Charitable Medication Distribution Improves Care for Uninsured Patients With Diabetes

ABSTRACT

Objectives: This study examined the impact of insulin products donated by a pharmaceutical manufacturer and dispensed by Dispensary of Hope–partnered pharmacies on medication access and treatment outcomes among uninsured patients with type 2 diabetes (T2D).

Study Design: This was a pilot, single-center, retrospective observational study.

Methods: Uninsured patients with diabetes who were newly established with Ascension Medical Group clinics for the treatment of T2D were included in this study. Participants were prescribed insulin glargine, insulin isophane, or insulin isophane/insulin regular insulin therapy between March 2020 and August 2021. A retrospective chart review was conducted. Information collected included participants’ hemoglobin A_1c (HbA_1c) level at baseline, 3 months, and 6 months; change in HbA_1c level; insulin prescribed; fill history; whether they had been referred to a patient assistance program; and whether they were seen by a pharmacist under a collaborative practice agreement.

Results: Thirty-eight participants were assessed, and 22 met criteria for the primary outcome. The mean HbA_1c level decreased from 11.2% at baseline to 8.9% at 3 months and 8.8% at 6 months, resulting in a mean change in HbA_1c of –2.4 percentage points (P = .033). Eleven participants (50%) had an HbA_1c level of less than 9% at 6 months. The mean proportion of days covered was 76%. The mean monthly savings for insulin ranged from $183.74 (insulin isophane) to $253.84 (insulin glargine) per participant.

Conclusions: Our results showed a significant improvement in glycemic control among participants, demonstrating the substantial impact that pharmacies partnered with charitable medication distributors such as the Dispensary of Hope can have on individuals with insulin-treated T2D.

Am J Manag Care. 2023;29(11):573-575. https://doi.org/10.37765/ajmc.2023.89453

Takeaway Points

This report illustrates how providing vital diabetes medications to uninsured patients through a charitable medication distributor improves clinical outcomes.

• The Dispensary of Hope is a charitable medication distributor that focuses on establishing partnerships with pharmaceutical manufacturers to provide pharmacies and clinics nationwide access to affordable medications.
• Uninsured patients who received diabetes medications through this distributor lowered their hemoglobin A_1c and reduced their monthly costs with fair medication adherence.
• Patients who were adherent to their medications likely avoided major costs from hospitalizations and emergency department visits.
• Pharmaceutical and medical device manufacturers should partner with charitable medication distributors to improve care and clinical outcomes for uninsured patients.

One of the major barriers to medication adherence is cost.¹ The Affordable Care Act in 2010 allowed Medicaid coverage to be extended to many individuals with low incomes and provided subsidies for marketplace coverage for those below 400% of the federal poverty level.² Nevertheless, the number of uninsured individuals in America has increased over the past few years to roughly 29 million individuals.² In a comparison of states with the largest uninsured rates, Tennessee—the location of the practices where this study was conducted—was 37th in 2019, with a rate of 11.74% of uninsured adults.³ Insurance status poses a disproportionate barrier to patients with chronic conditions, and roughly 75% of health care costs each year are related to 5 chronic conditions: hypertension, diabetes, heart disease, asthma, and mood disorders.⁴

Medication adherence for chronic conditions is often suboptimal due to the cost of therapy, especially for individuals who lack prescription drug coverage.⁴ With socioeconomic forces contributing to major limitations in health care for the treatment of diabetes as well as obesity in America, it is becoming increasingly more pertinent to determine effective ways to provide affordable care to the uninsured population of patients with diabetes in the United States.⁵ Charitable medication distributors are designed to collect and distribute millions of dollars of pharmaceuticals annually to pharmacies and clinics that have the potential to improve medication accessibility for eligible patients.⁶ There is, however, a limited amount of information regarding their effectiveness.⁶

The Dispensary of Hope is a charitable medication distributor that focuses on establishing partnerships with pharmaceutical manufacturers to provide pharmacies and clinics nationwide access to affordable medications.⁷ Through innovative stewardship of the pharmaceutical supply chain, the Dispensary of Hope collects and distributes millions of dollars of pharmaceuticals annually to pharmacies and safety-net clinics to dispense to low-income, chronically ill patients. Its mission is to impact the health of communities by improving access to affordable medications for the most vulnerable. In 2018, the Dispensary of Hope expanded its partnership with a pharmaceutical manufacturer to include 7 insulin products in addition to dulaglutide.

This study investigated the effectiveness of the donated insulin products as treatment for type 2 diabetes (T2D) and assessed the impact that the Dispensary of Hope has on glycemic control by facilitating medication access for uninsured patients.

METHODS

This was a pilot, single-center, retrospective chart review of patients who were seen at Saint Thomas Saint Louise Family Medicine Center, part of Ascension Medical Group Tennessee, to treat their uncontrolled T2D and were prescribed insulin glargine, insulin isophane, or insulin isophane/insulin regular therapy between March 2020 and August 2021. The study protocol was reviewed and approved by Sterling Institutional Review Board, an outside institutional review board. A waiver of informed consent was applied for and approved.

A target population of up to 40 individuals was recruited for this study to demonstrate significance (P < .05). Eligible participants included uninsured Ascension Medical Group patients who were at least 18 years old with a baseline hemoglobin A_1c (HbA_1c) level greater than 9% and newly initiated on insulin glargine, insulin isophane, or insulin isophane/insulin regular therapy from a Dispensary of Hope–partnered pharmacy.

A retrospective chart review was conducted for all study participants. Data collected included participants’ age at first visit; gender; race; ethnicity; primary language spoken; HbA_1c level at baseline, 3 months, and 6 months; change in HbA_1c level; insulin prescribed; fill history; whether they were referred for a patient assistance program; and whether they were seen by a pharmacist under a collaborative practice agreement.

The primary outcome was the change from baseline HbA_1c level in insulin treatment–naïve patients who received insulin therapy from the Dispensary of Hope. Variables for assessing the primary outcome were HbA_1c level at baseline, HbA_1c level at 3 months, and HbA_1c level at 6 months. Secondary outcomes were the percentage of patients achieving an HbA_1c level less than 9%, patient adherence, and cost avoidance associated with uncontrolled T2D. Variables for assessing secondary outcomes included the total number of patients achieving an HbA_1c level less than 9%, fill history, mean monthly cost savings for insulin, and medication adherence. Medication adherence was analyzed based on the proportion of days covered (PDC) using fill history for each participant. Descriptive statistics were used to identify common trends. A 1-sample t test was used to analyze the primary and secondary outcomes with continuous variables.

RESULTS

A total of 38 charts were reviewed; 22 participants were included in this pre-/post comparison, retrospective study, and 16 were excluded—13 previously received insulin therapy prior to establishing with the Dispensary of Hope, and 3 were lost to follow-up.

As shown in the Table, the population was predominantly Hispanic, with an even distribution between men and women. Of the 22 study participants, 20 were receiving insulin glargine and 2 were receiving insulin isophane. Eleven participants were seen by a pharmacist under a collaborative practice agreement for T2D, and 2 individuals were on a patient assistance program for their long-acting insulin therapy.

Primary Outcome

The change in HbA_1c level was normally distributed, with a mean baseline HbA_1c level of 11.2%. Significant reductions in HbA_1c levels were observed at 3 months (–2.3 percentage points; P = .046), which were sustained throughout the remaining observation period (–2.4 percentage points; P = .033) (Figure).

Secondary Outcomes

Eleven participants (50%) had an HbA_1c level less than 9% at 6 months. Participants received a mean of 7 mL of insulin glargine each month, resulting in a mean monthly cost savings of approximately $253.84 per patient receiving this drug. Patients received a mean of 10 mL of insulin isophane per month, resulting in a mean monthly cost savings of $183.74 per participant receiving this drug. The mean PDC was 76%, with 11 (50%) participants achieving a PDC of 80% or greater.

DISCUSSION

This pilot, single-center, retrospective, chart review study is to our knowledge the first of its kind to document the impact that pharmacists partnered with charitable medication distributors can make on glycemic control. This study demonstrated a clinically significant impact on disease control, as evidenced by a significant reduction in the mean HbA_1c level within 3 months.

Although participants were mostly adherent to their insulin therapies based on their fill history, the mean PDC fell short of the desired 80%, which may reflect other confounding social determinants of health inherent in our population. Two participants were referred to patient assistance programs for their insulin, which can also affect fill history. With regard to cost avoidance, nonadherence to antidiabetic agents alone costs a mean of $24.6 billion a year.⁸

Our study clearly demonstrates that by addressing the cost of the medications themselves, we can overcome much of the cost of nonadherence. Not included in this estimate are avoidable costs associated with diabetes-related complications and comorbidities.⁸ Considering this annual cost and the out-of-pocket costs of the long-acting insulin products evaluated, significant cost avoidance was achieved by providing affordable care to this vulnerable population.

Limitations

Some important limitations are notable. First, because we focused on only 3 long-acting insulin products, a large population of patients was not included in this study. If the scope was broadened to include all long-acting insulin products available at the Dispensary of Hope, the larger sample size may demonstrate greater generalizability to other insulin products. Second, the time associated with this study allowed for only a general overview of the cost avoidance associated with providing affordable insulin products. Future studies may consider the longer-term cost avoidance achieved through better glycemic control (and thus fewer complications) facilitated by closures of medication access gaps.

CONCLUSIONS

As cost continues to present a major barrier to medication adherence, it is essential to identify ways to provide patients with affordable medications. Considering the number of uninsured Americans today, it is even more important to bridge the gap between the cost of quality outpatient care and the avoidance of costs from nonadherence and hospital visits. The results of this retrospective cohort study show the significant impact that charitable medication distributors such as the Dispensary of Hope can have. Patients who were adherent to their medications likely avoided major costs from hospitalizations and emergency department visits.

Acknowledgments

The authors wish to thank Christopher G. Parkin, MS, CGParkin Communications, Inc, for his editorial assistance.

Author Affiliations: Ascension Saint Thomas Rutherford (JH, AS, PS, TM), Murfreesboro, TN; Belmont University (TC), Nashville, TN; Dispensary of Hope (HB), Nashville, TN.

Source of Funding: None.

Author Disclosures: The authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (JH, AS); acquisition of data (AS, PS, TM, TC); analysis and interpretation of data (JH, AS); drafting of the manuscript (JH); critical revision of the manuscript for important intellectual content (JH, AS, PS, TM, TC, HB); provision of patients or study materials (PS, TM, TC, HB); obtaining funding (HB); administrative, technical, or logistic support (PS, TM, TC, HB); and supervision (JH).

Address Correspondence to: Jonathan Hughes, PharmD, BCPS, BCACP, Ascension Saint Thomas Rutherford, 1700 Medical Center Pkwy, Murfreesboro, TN 37129. Email: jonathan.hughes@ascension.org.

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