Electronic Theses and Dissertations

Author

Sumit Verma

Date of Award

2011

Document Type

Dissertation

Degree Name

M.S. in Pharmaceutical Science

First Advisor

Benjamin F. Banahan

Second Advisor

Amit S. Patel

Third Advisor

John P. Bentley

Abstract

Objective. Objective The primary objective of this study was to explore a new methodological framework—Strategic Value Driver Model (SVDM), for examining value drivers for new pharmaceutical inhaled insulin in diabetes. Methods. A cross-sectional, internet-based survey was used to collect a sample of 483 Type 2 diabetic patients via national panel of diabetic patients. The sample had two subgroups—insulin-naïve (52.9%, n=255) and insulin-user (47.1%, n=227) patients. The comparative performance of insulin syringes/vials, insulin pen and inhaled insulin was captured on four product attributes (i.e., safety, convenience, clinical efficacy and cost) after asking the patients to report the importance of these attributes. The preference for inhaled insulin was used as dependent variable for running multivariable logistic regression with summated-scale score variables for the performance of the products as independent variables. Results. The respondents had an average age of 58 years. After considering product profiles and out-of-pocket monthly cost of three products, insulin pen and inhaled insulin were equally preferred products (by 36.9% and 36.3% of patients, respectively). The preference for inhaled insulin was significantly higher among insulin naïve patients (48.2% insulin naïve vs. 22.8% insulin users). Performance differentiation between inhaled and pen insulin on clinical efficacy and convenience significantly predicted the preference for inhaled insulin; whereas, performance differentiation between inhaled and syringe/vial insulin on clinical efficacy, safety and convenience significantly predicted the preference for inhaled insulin. A higher percentage of insulin naïve patients placed high importance on clinical efficacy, safety and convenience than insulin-user patients (76.9% vs. 65.8% for efficacy, 81.6% vs. 68.4% for safety, and 54.5% vs. 45.2% for convenience, respectively). The two subgroups were found to be different in terms of predictors for the preference of inhaled insulin. Conclusion. It will be critical for the manufacturer of new inhaled insulin to develop strategies to minimize out-of-pocket cost for the patient, along with promoting the clinical efficacy and safety of the new product. Furthermore, the results suggest that insulin naïve patients may be a potential market for this new inhaled insulin. A major limitation for this study was that almost all of the insulin-users had prior experience with Exubera (N=222, 97.4%).

Concentration/Emphasis

Pharmaceutics

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