Translating clinical evidence into value-based payment models: pooled analyses of innovative real-world outcomes agreements for ticagrelor in the United States.

Innovative value strategies for reimbursement of medications include value-based agreements (VBAs) between payers and pharmaceutical manufacturers, which have the potential to improve affordability and patient access to therapy, as well as lead to a reduction in downstream health events and associated medical costs. VBAs link payment for a medication to its performance in real-world clinical practice measured against prespecified outcomes that are aligned to existing evidence. Given its high prevalence, economic burden, and impact on mortality, cardiovascular disease (namely, coronary heart disease) represents an opportunity for VBAs to contribute to improved health outcomes and patient experiences while reducing or containing total medical costs. AstraZeneca developed a VBA framework directly comparing 2 antiplatelet therapies indicated to treat acute coronary syndrome (ACS)-ticagrelor and clopidogrel-based on the PLATO trial, which demonstrated superiority for ticagrelor in reducing the incidence of recurrent myocardial infarction (MI) in patients with ACS. Between 2015 and 2018, 11 contract-years of VBAs utilizing this framework were implemented in commercial and Part D health insurance plans, totaling nearly 32,000 unique patients in which pooled analyses were conducted. Aggregated VBA results indicate that ticagrelor consistently outperformed expectations in reducing recurrent MI vs clopidogrel, while also illustrating how comparative VBA frameworks of this nature may overcome challenges noted for VBAs and be utilized more broadly in future applications.

Modeling the economic impact of medication adherence in type 2 diabetes: a theoretical approach.

AIMS: While strong correlations exist between medication adherence and health economic outcomes in type 2 diabetes, current economic analyses do not adequately consider them. We propose a new approach to incorporate adherence in cost-effectiveness analysis. METHODS: We describe a theoretical approach to incorporating the effect of adherence when estimating the long-term costs and effectiveness of an antidiabetic medication. This approach was applied in a Markov model which includes common diabetic health states. We compared two treatments using hypothetical patient cohorts: injectable insulin (IDM) and oral (OAD) medications. Two analyses were performed, one which ignored adherence (analysis 1) and one which incorporated it (analysis 2). Results from the two analyses were then compared to explore the extent to which adherence may impact incremental cost-effectiveness ratios. RESULTS: In both analyses, IDM was more costly and more effective than OAD. When adherence was ignored, IDM generated an incremental cost-effectiveness of $12,097 per quality-adjusted life-year (QALY) gained versus OAD. Incorporation of adherence resulted in a slightly higher ratio ($16,241/QALY). This increase was primarily due to better adherence with OAD than with IDM, and the higher direct medical costs for IDM. CONCLUSIONS: Incorporating medication adherence into economic analyses can meaningfully influence the estimated cost-effectiveness of type 2 diabetes treatments, and should therefore be considered in health care decision-making. Future work on the impact of adherence on health economic outcomes, and validation of different approaches to modeling adherence, is warranted.

Relationships among self-management, patient perceptions of care, and health economic outcomes for decision-making and clinical practice in type 2 diabetes.

OBJECTIVES: Type 2 diabetes (T2D) treatment involves complex interactions between biological, psychological, and behavioral factors of care, requiring multifaceted efforts in clinical practice and disease management to reduce health and economic burdens. We aimed to quantify correlations among these factors and characterize their level of inclusion in economic analyses that are part of informed medical decision-making. METHODS: A comprehensive, stepwise systematic literature review was performed on published articles dated 1993 to 2008 using medical subject heading and keyword searches in electronic reference libraries. Data were collected using standardized techniques and were analyzed descriptively. RESULTS: A total of 97 articles fulfilling all inclusion criteria were reviewed, including 16 on economic models (17% of articles). Most studies were retrospective (41 of 97; 42%) and from managed care perspectives (66%). Oral antidiabetic drugs were a central focus, appearing in 83% of studies. Patient behaviors, particularly medication adherence and persistence in real-world settings, are well researched (n=65) and may influence diabetes outcomes, cardiovascular risk, mortality rates, and treatment-specific resource use (e.g., hospitalizations) and costs (