Pharmacoeconomics and Pharmaceutical Economics Commons^™

3rd Place Contest Entry: "Examining Physicians’ Behaviors Regarding Buprenorphine Prescribing For Opioid Use Disorder", Khashayar Eshtiaghi

Eric M. Scandrett Graduate Library Research Prize

This is Khashayar Eshtiaghi's submission for the 2026 Eric M. Scandrett Graduate Research Prize, which won third place. It contains their essay on using library resources, a summary of their research project on physicians' behaviors regarding buprenorphine prescribing for opioid use disorde, and their bibliography.

Khashayar is a student in the Ph.D. in Pharmaceutical Economics and Policy program at Chapman University. Their faculty mentor is Dr. Marc Fleming.

Community Pharmacies Face Critical Sustainability Challenges In The United States: Academic Pharmacy Can Help, Karl M. Hess, Peter Lim

Pharmacy Faculty Articles and Research

Community pharmacies in the United States (US) face an increasingly unsustainable future due to declining third-party reimbursement (remuneration) and ongoing cash flow challenges following the elimination of retroactive direct and indirect remuneration (DIR) fees. These pressures have contributed to widespread pharmacy closures, the emergence of pharmacy deserts, and reduced access to care for millions of patients. Despite these challenges, community pharmacy remains the most common employment setting for pharmacy school graduates in the US. However, currently required community pharmacy Advanced Pharmacy Practice Experience (APPE) student rotations may offer limited exposure to business, management, and entrepreneurial activities, potentially leaving students underprepared …

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 …

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 …

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 …

Renal Toxicity Warnings And Precautions Of Drugs Marketed In The Us, Mohammad Al Ghamdi

Pharmaceutical Sciences (MS) Theses

INTRODUCTION: The use of drugs can lead to renal adverse effects prompting the need to include warnings and precautions on medication labels. Studies evaluating renal warnings and precautions need to be improved. This study assessed the characteristics of FDA renal toxicity warnings and precautions included in the labels of drugs approved by the FDA and marked in the US. The study also evaluated the potential factors of including a boxed warning on a drug label.

METHODS: We extracted the labels of human prescription drugs with renal toxicity boxed warnings and warnings and precautions from the “FDA Label: Full-Text Search of …

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 …

An Exploration Of Ambulatory Visits And Medications Prescribed For Patients Diagnosed With Lupus Erythematosus In The United States, Salena Marie Preciado

Pharmaceutical Sciences (PhD) Dissertations

This dissertation sought to understand the management and treatment of patients diagnosed with lupus erythematosus. To accomplish the objectives of this research, three studies were conducted. First, a systematic literature review was done to assess the current landscape of available clinical guidelines for disease treatment. This research then used the National Ambulatory Medical Care Survey data from 2006-2016 to explore real-world trends in medications prescribed, comorbidities and chronic conditions associated with lupus. Data is weighted to be nationally representative of the U.S. The third study explored sociological influences or nonclinical factors on the prescribing of medications for patients with lupus. …

Approvals And Prices Of Systemic Antibiotics In Saudi Arabia And The United States, Saad Alharthi

Pharmaceutical Sciences (MS) Theses

Introduction

Antibiotics is one of the therapeutic classes with the highest level of consumption in the world. Despite the global diffusion of antibiotics, their availability and prices vary by country. This study assessed differences in the availability and prices of systemic antibiotics marketed in the United States (US) and Saudi Arabia and evaluated the factors associated with the differences in prices of systemic antibiotics marketed in both countries.

Material and Methods

We collected regulatory data from the US Food and Drug Administration (FDA) and the Saudi Food and Drug Authority (SFDA), the National Average Drug Acquisition Cost (NADAC) and the …

Orphan Drugs: Designations, Approvals, And Prices In The Us, Hana Althobaiti

Pharmaceutical Sciences (PhD) Dissertations

Introduction. Rare disease drug approvals have accelerated significantly in recent years. Even with these advances, patients continue to face challenges in receiving treatment, with most rare diseases lacking any approved treatments. Moreover, even when a treatment is available, it does not always reach the patients who benefit from it.

Objectives. This dissertation assessed the characteristics of orphan drug designations and approvals and the factors associated with the time lag between orphan designation and approval in the US from 1983 to 2021. It also evaluated the treatment cost of orphan and non-orphan drugs and factors explaining the treatment cost of new …

Financial Hardship From Purchasing Prescription Drugs Among Older Adults In The United States Before, During, And After The Medicare Part D “Donut Hole”: Findings From 1998, 2001, 2015, And 2021, Anthony W. Olson, Jon C. Schommer, David A. Mott, Olajide Adekunle, Lawrence M. Brown

Pharmacy Faculty Articles and Research

BACKGROUND: Cost-related nonadherence compromises successful and effective management of chronic disease. The Medicare Modernization Act of 2003 (MMA) and Patient Protection and Affordable Care Act of 2010 (ACA) aimed to increase the affordability of outpatient prescription drugs for older adults (older than age 64 years). The Medicare Part D prescription drug insurance coverage gap (“donut hole”) created by the MMA was fully closed in 2020 by the ACA.

OBJECTIVES: To (1) describe prescription drug coverage and financial hardship from purchasing prescription drugs among older American adults for 2021, (2) compare these results with findings from data collected before the MMA …

Cost-Effectiveness Analysis Of Tisagenlecleucel, Blinatumomab, And Clofarabine For Treatment Of B-Cell Precursor Acute Lymphoblastic Leukemia, Kamron Lotfi

Pharmaceutical Sciences (MS) Theses

Acute lymphoblastic leukemia (ALL) is a common type of adolescent and young adult leukemia in the United States (U.S.). Patients who are refractory or relapsed after receiving two or more lines of systemic therapy have the option of taking tisagenlecleucel. Due to the high cost of this treatment, a cost-effectiveness analysis was performed to assess the treatments for tisagenlecleucel, clofarabine combination, and blinatumomab. Objectives

The objective of this study is to evaluate the cost-effectiveness of tisagenlecleucel; clofarabine, etoposide, cyclophosphamide; and blinatumomab for the treatment of relapse- refractory ALL for adolescents and young adults from the U.S. health care payer perspective. …

The Landscape Of Cellular And Gene Therapy Products: Cost, Approvals, And Discontinuations, Vaishali Shukla, Enrique Seoane-Vazquez, Souhiela Fawaz, Lawrence M. Brown, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

Background The past 10 years witnessed a significant increase in the approval of cellular and gene therapy products worldwide. The US Food and Drug Administration (FDA) approved 3 gene therapy products within the last 4 months of 2017. The objective of this study was to examine the approval characteristics, discontinuations and cost of all cellular and gene therapy products approved worldwide. Data and Methods We conducted an electronic search of approved cell and gene therapy products from the databases of the main drug regulatory agencies including the US Food and Drug Administration, the European Medicines Agency (EMA), the Korea Ministry …

Ethical Imperatives Of Timely Access To Orphan Drugs: Is Possible To Reconcile Economic Incentives And Patients’ Health Needs?, Rosa Rodriguez-Monguio, T. Spargo, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

Background

More than 6,800 rare diseases and conditions have been identified in the US, which affect 25–30 million Americans. In 1983, the US Congress enacted the Orphan Drug Act (ODA) to encourage the development and marketing of drugs to treat rare diseases and conditions. This study analyzed all orphan designations and FDA approvals since 1983 through 2015, discussed the effectiveness of incentives for the development of treatments for rare diseases, and reflected on the ethical imperatives for timely access to orphan drugs.

Methods

Study data were derived from the Food and Drug Administration (FDA) Orange Book and the Office of …

Comparison Of Outcomes Following A Switch From A Brand To An Authorized Vs. Independent Generic Drug, Richard Hansen, Jingjing Qian, Richard L. Berg, James G. Linneman, Enrique Seoane-Vazquez, Sarah Dutcher, Saeid Raofi, C. David Page, Peggy L. Peissig

Pharmacy Faculty Articles and Research

Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999-2014, 5,234 unique patients were on brand drug prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12-months following the brand-to-generic switch, patients …

Entrepreneurial Orientation As A Basis For Classification Within A Service Industry: The Case Of Retail Pharmacy Industry, Thanigavelan Jambulingam, Ravi Kathuria, William R. Doucette

Business Faculty Articles and Research

To date, service classification research has primarily taken a macro view, creating service typologies or taxonomies by using dimensions such as customer contact or degree of labor intensity. Such classification schemes, though helpful in deciphering critical management issues and positioning strategies between service industries, tend to treat an entire industry, such as airlines, as a single homogenous entity. However, organizations in the same industry often use intangible resources, such as entrepreneurial orientation processes, to compete with one another. Resource-advantage theory suggests that organizations utilize intangible resources to build long-term strategies and a sustainable competitive advantage leading to superior performance. We …

Purchasing Pharmaceuticals (Health, Nutrition And Population (Hnp) Discussion Paper), Ulrika Enemark, Anita Alban, Enrique Seoane-Vazquez

Pharmacy Faculty Books and Book Chapters

This paper discusses the purchasing of pharmaceuticals as a key component of costeffective and equitable healthcare delivery. Pharmaceuticals account for a high, sometimes the dominant share of health expenditures in developing countries, but the desired health outcomes can only be achieved if the adequate medicines reach the right people and are used in the correct way. This requires purchasing arrangements that take into account the information asymmetry between patients and providers, ensure selection of effective, safe and affordable medicines and set economic incentives in a way that encourages rational drug use. The organizational and institutional frameworks define the roles of …

Reimbursement For Pharmaceutical Care Services: The California Experience, Jeffery A. Goad, Kathleen Johnson, Michael Rudolph

Pharmacy Faculty Articles and Research

"While it is true that pharmacists are changing their practice habits, they are doing so for the betterment of their patients’ drug therapy outcomes and the healthcare system. The pharmacist serves as the vital link between the patient, physician, and healthcare system. By working with patients and physicians, pharmacists have demonstrated in the literature that they can improve patient drug therapy outcomes, thus preventing unnecessary healthcare expenditures (Fincham, 1998). Pharmacists have long been held in highest esteem by patients, being voted the number one trusted professional for 10 consecutive years. The evidence is clear that pharmacists provide a valuable service …