OBJECTIVES

: Relugolix is a once daily oral androgen-deprivation therapy (ADT) approved in December 2020 in the U.S. for the treatment of advanced prostate cancer. Results from its head-to-head phase III randomized controlled trial demonstrated comparable efficacy to leuprolide injections given every three months. Relugolix provides a new alternative for ADT compared to currently available injectables, and it is therefore important to compare the difference in out-of-pocket (OOP) costs for patients between these two therapies.

METHODS

: We estimated the OOP costs for the average Medicare patient receiving relugolix 120mg once daily or leuprolide 22.5mg every 3 months for 12-calendar months in 2021. Relugolix OOP costs were calculated based on the 2021 Medicare Part D cost sharing structure using relugolix’s January 2021 wholesale-acquisition-cost (WAC) of $2,313 for a 30-day supply. Leuprolide OOP costs were calculated based on the 2021 Medicare Part B deductible of $203 and patients paying 20% of treatment costs. Leuprolide’s January 2021 Medicare average-sale price (ASP) of $228.93 per 7.5mg (J9217) plus 6% was used to calculate the price of leuprolide. Calculations were made with the assumption that patients did not have any additional co-insurance or financial assistance and did not include calculation of insurance premiums or administration costs.

RESULTS

: The total costs for 12-months of relugolix was estimated to be $27,756 while the total cost of 12-months leuprolide (4 injections) was estimated to be $2,912. The estimated annual OOP costs for relugolix was $3,731 while the estimated annual OOP costs for leuprolide was $745. Therefore, relugolix cost approximately $2,986 more OOP for one-year of treatment compared to leuprolide.

CONCLUSIONS

: While relugolix is the first orally available ADT, its use is associated with a substantially higher OOP cost for Medicare patients. Prescribers should consider the full risk versus benefits when deciding between relugolix and leuprolide, including the potential financial implications for patients.