The impact of a statewide insulin copay cap policy for insured patients with diabetes in Utah.

BACKGROUND: Insulin affordability is a huge concern for patients with diabetes in the United States. On March 30, 2020, Utah signed House Bill 207 into law, aimed at capping copayments for insulin at $30 for a 30-day supply. The bill was enacted on January 1, 2021. OBJECTIVE: To assess patient basal insulin adherence, out-of-pocket costs, health plan costs, total costs on insulin, and hemoglobin A1c (A1c) in prepolicy vs postpolicy periods. METHODS: This study is a retrospective analysis using data from a regional health plan in Utah from October 1, 2019, to September 30, 2021. Inclusion criteria were fully enrolled members of all ages, under commercial insurance, with at least 1 fill for any type of insulin in both the preperiod and the postperiod. Adherence was measured by proportion of days covered (PDC). Paired t-tests and Wilcoxon sign rank tests were conducted to compare the health and economic outcomes. RESULTS: Out of 24,150 commercially insured individuals, a total of 244 patients were included. Across all 244 patients, there was a significant decline in monthly median out-of-pocket costs of insulin by 58.5% (P < 0.001), whereas the monthly median health plan costs of insulin increased by 22.0% (P < 0.001). The total monthly costs of insulin (the sum of out-of-pocket and health plan costs) were unchanged (P = 0.115). Only 74 patients with enough basal insulin fills in both periods were included in the analysis for PDC changes. PDC change was not statistically significant (P = 0.43). Among the 74 patients with PDC calculations, 29 patients had A1c recorded in both periods. The change in A1c was not statistically significant (P = 0.23). CONCLUSIONS: An insulin copayment max of $30 in Utah demonstrated lower patient out-of-pocket costs, subsidized by the health plan. PDC did not change, and HbA1c did not improve. An assessment of a longer period and on a larger population is needed.

Understanding patient cost-sharing thresholds for diabetes treatment attributes via a discrete choice experiment.

BACKGROUND: The process used to prefer certain products across drug classes for diabetes is generally focused on comparative effectiveness and cost. However, payers rarely tie patient preference for treatment attributes to formulary management resulting in a misalignment of value defined by providers, payers, and patients. OBJECTIVES: To explore patients' willingness to pay (WTP) for the predetermined high-value and low-value type 2 diabetes mellitus (T2DM) treatments within a health plan. METHODS: A cross-sectional discrete choice experiment (DCE) survey was used to determine patient preference for the benefit, risk, and cost attributes of T2DM treatments. A comprehensive literature review of patient preference studies in diabetes and a review of guidelines and medical literature identified study attributes. Patients and diabetes experts were interviewed and instructed to identify, prioritize, and comment on which attributes of diabetes treatments were most important to T2DM patients. The patients enrolled in a health plan were asked to respond to the survey. A multinomial logit model was developed to determine the relative importance and the patient's WTP of each attribute. The patients' relative values based on WTPs for T2DM treatments were calculated and compared with the treatments by a health plan. RESULTS: A total of 7 attributes were selected to develop a web-based DCE questionnaire survey. The responses from a total of 58 patients were analyzed. Almost half (48.3%) of the respondents took oral medications and injections for T2DM. The most prevalent side effects due to diabetes medications were gastrointestinal (43.1%), followed by weight gain (39.7%) and nausea (32.8%). Patients were willing to pay more for treatments with proven cardiovascular benefit and for the risk reduction of hospitalization from heart failure. On the other hand, they would pay less for treatments with higher gastrointestinal side effects. Patients were willing to pay the most for sodium-glucose cotransporter 2 inhibitor and glucagon-like peptide 1 receptor agonist agents and the least for dipeptidyl peptidase-4 inhibitors and thiazolidinediones. CONCLUSIONS: This study provides information to better align patient, provider, and payer preferences in both benefit design and value-based formulary strategy for diabetes treatments. A preferred placement of treatments with cardiovascular benefits and lower adverse gastrointestinal side effects may lead to increased adherence to medications and improved clinical outcomes at a lower overall cost to both patients and their health plan. DISCLOSURES: This study was supported by a grant from the PhRMA Foundation.

Assessment of Anastomotic Viability With Spectroscopic Real-time Oxygen Saturation Measurement in a Porcine Study.

OBJECTIVE: Anastomotic leakage (AL) is a severe complication following intestinal procedures. Intra.Ox™ by ViOptix Inc (Newark, CA, USA) is a novel, FDA-approved spectroscopic device which enables real-time measurement of mixed tissue oxygen saturation (StO2). Using a porcine model, this study explores the correlation between StO2 measurements and AL formation as well as investigates the applicability of Intra.Ox™ in the clinical setting. METHODS: Eleven female swine were divided into 3 groups to explore AL formation in different ischemic conditions. Group 1: 100% mesenteric-vascular ligation, n = 3; Group 2: 50% ligation, n = 5; Group 3: No mesenteric ligation, n = 3. StO2 at the anastomotic line was measured before and after vessel ligation and anastomosis. Measurements were taken at 6 distinct locations along afferent and efferent loops. AL was evaluated on postoperative day 5 by re-laparotomy. RESULTS: AL rate was 100%, 60% and 0% in groups 1, 2 and 3, respectively. Post-anastomotic StO2 in group 1 (22.9 ± 18.5%) and 2 (39.2 ± 20.1%) were significantly lower than in group 3 (53.1 ± 8.3%, p<.0001). Post-anastomotic StO2 readings ≤40% indicated AL potential with 100% sensitivity,+ 80% specificity, positive predictive value of 85.7% and negative predictive value of 100%. CONCLUSION: This study demonstrates the value of Intra.Ox™ in assessing local perfusion and indicate the association between low StO2 and AL by providing accurate, real-time, noninvasive tissue oxygenation measurements at anastomotic sites. Further studies are required to investigate the clinical application of this novel device in intestinal surgery.