Generic drug pricing

BACKGROUND AND OBJECTIVE: There has been a shift toward systemic treatment intensification for men with metastatic hormone-sensitive prostate cancer (mHSPC). Recent trials have demonstrated the efficacy of triplet therapy with an androgen receptor signalling inhibitor (ARSI), docetaxel, and androgen deprivation therapy (ADT). However, ARSI treatment is expensive. The objective was to determine the cost effectiveness of current treatments strategies for men with mHSPC. METHODS: We developed a Markov state-transition model to simulate outcomes for men with newly diagnosed mHSPC...

In a pivotal decision, an application to extend the patent on bedaquiline submitted by the pharmaceutical company Johnson & Johnson was denied by the Indian Patent Office, an essential drug for the treatment of tuberculosis. This development marks the conclusion of eight years of drug exclusivity, potentially opening the door for generic and more affordable versions. Bedaquiline has been a game-changer in treating multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis and has shown remarkable clinical efficacy...

A consistent and uninterrupted supply of pharmaceuticals is essential for optimal pharmacotherapy. However, some cases of supply disruptions and recalls have been reported. In particular, the withdrawal of some drugs from the market was occurred in recent year. Nevertheless, the characteristics of these drugs were unknown. The aim of this study was to analyze the ratio of generic drugs and the profile of generic drugs that have been withdrawn from the market. Data were collected from a drug information database for the period between April 2017 and March 2022 and analyzed for characteristics, such as price, number of suppliers, and reasons for withdrawal...

BACKGROUND: Globally, pharmaceutical companies offer patient support programs in tandem with their products, which aim to enhance medication adherence and patient experience through education, training, support and financial assistance. We sought to identify the proportion and characteristics of such patient support programs in Canada and to describe the nature of supports provided. METHODS: We conducted a crosssectional study to identify and characterize all marketed prescription drugs available in Canada as of Aug...

Antimicrobial resistance (AMR) poses a global public health threat, with rates directly linked with consumption. The World Health Organization (WHO)'s AWaRe classification aims to guide antibiotic use, and is influenced by drug availability, affordability, and economic policies. In Jordan, a high proportion of consumed antibiotics belong to the 'Watch' category. Data from the WHO's AWaRe classification, the Essential Medicines List, and the Jordan Food and Drug Administration were analyzed. Antibiotics for adults were classified, their costs per defined daily dose (DDD) were determined and their affordability assessed...

To examine whether higher cost-sharing deterred prescription opioid use. Medicare Part D claims from 2007 to 2016 for a 20% random sample of Medicare enrollees. We obtain estimates of the effect of cost-sharing on prescription opioid use using ordinary least squares and instrumental variables methods. In both, we exploit the variation (change) in cost-sharing within plans over time for a sample of beneficiaries who remain in the same plan. Focusing on changes in cost-sharing within a plan for a constant sample of beneficiaries mitigates potential bias from plan selection and using a constant set of weights derived from use in year (t) eliminates changes in the cost-sharing indexes due to (endogenous) consumer choice in year (t+1)...

OBJECTIVE: To perform a cost analysis of generic and brand-name PDE5 inhibitors at different dosages and pharmacies across the US. METHODS: Using an all-payer retail pharmacy-claims database, we analyzed prescription drug data for three generic and six brand-name oral PDE5 inhibitors at different dosages across US chain and independent pharmacies in 2019. RESULTS: We obtained cash price data from 60,186 pharmacies (35,976 chain and 24,210 independent)...

BACKGROUND: Generic drugs have been seen as a potentially powerful way to alleviate the financial burden on patients and health care systems. Two strategies for achieving rational prices of generic drugs are tiered pricing framework and pooled purchasing power. We compare the pan-Canadian Tiered Pricing Framework (TPF) and the Chinese National Volume-Based Procurement (NVBP) as comparators to explore the similarities and differences between the two mechanisms and summarise lessons for other jurisdictions...

No abstract text is available yet for this article.

BACKGROUND: A heavy financial burden is imposed on patients suffering from chronic diseases due to medicine out-of-pocket payments. OBJECTIVES: This study focuses on assessing the affordability of medications used for chronic respiratory diseases (CRDs) such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF) in Iran, specifically on the category R medicines listed in the 2017 Iran drug list (IDL) that are used for the treatment of these diseases, based on the anatomical therapeutic chemical (ATC) drug code...

BACKGROUND: Patents and exclusive rights on reference biologics contribute to the emergence of biosimilars. Regulatory bodies, such as the Food and Drug Administration (FDA), World Health Organization (WHO), and EMA (European Medicines Agency) for assessing clinical safety, effectiveness, and consequences between biosimilars and reference medications, have established guidelines. Since generic small molecules from reference can be easily swapped, biosimilars cannot be used interchangeably and may not always indicate interchangeability due to highly restrictive properties...

This study conducted a cost-utility analysis and a budget impact analysis (BIA) of outpatient oral chemotherapy versus inpatient intravenous chemotherapy for stage III colorectal cancer (CRC) in Thailand. A Markov model was constructed to estimate the lifetime cost and health outcomes based on a societal perspective. Eight chemotherapy strategies were compared. Clinical and cost data on adjuvant chemotherapy were collected from the medical records of 1747 patients at Siriraj Hospital, Thailand. The cost-effectiveness results were interpreted against a Thai willingness-to-pay threshold of USD 5003/quality-adjusted life year (QALY) gained...

No abstract text is available yet for this article.

BACKGROUND: The burden from medication costs for treating heart failure can be financially toxic for uninsured/underinsured patients and their families. Prescription discount cards, which offer cash price reductions, may decrease out-of-pocket costs for patients without prescription benefits, but the degree to which they offer financial relief remains unclear. Our objective was to assess the financial burden for uninsured/underinsured patients prescribed a drug from each of the 4 standard classes of medications for heart failure with reduced ejection fraction...

CONTEXT: Clinical endocrinology encompasses many diseases requiring long-term drug therapy. Prohibitive pricing of some endocrine drugs classified as essential by the World Health Organisation has created sub-optimal care of patients with endocrine disorders. EVIDENCE ACQUISITION: This review is based on evidence obtained from several databases and search engines including PubMed, Google and Google Scholar, reference searches, manual searching for web pages of international regulatory bodies and the authors' experience from different healthcare settings...

In this paper, the case study of ketamine as a new treatment for severe depression is used to outline the challenges of repurposing established medicines and we suggest potential solutions. The antidepressant effects of generic racemic ketamine were identified over 20 years ago, but there were insufficient incentives for commercial entities to pursue its registration, or support for non-commercial entities to fill this gap. As a result, the evaluation of generic ketamine was delayed, piecemeal, uncoordinated, and insufficient to gain approval...

BACKGROUND: Adherence and retention concerns raise questions about the effectiveness and cost-effectiveness of oral HIV pre-exposure prophylaxis (PrEP) in young men who have sex with men (YMSM). METHODS: Using an adolescent-focused simulation model, we compared annual HIV screening alone with tenofovir disoproxil fumarate/emtricitabine-based oral PrEP with every 3-month HIV screening in YMSM (aged 15-24) at increased risk of HIV. Data derived from published sources included: age-stratified HIV incidence/100 person-years (PY) on- or off-PrEP (0...

A range of treatment options are available for both mild to moderate and moderate to severe acne, and these options vary widely in their clinical uses, effectiveness, and costs. With the continued rise of dermatologic drug prices and increased cost-sharing due to high-deductible health plans, the importance of cost-effective treatment continues to grow. Failure to consider cost-effective, patient-centered care may lead to increased financial toxicity, reduced adherence, and ultimately worse outcomes and patient satisfaction...

PURPOSE/OBJECTIVE(S): In 2022, the Mark Cuban Cost Plus Drugs Company (MCCPDC) launched with the goal of offering affordable generic drugs directly to patients through a transparent pricing model. This study aims to evaluate the patient-level potential savings per prescription for patients undergoing radiation oncology treatment, regardless of insurance status. MATERIALS/METHODS: We analyzed prescription patterns of radiation oncologists in 2019 using the Medicare Part D database and selected the top 100 most frequently prescribed drugs for further analysis...

OBJECTIVE: To report out-of-pocket costs associated with Overactive Bladder (OAB) medications among Medicare beneficiaries and the uninsured. METHODS: We performed a cross-sectional analysis of the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary Data (Q1-2022). FDA-approved medications for OAB were identified. We calculated out-of-pocket costs for Medicare beneficiaries in each Part D prescription benefit phase, average retail price, total yearly costs and discounted prices through cash-pay discount coupons (GoodRx) or online pharmacies like Mark Cuban Cost Plus Drug Company (MCCPDC)...