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Purpose Direct and indirect costs related to the growth of specialty pharmacy services and the insurance navigation process for specialty clinic patients are discussed, and development and implementation of a pharmacy-driven and system-wide prior authorization (PA) processing center within a health system are described. Summary Expensive specialty drugs require PA. Due to the concentration of specialists, health systems with multiple specialties experience higher PA burden and resulting care delays. Although clinic staff typically handle PA requests, health-system specialty pharmacies are well positioned to support patients, clinic staff, and physicians by assuming responsibility for the PA process entirely. University of Utah Health established its Pharmacy Ambulatory Clinical Care Center (PAC3) to centralize PA processing for selected specialty and primary care clinics within the health system. In fiscal year 2019, the PAC3 team (10 pharmacy technician and 1.5 pharmacist full-time equivalents) completed over 13,000 PAs. The pharmacy labor cost increase was significant; however, the benefits gained from increased services, quality, and financial strength surpassed all costs associated with the implementation and maintenance of the pharmacy operation. Other tangible benefits included decreased delays in therapy initiation, increased patient satisfaction, increased clinic visits, and increased staff and provider satisfaction and engagement. Conclusion Increased PA requests associated with specialty drugs have placed considerable stress and staff burden on specialty clinics within health systems. However, development and implementation of an efficient PA processing infrastructure within a health-system specialty pharmacy may reduce the burden, increase financial strength, and improve the patient experience.

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Purpose Direct-acting antivirals (DAAs) used to treat hepatitis C virus (HCV) infection are associated with significant drug-drug interactions (DDIs). Pharmacists are well positioned to identify and mitigate these DDIs. Data to guide assessment of the impact of HCV specialty pharmacy services on identifying and addressing DDIs with DAAs are lacking. The overall purpose of the study described here was to determine the incidence and severity of DDIs identified by specialty pharmacists among patients treated with DAAs prior to and 1 month into therapy. Methods An observational, retrospective study was conducted to evaluate the impact of specialty pharmacy services in mitigating DDIs associated with use of DAAs. Adult patients with HCV infection (n = 200) who received DAAs and were enrolled with a specialty pharmacy service over a 1-year period were included. Endpoints included number, severity, and type of DDIs and DDIs per patient at baseline and 1 month into therapy, pharmacists’ interventions, and safety and clinical outcomes. Results Fifty-nine percent of patients had at least 1 DDI. A total of 170 DDIs were identified (137 at baseline and 33 at 1-month follow-up), and the mean number of DDIs per patient significantly decreased from baseline to 1-month follow-up (from 1.38 to 0.16, P < 0.0001). The rate of “potentially clinically significant” or “critical” interactions was significantly lower at 1-month follow-up vs baseline assessment (69.6% vs 81.7%, P < 0.0001). The most commonly identified DDIs involved acid suppressive medications (49.6% and 66.6% of DDIs at baseline and follow-up assessment, respectively) and cardiovascular medications (26.2% and 21.2%, respectively). Total number of DDI interventions was 131, with an acceptance rate of 85%. Most common intervention was patient education and monitoring. Conclusion Approximately 60% of patients had DDIs with DAAs. Implementing HCV specialty pharmacy services significantly decreased DDIs while maintaining SVR12.

Purpose To provide health systems with baseline knowledge on existing and pipeline gene therapy treatments, including considerations that health-system pharmacies and specialty pharmacy programs may reference when evaluating and implementing services around gene therapies. Summary Advancements in research and biotechnology have recently led to the development and launch of the first commercially available gene therapy treatments in the United States. These treatments have the ability to significantly alter and even effectively cure diseases. Alongside these significant advances and clinical benefits, these therapies present unique challenges due to their cost and complexity. Given the large number of additional gene therapy treatments that are currently in late-stage clinical development, stakeholders across the healthcare industry must increasingly adapt and ready themselves to meet these challenges. The diagnosis and treatment of patients with diseases being targeted by gene therapies largely occurs within health systems, and judging by the gene therapy pipeline, this trend is likely to continue. To prepare for these novel treatments, health systems must understand and consider the methods in which gene therapies are developed, procured, reimbursed, administered, and monitored. Conclusion The future of health-system pharmacy practice must include comprehensive gene therapy services and stakeholder engagement strategies to ensure patients have access to these life-changing treatments.

Purpose The purpose of this study is to obtain insight into providers’ satisfaction with services offered by health-system integrated specialty pharmacies and to determine whether providers’ perceptions of services offered under an integrated model differ from perceptions of external specialty pharmacy services. Methods A multi-site, cross-sectional, online survey of specialty clinic healthcare providers at 10 academic health systems with integrated specialty pharmacies was conducted. The questionnaire was developed by members of the Vizient Specialty Pharmacy Outcomes and Benchmarking Workgroup and was pretested at 3 pilot sites prior to dissemination. Prescribers of specialty medications within each institution were identified and sent an email invitation to participate in the study that included a link to the anonymous questionnaire. Respondents were asked to rate their agreement with 10 statements regarding quality of services of integrated and external specialty pharmacies on a 5-point scale (1 = strongly disagree, 5 = strongly agree). An analysis to determine differences in providers’ overall satisfaction with the integrated and external specialty pharmacy practice models, as well as differences in satisfaction scores for each of the 10 statements, was performed using paired-samples t tests. Results The mean (SD) score for overall satisfaction with integrated specialty pharmacies was significantly higher than the score for satisfaction with external specialty pharmacies: 4.72 (0.58) vs 2.97 (1.20); 95% confidence interval, 1.64-1.87; P < 0.001. Provider ratings of the integrated specialty pharmacy model were also higher for all 10 items evaluating the quality of services (P < 0.05 for all comparisons). Conclusion The study results confirm that the health-system integrated specialty pharmacy practice model promotes high rates of provider satisfaction with services and perceived benefits.

PurposeThe high-value pharmacy enterprise (HVPE) framework and constituent best practice consensus statements are presented, and the methods used to develop the framework’s 8 domains are described.SummaryA panel of pharmacy leaders used an evidence- and expert opinion–based approach to define core and aspirational elements of practice that should be established within contemporary health-system pharmacy enterprises by calendar year 2025. Eight domains of an HVPE were identified: Patient Care Services; Business Services; Ambulatory and Specialty Pharmacy Services; Inpatient Operations; Safety and Quality; Pharmacy Workforce; Information Technology, Data, and Information Management; and Leadership. Phase 1 of the project consisted of the development of draft practice statements, performance elements, and supporting evidence for each domain by panelists, followed by a phase 2 in-person meeting for review and development of consensus for statements and performance elements in each domain. During phase 3, the project cochairs and panelists finalized the domain drafts and incorporated them into a full technical report and this summary report.ConclusionThe HVPE framework is a strategic roadmap to advance pharmacy practice by ensuring safe, effective, and patient-centered medication management and business practices throughout the health-system pharmacy enterprise. Grounded in evidence and expert recommendations, the statements and associated performance elements can be used to identify strategic priorities to improve patient outcomes and add value within health systems.

Purpose An institutional workflow developed by clinical pharmacists for initiation of directing-acting antiviral (DAA) therapy for patients who receive solid organ transplants from hepatitis C (HCV)–positive donors is described; programmatic challenges in providing pharmaceutical care to these patients are reviewed. Summary In recent years the introduction of new oral DAAs, coupled with faster screening of donor organs for HCV infection through use of a nucleic acid test (NAT), has facilitated transplants of organs from HCV-seropositive donors to HCV-seronegative recipients. The solid organ transplant program of a North Carolina health system began performing such transplants in December 2017. In the pharmacist-developed workflow, patients are initiated on DAA therapy in the outpatient clinic setting, and clinic pharmacists are consulted regarding drug selection. Prescriptions for DAA therapy are sent to an on-site specialty pharmacy, where pharmacists and pharmacy technicians work to obtain prior authorization and, if necessary, payment assistance through manufacturer-sponsored programs. The medical team is notified at the time of patient approval to begin treatment. Pharmacists provide counseling at the time of DAA therapy initiation and follow up with patients every 2 weeks to confirm adherence. As of June 2019, about 100 transplants of HCV NAT–positive organs had been performed (approximately 50% were kidney transplants; 15%, lung transplants; 20%, heart transplants; and 15%, liver transplants). Many challenges are encountered in the process of providing pharmaceutical care to this patient population, including challenges in patient selection and counseling, overcoming financial barriers and insurance restrictions, and coordinating with an internal specialty pharmacy to ensure timely delivery of medication to patients. Conclusion Within a solid organ transplantation program, clinical pharmacists and other pharmacy personnel can play vital roles in ensuring safe and effective DAA therapy for recipients of transplanted HCV NAT–positive organs.

Purpose The optimal health care delivery models for providing services to patients with infections caused by hepatitis C virus (HCV) remain unknown. Pharmacist involvement may be a key component of optimal HCV care delivery. We examined the comparative effectiveness of a pharmacist-managed HCV clinic versus a pharmacist-assisted HCV clinic. Methods This retrospective cohort study used electronic health record data on patients ≥18 years old initiating HCV treatment at a pharmacist-managed clinic or a pharmacist-assisted clinic within a single health-system between January 2015 and June 2017. Outcomes included treatment completion, sustained virologic response 12 weeks following treatment completion (SVR-12), and dispensation of direct-acting antiviral agents at the institution-based specialty pharmacy. Inverse probability of treatment-weighted (IPTW) logistic regression models were used to compare outcomes between the 2 clinic models. Results A total of 127 patients initiated HCV treatment therapy: 64 patients from the pharmacist-managed clinic and 63 patients from the pharmacist-assisted clinic. The cohort had a mean age of 55 years, was 51% male, and 68% white. In IPTW analyses, there was no difference in treatment completion (odds ratio [OR], 1.1; 95% confidence interval [CI], 0.1-13.8; p = 0.93), achievement of sustained virologic response at 12 months (SVR-12) (OR, 1.0; 95% CI, 0.2-4.5; p = 0.62), or use of institution-based specialty pharmacy (OR, 0.6; 95% CI, 0.2-1.7; p = 0.33) between pharmacist-managed and pharmacist-assisted clinics. Conclusion There were no significant differences in outcomes between patients receiving care at the pharmacist-managed HCV clinic and the pharmacist-assisted clinic. Given the frequency of SVR-12 achieved in both groups, both pharmacist-managed and pharmacist-assisted clinic models may be reasonable alternatives for providing outpatient HCV care.

Purpose Specialty drugs used in patients with inflammatory disease states are reviewed, with a focus on the pharmacist’s roles in facilitating medication procurement and in the clinical management of affected patients. Summary Pharmacists in the ambulatory care and community settings are strategically placed to be actively involved in specialty drug procurement and clinical management of patients with inflammatory diseases such as rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, inflammatory bowel disease, and ankylosing spondylitis. Specialty medications used in the treatment of these diseases include anti–tumor necrosis factor (TNF) disease-modifying antirheumatic drugs (DMARDs), non-TNF DMARDs, and interleukin inhibitors. Pharmacist involvement in drug procurement in this area includes navigating insurance barriers and helping patients address high out-of-pocket costs; clinical management activities can include ensuring appropriate baseline screening and vaccine administration, providing drug-specific patient education, and performing routine follow-up and assessment. Patient education is the single biggest area where pharmacists can have a direct impact on overall clinical management of patients receiving specialty drugs for the treatment of inflammatory diseases. These patients need to be educated about dosing, administration, storage and disposal, common and rare adverse effects, adverse-effect management strategies, expectations of drug effect, and considerations for unique circumstances such as illness and planned surgery. Conclusion Specialty drugs represent one of the fastest-growing sectors of pharmacy spending, with inflammatory disease therapies at the forefront. As pharmacists are accessible healthcare practitioners, their responsibilities should include financial and clinical management of patients with inflammatory diseases who are receiving specialty drugs.

Purpose The benefits of developing a collaborative, outcomes-based specialty pharmacy program are described. Summary With the implementation of risk-based payment models and the rapid growth of specialty pharmacy spend, opportunities exist to establish collaborative and outcomes-focused specialty pharmacy contracts and related programs with regional third-party payers. University of Wisconsin (UW) Health and Unity Health Plans Insurance Corporation have established a contract that sets standards for patient management, pharmacist training and education, electronic medical record documentation, and prescription fulfillment for patients receiving specialty pharmaceuticals. Reporting on metrics of compliance, persistence, and outcomes relative to published benchmarks is required annually. While the contract defines patients by the traditional metric of specialty medication use and includes reimbursement for dispensing activities, it differentiates itself by establishing core services and longitudinal practice expectations for patient care rather than focusing on reimbursement for prescription fulfillment. While it focuses on specialty pharmacy practice, the contract provides an ancillary benefit to all patients using UW Health pharmacies by elevating ambulatory care pharmacy practice standards and improving the patient care process. Conclusion The collaborative development of practice standards, service requirements, and patient management protocols offers the rapid elevation of specialty pharmacy services, which provides significant differentiation within the highly competitive specialty pharmacy and third-party payer marketplaces.

Purpose Currently available oral oncology therapies are reviewed, and specialty pharmacy services for patients receiving these drugs are described. Summary Market introductions of new oral oncology drugs have increased substantially over the past decade, and 25–30% of all oncology agents in development are oral medications. Oral agents for treatment of breast cancer include capecitabine, lafatinib, and palbociclib. Several oral agents are used in treating patients with lung cancer driven by mutations of genes coding for anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR); currently available agents include the ALK inhibitors certinib and crizotinib and the EGFR inhibitors afatinib, erlotinib, and gefitinib. Four oral targeted therapies are used in the treatment of melanoma associated with the B-Raf proto-oncogene, BRAF : cobimetinib, dabrafenib, trametinib, and vemurafenib. Oral agents for treatment of prostate cancer include abiraterone acetate and enzalutamide. Oral agents for treatment of renal cell carcinoma include axitinib, everolimus, pazopanib, sorafenib, and sunitinib. Specialty pharmacy services for patients receiving oral oncology agents can include (1) providing patient counseling and education on adverse effects and self-management strategies, (2) processing prior-authorization requests and helping patients navigate copayment assistance programs, and (3) monitoring for medication toxicities and recommending dose adjustments as appropriate. Conclusion Many oral oncology medications have been introduced over the past 10–15 years, with many others in clinical development. Due to the complexity of initiating and monitoring patients receiving these oral therapies, specialty pharmacy services are an essential component of many patients’ cancer care.

Affordability, access to care, and accountability are the cornerstones of contemporary, Affordable Care Act (ACA)-based healthcare. In this new paradigm, providers are assuming greater accountability for improving patient outcomes, reducing costs, and providing higher quality care through a team

Purpose The development and successful implementation of a comprehensive medication prior-authorization service are described. Summary At our 550-bed academic medical center, we found an increasing number of Medicare write-offs as a result of the off-label use of specialty medications. Furthermore, more insurers were requiring that prior authorization be attained before patients began treatment with a high-cost specialty medication. After investigating who was pursuing these prior authorizations and where they were documented, it became clear that no department within the hospital owned this responsibility. Our pharmacy department initiated a specialty medication prior-authorization and medication assistance program to review all medication orders written for high-cost specialty medications administered or infused in any of the health system’s outpatient clinics, including chemotherapy infusions. A full-time specialty pharmacy coordinator was hired in fall 2010. This pharmacist was responsible for spearheading the overall specialty medication strategy for the health system. Our prior-authorization work across our health system has not only helped to reduce Medicare write-offs and commercial insurance denials but also has resulted in closer working relationships with individuals in other departments of the hospital. Several million dollars in additional write-offs were avoided because our prior-authorization staff identified prescribed therapies that would not be covered by Medicare or commercial insurers before they were started. In total, we decreased write-offs or increased revenues by over $6.2 million during this time frame, a return on investment exceeding 20:1. Conclusion A comprehensive medication prior-authorization service generated additional revenue due to a decrease in lost charges and an increase in net reimbursement.