Identifying Outcome Measures for Type 2 Diabetes Value-Based Contracting Using the Delphi Method.

BACKGROUND

Value-based contracts (VBCs) between payers and pharmaceutical manufacturers link drug payments to predefined performance measures and require shared risk between both entities. It is unclear how outcome measures were selected in previously reported VBCs, and many VBCs have focused on surrogate endpoints often used in the conduct of clinical trials, which may not be valued by or of importance to patients.

OBJECTIVE

To identify outcome measures that are meaningful to key stakeholders and feasibly measured to inform VBCs for diabetes medications.

METHODS

We conducted a modified Delphi survey to incorporate views from patients (n = 9), endocrinologists (n = 5), primary care physicians (n = 4), payers (n = 3), pharmacy benefit managers (n = 3), and pharmaceutical company representatives (n = 2). A list of 12 diabetes-related outcome measures was generated from the literature and consultations with subject matter experts. Participants rated the importance of each outcome on a 5-point Likert scale and selected the 3 most meaningful outcomes. Nonpatient participants then used a Likert scale to rate the feasibility of collecting each outcome. Consensus was defined as ≥ 75% agreement on the importance and feasibility of an outcome (Likert scores 4 or 5 or selection of an outcome as most meaningful). A 2-sample test of proportions was performed to examine differences between patient and nonpatient stakeholder rankings of outcomes.

RESULTS

All 12 outcomes reached consensus for importance on the Likert scale. The measure "reducing risk of heart attacks" was the most meaningful outcome (84%), while "reducing A1c levels" ranked second (68%). The 2 measures rated as most feasibly collected were "reducing A1c levels" and "reducing risk of hospitalizations from diabetes" (93.8% each). The measures "weight loss," "reducing risk of diabetes-related kidney disease," "reducing risk of emergency room visits from diabetes," and "reducing risk of diabetes-related amputations and foot ulcers" also reached consensus for feasibility. There were statistically significant differences between patient and nonpatient stakeholders in the selection of "reducing A1c levels" (37.5% vs. 82.3%, respectively; P = 0.03) and "reducing risk of diabetes-related kidney disease" (50.0% vs. 11.8%, respectively; P = 0.03) as most meaningful outcomes.

CONCLUSIONS

The measures "reducing risk of heart attacks" and "reducing A1c levels" were identified as top priority diabetes outcome measures.

DISCLOSURES

Express Scripts provided research funding for this study to the UPMC Center for Value-Based Pharmacy Initiatives. Henderson is employed by Express Scripts and was involved in the conception and design of the study and manuscript approval. The other authors are employed by the UPMC Center for Value-Based Pharmacy Initiatives and have nothing to disclose.