Recent and anticipated novel drug approvals (Q2 2024 through Q1 2025).

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by providing periodic updates on new and anticipated novel drug approvals. SUMMARY: Selected drug approvals anticipated in the 12-month period covering the second quarter of 2024 through the first quarter of 2025 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics, as selected from 52 novel drugs awaiting US Food and Drug Administration approval. New cellular and gene therapies for cancers continued to strengthen the pipeline, in addition to new drugs targeting previously untreatable conditions. Several novel drugs are being developed for rare and ultra-rare diseases such as hemophilia, Niemann-Pick disease type C, hereditary angioedema, and aromatic L-amino acid decarboxylase deficiency. CONCLUSION: The current drug pipeline includes new drugs with various indications for cancers and rare diseases as well as diabetes, acute coronary syndrome, chronic skin disorder, and chronic obstructive pulmonary disease.

Conversion of an outpatient pharmacy to a mail-order pharmacy within a health system.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: The establishment of a new outpatient pharmacy provided a strategic opportunity to repurpose and convert an existing outpatient pharmacy into a closed-door mail-order pharmacy within a health system. This article describes the steps taken to successfully make this change and evaluates the impact. SUMMARY: The mail-order pharmacy conversion project was divided into 3 phases: phase 1 (before conversion) from July through August 2022, phase 2 (conversion) from October through November 2022, and phase 3 (after conversion) from December 2022 through February 2023. Phase 1 included standardizing workflows with standard operating procedure (SOP) development, improving automation, determining staffing ratios, gathering baseline staff engagement data, and identifying primary and secondary outcomes of interest. Phase 2 encompassed SOP implementation and training of mail-order team members. Phase 3 involved evaluating available pharmacy floorspace, marketing mail-order services, and the second distribution of the staff engagement survey. The measured outcomes of this project were total prescription volumes, increase in total revenue, and staff engagement. Data collection was completed in phase 3. CONCLUSION: The existing outpatient pharmacy was successfully converted to a closed-door pharmacy, and the associated prescription volume increased. Developing a strategic action plan to establish SOPs, calculate staffing performance metrics, and identify opportunities for growth and engaging frontline team members were essential to the success of this project.

National trends in prescription drug expenditures and projections for 2024.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2024 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2024 were reviewed-including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, endocrine drugs, generics, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2024 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2023, overall pharmaceutical expenditures in the US grew 13.6% compared to 2022, for a total of $722.5 billion. Utilization (a 6.5% increase), new drugs (a 4.2% increase) and price (a 2.9% increase) drove this increase. Semaglutide was the top drug in 2023, followed by adalimumab and apixaban. Drug expenditures were $37.1 billion (a 1.1% decrease) and $135.7 billion (a 15.0% increase) in nonfederal hospitals and clinics, respectively. In clinics, increased utilization drove growth, with a small impact from price and new products. In nonfederal hospitals, a drop in utilization led the decrease in expenditures, with price and new drugs modestly contributing to growth in spending. Several new drugs that will influence spending are expected to be approved in 2024. Specialty, endocrine, and cancer drugs will continue to drive expenditures. CONCLUSION: For 2024, we expect overall prescription drug spending to rise by 10.0% to 12.0%, whereas in clinics and hospitals we anticipate an 11.0% to 13.0% increase and a 0% to 2.0% increase, respectively, compared to 2023. These national estimates of future pharmaceutical expenditure growth may not be representative of any health system because of the myriad of local factors that influence actual spending.

Recent and anticipated novel drug approvals for 2024.

PURPOSE: Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by providing periodic updates on new and anticipated novel drug approvals. SUMMARY: Selected drug approvals anticipated in the 12-month period covering the first quarter of 2024 through the fourth quarter of 2024 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics, as selected from 59 novel drugs awaiting US Food and Drug Administration approval. This year's pipeline includes recently added drugs with various indications including oncology, infectious diseases, genetic disorders, and rare diseases. New cellular and gene therapies are rapidly evolving and being studied for several rare diseases and cancers. CONCLUSION: More oncology agents, including gene therapies, oral agents, and monoclonal antibodies, are in the pipeline this year. Additional diseases targeted by new novel drugs, including cellular and gene therapies, are hemophilia, nonalcoholic steatohepatitis, Alzheimer's disease, and rare diseases such as galactosemia and epidermolysis bullosa.

Recent and anticipated novel drug approvals for 2023 and 2024.

PURPOSE: Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by providing updates on new and anticipated novel drug approvals. SUMMARY: Selected drug approvals anticipated in the 12-month period covering the fourth quarter of 2023 through the third quarter of 2024 are reviewed. The analysis emphasizes drugs selected from 58 novel drugs awaiting FDA approval that are expected to have significant clinical and financial impact in hospitals and clinics. The pipeline includes recently added drugs with various indications, including oncology, infectious diseases such as complicated urinary tract infection and pneumonia, and rare diseases. CONCLUSION: Cellular and gene therapies continue to strengthen the pipeline as potential new treatment options for genetic disorders, rare diseases, and cancer. Additional diseases treated by new agents include pulmonary arterial hypertension, chronic obstructive pulmonary disease, diabetes, and obesity.

Recent and anticipated novel drug approvals for 2023 and 2024.

PURPOSE: Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by sharing new and anticipated novel drug approvals. SUMMARY: Selected drug approvals anticipated in the 12-month period covering the second quarter of 2023 through the first quarter of 2024 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics, as selected from 58 novel drugs awaiting Food and Drug Administration (FDA) approval at the time of data extraction. The pipeline includes drugs with various indications, such as oncology, inflammatory conditions, and rare diseases. Key developments in oncology are highlighted along with notable advancements in treating myelofibrosis, metastatic colorectal cancer, and low-grade gliomas. Cellular and gene therapies are anticipated to emerge prominently as treatment options for severe hemophilia A and sickle cell disease. Several monoclonal antibodies targeting autoimmune diseases are awaiting FDA approval. CONCLUSION: Several new novel drugs in the pipeline are intended for use in treating cancers, autoimmune conditions, and rare diseases such as sickle cell disease.

National trends in prescription drug expenditures and projections for 2023.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2023 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2023 were reviewed, including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, diabetes medications, generics, COVID-19 pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2023 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2022, overall pharmaceutical expenditures in the US grew 9.4% compared to 2021, for a total of $633.5 billion. Utilization (a 5.9% increase), price (a 1.7% increase) and new drugs (a 1.8% increase) drove this increase. Adalimumab was the top-selling drug in 2022, followed by semaglutide and apixaban. Drug expenditures were $37.2 billion (a 5.9% decrease) and $116.9 billion (a 10.4% increase) in nonfederal hospitals and clinics, respectively. In clinics, new products and increased utilization growth drove growth, with a small impact from price changes. In nonfederal hospitals, a drop in utilization led to a decrease in expenditures, with price changes and new drugs contributing to growth in spending. Several new drugs that will influence spending have been or are expected to be approved in 2023. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic. CONCLUSION: For 2023, we expect overall prescription drug spending to rise by 6.0% to 8.0%, whereas in clinics and hospitals we anticipate increases of 8.0% to 10.0% and 1.0% to 3.0%, respectively, compared to 2022. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

National trends in prescription drug expenditures and projections for 2022.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2022 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2022 were reviewed-including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, generics, COVID-19 pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2022 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2021, overall pharmaceutical expenditures in the US grew 7.7% compared to 2020, for a total of $576.9 billion. Utilization (a 4.8% increase), price (a 1.9% increase) and new drugs (a 1.1% increase) drove this increase. Adalimumab was the top drug in terms of overall expenditures in 2021, followed by apixaban and dulaglutide. Drug expenditures were $39.6 billion (a 8.4% increase) and $105.0 billion (a 7.7% increase) in nonfederal hospitals and in clinics, respectively. In clinics and hospitals, new products and increased utilization growth drove growth, with decreasing prices for both sectors acting as an expense restraint. Several new drugs that are likely to influence spending are expected to be approved in 2022. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic. CONCLUSION: For 2022, we expect overall prescription drug spending to rise by 4.0% to 6.0%, whereas in clinics and hospitals we anticipate increases of 7.0% to 9.0% and 3.0% to 5.0%, respectively, compared to 2021. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

National trends in prescription drug expenditures and projections for 2021.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2021 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2021 were reviewed-including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, generics, coronavirus disease 2019 (COVID-19) pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2021 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2020, overall pharmaceutical expenditures in the United States grew 4.9% compared to 2019, for a total of $535.3 billion. Utilization (a 2.9% increase) and new drugs (a 1.8% increase) drove this increase, with price changes having minimal influence (a 0.3% increase). Adalimumab was the top drug in 2020, followed by apixaban and insulin glargine. Drug expenditures were $35.3 billion (a 4.6% decrease) and $98.4 billion (an 8.1% increase) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals the decrease in expenditures was driven by reduced utilization. Several new drugs that will influence spending are expected to be approved in 2021. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic. CONCLUSION: For 2021, we expect overall prescription drug spending to rise by 4% to 6%, whereas in clinics and hospitals we anticipate increases of 7% to 9% and 3% to 5%, respectively, compared to 2020. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

Analyzing the costs of developing and operating an integrated health-system specialty pharmacy: The case of a centralized insurance navigation process for specialty clinic patients.

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.

National trends in prescription drug expenditures and projections for 2020.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2020 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2020 were reviewed, including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for specialty drugs, biosimilars, and diabetes medications. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2020 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2019, overall US pharmaceutical expenditures grew 5.4% compared to 2018, for a total of $507.9 billion. This increase was driven to similar degrees by prices, utilization, and new drugs. Adalimumab was the top drug in US expenditures in 2019, followed by apixaban and insulin glargine. Drug expenditures were $36.9 billion (a 1.5% increase from 2018) and $90.3 billion (an 11.8% increase from 2018) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals growth was driven by new products and price increases. Several new drugs that will likely influence spending are expected to be approved in 2020. Specialty and cancer drugs will continue to drive expenditures. CONCLUSION: For 2020 we expect overall prescription drug spending to rise by 4.0% to 6.0%, whereas in clinics and hospitals we anticipate increases of 9.0% to 11.0% and 2.0% to 4.0%, respectively, compared to 2019. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

Implementation and impact assessment of integrated electronic prior authorization in an academic health system.

OBJECTIVE: To describe the system-wide implementation of integrated electronic prior authorization (ePA) and its impact within a centralized prior authorization (PA) department in an academic health system. SETTING: Prescription drugs have been among the fastest growing areas of health care and continue to advance; therefore, costs associated with medications are continually rising. Pharmacy benefit managers implement tools such as PAs in an effort to manage costs. PAs are often viewed as inconvenient and irritating by both patients and clinical staff. PRACTICE DESCRIPTION: The pharmacy ambulatory clinical care center (PAC3), a centralized PA department, provides PA services to some clinics within the system. Since 2014, the system has worked to optimize the manual (by telephone and fax) PA process. However, it is still a time-consuming, multistep process. PRACTICE INNOVATION: A resolution to the PA problems that health systems face is ePA, which involves processing PAs electronically through an online portal or integrated within an electronic health record. The system began the implementation process with the selection of an ePA vendor, followed by implementation within the electronic health record. Once the software was ready, the system took a phased rollout approach and implemented ePA in a few specialty and primary care clinics at a time. EVALUATION: An average of 24% of PAs processed by PAC3 were completed by ePA. The system saw a 25% increase in the number of PAs processed per month by 1 PA coordinator full-time equivalent. In addition, a 62% decrease in the PA turnaround time allowed patients to receive medications faster. RESULTS: Not applicable. CONCLUSION: ePA offers several benefits to the system including decreased turnaround time. This allows patients to receive medications and start therapy earlier. The ePA process also increased efficiency, allowing PAC3 to centrally manage PAs for additional clinics, thereby decreasing the workload in the clinic.

Implementation of a centralized mail-order pharmacy service.

PURPOSE: The development and implementation of centralized mail-order pharmacy services in an academic healthcare system are described. SUMMARY: The use of mail-order pharmacy services continues to increase, as mail-order services offer patient benefits such as reduced copayments and improved clinical outcomes. Prior to undertaking an initiative to improve its mail-order pharmacy services, the University of Utah Health system's pharmacy department offered decentralized mail-order pharmacy services at all of its retail pharmacies, but there was no standardized process for processing mail-order prescriptions or providing phone support to mail-order patients. Centralized mail-order pharmacy services were developed and implemented by creating (1) a standard process for mail-order pharmacy services, (2) a centralized mail-order prescription filling center, and (3) a call center to support mail-order pharmacy services. Implementation of centralized mail-order pharmacy services resulted in an almost 50% reduction in time spent by pharmacy team members on mail-order prescription filling and packaging tasks. Use of a central call center resulted in a decreased call abandonment rate and contributed to a decreased pharmacy workload resulting from an overall reduction in call volume due to an increased rate of first-call issue resolution. CONCLUSION: Establishment of a centralized mail-order pharmacy service along with operational and infrastructure improvements resulted in improved quality and regulatory compliance and enhanced labor efficiency and patient communication.

National trends in prescription drug expenditures and projections for 2019.

PURPOSE: Historical trends and factors likely to influence future pharmaceutical expenditures are discussed, and projections are made for drug spending in 2019 in nonfederal hospitals, clinics, and overall (all sectors). METHODS: Drug expenditure data through calendar year 2018 were obtained from the IQVIA National Sales Perspectives database and analyzed. New drug approvals, patent expirations, and other factors that may influence drug spending in hospitals and clinics in 2019 were also reviewed. Expenditure projections for 2019 for nonfederal hospitals, clinics, and overall (all sectors) were made through a combination of quantitative analyses and expert opinion. RESULTS: U.S. prescription sales in calendar year 2018 totaled $476.2 billion, a 5.5% increase from 2017 spending. The top 3 drugs by expenditures were adalimumab ($19.1 billion), insulin glargine ($9.3 billion), and etanercept ($8.0 billion). Prescription expenditures in nonfederal hospitals totaled $35.8 billion, a 4.8% increase from 2017. Expenditures in clinics in 2018 increased by 13.0% to $80.5 billion. The increase in spending in nonfederal hospitals was largely driven by new products and increased utilization of existing products. The list of the top 25 drugs by expenditures in nonfederal hospitals and clinics was dominated by specialty drugs. CONCLUSION: We predict continued moderate growth of 4-6% in overall drug expenditures (across the entire U.S. market). We expect the clinic sector to continue to experience high (11-13%) growth in drug spending in 2019. Finally, for nonfederal hospitals we anticipate growth in the range of 3-5%. These estimates are at the national level. Health-system pharmacy leaders should carefully examine local drug utilization patterns to determine their own organization's anticipated spending in 2019.

Implementation and quality assessment of a pharmacy services call center for outpatient pharmacies and specialty pharmacy services in an academic health system.

PURPOSE: The implementation and quality assessment of a pharmacy services call center (PSCC) for outpatient pharmacies and specialty pharmacy services within an academic health system are described. SUMMARY: Prolonged wait times in outpatient pharmacies or hold times on the phone affect the ability of pharmacies to capture and retain prescriptions. To support outpatient pharmacy operations and improve quality, a PSCC was developed to centralize handling of all outpatient and specialty pharmacy calls. The purpose of the PSCC was to improve the quality of pharmacy telephone services by (1) decreasing the call abandonment rate, (2) improving the speed of answer, (3) increasing first-call resolution, (4) centralizing all specialty pharmacy and prior authorization calls, (5) increasing labor efficiency and pharmacy capacities, (6) implementing a quality evaluation program, and (7) improving workplace satisfaction and retention of outpatient pharmacy staff. The PSCC centralized pharmacy calls from 9 pharmacy locations, 2 outpatient clinics, and a specialty pharmacy. Since implementation, the PSCC has achieved and maintained program goals, including improved abandonment rate, speed of answer, and first-call resolution. A centralized 24-7 support line for specialty pharmacy patients was also successfully established. A quality calibration program was implemented to ensure service quality and excellent patient experience. Additional ongoing evaluations measure the impact of the PSCC on improving workplace satisfaction and retention of outpatient pharmacy staff. CONCLUSION: The design and implementation of the PSCC have significantly improved the health system's patient experiences, efficiency, and quality.

Development and implementation of a centralized comprehensive refill authorization program in an academic health system.

PURPOSE: The development and implementation of a centralized, comprehensive, refill authorization (CCRA) program within an academic health system are described. SUMMARY: In order to improve continuity of care for our medically complicated patients, ambulatory pharmacy services developed and implemented a highly coordinated CCRA program for multiple community clinics within the system. To implement the CCRA program, we centralized the refill-request intake process to the Pharmacy Ambulatory Clinical Care Center (PAC3). PAC3 technicians were incorporated into the refill authorization process, and the collaborative practice agreement was updated to standardize the pharmacist refill approval process at the PAC3. We successfully standardized and centralized the medication refill process from 10 community clinics with 95 family practice and internal medicine providers and 26 medical residents. We handled an average of 12,000 refill requests each month, and pharmacists documented any interventions performed with each refill request. The cost savings associated with the CCRA program were attributed to the increased efficiency of the staff reviewing refill requests. The CCRA program increased the refill approval up to 10% compared with the previous decentralized refill authorization model. With the increased approval rate, the CCRA program saved 510 hours of our providers' time annually, which created time for an additional 1,530 clinic visits. We demonstrated a faster average turnaround time for refill authorization, from an average of 72 hours before implementation to about 1 business day. CONCLUSION: Implementation of an integrated refill authorization service standardized the method by which patients' refill requests were addressed, increased refill efficiency, and improved refill authorization turnaround time.

Implementation of a patient-focused specialty pharmacy program in an academic healthcare system.

PURPOSE: The development and implementation of a systemwide specialty pharmacy program in an academic healthcare system are described. SUMMARY: Although the system's pharmacy department had developed specialty pharmacy services for patients with certain conditions, it was necessary to expand and standardize those services to meet the needs of all specialty clinics because (1) many of the clinics had experienced an increased volume of prior-authorization requests due to the introduction of new specialty drugs, (2) the dispensing pharmacies were operating at maximum capacity due to the previous decentralization of specialty pharmacy operations, and (3) payers had sent notice that they would require accreditation of the specialty pharmacy program as a condition of participation in their specialty pharmacy networks. To ensure standardization of services and successful preparation for increasing numbers of specialty prescriptions, all specialty pharmacy services were centralized to the healthcare system's Pharmacy Ambulatory Clinical Care Center (PAC(3)). PAC(3) centralized the prior-authorization process to selected specialty clinics. A call center was developed at PAC(3) to provide centralized specialty pharmacy services, including 24-7 patient support, a medication adherence program, home delivery service, and patient education. The program resulted in a 137% increase in specialty pharmacy revenues over a two-year period. PAC(3) processed 1860 prior-authorization cases and enrolled approximately 700 new patients in the specialty pharmacy program within nine months. CONCLUSION: A specialty pharmacy program was established along with operational and infrastructure improvements, resulting in increased revenue, systemwide services, and a fully accredited specialty pharmacy.