Wound closure in patients with DFU: a cost-effectiveness analysis of two cellular/tissue-derived products.

OBJECTIVE: Determine the cost-effectiveness of extracellular matrix (ECM) relative to human fibroblast-derived dermal substitute (HFDS) on diabetic foot ulcer (DFU) wound closure. METHOD: Outcomes data were obtained from a 12-week, randomised, clinical trial of adults aged 18 years or older diagnosed with type 1 or type 2 diabetes with a DFU. Patients were treated with either ECM or HFDS treatment. A two-state Markov model (healed and unhealed) with a 1-week cycle length was developed using wound-closure rates from the trial to estimate the number of closed-wound weeks and the expected DFU cost per patient. Results were recorded over 12 weeks to estimate the number of closed-wound weeks per treatment and the average cost to achieve epithelialisation (primary outcome). The perspective of the analysis was that of the payer, specifically the Centers for Medicare and Medicaid Services. No cost discounting was performed because of the short duration of the study. RESULTS: The study consisted of 26 patients, with 13 in each group. In the ECM group, 10 wounds closed (77%), with an average closure time of 36 days; 11 wounds closed in the HFDS group (85%), with an average closure time of 41 days. There was no significant difference between these results (p=0.73). Over 12 weeks, the expected cost per DFU was $2522 (£1634) for ECM and $3889 (£2524) for HFDS. Patients treated with HFDS incurred total treatment costs that were approximately 54% higher than those treated with ECM. Sensitivity analyses revealed that the total cost of care for two applications of HFDS was more costly than eight applications of ECM by approximately $500 (£325). CONCLUSION: In patients with DFU, ECM yielded similar clinical outcomes to HFDS but at a lower cost. Health-care providers should consider ECM as a cost-saving alternative to HFDS. DECLARATION OF INTEREST: A.M. Gilligan, and C.R. Waycaster, are employees of Smith & Nephew Inc.. This study was funded by Smith & Nephew Inc.. A.L. Landsman, reports no conflicts of interest.

Patient-reported outcomes with selpercatinib treatment in patients with RET-driven cancers in the phase I/II LIBRETTO-001 trial.

BACKGROUND: This post-hoc retrospective study describes long-term patient-reported outcomes (PROs) for REarranged during Transfection (RET)-altered non-small-cell lung cancer (NSCLC), medullary thyroid cancer (MTC), non-MTC thyroid cancer (TC), and tumor agnostic (TA) patients (Data cut-off: January 2023) from the LIBRETTO-001 trial. PATIENTS AND METHODS: Patients completed the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30). Patients with MTC also completed a modified version of the Systemic Therapy-Induced Diarrhea Assessment Tool (mSTIDAT). The proportion of patients with improved, stable, or worsened status after baseline was reported. PROs were summarized at 3 years (cycle 37) post-baseline for the NSCLC and MTC cohorts, and at 2 years (cycle 25) post-baseline for the TC and TA cohorts. Time-to-event outcomes (time to first improvement or worsening and duration of improvement) were reported. RESULTS: The baseline assessment was completed by 200 (63.3%), 209 (70.8%), 50 (76.9%), and 38 (73.1%) patients in the NSCLC, MTC, TC, and TA cohorts, respectively. The total compliance rate was 80%, 82%, 70%, and 85%, respectively. Approximately 75% (NSCLC), 81% (MTC), 75% (TC), and 40% (TA) of patients across all cohorts reported improved or stable QLQ-C30 scores at year 3 (NSCLC and MTC) or year 2 (TC and TA) with continuous selpercatinib use. Across cohorts, the median time to first improvement ranged from 2.0 to 19.4 months, the median duration of improvement ranged from 1.9 to 28.2 months, and the median time to first worsening ranged from 5.6 to 44.2 months. The total compliance rate for the mSTIDAT was 83.7% and the proportion of patients with MTC who reported diarrhea on the mSTIDAT was reduced from 80.8% at baseline to 35.6% at year 3. CONCLUSIONS: A majority of patients with RET-driven cancers improved or remained stable on most QLQ-C30 domains, demonstrating favorable health-related quality of life as measured by the QLQ-C30 during long-term treatment with selpercatinib.