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The pipeline for new treatments for Alzheimer's disease (AD) in the USA contains over 100 different agents, 80% of which can be categorized as disease-modifying therapies. The regulatory approval of the disease-modifying agent aducanumab has brought more attention to the complexity of the diagnosis, evaluation, and treatment of AD and the difficult decisions payers and policy makers will face over the next few years as innovation continues in this space. The value of AD treatment can vary widely according to the perspective of the analysis, sources of data, and methodological approach for the value assessment. This article focuses on AD-specific data gaps and measurement challenges and provides guidance for evidence generation to facilitate better value assessments for future AD treatments.

Background Hepatocellular carcinoma (HCC) is associated with significant financial burden for patients and payers. The objective of this study was to review economic models to identify, evaluate, and compare cost-effectiveness estimates for HCC treatments. Methods A systematic search of the PubMed, Embase, and Cochrane Library databases to identify economic evaluations was performed and studies that modeled treatments for HCC reporting costs and cost effectiveness were included. Risk of bias was assessed qualitatively, considering costing approach, reported study perspective, and funding received. Intervention costs were adjusted to 2021 US dollars for comparison. For studies reporting quality-adjusted life-years (QALYs), we conducted analyses stratified by comparison type to assess cost effectiveness at the time of the analysis. Results A total of 27 studies were included. Non-curative versus non-curative therapy comparisons were used in 20 (74.1%) studies, curative versus curative comparisons were used in 5 (18.5%) studies, and curative versus non-curative comparisons were used in 2 (7.4%) studies. Therapy effectiveness was estimated using a QALY measure in 20 (74.1%) studies, while 7 (25.9%) studies only assessed life-years gained (LYG). A health sector perspective was used in 26 (96.3%) of the evaluations, with only 1 study including costs beyond this perspective. Median intervention cost was $53,954 (range $4550–$4,760,835), with a median incremental cost of $6546 (range − $72,441 to $1,279,764). In cost-utility analyses, 11 (55%) studies found the intervention cost effective using a $100,000/QALY threshold at the time of the study, with an incremental cost-effectiveness ratio (ICER) ranging from − $1,176,091 to $1,152,440 when inflated to 2021 US dollars. Conclusion The majority of HCC treatments were found to be cost effective, but with significant variation and with few studies considering indirect costs. Standards for value assessment for HCC treatments may help improve consistency and comparability. Supplementary Information The online version contains supplementary material available at 10.1007/s41669-021-00298-z.

Objectives Congress and Medicare have required real-time benefit tools (RTBT) to provide patient-specific medication price information during prescribing to decrease the cost of medications. We sought physicians' perspectives on how these tools might most effectively improve their selection of low-cost medication. Methods We conducted 15 semi-structured interviews of physicians (6 oncologists, 1 endocrinologist, 4 rheumatologists, and 4 from internal medicine) and identified key themes across interviews during coding and analysis. Results Although physicians saw value in real-time medication price information, they were wary of the complexity of obtaining specific information and the potential for inaccuracies. Physicians described how medication price information would be used in various prescribing scenarios including from simple substitutions (different drug formulations) to more complex decisions (different drug classes). In more complex situations, physicians were concerned that price information might only be available after discussing options with the patient, which would be too late to inform decisions. Concern about adding more information to the electronic health record was common. Conclusion While most physicians saw value in implementation of RTBTs, they also expressed concerns related to the accuracy of information, the availability of information at the right time in the clinical workflow, and the most effective format for information. Many concerns raised paralleled the “Five Rights of Clinical Decision Support” framework and indicate the need for additional design work to achieve benefit from RTBTs. Beyond the public policy that has supported the availability of RTBTs, substantial development will be required to ensure that information is used to improve prescribing decisions.

ImportanceRising prescription drug costs and increasing prices for consumer goods may increase cost-related medication nonadherence. Cost-conscious prescribing can be supported by real-time benefit tools, but patient views on real-time benefit tool use and their potential benefits and harms are largely unexplored.ObjectiveTo assess older adults’ cost-related medication nonadherence, cost-coping strategies, and views on the use of real-time benefit tools in clinical practice.Design, Setting, and ParticipantsA weighted, nationally representative survey of adults aged 65 years and older administered via the internet and telephone from June 2022 to September 2022.Main Outcomes and MeasuresCost-related medication nonadherence; cost coping strategies; desire for cost conversations; potential benefits and harms from real-time benefit tool use.ResultsAmong 2005 respondents, most were female (54.7%) and partnered (59.7%); 40.4% were 75 years or older. Cost-related medication nonadherence was reported by 20.2% of participants. Some respondents used extreme forms of cost-coping, including foregoing basic needs (8.5%) or going into debt (4.8%) to afford medications. Of respondents, 89.0% reported being comfortable or neutral about being screened before a physician's visit for wanting to have medication cost conversations and 89.5% indicated a desire for their physician to use a real-time benefit tool. Respondents expressed concern if prices were inaccurate, with 49.9% of those with cost-related nonadherence and 39.3% of those without reporting they would be extremely upset if their actual medication price was more than what their physician estimated with a real-time benefit tool. If the actual price was much more than the estimated real-time benefit tool price, nearly 80% of respondents with cost-related nonadherence reported that it would affect their decision to start or keep taking a medication. Furthermore, 54.2% of those with any cost-related nonadherence and 30% of those without reported they would be moderately or extremely upset if their physicians used a medication price tool but chose not to discuss prices with them.Conclusions and RelevanceIn 2022, approximately 1 in 5 older adults reported cost-related nonadherence. Real-time benefit tools may support medication cost conversations and cost-conscious prescribing, and patients are enthusiastic about their use. However, if disclosed prices are inaccurate, there is potential for harm through loss of confidence in the physician and nonadherence to prescribed medications.

Pharmacy Benefit Managers (PBMs) originated in the 1960s to address a market need providing services to insurance companies in managing the newly introduced prescription drug benefits. Since then, PBMs have been expanding their roles in the prescription drug supply chain and have come under scrutiny. As of November 2021, all 50 states have enacted some form of regulation on PBMs. These state-level regulations focus on a variety of different policy levers, many of which align with advocacy efforts led by community pharmacists that focus on business transactions between pharmacies and PBMs without evidence supporting how these policies would enhance the patient experience, improve population health, lower costs, or improve the experience of health care providers. Many state policies could help increase transparency, prevent anticompetitive behavior between PBM-owned and independently-owned pharmacies, and increased accountability of PBMs to plan sponsors. However, there were no direct mechanisms to ensure that the potential benefits of these policies would ultimately be realized as savings for the health care system or consumers, improved health outcomes, or increased quality of care.

Objective Our objective was to review recent drug and medical device recalls, categorize recall types based on the free text descriptions posted within the recall announcements, and conduct exploratory analyses for researchers interested in pharmaceutical supply chain challenges. Methods A cross-sectional study of all current recalls, market withdrawals, and safety alerts published by the United States Food and Drug Administration pertaining to drugs was conducted. A manual review of all the recalls was also conducted to extract additional information including company details, recall type (labeling or quality), and location of failure in the pharmaceutical supply chain (manufacturing or distribution). Descriptive statistics and exploratory bivariate analyses were conducted to test any potential differences between drug and device recalls. Results Most recalls issued between January 2017 and September 2019 were pharmaceutical drug recalls (85.2%), while 34 (14.8%) medical device recalls were issued for the same period. For drug recalls, 85.1% (166/195) were because of quality, while 14.9% (29/195) were because of labeling issues. Of the quality issues for drug recalls, lack of sterility was the most frequent issue (139/166, 83.7%). There was no difference between drug or device recalls based on recall type (P = 0.16), top 20 pharmaceutical company (P = 0.62), or location of the supply chain failure (P = 0.20). Conclusions This study provides a process to categorize and evaluate drug and device recalls by recall type and location of the supply chain. By categorizing the free text provided in public recall data it would be easier to monitor trends over time.

Background and Objective Patient-centered care (PCC) is crucial for value-based care. We aimed to assess PCC dimensions addressed in hepatitis C virus direct-acting antiviral treatment delivery to people who inject drugs. Methods We conducted a scoping review to identify the studies that described hepatitis C virus treatment delivery to people who inject drugs in the direct-acting antiviral treatment era. We analyzed the included studies against eight PCC dimensions: (1) access to care; (2) coordination and integration of care; (3) continuity and translation; (4) physical comfort; (5) information, education, and communication; (6) emotional support; (7) involvement of family and friends; and (8) respect for individual patient preferences, perceived needs, and values. Additionally, we assessed the use of patient-centered terminology and the recognition of PCC importance and its relevance to treatment outcomes. Results None of the identified 36 studies addressed all PCC dimensions (highest seven, lowest two). Our findings revealed that PCC dimensions are prioritized differently and addressed using different approaches and strategies. Studies that used PCC terminology referred to personalized activities, which does not imply comprehensive PCC. About one-third of the studies acknowledged the importance of patient centeredness and two-thirds recognized its relevance to treatment outcomes. Conclusions Our findings suggest more engagement of people who inject drugs and comprehensive involvement of their families and friends in hepatitis C virus treatment journey, decisions, and outcomes. The recognition of PCC importance and its relevance to treatment outcomes in the analyzed studies emphasizes the need for more patient-centered hepatitis C virus treatment for people who inject drugs. Supplementary Information The online version contains supplementary material available at 10.1007/s40271-020-00489-6.

Background Successful medical crowdfunding campaigns may alleviate or even eliminate the financial burden of expensive, cumulative medical bills. GoFundMe® crowdfunding pages for hepatitis C virus (HCV) patients were reviewed and analyzed to better understand the characteristics that contribute to a successful fundraising campaign in a disease often associated with patients with a lower social standing or stigma. Methods A pilot cross-sectional study of all publicly available GoFundMe® crowdfunding pages was conducted for posts related to HCV on GoFundMe® in June 2019. Similar to data extraction steps in a systematic literature review, page data were reviewed to identify whether the source of the patient’s HCV infection was disclosed, if disclosed then how did the patient report contracting the disease, and all costs reported in the description as part of the rationale for requesting funds. Descriptive statistics of category and numeric variables were reported for the full sample, and exploratory analyses were conducted to determine any potential associations with categorical variables and the amount of donations received, categorized as small (

Early reports of potential treatment for coronavirus disease (COVID-19) have raised concerns related to pharmaceutical distribution. Despite the lack of high-quality evidence, the mere hope of effectiveness of potential treatments, such as hydroxychloroquine, has led to surges in demand for these products, and many pharmacists are already informally reporting shortages through social channels. As manufacturers and wholesale distributors struggle to fulfill orders for drugs such as hydroxychloroquine, short-term price increases may seem reasonable in a free market when demand increases. However, any price increases by manufacturers, wholesale distributors, and pharmacies might be seen as exploitive gouging of consumers during a declared emergency. In addition to concerns of price gouging, increases in prescription drug utilization during the pandemic may lead to increases in spending for all payers as members may be treated for COVID-19. This article explores pharmaceutical supply chain and drug pricing nuances that may cause problems for payers and pharmacies as the country battles this global pandemic. DISCLOSURES: No funding supported the writing of this article. Mattingly reports unrelated consulting fees from the National Health Council, Bristol Myers Squibb, G&W Laboratories, Allergy and Asthma Foundation of American, and the Massachusetts Health Policy Commission. Hogue has nothing to disclose.

Cost-effectiveness evaluations for hepatitis C virus (HCV) treatments have been published frequently, but new products with significant cost and effectiveness differences make these analyses obsolete. How valuable are economic models for a fixed time period in a dynamic market?To estimate the cost-effectiveness of the best available HCV treatment at different points in time, using the same comparator to demonstrate how rapid innovation in a disease area influences economic outcomes.A Markov model was used to calculate the cost-effectiveness of treatment in 2010, 2012, 2014, 2016, and 2018 compared with a standard comparator (no treatment) from the payer perspective. Expected drug costs and treatment effectiveness estimates for sustained virologic response (SVR) were calculated using recommended regimens for each of the 6 HCV genotypes at each time point and distribution of genotypes in the United States. Patients entered the model with different stages of fibrosis. Utility estimates for each health state were used to calculate quality-adjusted life-years (QALYs) earned at each cycle. Incremental cost-effectiveness ratios were reported for each year to compare the "treatment versus no treatment" decision at that time.No HCV treatment resulted in a gain of 11.54 QALYs over a 20-year time horizon at a cost of $42,938. Costs for treated groups were $69,075, $123,267, $125,431, $86,782, and $56,470 for the 2010, 2012, 2014, 2016, and 2018 scenarios, respectively. QALYs gained for treated groups were 12.90, 12.97, 13.34, 13.39, and 13.46 for the 2010, 2012, 2014, 2016, and 2018 scenarios, respectively. The incremental cost-effectiveness ratios in each year compared with no treatment were $19,218 per QALY, $56,104 per QALY, $45,829 per QALY, $23,699 per QALY, and $7,048 per QALY.Treatment effectiveness for HCV has increased steadily, while treatment costs increased substantially from 2010-2014 before decreasing to its lowest point in 2018. Thus, the dynamic nature of innovation creates the need for iterative cost-effectiveness analyses.No outside funding supported this study. Mattingly reports unrelated consulting from the National Health Council, Bristol Myers Squibb, GW Laboratories, Allergy and Asthma Foundation of American, and the Massachusetts Health Policy Commission. Love reports an unrelated research grant from the American Cancer Society.

Introduction To determine how a progression in community pharmacy prescription verification activities (PVAs) in a skills-based laboratory series impacts student confidence during community-based introductory pharmacy practice experiences (IPPEs). Methods Motivated by the 2016 Accreditation Council for Pharmacy Practice Education Standards, a progression of PVAs was implemented. As students progressed through three semesters of laboratory courses, the scope and verification error types expanded. A web-based survey was administered after students completed their IPPE. The survey was conducted over three years to collect data from students who completed one, two, or three semesters of PVAs. Two-way Analysis of Variance and Tukey-Kramer tests were used to analyze data. Results Over the three-year period, 395 students completed the survey. Students with two or three semesters of PVAs were significantly more confident than those with one semester of PVAs in verifying prescriptions on IPPEs, identifying legal concerns with prescriptions, and identifying and correcting prescription labels and expiration/discard dates. Students without professional pharmacy experience strongly agreed that PVAs prepared them for IPPEs compared to those with experience. Conclusions This is the first study evaluating the impact of PVAs in the didactic curriculum on student confidence during IPPEs. Systematic progression of multiple semesters of PVAs may have helped students prepare for IPPEs and may have influenced student confidence in several aspects of prescription verification. This study lays the foundation for further investigation into the impact of building confidence and examining if confidence leads to improved accuracy in patient care.

Ensuring the quality and safety of the pharmaceutical supply chain is a key policy focus vital to protecting the public from harmful or potentially harmful medications. Although the Food and Drug Administration (FDA) reports the number of recalled products per fiscal year and categorizes recalls based on product type and recall classification, these reports do not distinguish between manufactured and compounded products.This research aims to categorize drug recalls based on the reason for recall and then to compare this reason between manufacturers and compounders.All publicly available drug recall data were downloaded from the FDA Data Dashboard website on January 24, 2021. Two reviewers independently categorized the recalling firm, distribution pattern, and reason for recall, and a third reviewer resolved all conflicts. Descriptive statistics were reported for recall event classification, distribution, and recall reason for the full sample. Chi-square test of independence was used to assess categorical variables by facility type (manufacturer or compounder) as well as by event classification (class I, II, or III). A subgroup analysis was performed focusing on class I level recalls only, representing the most serious recall, and similar statistical procedures were performed.From June 8, 2012, to January 24, 2021, there were 12,343 drug products recalled; 6771 were from a manufacturer, and 5572 were from a compounder. Most recalls from both compounders and manufacturers were class II recalls with products being distributed to multiple states. Sterility assurance was the predominant reason for recall among compounders, whereas product quality was the most frequent recall reason for manufacturers. There were statistically significant differences in class I recalls between compounders and manufacturers and recall reason compared across recall classification.There was a statistically significant difference in the reason for a drug to be recalled, the distribution level, and the product class for manufactured and compounded products.

The Joint ISPOR-ISPE Special Task Force on Real-World Evidence included patient/stakeholder engagement as a recommended good procedural practice when designing, conducting, and disseminating real-world evidence (RWE). However, there are no guidelines describing how patient experience data (PED) can be applied when designing real-world data (RWD) studies. This article describes development of consensus recommendations to guide researchers in applying PED to develop patient-centered RWE.A multidisciplinary advisory board, identified through recommendations of collaborators, was established to guide development of recommendations. Semistructured interviews were conducted to identify how experienced RWD researchers (n = 15) would apply PED when designing a hypothetical RWD study. Transcripts were analyzed and emerging themes developed into preliminary methods recommendations. An eDelphi survey (n = 26) was conducted to refine/develop consensus on the draft recommendations.We identified 13 recommendations for incorporating PED throughout the design, conduct, and translation of RWE. The recommendations encompass themes related to the development of a patient-centered research question, designing a study, disseminating RWE, and general considerations. For example, consider how patient input can inform population/subgroups, comparators, and study period. Researchers can leverage existing information describing PED and may be able to apply those insights to studies relying on traditional RWD sources and/or patient registries.Applying these emerging recommendations may improve the patient centricity of RWE through improved relevance of RWE to patient communities of interest and foster greater multidisciplinary participation and transparency in RWD research. As researchers gather experience by applying the methods recommendations, further refinement of these consensus recommendations may lead to "best practices."

The pipeline for new treatments for Alzheimer's disease (AD) in the USA contains over 100 different agents, 80% of which can be categorized as disease-modifying therapies. The regulatory approval of the disease-modifying agent aducanumab has brought more attention to the complexity of the diagnosis, evaluation, and treatment of AD and the difficult decisions payers and policy makers will face over the next few years as innovation continues in this space. The value of AD treatment can vary widely according to the perspective of the analysis, sources of data, and methodological approach for the value assessment. This article focuses on AD-specific data gaps and measurement challenges and provides guidance for evidence generation to facilitate better value assessments for future AD treatments.

Oral sotalol, used in adults for sinus rhythm control, is initiated at 80 mg b.i.d. and titrated to a maximum safe dose. The US Food and Drug Administration recommends monitoring the corrected QT interval (QTc ) for at least 3 days, until steady-state exposure of the drug is reached, before patient discharge, which can significantly impact the total cost of treatment. The objectives of this research were to design an accelerated intravenous sotalol loading and maintenance therapy that will reduce the hospital length of stay and to also evaluate the pharmacoeconomic impact in a hospital setting. Pharmacokinetic simulations of sotalol plasma concentrations vs. times profiles were performed to determine the optimal intravenous/oral transition regimen. A cost minimization analysis from the health sector perspective was conducted to assess the cost savings for these proposed accelerated regimens. For a chosen target dose of 120 mg b.i.d., two infusions of 40 mg over 1 hour and 20 mg over 0.5 hour, each followed up by an evaluation of QTc , can be administered followed immediately by the target oral maintenance dose of 120 mg at the end of the second infusion. Consequently, steady-state exposure and, therefore, steady-state QTc are obtained on the first day of therapy, facilitating an earlier hospital discharge. Two and 1-day mean total cost of -$3,123 (95% confidence interval (CI), -$3,640, -$2,607) -$4,820 (95% CI, -$5,352, -$4,288) were observed for this strategy, respectively. We are proposing an intravenous to oral transition strategy for sotalol that has the potential to significantly reduce cost and increase patient convenience.

The “Reference Case” was developed to facilitate comparability among published cost-effectiveness analyses intended to contribute to decisions about the broad allocation of healthcare resources. Although the societal perspective is recommended for Reference Case analyses, empirical estimations rarely adequately represent the patient perspective, and more often, healthcare system or payer perspectives are used. In this commentary, we discuss the evolution of the Reference Case over the past 20 years and how it now needs to further evolve. This should begin with a patient-informed societal perspective. A realignment of the societal perspective to better include patient perspectives in CEA creates a conduit for patient inclusion. Engaging patients to both derive patient-informed value elements and prioritize value elements using stated preference methods will lead to patient inclusion in the societal perspective and a patient-informed Reference Case analysis.

Introduction In patients with hepatitis C virus (HCV), human immunodeficiency virus (HIV) represents a major cause of morbidity and economic burden. Economic evaluations in HIV-HCV typically focus on government-sponsored insurance plans rather than a commercially insured cohort. This study evaluated the clinical and economic burden of HIV-HCV co-infection compared with HCV alone in commercially insured patients throughout the United States. Methods Commercial medical and pharmacy claims from 2007 to 2015 from a 10% random sample of enrollees within the IQVIA PharMetrics Plus™ administrative claims database were analyzed. Patients were included based on the presence of a claim with a HCV diagnosis across three separate cross-sectional periods which were created from the full dataset (2007–2009, 2010–2012, and 2013–2015). Costs incurred were categorized as emergency department, inpatient, outpatient medical, outpatient pharmacy, and other, based on the claim place of service. Descriptive statistics and proportion of total costs in each group have been reported for all cost categories. Results The samples included 22,329 from 2007 to 2009, 23,186 from 2010 to 2012, and 27,288 from 2013 to 2015. In all three cross-sections, HIV-HCV individuals were more likely to be male and carriers of hepatitis B virus. Pharmacy costs were $29,368 in the HCV-only group, compared to $73,547 in the HIV-HCV group (p

What is known and objectives Despite the large body of evidence demonstrating equivalent efficacy and safety for branded drugs and their generic counterparts, some patients and providers have the perception that generics may be less safe and effective than branded agents. Authorized generics (AGs) are a category of generic drugs defined by the United States Food and Drug Administration (FDA) as being the same as the brand-name drug without the brand's name on the label and which may have minor differences, such as tablet or capsule markings for identification. Studies in which AGs are considered along with other generics may increase our understanding of factors that may influence perceptions about generics and shed light on areas where education may be impactful. The objectives of this paper are to provide information about AGs, review studies in which they have been evaluated and explore the role that AGs may fill in the individualized treatment of patients. Methods A literature review was conducted on 30 September 2019 with follow-up search on 4 March 2020. The search was focussed on published papers and meeting abstracts that provided information on AGs with respect to medical and health outcomes of therapy as well as switching in individuals receiving branded, AG, or other generic agents. Information about patients' perceptions of generic medications and adherence to therapy was also included. Additional information, including relevant government sources, such as the FDA website and the Federal Trade Commission Report, was included as appropriate. Results The literature specific to AGs is limited, but available data clearly highlight the importance of patient perception of generics as well as medication appearance as factors that may affect adherence and potentially more frequent switchbacks to branded agents from generics or AGs. What is new and conclusion To our knowledge, this is the first narrative review to provide a summary of the published evidence about AGs with respect to clinical and health outcomes and switching. There is a need for more research and education regarding the use of AGs in clinical practice if they are to become more recognized as a potential treatment choice for patients. Generic medications play an important role in the healthcare system, and AGs may be able to provide an option to meet the specific needs of individual patients.

Background: Food allergy is a major health problem that significantly impacts quality of life (QoL). There is growing focus to evaluate food allergy related QoL and treatment value beyond the clinical effectiveness perspective by engaging patients and caregivers. We aimed to identify and prioritize outcomes important to food allergy parents of children and patients allergic to milk, egg, and/or peanut, to guide comparative effectiveness research (CER) that focuses on evaluating food allergy treatment decisions. Methods: We conducted a modified 3-round Delphi study to identify and derive consensus on priority treatment outcomes for parents of children and adult patients with diagnosed allergies to at least one of three major allergenic foods (milk, egg, and peanut) from across the United States. Results: Round 1 yielded 44 statements for round 2, and 39 statements reached the agreement level for round 3 ranking. Statements were organized under 4 sections: 1) food allergy problems, 2) treatment experiences, 3) important treatment outcomes, and 4) value of different treatment options. Conclusion: Food allergy parents and patients face several social, psychological, medical, healthcare, financial, food selection, and awareness challenges. The areas of consensus on important treatment outcomes revealed shared priority for reducing the risk of potentially fatal allergic reactions and having reliable treatments. The most valued treatment options reflect hope for permanent cure and fear of serious allergic reactions.

Objective: To characterize shared governance models in US schools and colleges of pharmacy and to recommend best-practices to promote faculty engagement and satisfaction. Methods: Three strategies were utilized to identify existing shared governance practices and issues within pharmacy education. First, a thorough literature review of faculty governance within higher education was undertaken. Next, a survey of faculty was created and conducted to explore existing structures, concerns, and satisfaction with governance at their institutions. The third approach was hosting a forum at the Feb 2018 INspire (interim) meeting of AACP to gather additional thoughts, perspective and feedback regarding committee charges and to prioritize issues to be addressed. Results: The literature review revealed a number of recommendations in higher education but only one study specifically related to governance in pharmacy, which focused on student governance and some additional data in the annual AACP Faculty Survey. The survey yielded 926 responses, and almost 65% of respondents were satisfied or very satisfied with their faculty governance and level of input into faculty governance. Faculty with administrative ranks and those at public institutions were found to be more satisfied with governance. The interim meeting forum included participation from approximately 50 faculty and resulted in the development of five themes that were prioritized in order of significance. Conclusions: To optimize faculty governance and increase faculty satisfaction and participation in governance, the Council of Faculties Faculty Affairs Committee from 2017-18 makes eight recommendations to the academic pharmacy stakeholders.

The introduction of direct-acting antivirals (DAAs) represents a potential clinical cure for hepatitis C virus (HCV) infection. Identification of costs associated with different stages of untreated disease through cost-of-illness (COI) evaluation helps inform policy decisions and cost-effectiveness analyses (CEAs). This study’s objective was to review published real-world costs for patients with HCV to estimate the COI across different stages of disease progression. A literature search of EMBASE, Scopus, and PubMed from January 1, 2010 to August 31, 2019 was conducted to identify real-world evidence related to HCV. Data extraction included citation details, population, study type, costing method used, currency and inflation adjustments, and disease-specific costs. Standardized costing method categories (sum all medical, sum diagnosis specific, matching, regression, other incremental, and other total) were assigned. The risk of bias was assessed at the outcome level for influence on costs attributable to HCV. The search strategy identified 278 studies, with 31 included in the final review after inclusion and exclusion criteria were applied. Retrospective cohorts (77%) and cross-sectional analyses (16%) were most frequently encountered. Sum Diagnosis Specific was the most common costing method (39%), followed by Regression (32%). Of the 31 studies analyzed, 35% included costs that would be included in a societal model. Costs were identified for various stages and complications related to HCV disease progression. Several studies included were determined to have a high (48%) or moderate risk (42%) of bias related to COI estimates. Cost estimates for formal, informal, and non-health care services were identified in this review, but several challenges still exist in fully quantifying HCV burden. Future modeling studies including cost inputs should critically evaluate the risk of bias based on costing methods and data sources.

Purpose of review As drug allergy research aims to inform clinical practice, implementation of best practices may be influenced by financial resources required to incorporate new interventions and the resulting clinical and economic returns on those resource investments. The present review summarizes new insights into the economics of drug allergy over the past year. Recent findings While considering economic implications of recent drug allergy research, many studies have addressed different contextual factors related to the setting, provider, or outcomes. Advances in technology have enabled specialized allergists to support remote settings through telemedicine consultation. Training opportunities and interdisciplinary approaches to address drug allergy challenges have enabled multiple provider types to play a role in screening, diagnosis, and management. Penicillin allergy testing has been a major focus for many institutions, with several studies focused on de-labeling strategies including confirmatory skin testing and direct oral challenges. Summary Studies over the past year provide new opportunities for the field of drug allergy research. The focus of current research to capture direct health costs or savings associated with drug allergy interventions demonstrates opportunity for more cost-effective care delivery and opportunity to explore greater benefits to society.

Shifts in migration and border control policies may increase the likelihood of trauma exposure related to child–parent separation and result in costs to the health system and society. In the present study, we estimated direct and indirect costs per child as well as overall cohort costs of border control policies on migrant children and adolescents who were separated from their parents, detained, and placed in the custody of the United States following the implementation of the 2018 Zero Tolerance Policy. Economic modeling techniques, including a Markov process and Monte Carlo simulation, based on data from the National Child Traumatic Stress Network's Core Data Set (N = 458 migrant youth) and published studies were used to estimate economic costs associated with three immigration policies: No Detention, Family Detention, and Zero Tolerance. Clinical evaluation data on mental health symptoms and disorders were used to estimate the initial health state and risks associated with additional trauma exposure for each scenario. The total direct and indirect costs per child were conservatively estimated at $33,008, $33,790, and $34,544 after 5 years for No Detention, Family Detention, and Zero Tolerance, respectively. From a health system perspective, annual estimated spending increases ranged from $1.5 million to $14.9 million for Family Detention and $2.8 million to $29.3 million for Zero Tolerance compared to baseline spending under the No Detention scenario. Border control policies that increase the likelihood of child and adolescent trauma exposure are not only morally troubling but may also create additional economic concerns in the form of direct health care costs and indirect societal costs.

There has been steady and growing interest in addressing patient health beyond the traditional interactions with clinicians. Much attention has been given to the social determinants of health which are associated with many non-communicable diseases. A challenge to the healthcare delivery system is to incorporate these environmental circumstances into a coherent diagnosis and treatment framework. As clinicians are expected to help transform the healthcare delivery systems to consider these extra-clinical factors, they may benefit from better understanding of pathways to disease. Similarly, payment systems should incorporate health economics outcomes research to augment the healthcare utilization measures used frequently today.

Background Drug costs are frequently estimated in economic analyses using wholesale acquisition cost (WAC), but what is the best approach to develop these estimates? Pharmaceutical manufacturers recently released transparency reports disclosing net price increases after accounting for rebates and other discounts. Objective Our objective was to determine whether manufacturer net prices (MNPs) could approximate the discounted prices observed by the U.S. Department of Veterans Affairs (VA). Methods We compared the annual, average price discounts voluntarily reported by three pharmaceutical manufacturers with the VA price for specific products from each company. The top 10 drugs by total sales reported from company tax filings for 2016 were included. The discount observed by the VA was determined from each drug’s list price, reported as WAC, in 2016. Descriptive statistics were calculated for the VA discount observed and a weighted price index was calculated using the lowest price to the VA (Weighted VA Index), which was compared with the manufacturer index. Results The discounted price as a percentage of the WAC ranged from 9 to 74%. All three indexes estimated by the average discount to the VA were at or below the manufacturer indexes (42 vs. 50% for Eli Lilly, 56 vs. 65% for Johnson & Johnson, and 59 vs. 59% for Merck). Conclusions Manufacturer-reported average net prices may provide a close approximation of the average discounted price granted to the VA, suggesting they may be a useful proxy for the true pharmacy benefits manager (PBM) or payer cost. However, individual discounts for products have wide variation, making a standard discount adjustment across multiple products less acceptable.