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PURPOSE: The results of the 2022 American Society of Health-System Pharmacists (ASHP) Survey of Health-System Specialty Pharmacy (HSSP) Practice: Practice Models, Operations, and Workforce are presented. METHODS: A total of 273 leaders in HSSPs were contacted by email to complete a survey hosted using Qualtrics. The survey sample was compiled from ASHP member lists, the presence of a specialty pharmacy indicated in previous ASHP surveys, and outreach to ASHP member organizational leaders. RESULTS: The survey response rate was 35.9%. Most HSSPs dispense 30,000 or fewer specialty prescriptions annually. Most respondents have an annual revenue of $100 million or less, are part of a 340B-covered entity, operate one location, have 1 to 2 specialty pharmacy accreditations, dispense both nonspecialty and specialty medications, and employ an average of 15.5 pharmacists and 17.6 technicians. The majority (66.7%) dispense 50% or less of prescriptions written by internal providers due to payor and manufacturer network restrictions. Over one-third employ nonpharmacist and nontechnician professionals. Specialty pharmacists are involved in treatment decisions and therapy selection before prescription generation (69.8%), and 47.7% of respondents report pharmacists operating under collaborative practice agreements. Most (82.6%) offer experiential or formal education in specialty pharmacy. The top point of pride remains patient satisfaction and level of service. Top challenges include access to payor networks, the ability to hire and retain qualified staff, and shrinking reimbursement from payors. CONCLUSION: The HSSP is a continually maturing integrated advanced practice model focused on providing patient-centric care to all patients and employees of the health system regardless of network status. HSSPs are raising the standards for quality in specialty pharmacy care.

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OBJECTIVES: China is poised to become the world's second-largest oncology drug market. Its ability to continue broadening health coverage is in question. Institutional innovations such as performance-based risk-sharing agreements (PBRSAs) have been developed to promote access to novel therapeutics beyond that provided by public health insurance and central procurement systems. We examine in depth the financial implications of a PBRSA developed in China for the breast cancer drug palbociclib. METHODS: We generated a 2-state Markov model from PBRSA information made publicly available. Model inputs included breast cancer outcomes data from the published literature. The primary analysis estimates the percentage reduction in overall drug expenditures due to the PBRSA. Sensitivity analyses explored the financial impact of varied computed tomography scan utilization, rebate rate, and rebate duration. RESULTS: Estimated palbociclib expenditures for the PBRSA cohort totaled $36 278 000. Based on the publicly available information for the PBRSA, an effective discount of 1.3% was estimated. The effective discount was insensitive to changes in computed tomography scan utilization. CONCLUSIONS: The palbociclib PBRSA likely had negligible impact on patient access to therapy and limited downstream financial impact to patients and payers. The short duration of the rebate window, small rebate, and disease indolence contributed to the low expected rebate percentage.

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PURPOSE: To describe the development of a pilot specialty medication clinical dashboard targeting tumor necrosis factor (TNF)-α inhibitor therapy. SUMMARY: This was a quality improvement project conducted between August 2019 and April 2020. The dashboard was designed with collaboration between clinical pharmacists and specialty providers in rheumatology, gastroenterology, and dermatology. Data was queried from the Veterans Affairs Corporate Data Warehouse. Patients with an active prescription or intravenous order for a TNF-α inhibitor were included. Dashboard flag criteria focused on TNF-α inhibitor safety and adherence monitoring. Flag results from the dashboard were characterized from data captured at a single time point. For 431 patients on TNF-α inhibitor treatment at the institution, 304 flags corresponding to 223 unique patients (51.7%) were identified on the dashboard: 3% of patients had a new infection, 9% had overdue monitoring laboratory tests, 5% had a critical laboratory result, 2% were on 2 biologic agents, 27% were overdue for a refill, 6% had an emergency department visit, and 2% had an inpatient admission. No patients were flagged for heart failure exacerbation or new malignancy. Seventeen percent of patients were prescribed high-dose etanercept or adalimumab, representing a potential annual cost savings of $302,497 if 50% of these patients had their dose successfully reduced to labeled dosing. Opportunities for pharmacist intervention utilizing the dashboard were identified and characterized through chart review of flagged patients. CONCLUSION: Pharmacists have the opportunity to improve safety and adherence for TNF-α inhibitor therapy through use of a specialty medication clinical dashboard. The dashboard should be used in conjunction with collaborative practice protocols.

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Background: Specialty medications provide effective treatment with limited adverse effects to patients with psoriasis and psoriatic arthritis; however, variable coverage and high costs often create a barrier to treatment for patients with commercial health insurance. Objective: We aimed to evaluate coverage of psoriasis and psoriatic arthritis specialty medications by commercial insurance companies. Methods: We compiled data regarding specialty drug coverage for psoriasis and psoriatic arthritis using Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database and analyzed the data for any notable trends. The SPEC database lists coverage decisions for 158 specialty drugs by 17 of the largest US commercial health plans, as well as data regarding the types of evidence cited by these insurance plans when making coverage decisions. Results: Our results showed that insurance plans tend to be more restrictive than the U.S. Food and Drug Association (FDA) label when covering medications for psoriasis and psoriatic arthritis. Furthermore, medications for psoriatic arthritis tended to be less restricted than for psoriasis, and medications were most commonly approved as second line agents for both indications. Conclusion: Our analysis confirms that variability in insurance coverage exists for the indications of psoriasis and psoriatic arthritis.

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PURPOSE: Results of the first ASHP National Survey of Health-System Specialty Pharmacy Practice are presented. METHODS: A sample of 230 leaders in health-system specialty pharmacies were contacted by email and invited to participate in a survey hosted using an online survey application. The survey sample was compiled from ASHP member lists, through review of data from other ASHP surveys indicating the presence of specialty pharmacies, and by outreach to ASHP member organizational leaders. RESULTS: The response rate was 53.0%. Most health-system specialty pharmacies dispense 30,000 or fewer specialty prescriptions per year, have an annual revenue of $100 million or less, are part of an entity eligible to participate in the 340B Drug Pricing Program, operate 1 specialty pharmacy location, have at least 1 specialty pharmacy accreditation, dispense nonspecialty medications in addition to specialty medications, and employ an average of 13 pharmacists and 15 technicians. More than two-thirds of health-system specialty pharmacies (68.8%) dispense no more than half of the prescriptions written by their providers due to payer network restrictions or limited distribution drugs. The health-system specialty pharmacy practice model includes access to the electronic health record (100% of respondents), pharmacists and technicians dedicated to specific clinics (64.9% and 57.7%, respectively), specialty pharmacist involvement in treatment decisions and drug therapy selection prior to the prescription being written (64.9%), and documenting recommendations and progress notes in patients' electronic health record (93.4%). Most health-system specialty pharmacies (83.3%) offer experiential or formal education in specialty pharmacy. Top challenges that survey respondents expected to face in the next year included restricted access to payer networks and limited distribution drugs, 340B Drug Pricing Program changes, and shrinking reimbursement from payers. CONCLUSION: The health-system specialty pharmacy represents an integrated advanced practice model that incorporates specialty medication-use management across the continuum of care.

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BACKGROUND: Despite the rising popularity of using specialty medications for patients with rheumatoid arthritis (RA), little is known about the use or spending on medical services among these patients. OBJECTIVE: The objective of this study was to investigate health care utilization and expenditures among patients with RA using specialty medications compared with those using non-specialty (i.e., traditional) medications. METHODS: This was a retrospective cohort study using Medical Expenditure Panel Survey data from 2009 through 2015. Health care use and expenditures were examined using a (zero-truncated or zero-inflated) negative binomial model and a generalized linear model with a log link function and gamma distribution (or a two-part model). RESULTS: Compared to patients with RA who were traditional medication users (TMUs), those categorized as specialty medication users (SMUs) were prescribed about 24% fewer medications (incidence rate ratio [IRR] = 0.76, 95% CI = 0.66-0.89) and received fewer office-based visits (IRR = 0.84, 95% CI = 0.70-0.99). Although SMUs' spending on emergency department visits was lower, their spending on total health care was $14,570 higher than that of TMUs. Compared with TMUs, users of both specialty and traditional medications (BMUs) had fewer emergency department visits (IRR = 0.57, 95% CI = 0.39-0.81) with less spending on emergency service use. Overall, BMUs' total health care spending was $5720 higher than TMUs' total spending. CONCLUSIONS: There were some differences in health care use and expenditures for treating RA between patients using specialty medications and those using traditional medications. Total health care spending was higher for SMUs/BMUs despite their less frequent use of some types of medical services and lower spending on emergency department visits, because of the high cost of specialty medications for RA. The high costs of specialty medications implies the importance of the efficient use of these medications.

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BACKGROUND: Specialty medications include innovative drugs and biologic agents requiring special handling and close monitoring. Although specialty medications have been widely used for various chronic conditions, increased use of these medications has contributed a growing share of total health care expenditures. OBJECTIVE: The aim of this study was to examine patient characteristics related to specialty medication use. METHODS: Using Medical Expenditure Panel Survey (MEPS) data from 2000 through 2013, this study identified U.S. adults using specialty medications. Andersen's Health Services Utilization model was used to identify potential factors related to specialty medication use. Associations between the variables identified by Andersen's model and specialty medication use were analyzed using logistic multilevel modelling. Sampling weights were considered and standard errors were adjusted to account for the complex survey design. RESULTS: A fully adjusted model suggested that older adults, individuals with prescription drug insurance, or those using mail order services were more likely to use specialty medications regardless of whether they used traditional medications concurrently. Behaviors of using specialty medications were positively associated with married and active working status and negatively associated with middle or high income and having a usual source of care (visiting a doctor's office, clinic, or health center when sick) when comparing individuals using traditional medications and those using specialty medications. In addition, when comparing individuals using traditional medications with those using both specialty medications and traditional medications, behaviors of using specialty medications were positively associated with female gender, worse health state, and more comorbidities. CONCLUSION: This study identified characteristics of patients using specialty medications. Some sociodemographic, economic, and clinical factors were related to specialty medication use among U.S. adults.

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