Taylor R1, Lad S2, Petersen E3, Stauss T4, White J5, Healey B6, Baker-Wagner M7, Sacks N6, Patil S8, Caraway D8, Brooks E8
1University of Glasgow, Glasgow, UK, 2Duke University School of Medicine, Durham, NC, USA, 3University of Arkansas for Medical Sciences, Little Rock, AR, USA, 4Advanced Pain Management, Greenfield, WI, USA, 5AES Compass Orlando, Orlando, FL, USA, 6PRECISIONheor, Boston, MA, USA, 7Precision HEOR, Boston, MA, USA, 8Nevro, Redwood, CA, USA
OBJECTIVES Painful diabetic neuropathy (PDN) affects around 20% of people with diabetes and is associated with higher healthcare resource utilization (HRU) compared with non-PDN patients with diabetes (Mehra 2014; Kiyani 2020). Conventional medical management (CMM) includes pharmacotherapy, which has limited efficacy and adverse side effects. High-frequency 10-kHz spinal cord stimulation (SCS) has demonstrated significant pain reduction in individuals with refractory PDN in a safe and effective manner (Petersen 2021). This study sought to determine the effect of 10-kHz SCS+CMM on HRU. METHODS HRU were collected during the SENZA-PDN clinical trial (NCT03228420). They included hospitalizations, considered a serious adverse event, as well as emergency department (ED) visits, physician office visits, and prescriptions at baseline, one, three, and six months. HRU was compared between PDN patients treated with 10-kHz SCS+CMM plus CMM and those treated with CMM alone. Results at 6-month follow up are reported as means ± standard deviations with 2-group student’s t-test used to assess between group P-value. RESULTS Out of 183 randomized patients who completed 6-month follow-up, 88 were assigned to 10-kHz SCS+CMM (40% female, average age 60.3±10.9 years), and 95 to CMM alone (35% female, average age 60.7±10.2 years). Hospitalization rates were half as common for 10-kHz SCS+CMM patients (0.08±0.27 vs. CMM-alone: 0.15±0.46; p=0.11). The average length of stay per hospitalization was lower in 10-kHz SCS+CMM (4.14±2.61 days vs. CMM-alone: 5.21±5.31; p=0.27). Self-reported ED visits were the same (0.16±0.447 vs. CMM-alone: 0.15 ±.366; p=0.5) and physician office visit rates were similar (5.53±3.59 vs. CMM-alone: 6.22±3.87; p=0.1). Rates of prescriptions were similar across classes except for antidepressants which were lower for 10-kHz SCS+CMM (2.95±1.73 vs. 4.13±2.85; p<0.01). CONCLUSIONS High-frequency 10-kHz SCS may result in a reduction in hospitalization rates and length of stay in patients with refractory PDN while broader HRU reductions need to be evaluated for a longer time.
Conference/Value in Health Info
2021-11, ISPOR Europe 2021, Copenhagen, Denmark
Value in Health, Volume 24, Issue 12, S2 (December 2021)
Trial-Based Economic Evaluation