Inflation-adjusted analysis of ICER's Unsupported Price Increase reports: contextualizing drug spending changes.

Objective: The Institute for Clinical and Economic Review (ICER) publishes annual Unsupported Price Increase (UPI) reports on prescription drugs, which have gained attention from policymakers and healthcare stakeholders. These reports do not adjust for inflation in their analyses of net price changes. This study aimed to evaluate the economic context of reported drug price increases in ICER's UPI reports by applying inflation adjustments to the estimated impact on healthcare spending.

Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act.

Introduction: Recent research has raised questions about potential unintended consequences of the Inflation Reduction Act's Drug Price Negotiation Program (DPNP), suggesting that the timelines introduced by the law may reduce manufacturer incentives to invest in post-approval research towards additional indications. Given the role of multiple indications in expanding treatment options in patients with cancer, IRA-related changes to development incentives are especially relevant in oncology. This study aimed to describe heterogeneous drug-level trajectories and timelines of subsequent indications in a cohort of recently approved, multi-indication oncology drugs, including overall, across subgroups of drugs characterized by the timing and pace of additional indications, and by drug type (i.

Will the Institute for Clinical and Economic Review's Shared Savings Approach Decrease Value-Based Prices Most for the Most Severe Diseases?

Objectives: To identify the types of disease most likely to be affected by the Institute for Clinical and Economic Review's (ICER) shared savings assumptions.

Methods: For diseases with treatments that were Food and Drug Administration approved between 2019 and 2023, annual direct and indirect economic burden and characteristics of each disease were extracted from peer-reviewed literature. ICER's shared savings methodology was applied 2 ways: 50/50 shared savings and $150 000 cost-offset cap.

Cost-Effectiveness Analysis of a Prescription Digital Therapeutic in Type 2 Diabetes.

Introduction: BT-001 (AspyreRx™) prescription digital therapy, a form of personalized cognitive behavioral therapy, has demonstrated clinically meaningful and durable hemoglobin A1c reductions in patients with type 2 diabetes (T2D). The current study examined the cost-effectiveness of BT-001 plus standard of care (SoC) versus SoC alone in T2D over a lifetime horizon from a healthcare payer perspective.

Methods: We modeled the T2D pathway using an individual patient-level simulation; clinical data were sourced from the intention-to-treat subset of the BT-001 randomized clinical trial (RCT).

Clinical Events and Renal Function in the First Year Predict Long-Term Kidney Transplant Survival.

Background: Estimated glomerular filtration rate (eGFR) at 1 year post transplantation has been shown to be a strong predictor of long-term graft survival. However, intercurrent events (ICEs) may affect the relationship between eGFR and failure risk.

Methods: The OPTN and USRDS databases on single-organ kidney transplant recipients from 2012 to 2016 were linked.