Pharmacoeconomics and Pharmaceutical Economics Commons^™

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 …

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 …

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 …

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 …