WHA

ORGOVYX (relugolix)

SELF ADMINISTRATION - ORAL

Indication for Prior Authorization:
  • For the treatment of adult patients with advanced prostate cancer.
Coverage Criteria:

For diagnosis of advanced prostate cancer:

  • Patient is 18 years of age or older; AND
  • Chart note documentation is provided confirming the diagnosis of advanced prostate cancer; AND
  • Prescribed by or in consultation with an oncologist or urologist; AND
  • Patient has required at least one year of androgen deprivation therapy (e.g., brand Lupron® formulations, Xtandi®, Nubeqa®); AND
  • The disease is one of the following:
    • Evidence of biochemical or clinical relapse following local primary intervention with curative intent
    • Newly diagnosed androgen-sensitive metastatic disease
    • Advanced localized disease unlikely to be cured by local primary intervention with curative intent
Reauthorization:
  • Patient does not show evidence of progressive disease while on therapy; AND
  • Documentation of serum testosterone level less than 50 ng/dL
Additional Information:
  • QT prolongation.  Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval.  Electrolyte abnormalities should be corrected.  Consider periodic monitoring of electrocardiograms and electrolytes.
This Medication Is Not Approvable for the Following Condition(s):

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Dosing:
  • Initiate with a loading dose of 360 mg on the first day and continue treatment with a 120 mg dose taken orally once daily at approximately the same time each day.
  • Avoid co-administration of Orgovyx™ with combined P-gp and strong CYP3A inducers.  If c-administration is unavoidable, increase the Orgovyx™ dose to 240 mg once daily.
Coverage Duration:
  • 1 year
Review History:
  • 4/20/2021- Original review
References:
  • Orgovyx Prescribing Information. Myovant Sciences, Inc. Brisbane, CA. December 2020.

 

 

Last review date: April 20, 2021