Oncol 2021; 39:1274.

Clinical Guideline Revision / History Information

Original Date: 03/11/2021
Reviewed/Revised: 12/01/2021, 03/17/2022, 12/08/2022, 12/14/2023