Pharmacoeconomics and Pharmaceutical Economics Commons^™

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 …

Use Of Public Research And Manufacturing Enterprises To Lower Prescription Drug Prices And Increase Innovation, Alex Moss, Dana Brown, S. Sean Tu

Law Faculty Scholarship

This article proposes building on the success of publicly funded drug research and development and expanding the model to include the full cycle development, testing, manufacture and distribution of innovative and affordable new drugs.

Policies And Price Controls On The Research And Development Of Orphan Drugs In The United States And The European Union, Bena Pearl Filipczak Smith

Master's Theses

There is substantive literature surrounding the impact of price controls on the research and development (R&D) of new pharmaceutical products. The European Union (EU) and United States (US) are often studied in contrast to examine the influence of price controls as the US has fewer pharmaceutical price controls than the EU.

We find moderate evidence that the US spent more on annual domestic pharmaceutical R&D than the EU between 2004 and 2021, on average, before and after adjusting for GDP growth per capita and year. We find strong evidence that the US increased annual domestic R&D spending at a faster …

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.

A Systematic Review Of Economic Evaluations Of Clinical Pharmacy Services In The United States: 2018-2022, Abdullah Alsharif, Bertha De Los Santos, Micheal Kim, Daniel Touchette, Alexandra Perez

HCA-NSU MD Research Day

Title: A systematic review of economic evaluations of clinical pharmacy services in the United States: 2018-2022 Authors: Bertha De Los Santos PharmD MS, Michael Kim PharmD, Abdullah Alsharif PharmD, Daniel Touchette PharmD MA, Alexandra Perez PharmD MS Background: Our objective was to identify, evaluate and synthesize evidence on the economic impact of clinical pharmacy services (CPS) compared to usual or alternative care in the United States. Methods: We searched Ovid MEDLINE, PubMed, IPA, Embase, and CINAHL in September 2023 for US-based pharmacist-led clinical interventions published between January 2018 and December 2022. We excluded articles with a team-based intervention where the …

Pharmacoeconomics And Health Technology Assessment - Letter To The Editor, Samar Farid

Bulletin of Faculty of Pharmacy Cairo University

This is letter to the editor

Cost-Utility Analysis Of Adding Daratumumab To Bortezomib Plus Dexamethasone To Treat Relapsed/Refractory Multiple Myeloma In Egypt, Menna M. Elsherbiny, Ahmed M. Kamel, Samar F. Farid

Bulletin of Faculty of Pharmacy Cairo University

Background: According to the CASTOR trial, DARA is shown to be effective as a second line for RRMM patients either as monotherapy or in combination with the gold standard regimen. The current study is the first to evaluate the cost-effectiveness of DARA based on the full results (~80-month follow-up) of the CASTOR trial. The study aimed to assess the cost-effectiveness of incorporating DARA, with bortezomib and dexamethasone, in treating patients from the perspective of a healthcare payer over a lifetime horizon.

Methods: A partition survival model (PSM) was adopted. The alternative arms chosen were daratumumab added to bortezomib plus …

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 …

Utilizing Biosimilars To Help Increase Patients Access And Minimize The Financial Burden Of Health Care System In Egypt, Doaa M. Abd-El-Rady, Iman A. El-Baraky, Samar F. Farid

Bulletin of Faculty of Pharmacy Cairo University

Background: Biologics have provided enhanced clinical advantages, but at expense of enormous expenditures. The exorbitant expense of biologics was somewhat mitigated by the development of biosimilars. But biosimilars market access is still recessed in many countries including Egypt. To achieve biosimilars market sustainability, countries need to evaluate the health economic barriers that biosimilars face in gaining market access.

Methods: A retrospective budget impact analysis was conducted to compare the cost of biosimilars to that of their reference biologics from Egyptian regulatory perspective over a five-year period (2018-2022). Time series forecasting analysis was conducted to predict the cost savings …

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 …

Assessing The Impact Of Tuberculosis On Economic Growth In Asean Countries: A Conceptual Framework And Panel Data Analysis, Agus Fitriangga, Alex Alex

Jurnal Ekonomi Kesehatan Indonesia

Tuberculosis (TB) remains a major global health issue, particularly in Southeast Asia, where its impact extends beyond public health to affect economic performance. This study evaluates the economic implications of TB incidence on gross domestic product (GDP) growth across eight ASEAN countries from 2000 to 2020. We employed a panel data regression approach, utilizing Common Effect Model (CEM), Fixed Effects Model (FEM), and Random Effects Model (REM) to analyze the relationship between TB incidence and economic growth. The dataset included annual GDP figures, TB incidence rates, foreign direct investment (FDI), labor force size, and trade openness, sourced from international databases. …

Analisis Penerapan Activity-Based Costing Tindakan Debridemen Bedah Pada Diagnosis Tunggal Di Kamar Operasi Rskd Duren Sawit Tahun 2022, Reynaldi Fattah Zakaria, Mardiati Nadjib

Jurnal Ekonomi Kesehatan Indonesia

In 2022, RSKD Duren Sawit has officially held operating room services. The demand for more comprehensive operating room services increased rapidly. The temporary operating room rates were set by adapting the rates of other regional hospitals and the Governor of DKI Jakarta's regulations. There is a huge difference in costs between the hospital rates and the INA-CBGs claim rates, especially for surgical debridement performed in the operating room. One of the factors causing the difference is the undetermined cost for debridement based on the unit cost component. Knowing the unit-cost debridement in the operating room according to the cost per …

Analisis Pembiayaan Berdasarkan Lama Rawat Pasien Bpjs Diabetes Melitus Tipe Ii Komplikasi Sirkulasi Perifer Di Rsu Pku Muhammadiyah Bantul, Firman Firman, Kartika Lestari

Jurnal Ekonomi Kesehatan Indonesia

Length of stay (LOS) can increase hospital rates and become a cost issue for patients, potentially resulting in a discrepancy between hospital rates and INA-CBGs rates at the hospital. This study aims to determine the difference between the actual costs and BPJS claim costs for diabetic patients based on the length of stay and class level. The research method is observational with a descriptive approach. The data collection technique used retrospective medical record data from 50 patients. The results showed that the largest average difference between hospital costs and BPJS claim costs was for patients with a length of stay …

Cost Variation Analysis Of Oral Hypoglycemic Drugs In The Egyptian Market, George G. Abdelmessih, Aya M. Abdelmagid, Samar F. Farid

Bulletin of Faculty of Pharmacy Cairo University

Introduction: Type II diabetes mellitus is a lifelong condition requiring lifelong medication. This study aims to analyze the cost variation of the oral hypoglycemic drugs in the Egyptian pharmaceutical market.

Methodology: Egyptian drug database of the Egyptian Drug Authority was used to get the official prices of drugs in the Egyptian pharmaceutical market analyzed in this study. The cost ratio and the percentage cost variation were calculated. The price was documented using unit dose of 1 tablet per EGP.

Results: Out of 15 oral hypoglycemic drugs in the Egyptian market at closing 2022 (9 monotherapy and 6 combination therapy) of …

A Cross – Sectional Observational Study On Pharmacoeconomics Burden Of Covid -19 In Ashmoun Fever Hospital Delta Egypt, Marwa Helmi Desouki, Marwa G. Elhennawy, Samar F. Farid

Bulletin of Faculty of Pharmacy Cairo University

Background: A wide range of respiratory illnesses like common colds, Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) are caused by coronaviruses.

In 2019 scientists in Wuhan, China discovered a new coronavirus (COVID-19). Unknown new coronavirus that infected people for the first time and causes losses for humans. It has caused a large number of deaths around the world and a greater number of injuries, and the countries of the world began to take measures and closures to confront the spread of this virus, and the economy was greatly affected.

Aim of Study: This study provides …

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 …

A Cost Variation Analysis Of Various Statin Preparations Available In The Egyptian Market, Radwa Ahmed Ibrahim, Marwa G. Elhennawy, Samar F. Farid

Bulletin of Faculty of Pharmacy Cairo University

Introduction: Dyslipidemia is one of the main risk factors for cardiovascular diseases. Statin preparations are the most effective lipid-lowering preparations that reduce the risk of mortality related to cardiovascular diseases. In the Egyptian market, various statin preparations have different strengths and prices. Aim: The current study aims to assess the percentage of cost variations among different statin medications in the Egyptian market. Methods: This is a cost variation study conducted from November to December 2022. The data were collected by using the Egyptian master on therapeutic drugs, edition 2022, and from the Egyptian Drug Database (DDB) website. The maximum and …

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 …

Treatment Patterns And Clinical And Economic Burden In Patients With Merkel Cell Carcinoma: Statistical And Machine Learning Approaches, Yves Mbous

Graduate Theses, Dissertations, and Problem Reports (ETD)

Although considered a rare form of nonmelanoma skin cancer, Merkel Cell Carcinoma incidence rate has increased to 0.74 per 100,000 and projections expect this number to steadily rise over the next decades and to reach an average of 3,285 cases per year in 2025. MCC incidence increases significantly with age. Among those aged 40-44, it is 0.44, it rises to 1.0/100,000 in the 60-64 age group and soars to 9.8/100,000 among those ≥85 years and above. Due to the small number of cases, MCC is often managed using institutional practices or provider preferences. Formal clinical trials that enroll early stage …