Methodology for conducting a comprehensive product review in managed care.

The high degree of complexity of the product-review process and differences in procedures between organizations have resulted in a need for best practices and an overall product-review process to create efficiencies for health care decision makers. In an effort to streamline product-review concepts, this article outlines the different components of the review process, including clinical and economic review, formulary placement determination, and evaluation of alternatives within a drug class. The article also details opportunities for the near future, as technology continues to advance and alignment between medical and pharmacy benefits is desired. DISCLOSURES: Drs Linnerooth, Penley, Ha, and Craven report employment with Xcenda, which provided funding for the manuscript. Drs Sauvageau and Hydery report employment Xcenda, which provided funding for the manuscript, and stock holdings with AmerisourceBergen. Dr Feeney reports support for attending meetings and/or travel provided by Highmark, Inc. Dr Thomas reports receipt of consulting fees from ActiveRADAR, board member roles with ActiveRADAR and RoundtableRx, an adjunct professor role with the University of Minnesota, and stock options and pensions with Eli Lilly and Aetna/CVS. Dr Watkins reports payment or honoraria from ISPOR and for articles written for Value and Outcomes Spotlight, and support for attending meetings and/or travel by AMCP.

Advancing a managed care pharmacy research agenda: Generating real-world evidence to support US Food and Drug Administration Accelerated Approvals and improving benefit design to address health inequities.

To advance their research agenda, the Academy of Managed Care Pharmacy (AMCP) and the AMCP Foundation (AMCPF) invited a sample of AMCP membership to participate in focus groups and tasked them with developing tangible research aims for each of the top 2 previously identified AMCP/AMCPF research priorities: generating real-world evidence (RWE) to support US Food and Drug Administration (FDA) Accelerated Approvals and improving benefit design to address health inequities. The resulting research aims, which were further refined per feedback from additional stakeholders, will serve to guide requests for proposals for funding of specific research projects to address these top managed care priorities. Research aims identified by focus group participants related to generating RWE for FDA Accelerated Approvals include (1) creating a data survey tool for managed care to make RWE more readily available, (2) linking surrogate endpoints to meaningful clinical outcomes for drug development, and (3) improving patient outcomes by determining the optimal sequence of clinical pathways. Research aims identified by focus group participants related to improving benefit design to address health inequities include (1) identifying how the ability to navigate managed care benefit designs may impact inequities, (2) understanding the connection between health inequities and medication adherence, and (3) evaluating the impact of social determinants of health on medication affordability. DISCLOSURES: These proceedings were supported by Bridget Flavin, PharmD, Founder, Connected Content, Ltd. Connected Content, Ltd. received payment from AMCP for the preparation of this manuscript. Flavin is also an adjunct associate professor at the University of Florida College of Pharmacy. Diana Brixner received AMCP Foundation support of sabbatical to conduct this work, support of a medical writer to assist in putting the manuscript together, consulting fees from Millcreek Outcomes Group, Elevar, Sage, Haymarket, and AMCP funding of one trip to Alexandria, VA. This research and the development of this manuscript were funded by AMCP and the AMCP Foundation.

Perspectives of compounding pharmacists on alcohol-based hand sanitizer production and utilization for COVID-19 prevention in Addis Ababa, Ethiopia: A descriptive phenomenology study.

BACKGROUND: Globally, the safety of patients and healthcare providers is at risk due to health care-associated infections (HCAIs). World Health Organization and the Centers for Disease Control and Prevention recommend using alcohol-based hand rub (ABHR) for hand hygiene in healthcare settings to prevent HCAIs. Irrational use of ABHR will have undesirable consequences including wastage of products, exposure of healthcare providers to infections and emergence of microbial resistance to the alcohol in hand sanitizers. This study aimed to explore the perspective and experiences of compounding pharmacists on production and utilization of ABHR solution for coronavirus disease in 2019 (COVID-19) prevention in public hospitals of Addis Ababa, Ethiopia. METHODS: A descriptive qualitative study using in-depth interview of 13 key-informants serving as compounding pharmacists in public hospitals of Addis Ababa, Ethiopia, was conducted. The study participants were identified and selected by purposive sampling. All transcribed interviews were subjected to thematic analysis and transcripts were analyzed manually. FINDINGS: The compounding pharmacists in this study had a mean age of 30.6 (±3.1) years and nine of the thirteen participants were men. Ten participants believed that the compounding practice in their respective sites followed the principles of good compounding practice. More than half of the participants did not believe that ABHR products were used rationally in health facilities. They argued that users did not have enough awareness when and how to use sanitizers. Most of the interviewees reported that compounding personnel had no formal training on ABHR solution production. Study participants suggested incentive mechanisms and reimbursements for experts involved in the compounding of ABHR solutions. CONCLUSION: Three of the compounding pharmacists indicated that ABHR production in their setting lack compliance to good compounding practice due to inadequate compounding room, quality control tests, manpower and equipment. Despite this, most study participants preferred the in-house ABHR products than the commercially available ones. Thus, training, regular monitoring and follow-up of the hospital compounding services can further build staff confidence.

Assessment of burnout within a health-system pharmacy department.

PURPOSE: Workplace-related burnout is a state of mental and physical exhaustion caused by one's professional life. Literature demonstrates the link between physician burnout and serious consequences (reduced productivity, medical errors, and clinician suicide), but assessment of burnout in other healthcare professions is limited, especially in pharmacy. A quality improvement study was conducted to quantify burnout in a diverse health-system pharmacy department and identify potential strategies to improve well-being. METHODS: A survey was distributed to assess the perception and drivers of burnout within a health-system pharmacy. All associates received a survey comprised of the Maslach Burnout Inventory (MBI), demographic questions, and items affording respondents the opportunity to list stressors and potential solutions. Email reminders were sent weekly and site visits were conducted to encourage survey completion. Results were analyzed via descriptive statistics. RESULTS: Two hundred seventy-seven associates completed the survey (response rate, 40.5%). Seventy percent of those participants were experiencing moderate to high levels of burnout, with survey results indicating moderate levels of personal accomplishment and emotional exhaustion and low levels of depersonalization; there were no statistically significant differences in mean MBI scores by shift type, hours worked per week, or years of service. There were statistically significant differences in scores for personal accomplishment between males and females, as well as among positions and regions (P < 0.05). Participants identified issues related to workflow, control, and community as the greatest contributors to stress. CONCLUSION: The diverse staff of a health-system pharmacy department reported a moderate amount of burnout, with the greatest variation in the dimension of personal accomplishment. The mitigation strategies most commonly cited were staffing/workflow adjustments and creating a culture of well-being.

Community-Based Services by Pharmacists: A Systematic Review of Cost-Utility Analyses.

OBJECTIVES: To conduct a systematic review of cost-utility studies of community-based services provided by pharmacists and to examine their reporting and methodological quality. METHODS: A comprehensive literature search was performed in February 2019 using a replicable search strategy in bibliographic databases MEDLINE, EMBASE, and the NHS Economic Evaluations Database from their inception onwards. Two reviewers independently screened the literature, abstracted data from full-text articles, and assessed reporting and methodological quality using the Consolidated Health Economic Evaluation Reporting Standards and Quality of Health Economic Studies checklists. RESULTS: Twenty studies were included in this review, representing the healthcare systems of the United Kingdom, Spain, France, The Netherlands, Belgium, Italy, Canada, the United States of America, and Brazil. Descriptions of the context in which the studies were done, justification of data sources on patient and process outcomes, choices of model, and generalizability of study findings were often inadequately reported. Seven studies (35%) were deemed of high methodological quality, 11 studies (55%) of fair quality, and 2 studies (10%) of poor quality. In addition, various methodological issues related to the randomized controlled trials and observational studies used to generate effectiveness estimates were identified. CONCLUSIONS: In view of the lack of standardized definitions of expanded services, heterogeneity in study objectives, settings, comparators, methodology, outcomes, and the variable quality of these studies, the value of these services (in terms of costs) compared with quality-adjusted survival remains inconclusive.

Pharmacy in an Improved Health Care Delivery Model Using Maslow's Hierarchy of Needs.

Our objective is to suggest a revised model of health care delivery that emphasizes human connections in patient care and describes the role of pharmacists within the model. Improving the quality of patient experiences is one of the triple aims of health care delivery. Using the patient-centered medical home (PCMH) model as the basis, we describe an enhanced delivery model that adopts Maslow's hierarchy of needs and addresses the current deficiencies of the PCMH model. The model envisions the creation of "community centers for engagement" that employ patient care advocates and health care practitioners who work together in an interdisciplinary manner to improve the quality of patient care experiences. Pharmacists' roles in these centers of engagement are outlined based on Maslow's hierarchy of needs. The model aims to enhance patient-provider interactions and allow pharmacists to play a pivotal role in meeting patients' needs with the goal of developing a self-actualized patient.

Validating a Budget Impact Model Using Payer Insight and Claims Data: A Framework and Case Study.

BACKGROUND: There is a paucity of studies validating budget impact models. The lack of such studies may contribute to the underuse of budget impact models by payers in formulary decision making. OBJECTIVE: To assess the face validity, internal verification, and predictive validity of a previously published model that assessed the budgetary impact of antidiabetic formulary changes. METHODS: 4 experts with diverse backgrounds were selected and asked questions regarding the face validity of the structure/conceptual model, input data, and results from the budget impact model. To assess internal verification, structured "walk-throughs," unit tests, extreme condition tests, traces, replication tests, and double programming techniques were used. The predictive validity of the model was evaluated by comparing the predicted and realized budget using mean absolute scaled error. "Realized" budgetary impact of the formulary changes was calculated by taking the difference between realized budget in the year after the formulary changes and the budget had there been no formulary changes (i.e., the counterfactual). The counterfactual budget was modeled using the best fit autoregressive integrated moving average model. RESULTS: When assessing the face validity of the model, the 4 experts brought up issues such as how to incorporate other health insurance, recent policy changes, cost inflation, and potential impacts on insulin use. The 6 internal verification techniques caught mistakes in equations, missing data, and misclassified data. The realized budget was found to be lower than the predicted budget, with 13% error and an absolute scaled error of 2.60. After removing the model assumption that past utilization trends would continue, the model's predictive accuracy improved (the absolute scaled error dropped below 1 to 0.48). The "realized" budgetary impact was found to be greater than the predicted budgetary impact, largely because of lower-than-expected utilization. CONCLUSIONS: The budget impact model overpredicted utilization in the year after the formulary changes. Discoveries through the validation process improved the accuracy and transparency of the model. DISCLOSURES: This project was supported by grant number F32HS024857 from the Agency for Healthcare Research and Quality (AHRQ). The content is solely the responsibility of the authors and does not necessarily represent the official views of AHRQ. AHRQ had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or design to submit the manuscript for publication. The findings discussed in this manuscript represent the views of the authors and do not necessarily reflect the views of the Department of Defense, the Defense Health Agency, nor the Departments of the Army, Navy, and Air Force. Hung reports a grant from the AHRQ, during the conduct of the study, and personal fees from CVS Health and BlueCross BlueShield Association, outside the submitted work. Mullins reports grants and personal fees from Bayer and Pfizer and personal fees from Boehringer Ingelheim, Janssen/J&J, Regeneron, and Sanofi-Aventis, outside the submitted work. Mullins, Slejko, and Shaya are employed by the University of Maryland School of Pharmacy. Haines and Lugo have nothing to disclose. Part of this content was previously presented as a poster at the 2017 AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 27-30, 2017; Denver, CO, and as poster and oral presentations at the 2017 AMCP Nexus Meeting; October 16-19, 2017; Dallas, TX. Part of this content was published as Hung's PhD dissertation.

Willingness of patients to use unused medication returned to the pharmacy by another patient: a cross-sectional survey.

OBJECTIVES: Redispensing by pharmacies of medication unused by another patient could contribute to optimal use of healthcare resources. This study aimed to assess patient willingness to use medication returned by another patient and patient characteristics associated with this willingness. DESIGN: Cross-sectional survey. SETTING: A total of 41 community and 5 outpatient pharmacies in the Netherlands. PARTICIPANTS: Total of 2215 pharmacy visitors. PRIMARY AND SECONDARY OUTCOME MEASURES: Patients completed a questionnaire regarding their willingness to use medication returned unused to the pharmacy by another patient, assuming quality was guaranteed. Secondary outcome measures included patient sociodemographic characteristics that were associated with patient willingness, analysed using logistic regression analysis and reported as ORs with 95% CIs. RESULTS: Of the 2215 patients (mean (SD) age 50.6(18.0) years; 61.4% female), 61.2% were willing to use medication returned unused to the pharmacy by another patient. Patients who were unwilling mostly found it risky. Men were more willing to use returned medication (OR 1.3 95% CI 1.1 to 1.6), as did patients with a high educational level (OR 1.8 95% CI 1.3 to 2.5), those who regularly use 1-3 medications (OR 1.3 95% CI 1.1 to 1.7), those who returned medication to the pharmacy for disposal (OR 1.5 95% CI 1.0 to 2.3) and those who ever had unused medication themselves (OR 1.3 95% CI 1.1 to 1.6)). Patients with non-Dutch cultural background were less willing to use returned medication (OR 0.395% CI 0.3 to 0.4)). CONCLUSIONS: When quality is guaranteed, a substantial proportion of patients are willing to use medication returned unused to the pharmacy by another patient. This suggests that implementation of redispensing may be supported by patients.

Strategies for Overcoming Barriers to Adopting Biosimilars and Achieving Goals of the Biologics Price Competition and Innovation Act: A Survey of Managed Care and Specialty Pharmacy Professionals.

BACKGROUND: The Biologics Price Competition and Innovation Act (BPCIA) of 2009, which included pathways for FDA approval of biosimilar products, was designed to promote more affordable, expanded patient access to biologic therapies. Achieving these BPCIA goals depends on overcoming formidable barriers to biosimilar adoption. Managed care and specialty pharmacy professionals are uniquely qualified to inform initiatives to address these barriers. OBJECTIVE: To assess perceptions regarding strategies for overcoming barriers to biosimilar adoption among managed care and specialty pharmacy professionals by conducting a survey study. METHODS: Invitations to complete the online survey were emailed by the Academy of Managed Care Pharmacy (AMCP) to members and customers and to contacts sourced from a commercial database. In addition to questions on respondent demographics and perceptions of biosimilars, the survey listed 16 strategies for overcoming key barriers to biosimilar adoption. On a 5-point scale, participants rated their opinion on the likelihood that each strategy would have the potential to assist in achieving BPCIA goals. The survey also listed 6 barriers to biosimilar adoption. On a 5-point scale, participants rated their perceived difficulty in overcoming each barrier. The survey concluded with an open-text item that asked participants to list 3 additional strategies for overcoming biosimilar adoption barriers. Response frequencies were calculated to describe participants' ratings of the strategies and barriers. Statistical analyses were conducted to assess whether the ratings differed among respondents grouped by work organization. For the open-text item, we conducted qualitative content analyses to categorize strategies by stakeholder groups that might take primary implementation roles. RESULTS: A total of 300 managed care and specialty pharmacy professionals completed the survey. There was considerable variation in the preferences, policies, and practices regarding biosimilar adoption among respondents' work organizations. Responses to several survey items reflected positive attitudes about the safety and efficacy of biosimilars; for example, 84% agreed or strongly agreed that FDA-approved biosimilars are safe and effective for patients who switch from a reference biologic. Based on pooled percentages for ratings of likely and extremely likely to overcome barriers to biosimilar adoption, the highest-rated strategies were for prescriber education about evidence from switching studies (91%) and FDA guidance on pharmacy-level substitution of reference biologics with biosimilars (90%). The lowest-rated strategies were for requiring therapeutic drug monitoring for patients who switch to biosimilars (39%) and using quotas to incentivize providers to prescribe biosimilars (40%). For the qualitative analysis, the highest numbers of respondents' suggested strategies indicated primary implementation roles of biosimilar manufacturers (40%), the federal government (26%), and managed care organizations (15%). CONCLUSIONS: Reflecting the unique knowledge, perspectives, and practices of managed care and specialty pharmacy professionals, the study findings are relevant to informing and advancing initiatives for achieving BPCIA goals. DISCLOSURES: The survey study reported in this article was part of a continuing education program funded by an independent educational grant, which was awarded by Sandoz, a Novartis Division, to PRIME Education. The Academy of Managed Care Pharmacy (AMCP) received grant funding from PRIME to assist in developing the survey and writing the manuscript. The grantor had no role in the study design, execution, analysis, or reporting. Greene and Pardo are employed by PRIME. Singh and Carden are employed by AMCP. Greene, Singh, Carden, and Pardo have no other disclosures. Lichtenstein received an honorarium from PRIME for serving as faculty for the continuing education program and has been a consultant for Pfizer, Cellceutix, and Merck.

Meeting Abstracts - AMCP Managed Care & Specialty Pharmacy Annual Meeting 2019.

The AMCP Managed Care & Specialty Pharmacy Annual Meeting 2019 in San Diego, California, is expected to attract more than 4,000 managed care pharmacists and other health care professionals who manage and evaluate drug therapies, develop and manage networks, and work with medical managers and information specialists to improve the care of all individuals enrolled in managed care programs. The AMCP Abstracts program provides a forum through which authors can share their insights and outcomes of advanced managed care practice. Poster presentations are scheduled for Wednesday, March 27, from 11:30 am to 1:00 pm. Posters will also be displayed on Tuesday, March 26, from 5:30 pm to 7:00 pm, during the opening night reception in the Expo, and on Thursday, March 28, from 9:30 am to 11:00 am. Podium presentations for the Platinum award-winning abstracts are Tuesday, March 26, from 2:30 pm to 3:45 pm. Professional abstracts that have been reviewed are published in the Journal of Managed Care & Specialty Pharmacy's Meeting Abstracts supplement. Abstracts were submitted in the following categories.

Assessment of a simulated contraceptive prescribing activity for pharmacy students.

BACKGROUND AND PURPOSE: The role of the pharmacist has been shifting rapidly. One example of change is the passage of legislation allowing pharmacists to independently initiate self-administered hormonal contraceptives in several states. There is no evidence of this specific topic being covered in pharmacy school curricula, and many states are requiring additional post-graduate training. This activity was designed to determine the utility of a contraceptive prescribing simulation activity for pharmacy students. EDUCATIONAL ACTIVITY AND SETTING: Pharmacy students enrolled in a women's health elective learned about relevant state legislation and attended a clinical skills center simulation activity where they utilized an available prescribing algorithm. Students completed two scenarios and received grades based on their clinical decision-making and patient interaction skills. An electronic survey was distributed post-activity to assess student satisfaction and confidence when prescribing contraceptives. Responses and grades on the assignment were analyzed to determine the activity's utility. FINDINGS: Students finished with median scores of 15, 14.8, and 14.5 out of 15 possible points for the three scenarios. Students reported overall satisfaction with the activity, with general agreement that the activity was realistic and made them feel like they were prepared to prescribe contraceptives. SUMMARY: Independently initiating contraceptives is a novel practice area for pharmacists. This activity introduced students to the process of prescribing using realistic forms and scenarios. The utility of the activity was twofold - it introduced students to the changing environment of pharmacy practice and allowed students to apply their knowledge of contraceptives and women's health. Students performed well on the activity and reported high levels of satisfaction.

Facilitators and barriers to non-medical prescribing - A systematic review and thematic synthesis.

INTRODUCTION: Non-medical prescribing has the potential to deliver innovative healthcare within limited finances. However, uptake has been slow, and a proportion of non-medical prescribers do not use the qualification. This systematic review aimed to describe the facilitators and barriers to non-medical prescribing in the United Kingdom. METHODS: The systematic review and thematic analysis included qualitative and mixed methods papers reporting facilitators and barriers to independent non-medical prescribing in the United Kingdom. The following databases were searched to identify relevant papers: AMED, ASSIA, BNI, CINAHL, EMBASE, ERIC, MEDLINE, Open Grey, Open access theses and dissertations, and Web of Science. Papers published between 2006 and March 2017 were included. Studies were quality assessed using a validated tool (QATSDD), then underwent thematic analysis. The protocol was registered with PROSPERO (CRD42015019786). RESULTS: Of 3991 potentially relevant identified studies, 42 were eligible for inclusion. The studies were generally of moderate quality (83%), and most (71%) were published 2007-2012. The nursing profession dominated the studies (30/42). Thematic analysis identified three overarching themes: non-medical prescriber, human factors, and organisational aspects. Each theme consisted of several sub-themes; the four most highly mentioned were 'medical professionals', 'area of competence', 'impact on time' and 'service'. Sub-themes were frequently interdependent on each other, having the potential to act as a barrier or facilitator depending on circumstances. DISCUSSION: Addressing the identified themes and subthemes enables strategies to be developed to support and optimise non-medical prescribing. Further research is required to identify if similar themes are encountered by other non-medical prescribing groups than nurses and pharmacists.

An Evaluation of the Implementation of Pharmacist-Prescribed Hormonal Contraceptives in California.

OBJECTIVE: To evaluate the implementation of pharmacist-prescribed hormonal contraceptives in California after a recent expansion of pharmacists' scope of practice. METHODS: A probability sample of 480 licensed California retail pharmacies (stratified by nonrural or rural location and independent or chain status) was included in a cross-sectional "secret shopper" telephone survey assessing the availability of pharmacist-prescribed hormonal contraceptives and service details. Survey data were analyzed using weighted descriptive statistics, CIs, and Wald tests. RESULTS: Findings included data from 457 pharmacies (response rate 95.2%). Only 5.1% of pharmacies reported providing pharmacist-prescribed hormonal contraceptives (95% CI 2.9-7.2%). This proportion did not differ significantly between rural and nonrural pharmacies (P=.83) nor between independent and chain pharmacies (P=.40). Five of the 22 pharmacies that were providing pharmacist-prescribed hormonal contraceptives informed secret shoppers that all allowed hormonal methods were available; most of these pharmacies (77.3%) did proactively describe that a health history was required before receiving medications. Only half of pharmacies providing pharmacist-prescribed hormonal contraceptives would do so for minors although this was allowed by law. CONCLUSION: In the first year after statewide protocol implementation, only a small proportion of retail pharmacies across California has begun offering hormonal contraception services. In the absence of additional supportive legislation regarding reimbursement for pharmacist services, increases in scope of practice regulations to build a larger network of contraceptive providers may not be effective in increasing access to birth control.

Paying for Cures: How Can We Afford It? Managed Care Pharmacy Stakeholder Perceptions of Policy Options to Address Affordability of Prescription Drugs.

BACKGROUND: High-priced medications with curative potential, such as the newer hepatitis C therapies, have contributed to the recent growth in pharmaceutical expenditure. Despite the obvious benefits, health care decision makers are just beginning to grapple with questions of how to value and pay for curative therapies that may feature large upfront cost, followed by health benefits that are reaped over a patient's lifespan. Alternative policy options have been proposed to promote high value and financially sustainable use of these therapies. It is unclear which policy options would be most acceptable to health care payer and biomedical manufacturer stakeholders. OBJECTIVES: To (a) briefly review pharmaceutical policy options to address health system affordability and (b) assess the acceptability of alternative policy options to health care payers and biomedical manufacturers before and after an Academy of Managed Care Pharmacy (AMCP) continuing pharmacy education (CPE) session. METHODS: We searched MEDLINE and Cochran databases for pharmaceutical policy options addressing affordability. With input from a focus group of managed care professionals, we developed CPE session content and an 8-question survey focusing on the most promising policy options. We fielded the survey before and after the CPE session, which occurred as part of the 2016 AMCP Annual Meeting. We first conducted a chi-squared goodness-of-fit test to assess response distributions. Next, we tested how responses differed before and after by using an ordered logit and a multinomial logit to model Likert scale and unordered responses, respectively. RESULTS: Although risk-sharing payments over time remained the most favorable choice before (37%) and after (35%) the CPE session, this choice was closely followed by HealthCoin after the session, which increased in favorability from 4% to 33% of responses (P = 0.001). About half of the respondents (54%) indicated that legislative change is the most significant barrier to the implementation of any policy. CONCLUSIONS: As high-cost curative drugs reach the market, managed care stakeholders need information from a balanced education source regarding alternative policies to address affordability. We found that after the AMCP CPE session, risk-sharing payments over time and HealthCoin were the most favorable options. DISCLOSURES: No funding was provided for this research. Carlson reports consulting fees from Genentech, Pfizer, and Seattle Genetics. The other authors have nothing to disclose. Study concept and design were contributed by Yeung, Garrison, and Carlson. Yeung collected the data, which were interpreted by Yeung and Basu. The manuscript was written by Yeung, Suh, and Bansal and revised by Yeung. A portion of this research was presented at the Academy of Managed Care & Specialty Pharmacy Annual Meeting as a continuing education session entitled "Paying for Cures: How Can We Afford It?" on April 20, 2016, in San Francisco, California.

Changing the Way We Pay for Health Care: Is Value the New Plastic?

DISCLOSURES: Navarro is a clinical professor in the College of Pharmacy at the University of Florida, Gainesville, and is an assistant editor with the Journal of Managed Care and Specialty Pharmacy. Navarro reports consulting fees from Analysis Group, Amgen, Novartis, and Allergan.

Performance-Based Risk-Sharing Arrangements: U.S. Payer Experience.

BACKGROUND: As a result of global concern about rising drug costs, many U.S. payers and European agencies such as the National Health Service have partnered with pharmaceutical companies in performance-based risk-sharing arrangements (PBRSAs) by which manufacturers share financial risk with health care purchasing entities and authorities. However, PBRSAs present many administrative and legal challenges that have minimized successful contract experiences in the United States. OBJECTIVE: To (a) identify drug and disease characteristics and contract components that contribute to successful PBRSA experiences and the primary barriers to PBRSA execution and (b) explore solutions to facilitate contract negotiation and execution. METHODS: A 37-item, web-based survey instrument (Qualtrics), approximately 20 minutes in duration, was open during July and August 2016. The survey was emailed to 90 pharmacy and medical directors of various health care organizations. Statistical analysis included the Kruskal-Wallis test and chi-square tests to examine differences among payer responses. Survey responses were anonymized and data were aggregated. RESULTS: Twenty-seven individuals completed the survey (30% completion rate). The majority of respondents worked for regional health plans (52%, n = 14), covering at least 1 million lives (63%, n = 17), with at least 7 years of managed care experience (81%, n = 22). A total of 51 PBRSAs were active among respondents at the time of the survey. Easily obtainable and evaluable drug data and medical data were the most important drug and disease attributes for successful PBRSAs, respectively. Pharmacy claims and patient demographic data were assessed as "very easy and inexpensive" to collect. Type and amount of manufacturer payment for drug outcome performance failure, endpoint measurement, and necessary clinical data for drug performance measurement were all critical factors for successful PBRSAs. Standardized contract templates and transparent contract financial risk evaluation and modeling ranked highest among methods of manufacturer facilitation of PBRSAs. This study was limited by sample size and survey questions were limited to explanation of PBRSAs at the disease state level. CONCLUSIONS: On the basis of PBRSA experiences, respondents noted that drug use in chronic medical conditions and objective drug outcome performance measurements were favorable drug characteristics and serve as the primary source of satisfaction for these types of contracts. Third parties and manufacturers can facilitate the uptake and success of PBRSAs by developing standardized contracting templates in addition to other methods that increase their stake in the arrangement. Looking forward, mounting perceptions of success in this realm of contracting for pharmaceuticals may contribute in the quest for value-based payments in the U.S. health care system. DISCLOSURES: The construction of the survey and payment for survey respondents were supported by Charles River Associates. Parece is an employee of Charles River Associates. Goble and Ung are completing fellowship training sponsored by Novartis and Celgene, respectively, but do not have any conflicts of interest and did not receive any funding related to this study. Navarro reports consulting fees from Analysis Group, TEVA, and Amgen, unrelated to this study. Van Boemmel-Wegmann declares no conflict of interest. Study concept and design were contributed by Navarro, Goble, Ung, and Parece. Navarro took the lead in data collection, along with Goble and Ung, and data interpretation was performed by van Boemmel-Wegmann, Goble, and Ung. The manuscript was written by Goble, Ung, Navarro, and van Boemmel-Wegmann and revised by all of the authors.

Outcomes-Based Contracting Experience: Research Findings from U.S. and European Stakeholders.

BACKGROUND: Outcomes-based contracts (OBCs), a type of risk-sharing arrangement (RSA), have emerged as a promising avenue for payers to engage with pharmaceutical manufacturers to share risk and improve patient access to medicines via evaluation of real-world outcomes. OBJECTIVE: To assess the level of recent OBC activity and stakeholder perceptions of these arrangements, as well as the outlook for future OBC activity from a payer and manufacturer perspective in the United States and EU-5 (France, Germany, Italy, Spain, and the United Kingdom). METHODS: Using a structured questionnaire, interviews were conducted with 27 experts, including 14 U.S. payers, 5 EU-5 national payers, and 8 manufacturer pricing/market access executives (4 U.S., 4 EU-5). We also used the University of Washington's Performance Based Risk-Sharing (PBRS) database and other targeted publicly available information. RESULTS: Publicly disclosed information on OBCs understates the level of OBC activity, since many arrangements are confidential. Overall, U.S. and EU-5 interviewees generally expected that 2 to 3 times more OBCs would be implemented in the next 5 years than in the previous 5 years. Key drivers included the introduction of a national OBC framework in Spain, potentially a similar framework in the United Kingdom, a growing sickness fund activity in Germany, and a U.S. movement towards accountable care. Motivation for OBCs varied markedly across markets and stakeholders, with operational feasibility noted as a significant hurdle in the United States and France. Along with improving health outcomes, cost and financial risk reduction were the primary OBC motivators for payers, while potential access or reimbursement gains were key factors for manufacturers. CONCLUSIONS: Using direct input from U.S. and EU-5 payer and pharmaceutical manufacturer decision makers, this research suggests that high OBC growth is expected in the EU-5 and, to a more moderate extent, in the United States, particularly if clear, simpler OBC frameworks can be developed. DISCLOSURES: This study was funded by Novartis Pharmaceuticals. Novartis employees were involved in all aspects of this study. Vegesna and Sasane are employed by and own stock in Novartis. Nazareth and Ko were employees of Novartis at the time of this study. Frois, Demean, Carpenter, and Wu are or have been employed by Analysis Group, which received a grant from Novartis for this research. Navarro received consulting fees from Novartis for his involvement in this research. Study concept and design were contributed by Sasane, Frois, Nazareth, and Wu. Navarro, Demean, and Frois took the lead in data collection, assisted by Carpenter, Ko, and Nazareth. Data interpretation was provided by Frois, Carpenter, Nazareth, and Ko, along with Sasane, Demean, Wu, and Navarro. The manuscript was written by Frois, Demean, Nazareth, and Ko, along with Sasane, Carpenter, Wu, and Navarro, and revised by Frois, Ko, and Vegesna, along with Sasane, Nazareth, Wu, and Navarro.

Population health management: Review of concepts and definitions.

PURPOSE: The terms population health, population health improvement, and population health management are discussed. SUMMARY: A key concept in defining population health activities is clearly delineating the population(s) of focus. The Institute for Healthcare Improvement's (IHI's) Triple Aim Initiative uses the term population health management to describe the work by healthcare organizations to improve outcomes for individual patients to maximize population health. The National Academy of Medicine favors the term population health improvement and uses this term to describe work to identify and improve aspects of or contributors to population health, expanding the focus beyond traditional healthcare delivery systems. As organizations like IHI and the National Academy of Medicine continue to focus on population health, the terms and definitions used to describe these activities will continue to evolve. CONCLUSION: The use of consistent, clear definitions for population health activities is critical to the practice of pharmacy and healthcare delivery.