Indirect Treatment Comparisons of Lenacapavir Plus Optimized Background Regimen Versus Other Treatments for Multidrug-Resistant Human Immunodeficiency Virus.

BACKGROUND/AIMS: Heavily treatment-experienced (HTE) people with human immunodeficiency virus (HIV) (PWH) may not achieve virologic suppression (VS) with combination antiretroviral therapy due to multidrug resistance (MDR), intolerance, and safety concerns. These PWH often receive highly individualized treatment regimens, but these regimens may not enable PWH to achieve VS, thereby halting disease progression. Novel medications are required for treating individuals with MDR HIV. Lenacapavir (LEN), a first-in-class HIV capsid inhibitor, is under investigation for the treatment of HTE individuals with MDR HIV in the phase 2/3 CAPELLA study. This study aimed to compare LEN plus optimized background regimen (OBR) with fostemsavir (FTR) + OBR, ibalizumab (IBA) + OBR, and OBR alone in terms of VS, CD4 cell count change from baseline, immunologic recovery, and discontinuation due to adverse events, using indirect treatment comparisons. METHODS: A systematic review identified clinical evidence on HIV-1 treatments in HTE PWH. A feasibility assessment evaluated the identified studies for indirect treatment comparison analyses based on population characteristics, interventions, comparators, and outcomes of interest. Unanchored simulated treatment comparisons of LEN + OBR versus comparators were conducted. RESULTS: LEN + OBR had 6.57 times higher odds of VS at weeks 24 to 28 than FTR + OBR (95% confidence interval [CI] 1.34-32.28), 8.93 times higher odds of VS than IBA + OBR (95% CI 2.07-38.46), and 12.74 times higher odds of VS than OBR alone (95% CI 1.70-95.37). Change from baseline in CD4 cell count was similar across LEN + OBR, FTR + OBR, and IBA + OBR. CONCLUSION: LEN + OBR has statistically significantly greater odds of VS at weeks 24 to 28 than its comparators and represents a novel treatment for people with MDR HIV.

Primary Prophylaxis With Biosimilar Filgrastim for Patients at Intermediate Risk for Febrile Neutropenia: A Cost-Effectiveness Analysis.

PURPOSE: Temporary COVID-19 guideline recommendations have recently been issued to expand the use of colony-stimulating factors in patients with cancer with intermediate to high risk for febrile neutropenia (FN). We evaluated the cost-effectiveness of primary prophylaxis (PP) with biosimilar filgrastim-sndz in patients with intermediate risk of FN compared with secondary prophylaxis (SP) over three different cancer types. METHODS: A Markov decision analytic model was constructed from the US payer perspective over a lifetime horizon to evaluate PP versus SP in patients with breast cancer, non-small-cell lung cancer (NSCLC), and non-Hodgkin lymphoma (NHL). Cost-effectiveness was evaluated over a range of willingness-to-pay thresholds for incremental cost per FN avoided, life year gained, and quality-adjusted life year (QALY) gained. Sensitivity analyses evaluated uncertainty. RESULTS: Compared with SP, PP provided an additional 0.102-0.144 LYs and 0.065-0.130 QALYs. The incremental cost-effectiveness ranged from $5,660 in US dollars (USD) to $20,806 USD per FN event avoided, $5,123 to $31,077 USD per life year gained, and $7,213 to $35,563 USD per QALY gained. Over 1,000 iterations, there were 73.6%, 99.4%, and 91.8% probabilities that PP was cost-effective at a willingness to pay of $50,000 USD per QALY gained for breast cancer, NSCLC, and NHL, respectively. CONCLUSION: PP with a biosimilar filgrastim (specifically filgrastim-sndz) is cost-effective in patients with intermediate risk for FN receiving curative chemotherapy regimens for breast cancer, NSCLC, and NHL. Expanding the use of colony-stimulating factors for patients may be valuable in reducing unnecessary health care visits for patients with cancer at risk of complications because of COVID-19 and should be considered for the indefinite future.

Evaluating the Presence of Cognitive Biases in Health Care Decision Making: A Survey of U.S. Formulary Decision Makers.

BACKGROUND: Behavioral economics is a field of economics that draws on insights from psychology to understand and identify patterns of decision making. Cognitive biases are psychological tendencies to process information in predictable patterns that result in deviations from rational decision making. Previous research has not evaluated the influence of cognitive biases on decision making in a managed care setting. OBJECTIVE: To assess the presence of cognitive biases in formulary decision making. METHODS: An online survey was conducted with a panel of U.S. pharmacy and medical directors who worked at managed care organizations and served on pharmacy and therapeutics committees. Survey questions assessed 4 cognitive biases: relative versus absolute framing effect, risk aversion, zero-risk bias, and delay discounting. Simulated data were presented in various scenarios related to adverse event profiles, drug safety and efficacy, and drug pricing for new hypothetical oncology products. Survey questions prompted participants to select a preferred drug based on the information provided. Survey answers were analyzed to identify decision patterns that could be explained by the cognitive biases. Likelihood of bias was analyzed via chi-square tests for framing effect, risk aversion, and zero-risk bias. The delay discounting section used a published algorithm to characterize discounting patterns. RESULTS: A total of 35 pharmacy directors and 19 medical directors completed the survey. In the framing effect section, 80% of participants selected the suboptimal choice in the relative risk frame, compared with 38.9% in the absolute risk frame (P < 0.0001). When assessing risk aversion, 42.6% and 61.1% of participants displayed risk aversion in the cost- and efficacy-based scenarios, respectively, but these were not statistically significant (P = 0.27 and P = 0.10, respectively). In the zero-risk bias section, results from each scenario diverged. In the first zero-risk bias scenario, 90.7% of participants selected the drug with zero risk (P < 0.001), but in the second scenario, only 32.1% chose the zero-risk option (P < 0.01). In the section assessing delay discounting, 54% of survey participants favored a larger delayed rebate over a smaller immediate discount. A shallow delay discounting curve was produced, which indicated participants discounted delayed rewards to a minimal degree. CONCLUSIONS: Pharmacy and medical directors, like other decision makers, appear to be susceptible to some cognitive biases. Directors demonstrated a tendency to underestimate risks when they were presented in relative risk terms but made more accurate appraisals when information was presented in absolute risk terms. Delay discounting also may be applicable to directors when choosing immediate discounts over delayed rebates. However, directors neither displayed a statistically significant bias for risk aversion when assessing scenarios related to drug pricing or clinical efficacy nor were there significant conclusions for zero-risk biases. Further research with larger samples using real-world health care decisions is necessary to validate these findings. DISCLOSURES: This research was funded by Xcenda. Mezzio, Nguyen, and O'Day are employees of Xcenda. Kiselica was employed by Xcenda at the time the study was conducted. The authors have nothing to disclose. A portion of the preliminary data was presented as posters at the 2017 AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 27-30, 2017; in Denver, CO, and the 2017 International Society for Pharmacoeconomics and Outcomes Research 22nd Annual International Meeting; May 20-24, 2017; in Boston, MA.

Association of ABC (HbA1c, blood pressure, LDL-cholesterol) goal attainment with depression and health-related quality of life among adults with type 2 diabetes.

AIMS: To determine the relationship between ABC goal attainment, depression, and health-related quality of life (HRQoL) among a national sample of patients with type 2 diabetes (T2DM). METHODS: A retrospective, cross-sectional analysis was performed examining 808 non-pregnant patients ≥20 years old with T2DM from the National Health and Nutrition Examination Survey (NHANES) 2007-2012. ABC goals were defined as HbA1c<7%, BP<130/80 mm Hg, and LDL-C<100 mg/dL. Patient characteristics associated with ABC goal attainment were examined. RESULTS: Overall, 23.7% of participants achieved simultaneous ABC goals. Severe depression was significantly associated with lower rates of ABC goal attainment compared to those with no depression (5.0% vs. 25.4%, p=0.048). ABC goal attainment rates were lower among females, Hispanic and non-Hispanic black minority groups, and patients with a duration of diabetes over five years, while increased visits with health care professionals were significantly associated with meeting all three ABC goals for patients with T2DM. CONCLUSIONS: The relationship between simultaneous ABC goal attainment, depression and HRQoL is complex. Patients with T2DM unable to meet ABC goals may benefit from increased contact with health care professionals.