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Laura E Happe

Laura E Happe

· Clinical Professor; Director Of The POP Online M.S. Program

University of Florida · Pharmaceutical Outcomes and Policy

Active 2006–2025

h-index16
Citations1.2k
Papers10732 last 5y
Funding
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About

Laura E. Happe, Pharm.D., M.P.H., is a clinical professor and the director of the online M.S. program in Pharmaceutical Outcomes & Policy at the University of Florida College of Pharmacy. She specializes in using data to aid in decision making and leads a program established in 2006 that graduates approximately 50 students annually. Laura is also the Editor-in-Chief of the Journal of Managed Care and Specialty Pharmacy, the official peer-reviewed journal of the Academy of Managed Care Pharmacy, with a circulation of over 30,000. She serves on the Board of Directors of Cardinal Innovations Healthcare, a managed Medicaid plan in North Carolina. Her professional background includes serving as the Chief Pharmacy Officer of Humana, where she was responsible for advancing clinical pharmacy practices and integrating pharmacy into the company's care delivery model. During her tenure, she contributed to the enhancement of the company's research program, resulting in over 70 peer-reviewed publications. With more than 10 years of consulting experience, she has worked with notable clients such as GlaxoSmithKline, BMS, and Novartis. Laura earned her Doctorate of Pharmacy from Creighton University and is licensed in Florida and Arizona. She also holds a Master’s of Public Health with an emphasis in epidemiology from the University of South Florida and is fellowship trained in pharmacoeconomics and outcomes research. Additionally, she authored a book titled 'If You Give an Ox an Oxy,' aimed at educating parents about the hazards of opioid use.

Research topics

  • Political Science
  • Computer Science
  • Medicine
  • Data Mining
  • Family medicine
  • Data science
  • Statistics
  • Medical education
  • Nursing
  • Public relations
  • Mathematics
  • Psychology
  • Law
  • Library science

Selected publications

  • Advancing the conversation: 30 years of scholarship in managed care pharmacy

    Journal of Managed Care & Specialty Pharmacy · 2025-06-27

    articleOpen access1st authorCorresponding

    remains poised to guide managed care pharmacy through future challenges in pursuit of improved patient health through evidence-based decision-making.

  • Emerging trends in managed care pharmacy: A mixed-method study

    Journal of Managed Care & Specialty Pharmacy · 2025-01-01 · 1 citations

    articleOpen access

    BACKGROUND: Over the past 5 years, managed care pharmacy has been shaped by a global pandemic, advancements in generative artificial intelligence (AI), Medicare drug price negotiation policies, and significant therapeutic developments. Collective intelligence methods can be used to anticipate future developments in practice to help organizations plan and develop new strategies around those changes. OBJECTIVE: To identify emerging trends in managed care pharmacy. METHODS: In this sequential mixed-method study, we invited experts to participate in a multidisciplinary advisory panel to develop a survey with 5 overarching domains. The qualitative analysis for our advisory panel meetings used a thematic analysis approach. To analyze the cross-sectional survey results, we used descriptive statistics and exploratory bivariate statistics to test for possible relationships with survey respondent demographics and likelihood predictions. To assess respondent opinions on the overall likelihood of an event occurring in the next 5 years, we combined "Highly likely/Somewhat likely" responses and compared with "Highly unlikely/Somewhat unlikely" responses. RESULTS: Following our advisory panel focus groups, a total of 53 scenarios were developed for inclusion in the quantitative survey under the domains of (1) information technology, (2) therapeutics and diagnostics, (3) payment models, (4) pharmacy operations, and (5) public policy. A total of 1,238 individuals were invited to participate in the survey. Of eligible participants, 201 complete survey responses were received for a final response rate of 16.2%. Survey participants rated increased use of glucagon-like peptide-1 receptor agonists by at least 25%, at least 1 major data breach, more than 10 new orphan drug approvals, and AI use in more than half of prior authorization reviews as the most likely scenarios to occur in the next 5 years. Respondents identified the following broad issues as those most likely to impact their organizations (employers) in the next 5 years: federal and state policy changes impacting managed care, cell and gene therapies, impact of AI on managed care operations, and emerging payment models. CONCLUSIONS: This study provides valuable insights into the emerging trends that are expected to shape managed care pharmacy over the next 5 years. The integration of advanced technologies, such as AI, along with the increasing focus on specialty therapeutics, represents both opportunities and challenges for managed care organizations. However, areas with lower consensus highlight the need for caution in strategic planning.

  • Emerging trends in managed care pharmacy: A mixed-method study

    Journal of Managed Care & Specialty Pharmacy · 2025-01-31 · 3 citations

    articleOpen access

    BACKGROUND: Over the past 5 years, managed care pharmacy has been shaped by a global pandemic, advancements in generative artificial intelligence (AI), Medicare drug price negotiation policies, and significant therapeutic developments. Collective intelligence methods can be used to anticipate future developments in practice to help organizations plan and develop new strategies around those changes. OBJECTIVE: To identify emerging trends in managed care pharmacy. METHODS: In this sequential mixed-method study, we invited experts to participate in a multidisciplinary advisory panel to develop a survey with 5 overarching domains. The qualitative analysis for our advisory panel meetings used a thematic analysis approach. To analyze the cross-sectional survey results, we used descriptive statistics and exploratory bivariate statistics to test for possible relationships with survey respondent demographics and likelihood predictions. To assess respondent opinions on the overall likelihood of an event occurring in the next 5 years, we combined "Highly likely/Somewhat likely" responses and compared with "Highly unlikely/Somewhat unlikely" responses. RESULTS: Following our advisory panel focus groups, a total of 53 scenarios were developed for inclusion in the quantitative survey under the domains of (1) information technology, (2) therapeutics and diagnostics, (3) payment models, (4) pharmacy operations, and (5) public policy. A total of 1,238 individuals were invited to participate in the survey. Of eligible participants, 201 complete survey responses were received for a final response rate of 16.2%. Survey participants rated increased use of glucagon-like peptide-1 receptor agonists by at least 25%, at least 1 major data breach, more than 10 new orphan drug approvals, and AI use in more than half of prior authorization reviews as the most likely scenarios to occur in the next 5 years. Respondents identified the following broad issues as those most likely to impact their organizations (employers) in the next 5 years: federal and state policy changes impacting managed care, cell and gene therapies, impact of AI on managed care operations, and emerging payment models. CONCLUSIONS: This study provides valuable insights into the emerging trends that are expected to shape managed care pharmacy over the next 5 years. The integration of advanced technologies, such as AI, along with the increasing focus on specialty therapeutics, represents both opportunities and challenges for managed care organizations. However, areas with lower consensus highlight the need for caution in strategic planning.

  • Pharmacoequity measurement framework: A tool to reduce health disparities

    Journal of Managed Care & Specialty Pharmacy · 2025-02-01 · 3 citations

    articleOpen accessSenior author

    is a health system and policy goal of ensuring equitable access to high-quality medications for all individuals, regardless of factors such as race, ethnicity, socioeconomic status, or resource availability to reduce health disparities. Although measurement frameworks have been widely used in health equity contexts, a focused framework for pharmacoequity remains a critical gap. In this article, we introduce a novel pharmacoequity measurement framework anchored in the patient medication-use journey. The framework includes the following domains: (1) access to health care services, (2) prescription generation, (3) primary medication nonadherence, (4) secondary medication nonadherence, and (5) medication monitoring. For each domain, we provide examples of outcome measures and potential data sources that can be used for evaluation. We also outline an implementation workflow of the pharmacoequity measurement framework that population health stakeholders can use across various settings (eg, health systems, health plans). The framework provides a structured approach to identify existing gaps in the path toward achieving pharmacoequity and lay the foundation for targeted interventions. Additionally, it enables ongoing monitoring of progress toward achieving pharmacoequity while identifying interventions that are effective, scalable, and sustainable.

  • Pharmacoequity measurement framework: A tool to reduce health disparities

    Journal of Managed Care & Specialty Pharmacy · 2024-12-20 · 1 citations

    articleSenior author

    is a health system and policy goal of ensuring equitable access to high-quality medications for all individuals, regardless of factors such as race, ethnicity, socioeconomic status, or resource availability to reduce health disparities. Although measurement frameworks have been widely used in health equity contexts, a focused framework for pharmacoequity remains a critical gap. In this article, we introduce a novel pharmacoequity measurement framework anchored in the patient medication-use journey. The framework includes the following domains: (1) access to health care services, (2) prescription generation, (3) primary medication nonadherence, (4) secondary medication nonadherence, and (5) medication monitoring. For each domain, we provide examples of outcome measures and potential data sources that can be used for evaluation. We also outline an implementation workflow of the pharmacoequity measurement framework that population health stakeholders can use across various settings (eg, health systems, health plans). The framework provides a structured approach to identify existing gaps in the path toward achieving pharmacoequity and lay the foundation for targeted interventions. Additionally, it enables ongoing monitoring of progress toward achieving pharmacoequity while identifying interventions that are effective, scalable, and sustainable.

  • Themed issue on drug pricing policy and the Inflation Reduction Act

    Journal of Managed Care & Specialty Pharmacy · 2024-03-01

    letterOpen accessSenior author
  • Concentration of spending and share of specialty drug spending in Medicare Part D over a 10-year period

    Journal of Managed Care & Specialty Pharmacy · 2024-11-29 · 4 citations

    articleOpen access

    BACKGROUND: In 2021, Medicare Part D gross prescription drug spending amounted to $216 billion, a number that has more than doubled over the last 10 years. Spending in Medicare Part D is concentrated on a small number of drugs, and spending on specialty drugs has increased in recent years. However, the extent to which concentration in Part D spending has changed over time and the drivers of this change have not been described. OBJECTIVE: To quantify the time trends in Medicare Part D spending and utilization, the concentration of spending, and the share of spending accounted for by specialty drugs from 2012 to 2021. METHODS: In this repeated cross-sectional study, we used data from the Centers for Medicare & Medicaid Services Part D Drug Spending Dashboard to investigate the time trends in total gross spending, prescriptions claims, and the average cost of a prescription claim for Part D drugs. We assessed the concentration based on the share of total gross spending and prescriptions by the drugs with the top 1%, 5%, and 10% of the highest spending and Lorenz curves and Gini coefficients. In addition, we stratified our analyses by specialty and nonspecialty drugs. RESULTS: Over the last 10 years, total gross drug spending in Medicare Part D increased by 103.5%, with a compounded annual growth rate of 8.2%. This change was driven by both increases in prescription claims and price increases of existing drugs to a similar degree. The concentration of spending intensified, with the top 1% of drugs accounting for an escalating share of total spending (from 31.4% to 41.1%). Over the 10-year study period, these top-spending drugs accounted for 5.6% of prescriptions but 34.6% of spending. Lorenz curves and increased Gini coefficients similarly showed that a smaller number of drugs accounted for increased spending over the study period. Specialty drug spending increased by 566.5%, with a compounded annual growth rate of 23.5%. The share of total spending on specialty drugs increased from 21.7% in 2012 to 71.1% in 2021. In 2021, specialty drugs accounted for 6.2% of prescriptions but 71.1% of total spending. CONCLUSIONS: Medicare Part D gross drug spending became increasingly more concentrated from 2012 to 2021, which was especially pronounced for specialty drugs. Increases in prices for specialty and other brand-name drugs will likely continue to drive gross spending upward. Although the Inflation Reduction Act provisions will likely reduce net spending on selected drugs, other policy changes may be warranted.

  • Navigating Real-World Evidence Reporting Guidelines

    AMWA Journal · 2024-12-16

    article1st authorCorresponding

    Real-world evidence (RWE) has gained traction over the last several years and is now an integral part of the drug approval process\ and life cycle. Conducting well-designed studies and transparent reporting of studies has recently become the focus of guidance issued by multiple regulatory agencies and professional organizations across the globe. Knowledge of the available resources is paramount for medical writers. Although the first guidance, STROBE, dates back to 2007 and was widely known for its checklist for the reporting of observational studies, the advancements in electronic medical records, disease registries, and administration necessitated the development of the Reporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) guidance. ISPOR, the Professional Society for Health Economics and Outcomes Research and the International Society for Pharmacoepidemiology have developed guidance specific to the reporting of RWE studies and provided a template to assist with the description of longitudinal studies using routinely collected health care data. Although these options are helpful for a general approach to RWE reporting, other organizations like the European Society for Medical Oncology have recognized the need for guidelines for disease- specific research and have developed more specific guidance. Navigating the resources that are available is imperative for medical writers. This paper provides a guide to relevant contemporary resources to aid medical writers in the reporting and publication of RWE studies. Because of the expansiveness of the types of studies that fall under RWE, this paper focuses on traditional RWE studies that employ a longitudinal approach to the analysis of routinely collected health care data.

  • Introducing the Managed Care Pharmacy Primer Series

    Journal of Managed Care & Specialty Pharmacy · 2023-12-01 · 1 citations

    letterOpen access1st authorCorresponding
  • A primer on managed care pharmacy

    Journal of Managed Care & Specialty Pharmacy · 2023-12-01 · 7 citations

    articleOpen access1st authorCorresponding

    This primer defines the practice of managed care pharmacy and introduces key competencies of managed care pharmacy organizations, including pharmacy benefit design and implementation, formulary and medication utilization management, clinical program development and implementation, quality and safety program management, and promotion of affordability.

Frequent coauthors

  • Patty Taddei-Allen

    232 shared
  • Craig Stern

    Pharmac

    231 shared
  • Prabashni Reddy

    Mass General Brigham

    231 shared
  • Rolin L. Wade

    IQVIA (United States)

    231 shared
  • M. L. Hunter

    Maine Department of Marine Resources

    230 shared
  • Karen L. Rascati

    The University of Texas at Austin

    230 shared
  • Carol Blumentritt

    University of Illinois Chicago

    230 shared
  • Jennifer Booker

    University of Nebraska Medical Center

    230 shared
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