Pharmacoeconomics and Pharmaceutical Economics Commons^™

Pharmacoeconomics Of Metastatic Colorectal Cancer Treatment With Targeted Therapies Guided By Companion Molecular Diagnostics, Luis E. Fernández-Garza, Hector Sánchez-Ibarra, Daniela Treviño-Sáenz, Hugo A. Barrera-Saldaña

Research Symposium

Background: To guide the treatment with monoclonal antibodies (MAbs) against the epidermal growth factor receptor (EGFR) of metastatic colorectal cancer (mCRC), the FDA recommends prior companion molecular diagnosis (CMDx). It initially recommended screening for mutations in exon 2 of the KRAS gene, and most recently to extend to screening to exons 2, 3, and 4 of KRAS and 2, 3, and 4 of NRAS genes; furthermore, to evaluate the BRAF exon 15 mutation status (including V600E). To date, no studies have been done to compare the cost-benefit of these different CMDXs.

Methods: We have compared the cost of treatment without …

The Price Of Competition: Analyzing Anticompetitive Tactics In Pharmaceutical Markets During The Hatch-Waxman Era, William Ulrich

Notre Dame Journal on Emerging Technologies

Pharmaceutical manufacturers can delay the generic entry for a blockbuster drug. In order to keep the generic system on track, it is critical to expose the various avenues of generic delay. Part I of this Note briefly describes the generic entry process as prescribed by the Hatch-Waxman Act. Part II details four well-known tactics used by brand-name manufacturers to block or delay the entry of generic competition, highlighting how the tactics are successful. Part III concludes by examining the nature of the various problems and arguing that the first step towards ending the different forms of anticompetitive behavior is through …

The High Cost Of Pharmaceutical Acquisitions: Increasing Social Welfare Or Furthering Inequality?, Timothy J. Haltermann

Notre Dame Journal on Emerging Technologies

This note will argue that government and regulatory authorities should focus on easing access to downstream innovation by broadening research exemptions to patent infringement. Part I of this note will focus on the current state of patent protection and exclusivity afforded to pharmaceutical companies. Part II will discuss incentives created that lead rational actors to engage in M&A instead of through internal R&D. Part III will address the development of innovation as a standalone theory of harm in merger review, and the fallacies associated with labeling certain transactions as “killer acquisitions.” Finally, Part IV of the note will look at …

A Tale Of Two Situations: A Case Report Of The Merger Between Dermatology Outcomes And Prescription Drug Access, Kara Ye, Yasseen Amellal, Will Evans, Theresa Rohr-Kirchgraber

Cooper Rowan Medical Journal

This case report illustrates a case of guttate psoriasis in a young adult and the logistical role dermatologists can play in patients acquiring their prescriptions and improving the quality of their care.

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 …

Evaluasi Penerapan Pilot Project Global Budget Sebagai Sistem Pembayaran Klaim Pada Rsud Wates, Mega Handayani, Laili Rahmatul Ilmi, Zennul Mubarrok1 Mubarrok

Jurnal Ekonomi Kesehatan Indonesia

Claims payment for health services is one of the factors that affect the financial health of a hospital. Indonesia itself has experienced several changes to the existing payment system. BPJS-K started an operational study on the implementation of the INA-CBGs and the Global Budget mixed-method payment system since 2018 with three stages in five districts/city in Indonesia. This study aims to evaluate the implementation of the Global Budget system at RSUD Wates in Kulon Progo Regency that appointed as a BPJS-K pilot project. This research is qualitative research and data collection was carried out by studying documents and interviews. As …

Hubungan Karakteristik Pasien, Prosedur, Dan Penyakit Penyerta Dengan Biaya Langsung Medis Pada Pasien Rawat Inap Jantung Koroner, Rita Tri Wahyuni, Eri Witcahyo, Yennike Tri Herawati

Jurnal Ekonomi Kesehatan Indonesia

Coronary heart disease is a catastrophic disease that causes a high burden of medical costs. At Dr.Iskak Tulungagung hospital, coronary heart disease is the disease with the highest cost. The number of coronary heart patients who are hospitalized is also increasing every year. Several Previous studies have shown that the amount of direct medical costs of coronary heart patients reach more than 50% of the total costs of treatment. Therefore, it is necessary to do research on the factors associated with the increasing direct medical costs of coronary heart patients. The purpose of this study was to analyze the factors …

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 …

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: …

The Rubik's Cube Of Manufacturers' Coupons: Making The Case For Sneetches, Bruce Wolf

HCA Healthcare Journal of Medicine

Asthma maintenance inhalers are inordinately expensive, inhibiting patients from affording their medication and compromising compliance and adherence and optimal health outcomes. The objective of this article was to examine and highlight the competitive world and challenged opportunity of manufacturers' coupons discounting the inordinate cost of respiratory inhalers and asthma treatment. The cost of asthma treatment, in particular the cost of respiratory medicines, even with health insurance, can be prohibitive (upwards of $700 per month for one inhaler). Medication costs restrict medication access. Compliance and adherence suffer attested by monthly maintenance inhalers being filled less than 50% of the time. Pharmaceutical …

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.

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, …

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 …