Preparing for the market entry of adalimumab biosimilars in the US in 2023: A primer for specialty pharmacists.

DISCLAIMER: In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these 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 impact of the market entry of adalimumab biosimilars on clinical practices and specialty pharmacies is explained. A roadmap is also provided for how pharmacists can successfully navigate this landscape. SUMMARY: Biosimilars have previously been introduced as a mechanism to help curb biologic expenditures, with biosimilars undergoing an abbreviated regulatory approval process that focuses on biosimilarity and generating product competition. Adalimumab is currently the leading product in the biologics market, generating approximately $20 to $30 billion in sales worldwide consecutively from 2019 to 2021. Many adalimumab biosimilars are slated to enter the market in 2023 and become available for patient use. However, compared to other biosimilars, adalimumab biosimilars have several unique considerations, such as interchangeability and concentration, that will impact pharmacy practices and workflows. Because pharmacists embedded in clinical practices and specialty pharmacies will be significantly involved in the processes relating to adalimumab biosimilar implementation, adoption, and use, a primer on understanding the various adalimumab biosimilar products available and considerations surrounding these products with regard to workflow and patient use is critical. Several resources are also provided to help pharmacists successfully navigate the adalimumab biosimilar landscape. CONCLUSION: The biosimilar landscape continues to evolve, and 2023 will see the launch of several adalimumab biosimilar products, which vary with regard to formulation, concentration, and interchangeability status. Pharmacists are well positioned to educate providers and patients about this landscape and help implement an efficient workflow to support adalimumab biosimilar adoption and use.

Development and implementation of a laboratory monitoring dashboard to reduce treatment gaps in inflammatory bowel disease.

DISCLAIMER: In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these 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: Patients on biologic therapy for inflammatory bowel disease (IBD) require routine laboratory monitoring to ensure the safety and efficacy of therapy. The purpose of this quality improvement project was to evaluate the implementation of a dashboard to prevent treatment gaps by prospectively identifying patients with IBD and outdated laboratory results on biologics. METHODS: We performed a pre/post analysis of dashboard implementation to assess the number of patients with overdue laboratory work resulting in treatment gaps. The dashboard combined data from the electronic health record (EHR) and pharmacy claims database to identify patients on a biologic with laboratory tests (white blood cell count, liver transaminase levels, C-reactive protein levels, and erythrocyte sedimentation rate) completed 5 or more months ago and/or a tuberculosis screen completed 11 or more months ago. After implementation, specialty pharmacists reviewed the dashboard and communicated via EHR if a new prescription and laboratory tests were needed. Messages were sent 4 weeks in advance of the next refill-eligible date. Mixed methods were used for analysis of qualitative data, including surveys, and quantitative data, assessing treatment gap length. RESULTS: We included 15 patients from before implementation and 25 patients from after implementation. The frequency of a treatment gap decreased from 80% (n = 12) in the preimplementation phase to 32% (n = 8) in the postimplementation phase. The median gap length was shorter after implementation than before implementation, decreasing from 21 days (range, 3-97 days) to 11 days (range, 2-23 days). CONCLUSION: Utilization of a quality measures dashboard decreased treatment gaps in patients with IBD on biologic therapy. Integrated specialty pharmacists are uniquely positioned to monitor adherence to laboratory monitoring parameters for patients on biologics.

Development of a Comprehensive, Integrated Patient Data Repository of US Pulmonary Arterial Hypertension (PAH) Patients to Assess the Impact of Clinical Care on Patient Outcomes

RATIONALE: Advances in PAH management and well-established treatment guidelines have improved the prognosis for patients. However, the extent to which guidelines are implemented in real-world practice and the relationship between guidelines and real-world patient outcomes remain in question. To assess real-world treatment and outcomes, a new type of comprehensive, integrated patient data repository (CIPDR) was created. Here, we describe the process to create this repository to enable interpretation of the collected data. METHODS: The TRIO CIPDR was created with guidance from six pulmonologists who have experience in design of and/or participation in PH registries (e.g. REVEAL). The CIPDR includes data elements of demographics, disease, comorbidities, laboratory data, pulmonary function testing, functional status, PAH treatment, reasons for treatment discontinuation/switch, hospitalizations, and death, which are collected through HIPAA-secure online forms. To minimize entry errors, participating sites received form training and ongoing support, and each form contained logic to identify improbable entries. All data were deidentified prior to storage in secure, redundant servers. The site engagement, data collection forms, data storage, and data output processes were all designed to allow both retrospective and prospective data collection and for near-immediate repository expansion through addition of other PAH-treating centers. Eleven Pulmonary Hypertension Association-certified care centers initially contributed to the CIPDR though two centers were unable to continue participation due to COVID19 impact. Central IRB approval was obtained though many sites independently received approval for the repository protocol by their IRBs. To facilitate enrollment, specialty pharmacy data corresponding to each site were used to identify potential patients and pre-populate qualification forms. Each site reviewed and qualified patients who met repository criteria: age >18 years, prescribed PAH-specific medications, and confirmation of PAH diagnosis by right heart catheterization (mean Pulmonary Arterial Pressure ≥25mmHg, Pulmonary Capillary Wedge Pressure ≤15 mmHg, and Pulmonary Vascular Resistance ≥3.0 Wood Units at rest). The initial data collection included care encounters between Jan 2019 and Dec 2020 and data concerning diagnosis, onset of symptoms, procedures, and laboratory values closest to enrollment. After completion of data collection, all data were reviewed by Trio Health and adjudicated with each site. RESULTS: Of 3200 patients identified as potentially qualified, 1009 were initially enrolled and their retrospective data encompassing 4489 visits collected. Descriptive measures of the repository are presented in the TABLE. CONCLUSION: The Trio CIPDR is an important step forward to uniquely characterize the patient journey ,treatment patterns, and outcomes for patients with PAH.

A new perspective: Practice-enhancing publications about the medication-use process in ambulatory care in 2020.

PURPOSE: This article identifies, prioritizes, and summarizes published literature on the ambulatory care medication-use process (ACMUP) from calendar year 2020 that can impact ambulatory pharmacy practice. SUMMARY: The medication-use process is the foundational system that provides the framework for safe medication utilization within the healthcare environment and was reimagined to focus on new innovations and advancements in ambulatory pharmacy practice. The ACMUP is defined in this article as having the following components: transitions of care, prescribing and collaborative practice, accessing care, adherence, and monitoring and quality. Articles evaluating at least one step of the ACMUP were assessed for their usefulness toward practice improvement. A PubMed search covering calendar year 2020 was conducted in January 2021 using targeted Medical Subject Headings (MeSH) keywords and the table of contents of selected pharmacy journals, providing a total of 9,433 articles. A thorough review identified 65 potentially practice-enhancing articles: 14 for transitions of care, 19 for prescribing and collaborative practice, 10 for adherence, 6 for accessing care, and 16 for monitoring and quality. Ranking of the articles for importance by peers led to the selection of key articles from each category. The highest-ranked articles are briefly summarized, with a mention of why each article is important. The other articles are listed for further review and evaluation. CONCLUSION: It is important to routinely review the published literature and to incorporate significant findings into daily practice. This article is the first to define and evaluate the currently published literature pertinent to the ACMUP. As healthcare continues to advance and care shifts to ambulatory settings, the ACMUP will continue to be a crucial process to evaluate.

Virtualization and standardization of a health-system specialty pharmacy call center.

PURPOSE: The coronavirus disease 2019 (COVID-19) pandemic provided an opportunity to change how health-system specialty pharmacy (HSSP) call center operations are organized. This article describes the steps taken to virtualize the current operations of a specialty pharmacy services call center and evaluate the impact. SUMMARY: The onset of the COVID-19 pandemic and its impact on the normal provision of healthcare necessitated that HSSPs drastically modify existing procedures to both accommodate the expectations of staff and overcome the many barriers to care being experienced by patients. To fully understand and improve upon the workflow processes of an HSSP call center, a combination of qualitative feedback from patients, quantitative claims data, and quality metrics was evaluated. This project was divided into 3 phases: phase 1 (baseline) from July 2020 through August 2020, phase 2 (implementation) from September 2020 through December 2020, and phase 3 (analysis) from January 2021 through March 2021. Phase 1 included baseline review of workflow. Phase 2 encompassed development of new standard operating procedures (SOPs), making critical decisions to promote virtual capabilities of staff, and collaboration with team members to increase efficiency of current workflow. During phase 3, an evaluation of operational and service-related metrics was conducted to determine the impact of phase 2 workflow changes. Optimization of the specialty pharmacy call center allowed for staff members to transition to remote work to minimize exposure risk and prioritize the safety of patients and team members. CONCLUSION: The call center team was able to transition to fully remote operations, implement new SOPs, and undergo significant workflow changes to optimize performance while still maintaining all call center metric goals and without increased complaints from patients or errors. This approach allowed for added staff value and safety and improved organization during the COVID-19 pandemic.

Prescription cannabidiol for seizure disorder management: Initial drug-drug interaction management by specialty pharmacists.

PURPOSE: To describe the presence, type, and management of drug-drug interactions (DDIs) at prescription cannabidiol (CBD) therapy initiation. METHODS: We conducted a single-center, retrospective study of patients prescribed CBD from a medical center's neurology clinic for seizure management from January 2019 through April 2020. Patients were excluded if they were enrolled in a CBD clinical trial or the insurance approval or medication fulfillment process was not completed by the center's specialty pharmacy. The primary outcomes were the numbers, types, and management of DDIs identified at the time of CBD prescribing. RESULTS: Of the 136 patients included, 109 (80%) had a DDI identified at baseline. Of the 260 DDIs, 71% (n = 184) were pharmacodynamic and 29% (n = 76) were pharmacokinetic in nature. Management of the 260 DDIs detected included counseling only (89% [n = 232 interactions]), discontinuation of the interacting agent [9% (n = 22 interactions]), and dosage change for the interacting agent [2% (n = 6 interactions]). Clobazam was the most commonly identified interacting medication (n = 63, 24%), while valproic acid accounted for 10% (n = 26) of the DDIs. The population was predominantly white (n = 115, 85%), 18 years of age or younger (n = 92, 68%), and had an indication for prescription CBD treatment of Lennox-Gastaut syndrome (n = 117, 86%). CONCLUSION: This study provides new information on the role that integrated specialty pharmacists can play in identifying and managing initial DDIs in patients starting prescription CBD.

IMPACT OF COVID-19 PANDEMIC ON ADHERENCE TO ORAL ONCOLOGY MEDICATIONS AND QUALITY OF LIFE OF CANCER PATIENTS ON THE SERVICE OF A SPECIALTY PHARMACY

BACKGROUND: In late winter 2019-2021 SARS-CoV-2 became pandemic (CoVID-19 or P). During P, treating patients with chronic disease burden, i.e., cancer (O), with O drugs and achieving high medication adherence was reported to be challenging, e.g., delayed/missed provider visits, prescriptions, lab tests, and P-related financial difficulties and feelings of depression or anxiety. OBJECTIVE: There are two objectives that characterize how the P may be associated with changes in: 1. adherence to specialty pharmacy O medications (O-SP-D) and 2. O patient- reported quality of life (QoL). METHODS: A retrospective, observational, pre-/post- design study of 393 USA O patients' adherence to O-SP-D and their reported QoL was conducted Pre-P (1/1-12/31/2019) and Post-P (3/1-8/31/2020). Patient assessments (PA), including medication therapy management (SPMTM) and the EQ-5D-5L QoL instrument, occurred at start-of-care (SOC) and 7-10 days before refills (F-U). Descriptive statics were used to calculate Pre-P Dimensional means before and after starting O-SP-D with SPMTM and again at F-U Post-P. The means of QoL measures in the Pre-P and Post-P periods were compared for differences, representing improved or diminished QoL associated with P. The mean medication possession ratio (MPR or adherence) was calculated, using the F-U from Pre-P and Post-P. RESULTS: MPR was 0.976 Pre-P and 0.98 during Post-P (0.4% improvement). Differences between QoL means Pre-P vs Post-P were: Mobility -0.31 (31%), Self-Care 0 (no change), Usual Activities -0.02 (2%), Pain/Discomfort -0.09 (9%), Anxiety/Depression -0.3 (30%), Overall Health State +2.37 (2.4%). (Minus (-) is improvement in Dimensions 1-5;Positive (+) is improvement in Overall Health State.) CONCLUSIONS: Post-P MPR improved 0.4% compared to Pre-P, and both were higher than the industry standard of 0.8. On average, for all QoL Dimensions (except Self Care), O patients reported improvements during Post-P compared to Pre-P. Explanations associated with improvements are suggested. Additional studies are suggested.

ASSOCIATION OF COVID-19 WITH ADHERENCE TO ORAL NEUROLOGY MEDICATIONS AND QUALITY OF LIFE OF NEUROLOGY PATIENTS ON THE SERVICE OF A SPECIALTY PHARMACY

BACKGROUND: In late winter 2019-2021 SARS-CoV-2 became pandemic (CoVID-19 or P). During P, treating patients with chronic disease burden, i.e., neurologic (N) conditions with N drugs and achieving high medication adherence was reported to be challenging, e.g., delayed/missed provider visits, prescriptions, lab tests, and P-related financial difficulties and feelings of depression or anxiety. OBJECTIVE: The two objectives are how the P may be associated with changes in: 1. adherence to specialty pharmacy N medications (N-SP-D) and 2. N patient-reported quality of life (QoL). METHODS: A retrospective, observational, pre-/post- design study of 1,652 N patients' adherence to N-SP-D and their reported QoL was conducted Pre-P (1/1-12/31/2019) and Post-P (3/1-8/31/2020). Patient assessments (PA), including medication therapy management (SPMTM) and the EQ-5D-5L QoL instrument, occurred at start-of-care (SOC) and 7-10 days before refills (F-U). Descriptive statics were used to calculate Pre-P Dimensional means before and after starting N-SP-D with SPMTM and again at F-U Post-P. The means of QoL measures in the Pre-P and Post-P periods were compared for differences, representing improved or diminished QoL associated with P. The mean medication possession ratio (MPR or adherence) was calculated, using the F-U from Pre-P and Post-P. RESULTS: MPR was 0.965 Pre-P and 0.975 during Post-P (1% improvement). Differences between QoL means Pre-P vs Post-P were: Mobility +0.53 (53%), Self-Care +0.44 (44%), Usual Activities +0.46 (46%), Pain/Discomfort +0.5 (50%), Anxiety/Depression -0.14 (14%), Overall Health State -7.06 (2.4%). Positive (+) = decrease in Dimensions 1-5;Negative (-) = decrease in Overall Health State. CONCLUSIONS: Post-P MPR increased 1% compared to Pre- P, and both were higher than the industry standard of 0.8. On average, for all QoL Dimensions (except Anxiety/Depression which improved), N patients reported decreased QoL Post-P compared to Pre-P. Explanations associated with improvements are suggested. Additional studies are suggested.

ADVANCING THE MANAGED CARE PHARMACY RESEARCH AGENDA VIA MAPPING OF RESEARCH PILLARS AND PRIORITIES

BACKGROUND: The most critical evidentiary gaps in managed care pharmacy informed the research agenda of the Academy of Managed Care Pharmacy (AMCP) and AMCP Foundation. Four overarching research pillars and six relevant research priorities were published in the Journal for Managed Care and Specialty Pharmacy (April 2020). Research pillars and priorities need to align to address evidence gaps in managed care pharmacy and support the members served. OBJECTIVE: To review and map research priorities onto pillars and determine appropriate research questions that will advance the AMCP research agenda. METHODS: The six previously-identified priorities were reviewed by the AMCP/Foundation Joint Research Committee and AMCP staff against current health care concerns and the four research pillars: 1) Real World Evidence (RWE) 2) Value Based Models (VBM) 3) Utilization Management (UM) and Benefit Design (BD) and 4) Patient Care Services (PCS). The top research priorities were selected across the four research pillars. To define research questions a Delphi approach representing managed care pharmacy stakeholders will be conducted via focus groups, priority-based workshops, interim surveys and discussion. This approach will culminate in consensus on the most essential, specific research questions for the next year. RESULTS: After the review of current priorities, two currently relevant priorities were added;addressing disparities in health care delivery and evaluating programs directed toward patients impacted by COVID. Of the eight research priorities, five focus priorities were chosen, mapped and prioritized as follows: 1) Health disparities (RWE);2) Limited data available at the time of launch due to expedited review (RWE);3) Managed care pharmacy programs focused on patient care (PCS) 4) Demonstrating the impact of formulary management on medication access and patient outcomes (UM and BD);and 5) Assessing the impact of legislative activities and policies in addressing the total cost of care (VBM). Results from the rolling focus groups, workshops and surveys will lead to a consensus on prioritized research questions to support managed care pharmacy for 2021-2022. CONCLUSIONS: AMCP and the AMCP Foundation will advance their research agenda through answering research questions aligned with the top areas of concern to managed care pharmacy. Implementing the research agenda will close critical evidence gaps, thereby optimizing medicine and improving lives.

POSC374 Association of COVID-19 on Adherence to Oral Specialty Pharmacy Oncology Medications and Quality of Life of Multiple Myeloma Patients

Objectives: In winter of 2019-2021 SARS-CoV-2 became pandemic (CoVID-19 or P). During P, treating patients with chronic disease burden, i.e., cancer (O), with multiple myeloma (MM) oncologics and achieving high medication adherence was reported to be challenging, e.g., delayed/missed provider visits, prescriptions, lab tests, and P-related financial difficulties and feelings of depression or anxiety. There are two Objectives: that characterize how the P may be associated with changes in: 1. adherence to specialty pharmacy MM medications (O-SP-D) and 2. MM patient-reported quality of life (QoL). Methods: A retrospective, observational, pre-/post- design study of 199 USA MM patients’ adherence to MM-SP-D and their reported QoL was conducted Pre-P (1/1-12/31/2019) and Post-P (3/1-8/31/2020). Patient assessments(PA), including medication therapy management (SPMTM) and the EQ-5D-5L QoL instrument, occurred at start-of-care (SOC) and 7-10 days before refills (F-U). Descriptive statics were used to calculate Pre-P Dimensional means before and after starting O-SP-D with SPMTM and again at F-U Post-P. The means of QoL measures in the Pre-P and Post-P periods were compared for differences, representing improved or diminished QoL associated with P. The mean medication possession ratio (MPR or adherence) was calculated, using the F-U from Pre-P and Post-P. Results: MPR was 1.0 Pre-P and 0.999 during Post-P (0.1% decrease). Differences between QoL means Pre-P vs Post-P were: Mobility +0.657 (65.7%), Self-Care +0.538 (53.8%), Usual Activities +0.642 (64.2%), Pain/Discomfort+0.884 (88.4%), Anxiety/Depression +0.641 (64.1%), Overall Health State +16.0 (16%). Plus “+” is decreased/worsened in Dimensions 1-5;Positive “+” is improvement in Overall Health State. Conclusions: Post-P MPR decreased 0.1% compared to Pre-P, and both were higher than the industry standard of 0.8. On average MM patients reported decreases all QoL Dimensions Post-P compared to Pre-P. Explanations associated with the decreases are suggested. Additional studies are suggested.

A framework for graduate and postgraduate specialty pharmacy training.

PURPOSE: There is a growing need for specialty pharmacy leaders within integrated delivery networks (IDNs). Traditional training for students and residents has not met the demand for pharmacy leaders in this space. This article describes the partnership between UW Health (UWH) and the University of Wisconsin School of Pharmacy (UWSOP) in developing a specialty pharmacy elective course at UWSOP and in creating a postgraduate residency training program at UWH. Future directions for the partnership are discussed. SUMMARY: Members of the leaderships of UWH and UWSOP met to discuss expanding coursework related to specialty pharmacy business fundamentals at UWSOP. This meeting led to the development of a 2-credit elective course beginning in spring 2017. The course focused on marketplace economics, channel strategies, and specialty pharmacy practice development. Additionally, UWH identified the need to provide postgraduate training to meet the increasing demand across IDNs for specialty pharmacy leaders. The residency program was initiated in 2013 and received accreditation in 2016. The residency provides experience in specialty pharmacy leadership, managed care, finance, the revenue cycle, accreditation, and the supply chain. Future partnership opportunities include creation of a longitudinal student pharmacist track and joint project coordination between UWSOP students and UWH residents. CONCLUSION: This partnership has provided a pathway for students to gain expertise in specialty pharmacy business fundamentals as well as postgraduate training opportunities for future specialty pharmacy leaders. IDN and school of pharmacy partnerships can expand educational opportunities for future specialty pharmacy leaders and help fulfill the market gap in specialty pharmacy leaders.

Comparison of provider satisfaction with specialty pharmacy services in integrated health-system and external practice models: A multisite survey.

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.