Pathways for innovation—Expansion of health system specialty pharmacy services: A pilot initiative in dermatology and rheumatology clinics

Abstract

Hospitals incorporate health system specialty pharmacies (HSSPs) to drive efficient, collaborative care and improve health outcomes for patients with complex, resource-intensive conditions. Specialty pharmacy teams, made up of clinical pharmacists, pharmacy technicians, and ancillary staff, provide vertically integrated, comprehensive, and coordinated care. Benefits of HSSPs to patients and health systems include improved utilization of medications (ie, access, initiation, and adherence) and enhanced health care services. Strategies for expanding the footprint of specialty services have not been well described. The purpose of this report is to share a model of HSSP clinical services and a framework for service expansion that ensures sustainable and equitable care across the health system. UC Davis Health established an internal HSSP to deliver comprehensive clinical services to 12 specialty therapeutic areas. Further service expansion was vital to ensure comprehensive and equitable services were provided to all patients. Service location was identified as a primary source of the disparities in care between hospital- and community-based clinics. Remedying these disparities required recognition of service gaps and barriers, strategic planning, stakeholder engagement, and workflow modification. Standardized therapy-specific outcomes (TSOs) were developed in collaboration with pharmacists and physician champions. Legal counsel and 340B Health resources guided compliance with regulatory standards. Information technology facilitated the implementation of the new operational workflow. Outcomes of the initiative included referral and enrollment rates, time to treatment, patient cost savings, medication adherence, and provider satisfaction. This report describes a model for expansion of an HSSP framework that supports growth of comprehensive and equitable pharmacy services, meaningful metrics and tracking, and patient outcomes. Beneficial outcomes included time to treatment, patient cost savings, medication adherence, TSO tracking, and provider satisfaction.

Plain language summary

Health system specialty pharmacies (HSSPs) are increasingly common within academic health systems. Many benefits of this model are known, but a gap exists to understand how to expand specialty pharmacy services. This review describes the expansion process of clinical services at a single-center HSSP.

Implications for managed care pharmacy

Expansion of an HSSP applied existing resources to ensure comprehensive and equitable services. Pharmacy services were expanded to all patients taking specialty medications, regardless of where they were seen in the ambulatory care setting. Key outcomes included time to therapy, patient cost of care, medication adherence, tracking of therapeutic outcomes, and provider satisfaction. This collaborative expansion model may be translated to other HSSPs to promote high-quality care.

Background

Health system specialty pharmacies (HSSPs) drive efficient, integrated care to improve health outcomes for patients with complex, resource-intensive conditions. Specialty pharmacy teams collaborate with patients, caregivers, clinic staff, payers, pharmacy benefit managers, and manufacturers to deliver patient-centered services along the entire continuum of care.^1–4 Patients and health systems benefit from improved utilization of medications (ie, access, initiation, and adherence) and enhanced health care services.⁵ HSSPs offer focused care through improved visibility and communication within interdisciplinary teams. The federal 340B Drug Pricing Program is intended to extend “scarce federal resources… to [reach] more eligible patients and [provide] more comprehensive services.”⁶ One of the goals of the pilot initiative was to show proof of concept of this model and create a sustainable new model for further service expansion through reinvestment of resources back into staffing.

UC Davis Health (UCDH) is an academic health center that offers primary and specialty care services. UCDH launched an internal HSSP in 2010 and has since expanded to deliver comprehensive clinical services in 12 specialty therapeutic areas (eg, dermatology, oncology, and rheumatology). The UC Davis Specialty Pharmacy (UCDSP) is accredited by the Utilization Review Accreditation Commission with more than 75 staff members. Care is provided by pharmacists, technicians, ancillary personnel, and a substantial cohort of pharmacy students and residents. UCDSP is committed to tracking and trending metrics that improve therapy-specific outcomes (TSOs). Satisfaction with pharmacy and pharmacist clinical services is monitored annually.

Specialty pharmacists are embedded members of clinic care teams who serve patients along their entire care journey.⁷ This integrated practice model enables pharmacists to provide comprehensive medication management services. Collaborative practice agreements (CPAs) enable pharmacists to adjust medications and monitor laboratory values for safety and efficacy. Dedicated technicians and ancillary staff coordinate prior authorizations and financial assistance to improve medication access. In addition, they facilitate time-sensitive preparation and delivery of critical, high-cost medications for each specialty area. This bundle of concierge services was offered to all patients treated at hospital-based clinics (HBCs; Figure 1). The HBCs for Rheumatology and Dermatology funded pharmacy services through specialty prescription revenue. The Rheumatology and Dermatology HBCs were located on or near the main medical campus. There were also 4 Rheumatology and 3 Dermatology community-based clinics (CBCs) dispersed throughout the surrounding region. Pharmacy services for these CBCs were not available because of a lack of funding and resources.

FIGURE 1.

UCDSP Workflow

PA = prior authorization; UCDSP = University of California Davis Specialty Pharmacy.

Differences in services and support represent inequities in patient care that translate into disparities in health outcomes.⁸ Directions and pathways for further expansion of specialty pharmacy services have not been well described. The purpose of this report is to share a model and framework for expansion of HSSP services that ensures sustainable and equitable care across the health system.

GAPS AND BARRIERS

The goal of HSSP clinic expansion was to provide the best possible care in fulfillment of the high-value pharmacy enterprise framework objectives.⁹ However, leadership openly acknowledged that unintended service disparities had stemmed from uneven and competitive distribution of resources. Clinical pharmacy services were initially directed to HBCs, which is where most specialty providers practiced. Funding and staff were further triaged based on demand and availability. These services then began to grow beyond HBCs into the CBCs, also known as Community Physician Groups (CPGs), to meet the needs of patients and physicians in outlying areas. In addition, providers were petitioning for enterprise-wide specialty pharmacy support to ensure consistent, comprehensive, and equitable services for all patients in their care.

Patients observed at CPGs often encountered delays in initiating specialty therapies because of complex prior authorization requirements, insurance denials, disjointed communication, and lack of care coordination. Prior authorization approvals were either completed by a centralized pharmacy technician team or clinic staff. However, if insurance required additional clinical information or denied therapies, then it would fall back on the physician to address. Prescriptions were also often routed to incorrect specialty pharmacies, leading to further delays or gaps in therapy. There was no standardized workflow to close care gaps, and issues often took 1-2 months to be resolved. The contrast in services and support between the HBCs and CPGs provided the impetus for the HSSP service expansion.

The CPG Rheumatology clinic and the CPG Dermatology clinic were prioritized for expansion given the volume of patients and maturity of the programs. Crucially, providers at the HBC also had practicing privileges at CPG locations. The clinical pharmacists and pharmacy leadership met with clinic leadership, physicians, and clinic staff (eg, medical assistants and nurses) to understand the current workflows, obstacles, and other pain points with the prescription process. These teams then identified high-priority interventions, which included medication access, patient counseling, side effect management, agent selection, and dose adjustment. Common operational barriers were also readily recognized, including prior authorizations, denials, high copays, coordination with other specialty pharmacies, and compliance with regulatory standards.

INFRASTRUCTURE AND COMPLIANCE

The opportunity to expand was contingent on referral of patients from CPGs to pharmacists based in HBCs. This pharmacist-driven model leveraged the health system’s existing specialty pharmacy program. Pharmacists completed comprehensive medication management via in-person and video visits. Referrals enabled pharmacists to practice under CPAs and offer patients pharmacist-led visits.

The specialty pharmacy service worked with a dedicated project management team at the health system to develop and streamline the expansion process. The project management team encompassed information technology (IT), Epic, billing, pharmacy leaders, and legal and compliance stakeholders. The goal of the team was to systematically address the technical and operational aspects needed for the expansion. This included the creation of a referral system, pharmacist visit templates, and employee job aids (ie, brief, readily accessible guides for specific tasks and workflows). Referral work queues were created to compile a list of referrals placed by providers. The pharmacist monitored the work queue regularly for new patients to ensure timely enrollment. Visit templates were built under the hospital-based clinic departments to facilitate pharmacist clinic and video visits.

The legal and compliance departments provided guidance for compliance with state and federal laws, Health Resources and Services Administration standards, and 340B Health guidance. Regulations that merited special attention included pharmacist scope of practice, provider credentialing and privileging, referral processes, and billing requirements. Ensuring that the IT build met the legal and regulatory requirements was paramount to automating the operational and clinical practices. For example, the electronic medical record (EMR) team mapped the visit type and provider type in the EMR in accordance with established regulatory policies.

WORKFLOW MODIFICATIONS

Patients were enrolled from CPG clinics in the new system through a referral from a CPG clinic provider to qualify for hospital-based specialty pharmacy services. The provider also routed the initial prescriptions to UCDSP. Once a prescription was received, the pharmacist assessed the appropriateness of therapy, and a pharmacy technician submitted the prior authorization. The pharmacist scheduled the patient for a clinic or video visit under the HBC department upon prior authorization approval following the standard patient care model (Figure 1). The pharmacist conducted the visit and provided comprehensive medication counseling. The pharmacist ensured the prescription was routed to the correct specialty pharmacy based on patient preference and insurance coverage. The patient continued to receive robust specialty pharmacy support and services regardless of where the prescription was filled. These services included initial patient counseling, therapy management (eg, contacting the patient to follow up on tolerability and adherence) and laboratory monitoring. With this new system, patients observed at the HBC and CPG received care through an equitable care model. The initial expansion of pharmacy services outpaced growth in pharmacy staff, creating significant strain on staff and performance metrics. Growth of pharmacy staff (ie, pharmacists and technicians) in subsequent years was targeted to mitigate burnout and create sustainable service lines.

Annually, the pharmacist pended the referral to the provider and scheduled the patient for a visit. The priorities of these appointments were to maintain the patient-pharmacist relationship, resolve barriers to care, ensure effective medication therapy, and address tolerability and adherence issues.

KEY TAKEAWAYS FOR SUCCESS

The service expansion provided common themes for progress and presented unique challenges that required creative strategies. Launching a successful service line demanded more than securing resources. An inclusive multidisciplinary team was critical to strategic and logistical planning. This framework helped anticipate and address gaps and barriers in advance of service go-live. An open forum for communication also enabled proactive problem-solving. The collaborative approach strengthened relationships among key stakeholders through shared goals and values.

Establishing collaborative relationships with the clinic staff and providers was another key to success. Ambiguity in roles, expectations, and workflows was a common source of friction. Clear communication and leadership guidance regarding changes in responsibilities were particularly important. Building effective workflows and rapport took time. In-person engagement, collaborative goal setting, and accountability were essential to resolve conflicts and foster team cohesion.

Outcomes of Expansion

This was a retrospective pre-post analysis at a large academic health system. Adult patients who received care at the rheumatology and dermatology HBC and CPG locations between April 2022 through June 2023 were eligible for inclusion. The pre-group included patients who were enrolled in specialty pharmacy services after being seen at HBCs between January 2021 through March 2022. The post-group included patients who were referred to be enrolled in specialty pharmacy services via pharmacist-led visit after being seen in CPG clinics.

Before the expansion, pharmacists managed 534 patients at the Dermatology and 266 at the Rheumatology HBCs. This generated 601 and 210 prescriptions for dermatology and rheumatology, respectively, at the internal HSSP. During the first 15 months of pilot expansion, dermatology grew by 173 patients and rheumatology by 153 patients. This translated to an additional 226 and 206 prescriptions generated for dermatology and rheumatology. The average turnaround time (TAT) for new biologic therapies increased during the expansion period from 2.07 to 2.49 and from 3.09 to 3.27 days for prescriptions that required pharmacist intervention and those that did not require intervention, respectively. Figure 2 shows the increase in completed pharmacist visits for each clinic over the initial pilot period. As part of service expansion to a new CPG clinic, providers placed referrals for all eligible patients. Patients declined in-person or video visits with the pharmacist if they felt the telephonic injection counseling was sufficient. These were often patients who were stable on therapy. Patients who declined visits still received specialty pharmacy services to ensure equitable care.

FIGURE 2.

Growth of Patients at HSSP Clinics Based on Completion of Patients Visits Over a 12-Month Period After Implementation of the Expansion Initiative

HSSP = health system specialty pharmacy.

The visits were 1 aspect of the expansion of services. Patients referred to the pharmacy team were offered comprehensive clinical medication management. The pharmacist helped patients understand their diagnosis, mitigate treatment costs, and navigate the medication procurement process. The pharmacist provided injection training and disease state management education during these visits. Crucially, pharmacists started tracking TSOs to trend clinical disease progression and the impact of pharmacist intervention.

Before the expansion, collection and documentation of TSOs were inconsistent. This delayed prior authorization renewals as updated TSOs were commonly required by payers. Pharmacists standardized the TSO workflow during the expansion. The Dermatology Life Quality Index (DLQI) was implemented to monitor patient-reported quality of life. In rheumatology, the Routine Assessment of Patient Index Data 3 (RAPID3) score was chosen because of its ease of administration and validity in monitoring disease progression and severity. This aligned rheumatology clinic practice with the American College of Rheumatology 2021 rheumatology guidelines, which recommended a treat-to-target approach with the goal of disease remission.¹⁰ The rheumatology pharmacist captured 248 RAPID3 scores during this expansion and successfully integrated TSO documentation into the EMR. These efforts ensured patients had an annual TSO to guide future therapy decisions and facilitate insurance renewals.

Cost savings in the form of patient copayment assistance was another benefit of the expansion. Financial assistance was provided for 89 patients during this pilot period (April 2022 to June 2023), with an average savings of approximately $3,300 per patient. This evaluation was likely an underestimation because manufacturer foundation patient assistance programs were not included in the analysis. Financial assistance included copay cards and the UCDH Pharmacy Medication Financial Assistance Program. A financial assistance program was used to reduce patient financial burden and supports the intent of the 340B Program to serve low-income and uninsured or underinsured patients.

Patient medication adherence was considered a vital benefit of the pilot and was measured by the proportion of days covered (PDC). The expansion of services included pharmacist-led medication counseling and injection training. The PDC measured during the pilot phase was 0.91 and 0.90 for dermatology and rheumatology specialty medications, respectively. Of note, there was no reliable way to trend medication adherence for patients who filled prescriptions outside of the HSSP.

Clinicians reported positive feedback regarding the partnership with specialty pharmacy and improved patient access to therapy and clinician efficiency. Fourteen providers (54%) from the HBCs and CPGs responded to the survey. The overall mean score for quality and performance of pharmacy services was 4.86 of 5. The physicians strongly agreed that specialty pharmacy “allowed staff to care for more patients” (92.9%), “improved patients’ positive therapeutic outcomes” (85.7%), improved “timeliness of getting patients started on new medications” (78.6%), and “brought value to the practice” (100%). The survey did not differentiate between patients who were seen by the pharmacist in-person vs virtually. The expansion demonstrated the ability to offload work from providers, saving them time and creating space for additional high-quality patient care. Furthermore, physician responses highlighted the clinical and operational value brought to clinical practice through the expansion.

DISCUSSION OF OUTCOMES

The increase in TAT was likely because of rapid growth in the number of patients enrolled in the specialty pharmacy programs. This finding highlighted the need for commensurate growth in pharmacy staff. The standardization of the TSO workflow facilitated capture of DLQI and RAPID3 scores for dermatology and rheumatology patients. These outcome values provided evidence of clinical benefit to payors, which mitigated delays in prior authorization renewals. The level of adherence measured during the pilot period exceeded the industry standard of 0.80 and corresponded with a high level of patient compliance to therapy.

Conclusions

Specialty pharmacy expansion was crucial to ensure that all specialty patients received comprehensive and equitable services. The multidisciplinary team leveraged existing resources, clinic locations, and operational framework to expand comprehensive pharmacy services to all patients. Beneficial outcomes included time to treatment, patient cost savings, medication adherence, TSO tracking, and provider satisfaction. The expansion process and collaborative framework may be translated to other HSSPs to support more equitable care.

Disclosures

The authors have no conflicts of interest relevant to this manuscript.

The authors received no financial support for the research, authorship, and/or publication of this article.