Pharmacoeconomics and Pharmaceutical Economics Commons^™

Crosstalk Between Gut Microbiota And Antihypertensive Drugs: A Systematic Review, Dhiya'ul Haq, Keri Lestari

Pharmacology and Clinical Pharmacy Research

Hypertension is a multifactorial condition characterized by persistently elevated blood pressure. In addition to genetic and environmental factors, recent studies suggest that the gut microbiota contributes to the development of hypertension and modulates the response to antihypertensive therapy. This review aims to summarize the latest knowledge on the bidirectional interaction between gut microbiota and antihypertensive drugs. Original studies published up to May 2025 on this topic were collected from two online databases: PubMed and Scopus. A total of 220 articles were identified, and 9 articles met the inclusion criteria for further discussion. Three of these included articles discussed how gut …

Anti-Inflammatory Actions Of Trigonella Foenum-Graecum L. In Acute And Chronic Inflammation: Insights From Preclinical Studies, Angel Christella, Dzava P. F. Ismail, Eli Halimah

Pharmacology and Clinical Pharmacy Research

Chronic inflammation is a major factor in various degenerative diseases. The use of non-steroidal anti-inflammatory drugs (NSAIDs) is often the main choice, but long-term side effects such as gastrointestinal irritation and nephrotoxicity limit their use. Therefore, natural alternatives such as Trigonella foenum-graecum (fenugreek) have attracted attention due to their bioactive compound contents with anti-inflammatory properties. This narrative review was conducted through a systematic search of articles from the last 10 years in PubMed and Scopus. Keywords used a combination of MeSH and free terms related to fenugreek and anti-inflammatory agents. In vitro and in vivo studies evaluating the anti-inflammatory effects …

Comparative Analysis Of Tuberculosis Treatment Costs: Drug-Resistant Vs. Drug-Sensitive Cases In Vietnam, Thi-Kim-Thang Dao, Dao Dinh, Mai-Hien Chuc, Hai-Anh Ha

Bulletin of Faculty of Pharmacy Cairo University

This study analyses the economic and clinical implications of treating pulmonary tuberculosis (TB), focusing on direct treatment costs and patient outcomes at Da Nang Hospital for Lung Diseases in Vietnam. Data were collected from 448 inpatient TB cases throughout 2022, encompassing both drug-sensitive and drug-resistant forms of TB. Analysis revealed that drug-resistant TB patients incur significantly higher treatment costs compared to those with drug-sensitive TB, with costs escalating further among older adults and patients with multiple comorbid conditions. Specifically, treatment for drug-resistant TB averaged $463.84 per patient, significantly surpassing the $217.09 average for drug-sensitive cases, indicating the economic burden posed …

Pharmacist Quality Of Work-Life During Covid-19 Pandemic In Cagayan De Oro, Junnin Gay Labrigas Garay, Rugine Riel D. Barsobia, Zoe Kyra Evasco, Bonnie Louise Elorde

Pacific Journal of Health

During the COVID-19 pandemic, pharmacists have been one of the most accessible healthcare workers working in the frontline providing the medication and drug needs of patients. Their roles and responsibilities in work expanded and to some redefined as the pandemic hit. Adjustments in their work, and workplaces were also implemented in adherence to the pandemic situation. The quality of work life of frontline pharmacists were affected because of the changes brought by the pandemic. A descriptive qualitative study design was used to determine the pharmacist’s quality of work-life during the COVID-19 pandemic in Cagayan de Oro City. The place was …

Exploring The Link Between Physicians’ Familiarity And Biosimilar Prescribing In Thailand, Ekapong Kachai, Chaoncin Sooksriwong, Wanruchada Katchamart, Tuangrat Phodha

The Thai Journal of Pharmaceutical Sciences

Background: Despite the availability of various biosimilars in Thailand, the link between physicians’ familiarity and biosimilars prescribing practice remains still unclear.

Objectives: This study aimed to find the association between physicians’ familiarity and biosimilars prescribing practice among physicians in Thailand.

Methods: This research adopted an extended analysis framework, utilizing survey data from a pilot study on the surveillance of Thai physicians regarding biosimilar uptake. The familiarity with biosimilars among respondents was evaluated.

Results: The result showed that 82 respondents were included in the study. There was 79.3% of respondents indicated prescribing biosimilars. Overall, most respondents (75.6%) showed an “adequate” level …

Mergers And Acquisitions (M&As) In Pharmaceutical Markets: Associations With Market Concentration, Prices, Drug Quantity Sold, And Shortages, J. Daniel Mcgeeney M.S., Aylin Sertkaya Ph.D., Leah Ross M.A., Fred Ledley M.D., Cody Hyman Ph.D.

CISI Publication

In recent decades, the pharmaceutical industry has become increasingly concentrated in the United States, in part due to mergers and acquisitions (M&As) between drug manufacturers. This consolidation from M&As has been cited as a key factor affecting drug prices and drug shortages (U.S. Federal Trade Commission, 2022). In this study, we assessed trends in pharmaceutical M&As during 2010–2023 and evaluated the characteristics of drugs and companies involved in those M&As. We considered the effects of M&As on market concentration, drug prices, drug quantity sold, and drug shortages. We also considered how these associations vary by drug characteristics, including brand drugs …

Pharmaceutical-Telehealth Confederacies, Michael S. Sinha

All Faculty Scholarship

Access to prescription pharmaceuticals has historically been controlled by a physician’s pen. As a result, pharmaceutical companies spend billions of dollars on advertising and promotion to mitigate this barrier: first and primarily, to physicians and other prescribers, and more recently, to the general public through direct-to-consumer advertising. The success of these promotional efforts can be seen in greater prescribing of costly brand-name medicines, even in settings where lower-priced generic alternatives exist. Brand-name prescriptions now make up only 10% of all prescriptions written yet account for 87% of drug spending. Despite these substantial returns on investment, companies continue to seek opportunities …

The Revised Cdc Chronic Pain Guidelines And Payer Opioid Analgesic Policies In Michigan, Victoria Tutag Lehr, Cynthia L. Arfken

Michigan Journal of Public Health

Abstract

The 2016 publication of A Guideline for Prescribing Opioids for Chronic Pain by the Centers for Disease Control and Prevention motivated commercial and Medicaid payers to restrict their opioid prescribing policies including the imposition of hard limits on opioid daily dosages and duration. One result of these policies was an increase in abrupt opioid discontinuation and rapid tapering events for patients receiving long-term opioid therapy. Responding to this misapplication of the 2016 guideline, the 2022 revised guidelines emphasized individualized opioid therapy and exclusion of certain chronic diseases. However, it is not known if the payers changed their policies to …

Payment Disrupters And Opportunities: Key Trends That Impacted Pharmacy In 2024, Craig Kimble, Thomas Pile, Alberto Coustasse

Management Faculty Research

In 2023, the United States experienced the most significant increase in prescription drug spending (13.6%), totaling $89 billion.1 This was driven by higher utilization and the introduction of new, expensive specialty and biotech drugs. In 2024, other factors continue to drive costs and disrupt the pharmacy landscape, including the implementation of new business models, pharmacy benefit manager (PBM) practices, the rebate system, regulatory changes, advancements in provider status, and potential Federal Trade Commission (FTC) interventions.

Comments Re: Draft Nih Intramural Research Program Policy: Promoting Equity Through Access Planning, Fred Ledley M.D., Edward Zhou Pharmd., Paula Chaves Da Silva Ph.D.

CISI Publication

We commend the NIH initiative to require that licensees of technologies that enable discovery or development of FDA-approved products arising from the NIH intramural program to include an Access Plan to promote “product affordability, availability, acceptability, and sustainability” and recognition that such protections are essential to ensuring a “return on taxpayers' investment in biomedical research.” Recognizing the complexity of anticipating appropriate terms for products that are in pre-clinical or early clinical development at the time of licensing, we also support the proposal that the Access Plan be submitted in late-stage clinical development, though we argue that …

Developing Public-Private R&D Consortia To Accelerate Alzheimer’S Disease Drug Development, Joel West, Paul Olk

Management: Faculty Scholarship

Efforts to accelerate Alzheimer's disease (AD) drug development have been spurred on by the creation of open science, public-private R&D consortia. An R&D consortium provides an improved structure for generating and disseminating AD knowledge across a range of organizations while also aligning their interests. Drawing from archival and interview data collected on 46 public-private R&D consortia focused wholly or in part on AD, we uncover two important innovations: the creation of novel consortium types that facilitate coordination beyond the individual consortium, and the practice of organizations joining multiple consortia. Collectively these innovations provide member organizations with different pathways for advancing …

Medicare Drug Price Negotiation Program Draft Guidance, Fred Ledley M.D., Edward Zhou Pharmd, Paula Chaves Da Silva Ph.D.

CISI Publication

This comment focuses on Section 50.1, provisions 1 & 3 of the draft guidance regarding the negotiation of a “maximum fair price” under the Inflation Reduction Act (IRA), research and development (R&D) costs of the primary manufacturer, and prior federal financial support for novel therapeutic discovery and development. Specifically, we argue that a negotiated, “maximum fair price” must consider both public sector (federal) and private sector (manufacturer) investments and provide returns to both commensurate with the scale and risk of their investments. This comment addresses three issues and makes specific recommendations regarding each:

1. In negotiating a “maximum fair price,” both …

Approvals, Utilization, And Cost Of Biologics For The Treatment Of Rheumatoid Arthritis, Roya Hosseini

Pharmaceutical Sciences (PhD) Dissertations

Introduction: RA treatment has been revolutionized by the development and approval of biologic disease-modifying antirheumatic drugs (bDMARDs). However, the approval status, utilization, and high cost of bDMARDs pose challenges in RA management.

Objectives: This dissertation evaluated the association between the utilization of bDMARDs and the sociodemographic characteristics of the RA patient population. It also identified the FDA approval status of bDMARDs and assessed the annual cost of bDMARDs used in RA treatment, evaluated the factors explaining annual cost at market entry.

Methods: In the retrospective analysis of Medical Expenditure Panel Survey (MEPS) data from 2010-2021, the population includes RA patients …

Considering Returns On Federal Investment In The Negotiated “Maximum Fair Price” Of Drugs Under The Inflation Reduction Act: An Analysis, Edward W. Zhou, Paula G. Chaves Da Silva, Debbie Quijada, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

The Inflation Reduction Act (IRA) of 2022 contained landmark provisions authorizing government to negotiate a “maximum fair price” for selected Medicare Part D drugs considering the manufacturer’s research and development costs, federal support for discovery and development, the extent to which the drugs address unmet medical needs, and other factors. This working paper describes federal investment in the discovery and development of the ten drugs selected for price negotiation in the first year of the IRA as well as the health value created through Medicare Part D spending on these drugs. We identified $11.7 billion in NIH funding for basic …

Application Of Interpretable Machine Learning Methods To Study The Disease Characteristics And Healthcare Expenditures In Hodgkin’S Lymphoma, Zasim Azhar Dil Hasan Siddiqui

Graduate Theses, Dissertations, and Problem Reports (ETD)

Hodgkin’s lymphoma (HL) is a rare malignancy of lymphocytes that predominantly occurs in young adults aged 20-30 years or elderly individuals aged 65-75 years. Despite its low incidence, there were an estimated 223,512 HL survivors in the US in 2020. Hodgkin’s lymphoma shows a favorable prognosis among young adults, with a high cure rate of 85-90%; however, older adults experience poor prognosis, with a 5-year overall survival rate of 40-55% in patients over 60 years. HL survivors incur high total and out-of-pocket (OOP) healthcare expenditures, averaging $78,183 and $4,180 per patient in the first year after diagnosis, highlighting a considerable …

An Economic And Regulatory Analysis Of Gene Therapy Products Authorized By The Us Food And Drug Administration And The European Medicines Agency, Buthainah Ghanem

Pharmaceutical Sciences (PhD) Dissertations

Background: Gene therapy has recently emerged as an alternative for preventing and treating disease. Concerns have been expressed about the clinical value and the high cost of gene therapies.

Objective: This study assessed the authorization process of gene therapy products by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), evaluated the post-marketing safety signals reported to the FDA Adverse Event Reporting System (FAERS), and assessed the cost-effectiveness analysis of three gene therapies axicabtagene ciloleucel(axi-cel), lisocabtagene maraleucel (liso-cel), and tisagenlecleucel (tisa-cel).

Research Design: For aim 1; data was collected using regulatory information from the FDA and the …

Efficacy And Safety Of Ciltacabtagene Autoleucel And Idecabtagene Vicleucel In Multiple Myeloma Patients, Buthainah Ghanem, Marc L. Fleming, Lawrence M. Brown, Rosa Rodriguez-Monguio, Enrique Seoane-Vazquez

Student Scholar Symposium Abstracts and Posters

Background: Ciltacabtagene autoleucel (cilta-cel) and idecabtagene vicleucel (ide-cel) are chimeric antigen receptor (CAR) T-cell therapies used to treat adult patients with relapsed or refractory multiple myeloma (rrMM) after at least four lines of therapy. However, no head-to-head clinical trials to compare them have been conducted.

Objective: To compare between CARTITUDE-1 and KarMMa clinical trials in terms of efficacy, safety, and patient characteristics.

Method: Overall response rate (ORR) and safety signals were compared using reporting odds ratios (RORs) with 95% confidence intervals (CIs) at p < 0.05. Overall survival (OS) and progression-free survival (PFS) were compared using the Kaplan–Meier method with a log-rank test. Patient characteristics were compared using the chi-square test. Statistical analyses were conducted using Microsoft Excel and R version 4.0.5.

Results: Statistically significant differences were observed between cilta-cel and ide-cel in terms of ORR, complete response …

Authorizations, Prices, And Labeling Differences Of Therapeutic Biologics Marketed In The United States And Saudi Arabia, Turki Altowairgi

Pharmaceutical Sciences (PhD) Dissertations

BACKGROUND: Since 1982, Saudi Arabia (SA) and the United States (US) have seen an increase in therapeutic biologics authorization. However, each country has regulatory regulations governing the approval of these cutting-edge drugs. The high cost of biologics financially burdens healthcare systems and delays patient access to these treatments. Sometimes a company selling the same medications in various countries will have conflicting information on drug labels.

OBJECTIVES: This study compared the characteristics of therapeutic biologics authorization by the Saudi Food and Drug Authority (SFDA) and Food and Drug Administration (FDA) as of December 31, 2021. The study also compared the US …

Comments Re: Workshop On Transforming Discoveries Into Products: Maximizing Nih’S Levers To Catalyze Technology Transfer, Fred D. Ledley M.D., Edward Zhou Pharm. D, Paula Chaves Da Silva, Ph. D.

CISI Publication

We are pleased to offer written comments to this workshop focused on “… making federally funded inventions more accessible to the public… .” These comments are informed by recent research from the Center for Integration of Science and Industry at Bentley University that has:

• Quantified the scope of NIH funding for basic or applied research, clinical development, or patents associated with drugs approved by the FDA 2010-2019. This work identified $187 billion in NIH-funded research directly related to these drugs (applied research – 17%) or their biological targets (basic research – 83%), representing a (discounted) investment comparable to reported levels …

Spending On Phased Clinical Development Of Approved Drugs By The Us National Institutes Of Health Compared With Industry, Edward W. Zhou, Matthew J. Jackson, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

The launch of the Advanced Research Projects Agency for Health to advance new cures and address public concern regarding drug prices has raised questions about the roles of government and industry in drug development.

This cross-sectional study examined NIH funding for published research reporting the results of phased clinical trials of drugs approved between 2010 and 2019 and compared the findings with reported industry spending estimates. Data analysis was performed between May 2021 and August 2022 using PubMed data from January 1999 through October 2021 and NIH Research Portfolio Online Reporting Tools Expenditures and Results data from January 1999 through …

An Analysis Of Trends Of Generic Drugs And Biologic Prices In The U.S., Mohammed Jamjoom

Pharmaceutical Sciences (PhD) Dissertations

Introduction: Drug prices are a significant problem for the US healthcare system. Generic and biosimilar market competition reduces drug and biologic prices, results in substantial savings, and improves patient access and outcomes. As the costs of healthcare and prescription drugs continue to rise, the discussion about drug prices has taken a prominent place at the forefront of national discourse. This study assessed impacting trends in prices of generic, biosimilar, and reference products in the US. We also evaluated the effect of the Affordable Care Act (ACA) of 2010 on biologic prices.

Methods: We extracted a list of the new generic …

An Economic And Regulatory Analysis Of Breast Cancer Drugs Approved By The Us Food And Drug Administration, Abdullah Althomali

Pharmaceutical Sciences (MS) Theses

Introduction

Breast cancer is the most common cancer among women and the leading cause of cancer death among women worldwide. The pharmacological options for breast cancer include chemotherapy, hormone therapy, targeted therapy, and immunotherapy, which are used for the prevention or treatment of breast cancer. This study assessed trends in FDA approvals and prices at the market entry of new drugs indicated for breast cancer in the period 1980-2022. The study also evaluated the factors associated with the price of the new breast cancer drugs at market entry.

Material and Methods

Regulatory data were collected from the FDA website, and …

The Association Of Long Working Hours And The Use Of Prescription Sedatives Among U.S. Workers., Emmanuel Ezekekwu

Electronic Theses and Dissertations

BACKGROUND: Meeting the needs of a round-the-clock and globalized society has led to an increase in long working hours. This trend has been accompanied by a corresponding rise in sleep disorders and subsequent use of sedating medications. Overtime hours have been associated with adverse health outcomes such as cardiovascular diseases, symptoms of psychological distress, and health behaviors, including risky intake of alcohol and smoking. Hence, the main objectives of this three-paper dissertation were to examine the multi-faceted relationship between working hours, the use of prescription sleep aids, the onset of psychological distress, and the use of health care services. METHODS: …

Disentangling The Cost Of Orphan Drugs Marketed In The United States, Hana Althobaiti, Enrique Seoane-Vazquez, Lawrence B. Brown, Marc L. Fleming, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

The increasing number and high prices of orphan drugs have triggered concern among patients, payers, and policymakers about the affordability of new drugs approved using the incentives set by the Orphan Drug Act (ODA) of 1983. This study evaluated the factors associated to the differences in the treatment cost of new orphan and non-orphan drugs approved by the FDA from 2017 to 2021. A generalized linear model (GLM) with the Gamma log-link analysis was used to ascertain the association of drug characteristics with the treatment costs of orphan and non-orphan drugs. The results of the study showed that the median …

Prescription Drug Retail Sales In The Mountain West, Caren Royce Yap, Caitlin J. Saladino, William E. Brown Jr.

Health

This fact sheet synthesizes data on prescription drug retail sales in the Mountain West (Arizona, Colorado, Nevada, New Mexico, and Utah). "Retail Sales for Prescription Drugs Filled at Pharmacies by Payer," a 2019 report by the Kaiser Family Foundation, includes data on the amount of retail sales for prescription drugs made in each state by dollar amount, along with the method of coverage, including commercial, Medicare, Medicaid and cash payment.

Population-Based Evaluation Of Treatment Patterns, Drug-Drug Interactions, And Cardiovascular Risk In Patients With Metastatic Castration-Resistant Prostate Cancer, Yue Cheng

Theses and Dissertations--Pharmacy

Prostate cancer has the highest increasing rate and new cases among all cancer in men in the United States and has a higher risk in elderly men. Metastatic castration-resistant prostate cancer (mCRPC) is the late stage of prostate cancer and associated with poor prognosis (median survival 13 months). Androgen deprivation therapy (ADT) use with novel hormone therapy or standard chemotherapy are recommended for mCRPC treatment. Although, the treatment options expanded significantly in recent years, new challenges are present because of the aging population, larger treatment spectrum and co-administrated medication use for other underlying medical conditions, especially for cardiovascular disease (CVD), …

Redlining And Opioid Overdose Outcomes: Do Historical Housing Policies Still Impact Health Today?, Sahana Paravantavida

Honors Theses

This study examines the relationship between historical housing policies and current health outcomes, specifically the impact of redlining on opioid overdose rates. Using data collected from the state of New Jersey, neighborhoods with a history of redlining have higher rates of opioid overdose deaths. My findings suggest that historical housing policies, which systematically excluded certain populations from accessing affordable housing and resources, continue to impact health outcomes today.

Long-Term Prescription Opioid Use, Cancer Stage, And Economic Burden Among Older Cancer Survivors With Non-Cancer Chronic Pain Conditions, Rudi Safarudin

Graduate Theses, Dissertations, and Problem Reports (ETD)

Opioids are commonly prescribed to treat pain conditions, which are highly prevalent among older adults (≥65 years). Recent evidence shows that opioids may have carcinogenic effects through immunosuppression and free-radical pathways, which could promote cancer growth. Two population-based studies have reported an association of opioid use with incident cancer. Many individuals with non-cancer chronic pain conditions (NCPCs) may use opioids for a long term. However, the association of long-term prescription opioid (LPO) use with cancer stage at diagnosis is still unknown. Furthermore, evidence suggests that individuals with cancer and pre-existing NCPCs may persistently use opioids, even in the absence of …

A Quality Improvement Project To Improve Management Of Urinary Tract Infections In A System Of Pediatric Urgent Care Centers, Benjamin Klick, Tammy Speerhas, Jessica Parrott, Jeffrey Bobrowitz, Anne Mcevoy, Debra Conrad, Theresa Guins

Ellmer School of Nursing Faculty Publications

Background and objective: Urinary tract infections (UTIs) are a common problem in pediatric urgent care medicine. There are multiple quality improvement (QI) projects related to the management of UTIs documented in the pediatric literature. We developed a project to decrease the prescribing of ultimately unneeded antibiotics for possible UTIs in a pediatric urgent care setting. A similar project has not been described in the pediatric literature.

Methods: We first reviewed the charts of patients presenting to a system of pediatric urgent care centers with a possible UTI over a 2-year period. We then launched a QI project with three plan, …

Racial And Ethnic Differences In The Receipt Of Metabolic Syndrome Risk Factor Screening And Treatment Among Prostate Cancer Patients Treated With Androgen Deprivation Therapy., Yazan K. Barqawi

Pharmaceutical Sciences ETDs

Background: Racial and ethnic health disparities in prostate cancer prevalence, incidence, mortality, quality of life, screening, and treatment constitute the largest of all cancer disparities. These health disparities are associated with higher morbidity and mortality rates in minority populations. Treatment with androgen deprivation therapy (ADT) has been the most widely used therapeutic modality to reduce the progression of prostate cancer to a worse disease stage and relieve potential obstructive symptoms. However, ADT is associated with possible toxic metabolic and cardiovascular (CVS) adverse events that may occur within six months of ADT initiation. These adverse events include metabolic syndrome, type II …