• Budgetary Impact of TRICARE Antidiabetic Drug Formulary Changes

      Hung, Anna; Mullins, C. Daniel (2018)
      Background: There is guidance on how to conduct budget impact analyses (BIA) from the International Society of Pharmacoeconomics and Outcomes Research (ISPOR). However, there is a growing need to ensure that budget impact models are valid, accurate, and usable to payers. In 2016, the Defense Health Agency implemented antidiabetic formulary changes to the TRICARE pharmacy benefit. The goal of this dissertation is to predict and validate the budget impact of these formulary changes. Objective: The specific objectives of this study were to: i) estimate the annual financial consequences of antidiabetic formulary changes from the TRICARE payer perspective using TRICARE claims data over three years; ii) assess the face validity, internal validity, and predictive validity of the model; and iii) identify and compare cost drivers of both the budget and the budget impact identified through the model versus the empirical analysis. Methods: Following the ISPOR BIA guidance, a budget impact model was created in Microsoft Excel®. The counterfactual was predicted using autoregressive integrated moving average models. One year after the formulary changes, actual utilization was used to determine the realized budget and compare this to what was predicted in the budget impact model. Cost drivers were determined through one-way sensitivity analyses, subgroup analyses, and the comparison of utilization versus price in the model versus the empirical analysis. Results: In the year after the formulary changes, the model predicted a lower budget impact than what was realized ($24 million in savings versus $49 million in savings). Meanwhile, the model predicted a higher annual budget than what was realized ($686 million versus $609 million). The higher-than-predicted savings was largely due to lower utilization seen in the empirical analysis compared to the model. The antidiabetic drug classes that contributed most to these savings were the dipeptidyl peptidase-4 inhibitors, glucagon-like receptor-1 agonists, and sodium-glucose cotransporter 2 inhibitors. Conclusion: Future budget impact models should be validated by waiting at least one year and comparing model predictions to what is realized. The end user of the model should also be involved in the process of creating the model.
    • Developing a patient-driven cost-effectiveness analysis of pharmacological treatments for patients with chronic hepatitis C

      Mattingly II, T. Joseph; Mullins, C. Daniel; 0000-0001-7786-5780 (2019)
      Background: Innovations in hepatitis C virus (HCV) drug therapy included in comparative clinical effectiveness evaluations focus on sustained virologic response (SVR) without consideration of socioeconomic or psychological outcomes. This study aimed to identify and prioritize variables important to patients and determine the impact of patient-centered parameters on the cost effectiveness of HCV treatments. Methods: An individual-based state-transition model was developed with the guidance of a patient-centered multi-stakeholder advisory board and patient-only Delphi panel. The model was used to perform a patient-driven cost-effectiveness analysis (CEA) of direct acting antivirals (DAAs) over 10 and 20 year time horizons from both health sector and societal perspectives. The patient-centered model and CEA results were then compared with recently published HCV CEAs. Results: Patients identified treatment effectiveness, longer life, fear of complications, financial issues, quality of life, and impact on society as important factors to include. Fear of harming others was considered more important than physical symptoms in terms of patient-reported problems caused by HCV. Total infected life-years (ILYs) and work days missed were reduced in the treatment group for both 10 and 20 year health sector models in addition to quality-adjusted life-year gains. Compared to no treatment, the incremental cost-effectiveness ratio for treatment would be $3,464/ILYs avoided, $715/work day missed, and $39,086/QALY gained. When costs of absenteeism, presenteeism, and patient/caregiver time were included, the DAA intervention was cost-saving at both 10 and 20 years. Very few traditional economic models for HCV treatments attempt to capture the indirect and non-medical costs or outcomes that may impact HCV patients. Conclusions: Treatment was cost-effective from a health sector perspective and cost-saving when including non-health costs such as patient/caregiver time and productivity. Compared to published HCV CEAs that focused mainly on SVR, our patient-centered CEA provides results that reflect the outcomes of interest informed by direct patient engagement.
    • Use of pharmacoeconomic data for formulary decision making in teaching hospitals

      Kulsomboon, Vithaya; Palumbo, Francis Bernard, 1945- (2000)
      A national mail survey of Pharmacy Directors in teaching hospitals was performed to determine the criteria and applicability of the use of Pharmacoeconomics (PE) data for formulary decisions, to identify the determinants of PE-based formulary decisions, and to assess the quality of available PE data. Of the 166 (39.6%) hospitals responding to the survey during April through July, 1999, 83.1% reported using PE-based formulary decisions. The two significant determinants of whether hospitals used or did not use PE data were census and annual pharmacy drug budgets. The two most important criteria for PE data use were the impact of a new medication on institutional costs and the anticipated annual budget for a new medication. To determine the degree of use of PE-based formulary decisions, principal components analysis was employed to reduce and classify survey-items for a PE-index. PE-index scores were calculated by summing the PE-index item scores. A stepwise multiple regression showed that five determinants jointly explained 49.8% of the variance (Adjusted R2 = 46.7%) of the PE-index scores [F (7,115) = 16.3, p < 0.001]. Hospitals with higher cost-savings from using PE data, higher FTEs, higher number of staff types responsible for PE analyses, and ranking of anti-infective drugs as the most important drug class in requiring PE data, were associated with an increase in PE-index scores. "Hospitals located in the South" was associated with a decrease in PE-index scores. Hospitals reporting a higher degree of comfort if PE data were reviewed and approved by the FDA expected an increase in PE data use. The study findings suggest that the hospitals use PE data based on cost impact to their institutions. Cost-savings from PE-based formulary decisions would motivate hospitals to devote more resources to PE evaluations and increase the use of PE data. The use of PE data from pharmaceutical companies might increase if the FDA reviewed and approved such data.