PMID- 38174553
OWN - NLM
STAT- MEDLINE
DCOM- 20240109
LR  - 20240116
IS  - 1941-837X (Electronic)
IS  - 1369-6998 (Linking)
VI  - 27
IP  - 1
DP  - 2024 Jan-Dec
TI  - Adverse events and costs among non-metastatic castration-resistant prostate 
      cancer patients.
PG  - 145-152
LID - 10.1080/13696998.2023.2299179 [doi]
AB  - BACKGROUND: Limited real-world evidence exists on the economic burden of adverse 
      events (AEs) to the healthcare system among patients with non-metastatic 
      castration-resistant prostate cancer (nmCRPC) treated with second-generation 
      androgen receptor antagonists (ARAs). Current data is needed to understand 
      real-world clinical event rates among ARAs and the cost of these events. 
      OBJECTIVES: Describe the incidence of non-central nervous system (CNS)-related 
      AEs and CNS-related AEs among nmCRPC patients treated in the United States with 
      second-generation ARAs (apalutamide and enzalutamide) and evaluate healthcare 
      resource utilization (HCRU) and costs for these patients. METHODS AND STUDY 
      DESIGN: This was a retrospective observational cohort study using claims data 
      from Optum Clinformatics Data Mart to identify adult males with prostate cancer, 
      castration, no metastases, and >1 claim for apalutamide or enzalutamide. The 
      study was conducted from January 2017 to March 2020, with a patient index 
      identification period from January 2018 to December 2019. AEs were classified as 
      CNS-related or non-CNS-related. RESULTS: Of 605 patients (156 apalutamide and 449 
      enzalutamide), most were >/=65 years (94%) and had >/=1 non-CNS-related AE (55%). 
      Many had >/=1 CNS-related AE (32%). Pain (12%) and arthralgia (11%) were the most 
      frequently reported non-CNS-related AEs. Fatigue/asthenia (14%) and dizziness 
      (7%) were the most frequently reported CNS-related AEs. Among patients with 
      versus without non-CNS-related AEs, 34% versus 8% had emergency room (ER) events, 
      and 25% versus 2% had inpatient events. Among patients with versus without 
      CNS-related AEs, 41% versus 14% had ER events, and 38% versus 4% had inpatient 
      events. Adjusted per-patient per-year cost (in 2020 USD) differences were 
      significant between patients with and without non-CNS-related AEs ($30,765, 
      p = 0.0018) and between patients with and without CNS-related AEs ($40,689, 
      p = 0.0017). CONCLUSION: There is significant HCRU and cost burden among nmCRPC 
      patients treated with ARAs developing AEs, highlighting the need for treatments 
      with improved tolerability. Additional studies are warranted to include recently 
      approved agents.
FAU - Appukkuttan, Sreevalsa
AU  - Appukkuttan S
AD  - Bayer HealthCare Pharmaceuticals Inc, Whippany, NJ, USA.
FAU - Yao, Jianying
AU  - Yao J
AD  - Bayer HealthCare Pharmaceuticals Inc, Whippany, NJ, USA.
FAU - Partridge, Jamie
AU  - Partridge J
AD  - Bayer HealthCare Pharmaceuticals Inc, Whippany, NJ, USA.
FAU - Kong, Sheldon X
AU  - Kong SX
AD  - Bayer HealthCare Pharmaceuticals Inc, Whippany, NJ, USA.
FAU - Parkin, Jacqueline
AU  - Parkin J
AD  - Bayer HealthCare Pharmaceuticals Inc, Whippany, NJ, USA.
FAU - Freedland, Stephen J
AU  - Freedland SJ
AD  - Cedar-Sinai Medical Center, Los Angeles, CA, USA.
AD  - Durham VA Medical Center, Durham, NC, USA.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20240108
PL  - England
TA  - J Med Econ
JT  - Journal of medical economics
JID - 9892255
RN  - 93T0T9GKNU (enzalutamide)
RN  - 2010-15-3 (Phenylthiohydantoin)
RN  - 0 (Benzamides)
SB  - IM
MH  - Male
MH  - Adult
MH  - Humans
MH  - United States
MH  - *Prostatic Neoplasms, Castration-Resistant/drug therapy/pathology
MH  - Cohort Studies
MH  - Phenylthiohydantoin
MH  - Benzamides/therapeutic use
OTO - NOTNLM
OT  - I
OT  - I00
OT  - I1
OT  - I19
OT  - Prostate cancer
OT  - adverse drug event
OT  - castration-resistant
OT  - economic burden of disease
OT  - health expenditures
OT  - healthcare resource utilization
EDAT- 2024/01/04 11:44
MHDA- 2024/01/09 06:41
CRDT- 2024/01/04 05:34
PHST- 2024/01/09 06:41 [medline]
PHST- 2024/01/04 11:44 [pubmed]
PHST- 2024/01/04 05:34 [entrez]
AID - 10.1080/13696998.2023.2299179 [doi]
PST - ppublish
SO  - J Med Econ. 2024 Jan-Dec;27(1):145-152. doi: 10.1080/13696998.2023.2299179. Epub 
      2024 Jan 8.