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.

Real-world evidence in the use of Bevacizumab in age-related macular degeneration (ArMD): a scoping review.

PURPOSE: Pharmacological treatments for age-related macular degeneration (ArMD) include anti-vascular endothelial growth factor therapies. Bevacizumab is used off-label, as it has no indication for ArMD. This study aims to identify and describe literature on real-world evidence of bevacizumab (originator or biosimilars) use in ArMD. METHODS: A scoping review was conducted in Medline, CINAHL and Embase databases. Studies published in English after September 2017, conducted in USA, including adults (≥ 18 years old) with ArMD who received treatment with bevacizumab for ArMD were included. The review was further limited to peer-reviewed observational studies that quantitatively analyze either clinical or patient-reported outcomes among patients treated with bevacizumab for ArMD. RESULTS: The search strategy retrieved 543 studies. After title and abstract screening, a total of 142 studies were selected for full-text review leading to a total of 12 studies qualifying for data charting. All were retrospective studies. Five (41.6%) of the studies had less than 500 eyes included in the analysis, and the rest had over a thousand eyes. All except one study reported clinical outcomes (visual acuity was the main outcome in 8 (66.6%) studies). There were 3 (25%) studies reporting adverse events of bevacizumab intravitreal injections. None of the studies specified using biosimilars for bevacizumab and none mentioned patient-reported outcomes. CONCLUSION: The lack of studies aiming to study the patient-reported outcomes as well as the use of biosimilars of bevacizumab in ArMD makes this field a potential for future research. The different exposures and times to follow-up make it difficult to compare results among the selected studies.

The implementation of value-based frameworks, clinical care pathways, and alternative payment models for cancer care in the United States.

BACKGROUND: Cancer treatment is a significant driver of rising health care costs in the United States, where the annual cost of cancer care is estimated to reach $246 billion in 2030. As a result, cancer centers are considering moving away from fee-for-service models and transitioning to value-based care models, including value-based frameworks (VBFs), clinical care pathways (CCPs), and alternative payment models (APMs). OBJECTIVE: To assess the barriers and motivations for using value-based care models from the perspectives of physicians and quality officers (QOs) at US cancer centers. METHODS: Sites were recruited from cancer centers in the Midwest, Northeast, South, and West regions in a 15/15/20/10 relative distribution. Cancer centers were identified based on prior research relationships and known participation in the Oncology Care Model or other APMs. Based on a literature search, multiple choice and open-ended questions were developed for the survey. A link to the survey was emailed to hematologists/oncologists and QOs at academic and community cancer centers from August to November 2020. Results were summarized using descriptive statistics. RESULTS: A total of 136 sites were contacted; 28 (21%) centers returned completed surveys, which were included in the final analysis. 45 surveys (23 from community centers, 22 from academic centers) were completed: 59% (26/44), 76% (34/45), and 67% (30/45) of physicians/QOs respondents had used or implemented a VBF, CCP, and APM, respectively. The top motivator for VBF use was "producing real-world data for providers, payers, and patients" (50% [13/26]). Among those not using CCPs, the most common barrier was a "lack of consensus on pathway choices" (64% [7/11]). For APMs, the most common difficulty was that "innovations in health care services and therapies must be adopted at the site's own financial risk" (27% [8/30]). CONCLUSIONS: The ability to measure improvements in cancer health outcomes was a large motivator for implementing value-based models. However, heterogeneity in practice size, limited resources, and potential increase in costs were possible barriers to implementation. Payers need to be willing to negotiate with cancer centers and providers to implement the payment model that will most benefit patients. The future integration of VBFs, CCPs, and APMs will depend on reducing the complexity and burden of implementation. DISCLOSURES :Dr Panchal was affiliated with the University of Utah at the time this study was conducted and discloses current employment with ZS. Dr McBride discloses employment with Bristol Myers Squibb. Dr Huggar and Dr Copher report employment, stock, and other ownership interests in Bristol Myers Squibb. The other authors have no competing interests to disclose. This study was funded by an unrestricted research grant from Bristol Myers Squibb to the University of Utah.

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.

Advancing a managed care pharmacy research agenda: Generating real-world evidence to support US Food and Drug Administration Accelerated Approvals and improving benefit design to address health inequities.

To advance their research agenda, the Academy of Managed Care Pharmacy (AMCP) and the AMCP Foundation (AMCPF) invited a sample of AMCP membership to participate in focus groups and tasked them with developing tangible research aims for each of the top 2 previously identified AMCP/AMCPF research priorities: generating real-world evidence (RWE) to support US Food and Drug Administration (FDA) Accelerated Approvals and improving benefit design to address health inequities. The resulting research aims, which were further refined per feedback from additional stakeholders, will serve to guide requests for proposals for funding of specific research projects to address these top managed care priorities. Research aims identified by focus group participants related to generating RWE for FDA Accelerated Approvals include (1) creating a data survey tool for managed care to make RWE more readily available, (2) linking surrogate endpoints to meaningful clinical outcomes for drug development, and (3) improving patient outcomes by determining the optimal sequence of clinical pathways. Research aims identified by focus group participants related to improving benefit design to address health inequities include (1) identifying how the ability to navigate managed care benefit designs may impact inequities, (2) understanding the connection between health inequities and medication adherence, and (3) evaluating the impact of social determinants of health on medication affordability. DISCLOSURES: These proceedings were supported by Bridget Flavin, PharmD, Founder, Connected Content, Ltd. Connected Content, Ltd. received payment from AMCP for the preparation of this manuscript. Flavin is also an adjunct associate professor at the University of Florida College of Pharmacy. Diana Brixner received AMCP Foundation support of sabbatical to conduct this work, support of a medical writer to assist in putting the manuscript together, consulting fees from Millcreek Outcomes Group, Elevar, Sage, Haymarket, and AMCP funding of one trip to Alexandria, VA. This research and the development of this manuscript were funded by AMCP and the AMCP Foundation.

National Trends in Oral Antibiotic Prescribing in United States Physician Offices from 2009 to 2016.

BACKGROUND: Prior studies have found that outpatient antibiotics are commonly prescribed for non-bacterial conditions. It is unclear if national prescribing has changed in recent years given recent public health and antimicrobial stewardship initiatives. This study aimed to describe antibiotic prescribing in United States (U.S.) physician offices. MATERIALS/METHODS: This was a cross-sectional study of all sampled patient visits in the Centers for Disease Control and Prevention's National Ambulatory Medical Care Survey from 2009 to 2016. Antibiotic use was defined as at least one oral antibiotic prescription during the visit as identified by Multum code(s). Patient visits were categorized by U.S. geographic region and season. ICD-9-CM and ICD-10 codes were used to assess diagnoses and categorize antibiotic use as appropriate, possibly appropriate, or inappropriate. RESULTS: Seven billion visits were included for analysis, with 793,415,182 (11.3%) including an antibiotic. Prescribing rates were relatively stable over the study period (102.9-124.9 prescriptions per 1000 visits); however, 2016 had one of the lowest prescribing rates (107.7 per 1000 visits). The most commonly prescribed antibiotic class was macrolides (25 per 1000 visits). The South region and winter season had the highest antibiotic prescribing (118.2 and 129.7 per 1000 visits, respectively). Of patients who received an antibiotic, 55.9%, 35.7%, and 8.4% were classified as inappropriate, possibly appropriate, and appropriate, respectively. The most common conditions in which antibiotics were prescribed inappropriately included those with no indication in any of the predefined diagnosis codes (40.1%), other skin conditions (17.3%), and viral upper respiratory conditions (13.3%). CONCLUSIONS: There was no significant reduction in outpatient antibiotic prescribing rates among U.S. outpatients from 2009 to 2016 and prescribing varied by region and season. These data suggest that more than half of antibiotics were prescribed inappropriately, with the majority of antibiotics prescribed with no indication. However, these findings need to be confirmed with robust prospective studies.

GABAergic but not Antidepressant Medications Increase Risk for Clostridioides difficile Infection in a National Cohort of Veterans.

BACKGROUND: Clostridioides difficile infection (CDI) is primarily mediated by alterations in the host gut ecosystem. While antibiotic use is the primary risk factor for CDI, other medications that modulate the gut ecosystem, particularly those targeting the gut-brain axis, could impact CDI risk. This study aimed to investigate the association between recent antidepressant and gamma-aminobutyric acid (GABA)-ergic medication use with CDI risk in a national cohort of United States veterans. METHODS: This was a retrospective case-control study of patients seen in Veterans Health Administration facilities from October 2002 to September 2014. CDI and non-CDI control patients were propensity score matched 1:1 using a maximum caliper of 0.0001. Antidepressant and GABAergic medication use 90 days before cohort inclusion were analyzed for CDI association using bivariable and multivariable logistic regression models. RESULTS: A total of 85 831 patients were included, and 9287 CDI and 9287 control patients were propensity score matched. Antidepressant use overall was not significantly associated with CDI risk (odds ratio [OR], 1.05; 95% CI, 0.98-1.12), although GABAergic medication use was associated with increased risk (OR, 1.81; 95% CI, 1.70-1.92). In multivariable models of individual medications/classes, benzodiazepines had the strongest CDI association (OR, 1.91; 95% CI, 1.77-2.07). SSRIs (OR, 0.88; 95% CI, 0.81-0.95) and bupropion (OR, 0.67; 95% CI, 0.57-0.78) were negatively associated with CDI. CONCLUSIONS: In this national study of veterans, GABAergic medication use was a positive predictor of CDI risk, though antidepressant use was not. Further research is needed to understand biological mechanisms, and confirmatory studies are needed to validate these findings.