Characterization of an Oral Oncology Drug Repository Program for Hematology and Hematopoietic Cell Transplant Patients at a Comprehensive Cancer Center
Authors: Waller Allyson , Tossey Justin , Frazier Lexus , Kumar Pooja , Freeman Tracelyn , Fleming Megan , James Stephanie , Mims Alice 
Published: December 2024

INTRODUCTION
Cancer patients face many barriers to timely access of oral anti-cancer agents, including delays in insurance approval, high costs, and enrollment in patient assistance programs (PAP). The Ohio State University Comprehensive Cancer Center (OSUCCC) launched a pharmacist-led Oral Oncology Drug Donation Repository (OODDR) program in 2020. This was possible due to changes made by the State of Ohio Board of Pharmacy in 2019 to allow patients to donate unused oral oncology medications with the intent to re-dispense the medication to other patients in need (Ohio Rev. Code § 3715.87). The pilot program started with two medications and has expanded to include over 40 oral oncology medications. We present a description of the OODDR process and our institutional experience in select hematologic disease states.

METHODS
A retrospective chart review was conducted for Hematology and Transplant Clinic (HTC) patients who received at least one dispense of oral oncology medication from the start of the program in February 2020 through June 30, 2024. Medications accepted for donation to the repository require consent from the donor, no signs of adulteration, and an expiration date of at least 6 months from the day of donation. Patients are identified as candidates to receive OODDR supply by clinical pharmacists and care teams based on financial hardship and barriers to medication access, disease acuity, and urgency for treatment. Patients must acknowledge their understanding that the medication has been donated for re-dispensing without guarantee of future availability. Care teams continue to work on long-term access to medications for these patients, including PAP through drug manufacturers and/or various grants.

RESULTS
Fifty patients, accounting for 52 unique medication access encounters, were identified through OODDR dispense reports. The most common disease states included acute myeloid leukemia (18 patients), acute lymphoblastic leukemia (10 patients), chronic myeloid leukemia (8 patients), and graft-versus-host disease (6 patients). The median age of patients was 56 years, and majority were male (62%), white (80%), and had commercial insurance (52%) or Medicare/Medicaid (30%). The most common medications dispensed through the OODDR were venetoclax (40%), dasatinib (19%) midostaurin (13%), and ruxolitinib (12%). Of the 52 medication access encounters, 60% included on-label use of the requested medication and 50% initiated therapy in the outpatient setting. The majority (92%) of these 52 cases used repository supply as a bridge therapy to definitive medication access through insurance approval (40%), PAP (46%), or a grant (6%) to continue therapy. The most common reasons for needing repository supply (multiple may apply) included delays in PAP application approval and medication shipment (31%), insurance prior authorization (PA) denials (23%), delay in PA and/or appeal process (23%), delays in medication access from external pharmacies (17%), no initial insurance (15%), and change or loss of insurance (12%). The total quantity of medication dispensed was one month or less in 89% of cases. The median time to repository medication initiation was 5 days compared to 14 days for non-repository drug access (data available for 45 patients). The total retail acquisition cost of medications that were dispensed to HTC patients at no charge from the OODDR was $418,299.74.

CONCLUSIONS
The OSUCCC OODDR is an instrumental resource for patients and care teams to remove barriers and improve access to oncology medications. Patients with acute hematologic and transplant-related diagnoses were able to initiate therapy sooner using the OODDR than would have otherwise been possible using routine insurance and assistance program processes. Given the increasing number of oral oncology medications with cost and access issues, additional support and resources for assistance are vital components of oncology patient care. Future efforts should strive to improve medication access through expanded OODDR programs and eliminate barriers to insurance or assistance program approval.