Case Studies

Comparative Effectiveness Review - Diabetes

Insight

One of the world’s largest pharmaceutical companies required a comparative effectiveness review of premixed insulin analogs compared to basal or basal-bolus regimens (utilizing glargine and/or glulisine) for individuals with type 2 diabetes mellitus on oral agents as a response to a health technology assessment developed by the agency for Healthcare Research and Quality (AHRQ).

Strategy

In order to address this question, The Aequitas Group conducted a systematic literature review and performed meta-analyses of available randomized clinical trials (RCTs) comparing premixed insulin with glargine in individuals with type 2 diabetes. Literature searches, article selection/review, validity ratings of reviewed studies, data management, extraction, and statistical analysis were performed in accordance with nationally recognized standards (AHRQ, Cochrane, and Oregon Evidence-based Practice Center Drug Effectiveness Review Project). The Aequitas Group provided an additional Cost-Effectiveness Analysis (CEA) to demonstrate economic value in comparison to other products. At each step of the process, we assisted the client with defining the patient population, synthesizing complex cost and utilization variables, placing adverse events into context, and developing survival curves that were of critical importance to their bottom line value message that long-acting insulins are safer than the alternative formulations. A sensitivity analysis was developed to combine the cost-effectiveness analysis and a health economic summary while providing a solid foundation for key value messages.

Execution

The results and implications of this systematic review and meta-analysis were of great interest to the client, as well as to clinicians, caring for patients with type 2 diabetes. The final phase of the report included collaborating with world renowned endocrinologists with whom The Aequitas Group submitted two abstracts and a manuscript for presentation and publication. All submissions are currently under review.