Beyond Approval: Delivering Gene Therapies to Adult Hemoglobinopathy Patients at Fred Hutch Cancer Center

Abstract

Objective: This single center, qualitative case study evaluates the facilitators, barriers, and equity considerations for implementing CGTs for adult hemoglobinopathy patients at Fred Huth Cancer Center to inform improvement efforts for institution-specific systems and reduce future product onboarding times.Methods: Using the 2022 Updated Consolidated Framework for Implementation Research (CFIR 2.0) to guide both study design and analysis, 15 semi-structured interviews with 17 participants of varying professional roles that were involved in implementation efforts were conducted. Interviews ranged from 20 to 40 minutes in length and took place either in person or using the Microsoft Teams platform. A total of 7 hours and 30 minutes of interviews were collected. Inductive and deductive coding were used to generate themes. Results: Four overarching barriers and three facilitators were identified in this case study. Barriers centered innovation cost and complexity, and institutional-level constraints such as perceived institutional risk capacity, contracting with academic institutions, and lack of centralized leadership for CGT product onboarding. Facilitators included a patient-centered culture among implementation teams, teaming efforts by the Service Line and Scientific Directors, and access to shared knowledge among immunotherapy and pediatric teams. Equity considerations for implementing therapies were grouped with facilitators, as it was noted among the patient-centered culture as a main facilitator. Discussion: Even in an ideal setting, onboarding for CGTs remains extremely complex with a variety of institutional-level barriers at FHCC leading to nearly 8 months of additional delays in patient care. To aid in institutional quality improvement, identifying an implementation lead who has the capacity to orchestrate all onboarding efforts, streamline service line and physician teaming efforts, and clarify executive priorities for product onboarding would greatly benefit future product onboarding. Implications: To date peer reviewed resources for implementation of CGTs focus on other indications, or are hypothetical frameworks developed by countries with universal health systems. This single-center case study provides valuable documentation for onboarding gene therapies at a single institution that was not part of the original gene therapy clinical trials for these products within the context of the US’s mixed public-private health delivery model.