Pharmacist-Driven SMART Formulary Improves Pharmacoequity

ABSTRACT

Objectives: A large academic medical center piloted a pharmacist-driven charitable medication access program. The financial and health outcomes of the program were evaluated and compared with existing benchmarks.

Study Design: This retrospective cohort study analyzed electronic health records for study participants and pharmacy dispensing information. The study period was January 1, 2023, through August 31, 2024.

Methods: A pre-post analysis was performed to determine the impacts of the program. First, characterizations of the number, type, and cost of medications provided to charitable care patients via the Streamlined Medication Access for High-Risk Patients (SMART) formulary were compared with existing benchmarks. Second, emergency department (ED) and hospital utilization data were reviewed for charitable care patients after implementation of the SMART formulary and compared with utilization prior to implementation.

Results: From January 1, 2023, through August 31, 2024, the SMART formulary provided 6791 medications to 418 unique patients, totaling more than 4.5 times more prescriptions to nearly 3 times more unique patients than the benchmark charitable care spending (March 1, 2019, to June 30, 2021). Drug costs per patient and costs per prescription were reduced by 62% and 72%, respectively. Reductions in ED visits (10%) and hospitalizations (34%) occurred, reducing the total health care spend by $6163 per month. The SMART formulary team facilitated the completion of 74 patient assistance program applications and connected patients to manufacturer insulin savings programs, estimating an additional indirect cost savings of $310,168.

Conclusions: The SMART formulary reduced the total cost of care for a cohort of charitable care patients enrolled in a primary care clinic at a large urban academic medical center in Baltimore, Maryland.

Am J Manag Care. 2025;31(6):In Press

Takeaway Points

The implementation of a charitable care formulary with clinical pharmacist oversight promoted more efficient and equitable use of charitable funds for uninsured patients, promoting continuity of care and increasing health care access.

• Implementation of this program increased the mean number of monthly prescriptions filled by 448%.
• Although more patients were seen, this program decreased the expense per prescription by 72% and decreased the mean expense per unique patient by 62%.
• In addition to promoting more efficient usage of charitable care funding, this program also assisted in reducing emergency department visits by 10% and hospitalizations by 34%, saving the health system $49,720.

Pharmacoequity, a term coined in 2021 by Utibe R. Essien, MD, MPH, of the University of Pittsburgh School of Medicine in Pennsylvania, is the ideal that all individuals should have access to the highest-quality evidence-based medication necessary to manage their disease.1 Medication access is a critical aspect of pharmacoequity, and cost is a significant barrier.2-4 Medication nonadherence occurs when patients do not consistently take their medications for their chronic health conditions. Although several factors may contribute to nonadherence, cost is often significant.4 Medication nonadherence has been associated with increased rates of emergency department (ED) visits, hospitalizations, health care expenditures, and medication errors.5-9 Chronic conditions with higher rates of complications related to medication nonadherence include cardiovascular disease, mental health disorders, and diabetes.10,11

Low-cost or free provision of medications for patients is an attractive option to reduce avoidable health care utilization and improve morbidity and mortality. As outlined by Allaire et al, one approach to minimize poor outcomes for patients receiving charitable care is to provide cost-effective, safe, and sustainable medication access.12 They reported that patients receiving free medications experienced significant reductions in total health care costs and inpatient utilization.12 Roebuck et al reported that improved medication adherence in patients with 4 chronic vascular diseases increased pharmacy costs but also produced substantial medical savings through reductions in ED visits and hospitalization.13 Hughes et al reported in a 2023 study that a charitable medication distribution pilot program for uninsured patients with diabetes showed significant improvement in glycemic control.14 Cong et al reported that elimination of co-pays for medications indicated for the treatment of chronic conditions led to increased adherence and reductions in overall spending.15 The mean out-of-pocket cost for prescription medications in the US with insurance, which represents approximately 20% or less of the actual drug cost, is $581 for Medicare beneficiaries, $297 for Medicaid beneficiaries, and $156 for patients with private insurance.16 Therefore, for patients who do not qualify for insurance coverage in the US, medication costs may be insurmountable.17 Low-income patients have been shown to have barriers to accessing health care, ultimately leading to worse health outcomes.18,19 Barriers to health care access often include financial limitations and affordability barriers, but they can also include factors such as transportation, health care accessibility, language barriers, and poor health literacy.20

To address the barrier of cost-based medication nonadherence for a subset of the charitable care population at a large urban academic medical center, the Streamlined Medication Access for High-Risk Patients (SMART) formulary was implemented. The SMART formulary provides most generic medications to charitable care patients at no cost, assists with applying to patient assistance programs (PAPs), and provides pharmacist-led, cost-conscious, evidence-based clinical prescribing guidance to prescribers. The SMART formulary can be accessed through outpatient pharmacies affiliated with the medical center located in the same building as the primary care clinics that are eligible for this formulary. Prior to the SMART formulary pilot, the existing charitable care program at the academic medical center supported inpatient and outpatient medical care, but not the cost of medications. The charitable care population is at a disproportionately higher risk of cost-related medication nonadherence compared with patients who have health insurance. The preexisting process for medication acquisition was inconsistent, was intended for short-term use only, and did not address long-term medication access issues. In addition, the choice to provide charitable medication coverage was overseen by social workers who do not have the necessary clinical training to suggest cost-conscious therapeutic alternatives to prescribers. Although social workers can provide valuable insight into identifying medication affordability issues, pharmacists specializing in medication management are better poised to recommend cost-effective, sustainable therapeutic alternatives. The objective of this manuscript was to characterize the impact of the SMART formulary, including the number of medications provided, number of patients served, direct cost of medications provided, changes in health care utilization as a result of this program, and changes in the total cost of care.

METHODS

The SMART formulary was implemented at an urban academic medical center in Baltimore, Maryland. Patients included were adults followed at internal medicine clinics affiliated with the academic medical center and enrolled in the charitable care program at any time from January 1, 2023, to August 31, 2024. Patients are eligible to participate in the charitable care program if they are enrolled at this site. Other eligibility criteria include being unable to qualify for state-sponsored or other health insurance, with income at or below 200% of the federal poverty level and residency within the program’s designated geographic area. Patients were excluded if they were younger than 18 years, not enrolled in the charitable care program, or not followed at internal medicine clinics affiliated with the academic medical center.

The SMART formulary team consists of a medical director, 2 clinical pharmacy specialists, and a clinical coordinator pharmacist. They developed workflows for prescribers, patients, and the Johns Hopkins outpatient pharmacy. The team also partners with Hopkins Care Connection and the PAP clinical team for PAP enrollment assistance. Data were identified by performing a retrospective review of electronic health records, which included pharmacy claims, utilization data, patient demographics, and medication information.

This analysis included 2 components. The first component was the pre-post analysis to characterize the impact of the SMART formulary, including the number of medications provided, number of patients served, and direct cost of medications. These data were compared against benchmark charitable care data published previously. The benchmark charitable care spending data covered a 28-month period (March 1, 2019, to June 30, 2021), and only the first 20 months of the SMART formulary (January 1, 2023, to August 31, 2024) were available for accurate analysis. Monthly means were utilized for comparison. The benchmark data showed that medication costs for patients from these clinics per month averaged $3966.14 for 62 prescriptions serving 5 unique patients per month.21 Data were also collected regarding the use of PAP enrollment, and estimated cost savings were computed.

The second component was a retrospective cohort study analyzing electronic health record data on acute care utilization. A review from January 1, 2022, to December 31, 2023, was conducted to review the number of ED visits and hospitalizations. Patients were included in this review if they were enrolled in the charitable care program in 2022 and 2023 and had at least 1 medication filled through the SMART formulary in 2023. Patients were excluded if they were not enrolled in the charitable care program in 2022 and 2023 or did not fill a medication under the SMART formulary. The objective of this analysis was to characterize the changes in health care utilization as a result of the SMART formulary and, with the inclusion of the direct medication costs above, calculate the changes in the total cost of care. The finance department at the academic medical center provided the mean expenses for an ED visit and a hospitalization, which were $365.80 and $2550, respectively, for 2023.22

Descriptive statistics were utilized to characterize number of patients served, number of prescriptions provided, cost per prescription, cost per patient, and total costs on a monthly basis, as well as to report the number of ED visits and hospitalizations. This project was approved by the Johns Hopkins School of Medicine institutional review board (IRB00413992). Excel (Microsoft) was utilized to analyze data.

RESULTS

The demographics of the patients in this population were described in a previous study by Kumar et al and were not repeated for this analysis.21 In summary, patients had a mean age of 47 years, primarily identified as Hispanic, and qualified for charitable care on the basis of low income and lack of insurability. Additionally, 87% of patients indicated Spanish as their preferred language.

The SMART formulary’s mean monthly cost for the first 20 months of the formulary (January 1, 2023, to August 31, 2024) was $5986, representing a 51% increase from benchmark charitable care medication cost, which had a mean monthly cost of $3966 (Table 1). However, the SMART formulary provided a mean of 340 prescriptions per month, which is an increase of more than 400% compared with the benchmark charitable care spending data of 62 prescriptions on averageper month. As such, the SMART formulary had a lower mean monthly cost per prescription of $18 compared with $64 for the benchmark time period, a 72% reduction in costs per prescription. Additionally, the SMART formulary improved medication access by serving a mean of 21 unique patients per month compared with 5 patients per month (320% increase).

Furthermore, the SMART formulary facilitated the approval of 74 PAP applications, with an estimated indirect cost savings of $232,566. Utilization of manufacturer insulin savings programs led to an overall indirect cost savings of $77,602 (Figure).

For the utilization analysis, 114 unique patients were identified for inclusion. These patients were enrolled in the charitable care program during 2022 and 2023 and received at least 1 medication through the SMART formulary program (which began January 1, 2023). In 2022, the year prior to the start of the formulary, these patients had 69 ED visits and 83 hospitalizations. In 2023, after the SMART formulary implementation, these patients had 62 ED visits and 55 hospitalizations. Thus, in 2023, the year the SMART formulary was implemented, ED visits and hospital utilization were reduced by 10% and 34%, respectively (Table 2), translating to a mean monthly reduction in acute health care utilization of $6163. This corresponds to a mean expense reduction of $649 per patient. When the reduced costs of health care utilization were combined with medication costs, the SMART formulary provided an annual net savings of $49,720, or $4143 monthly (Table 3).

DISCUSSION

The SMART formulary’s provision of lower-cost therapeutic alternatives, with ongoing clinical review of pharmacy claims and quality improvement, assisted in improving pharmacoequity for charitable care patients while containing costs and improving outcomes. Notably, the mean monthly expense of the SMART formulary was about $2000 higher than the nonregulated preexisting process for providing charitable medication coverage. However, the SMART formulary was more efficient in allocating funds, resulting in a 72% reduced cost per prescription, a 448% increased number of prescriptions filled, and a 320% increase in unique patients served. As the results of this pilot show, carefully designed formularies encompassing clinical criteria, prescription processes, medication access policies, and clinical guidance are essential to move toward a more pharmacoequitable health care model. Data have historically shown that patients from marginalized populations face greater medical complications and substantial barriers to accessing care, including medications that are often unaffordable yet vital to the management of chronic conditions.23 Cost-conscious charitable medication formularies are essential to providing quality, equitable health care by ensuring appropriate access to medications to vulnerable patient populations.24

Furthermore, the SMART formulary team promoted pharmacoequity by facilitating utilization of PAPs. This aspect of the formulary made cost-prohibitive but guideline-directed medications accessible, including basal/bolus insulin regimens instead of NPH insulin–based regimens in patients with type 2 diabetes, maintenance inhalers for asthma or chronic obstructive pulmonary disease, direct oral anticoagulants, and sodium-glucose cotransporter 2 inhibitors for heart failure and/or type 2 diabetes. Prior to the SMART formulary, no formalized process existed to identify these programs and provide application assistance to patients and provider teams. Therefore, the SMART formulary offered a level of support to medicine teams that has enhanced patient care significantly and reduced the amount of time providers spend assisting with medication access.

In addition to the cost-efficiency and medication access benefits, the SMART formulary was also shown to reduce acute health care utilization for a subset of 114 unique patients. It is anticipated that if the entire population were reviewed, this effect on health care utilization would be greater. This analysis was limited to the health system only; outside ED visits and hospitalizations were not accounted for. Therefore, the overall impact on acute health care utilization may be larger. These findings are consistent with those of other studies that linked the provision of medications to improved therapeutic outcomes and reductions in overall spending.13-15 Reducing acute health care utilization is of particular interest in this patient population because the medical center covers all of their medical expenses. This reduction in spending on acute health care utilization could result in reallocation of these charitable funds to help more patients, improve preventive care, and further enhance medication access. In addition to preventing morbidity, this initial review suggests that ensuring pharmacoequity leads to overall cost containment for the medical center, as the relative cost of medications is far exceeded by costs of complications that arise from nonadherence.13,25-30

Lastly, the driver for this formulary was pharmacists. Pharmacists have a unique knowledge of pharmacology, pharmacotherapy, and therapeutic alternatives. Compared with other disciplines, pharmacists have advanced insight into appropriate therapeutic alternatives. The pharmacists on this team were focused on ambulatory and outpatient pharmacy and had additional skills in medication affordability and access.31-33 Clinical pharmacists can also aid in the deprescribing of unnecessary medications and mitigating potentially dangerous polypharmacy instances, further providing pharmacoequity and optimized patient outcomes.34 The success of this formulary indicates that trained ambulatory care clinical pharmacy specialists and a strong relationship with an outpatient pharmacy are key to ensuring success when implementing a charitable access formulary.

Limitations

Although the SMART formulary program was successful, the team acknowledges that there are several limitations to this analysis. To begin, this study was completed at a single center; therefore, the results may not be generalizable to the population as a whole. Likewise, the study’s pre-post analysis design lacked a contemporary control group. Therefore, confounding variables and other factors occurring at the same time as the intervention cannot necessarily be controlled for or ruled out. A small portion of the overall medication expenses may be due to inappropriate billing for patients in other departments (eg, patients in nonaffiliated clinics). Likewise, preliminary data were collected during the COVID-19 pandemic, during which utilization was approximately one-third of typical utilization. Additionally, many intangible benefits of the SMART formulary were not described in this analysis but contribute to the value of this program, including provider and social work time savings. Thus, the cost benefits of the SMART formulary are anticipated to be larger. Another limitation of this study is that ED visits and hospitalizations were only reported if they occurred within the academic medical center’s health system, not at an outside facility. Thus, if this analysis had encompassed all the ED visits and hospitalizations, the impact on avoidable utilization may have been greater. This analysis could not assess all drivers of acute health care utilization, which is multifactorial, and this is a potential limitation.

CONCLUSIONS

The SMART formulary has successfully addressed several critical health care objectives, demonstrating its effectiveness in promoting pharmacoequity. Through the provision of safe, effective, and evidence-based medicines, the SMART formulary promoted positive health outcomes. Additionally, the SMART formulary was able to offset medication expenses via reductions in acute health care utilization, leading to an overall reduction in the total cost of care. Therefore, by improving access to necessary medications, the SMART formulary has demonstrated benefits for both patients and the health system. Additionally, these findings underscore the importance of clinical pharmacists in optimizing patient medication management and cost containment for charitable access formularies. The SMART formulary team is planning to expand services into the postdischarge setting and create a structured medication access resource for medical teams.

Author Affiliations: Johns Hopkins Health System (EVM, CD-G, SR, RG, AB, RS), Baltimore, MD.

Source of Funding: None.

Author Disclosures: Dr Stewart is faculty at the Johns Hopkins School of Medicine, where she works with care coordination and the vouchering system; Johns Hopkins Hospital is the entity providing the medications. The remaining 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 (EVM, CD-G, RG, RS); acquisition of data (EVM, CD-G, RG); analysis and interpretation of data (EVM, CD-G, SR, RG, AB); drafting of the manuscript (EVM, CD-G, SR, AB, RS); critical revision of the manuscript for important intellectual content (EVM, CD-G, SR, RS); statistical analysis (EVM, CD-G, RG); administrative, technical, or logistic support (EVM, SR, RG, AB, RS); and supervision (EVM, CD-G, RG, RS).

Address Correspondence to: Caitlin Dowd-Green, PharmD, MBA, Johns Hopkins Health System, 600 N Wolfe St, Carnegie 180, Baltimore, MD 21287. Email: cdowd2@jhmi.edu.

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