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Efficacy and Safety of Oral and IV Levonadifloxacin Therapy in Management of Bacterial Infections: Findings of a Prospective, Observational, Multi-center, Post-marketing Surveillance Study.
Cureus
February 2024
Medical Affairs, Wockhardt Ltd., Mumbai, IND.
Background Antimicrobial resistance by bacteria poses a substantial threat to morbidity and mortality worldwide, and treatment of resistant infections is a challenge for the treating clinician. Levonadifloxacin is a novel broad-spectrum agent belonging to the benzoquinolizine subclass of quinolone, which can be used by both oral and intravenous administration for the treatment of infections caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA). Patients and methods This prescription event monitoring study captured data from 1266 patients receiving levonadifloxacin (oral and/or IV) in a real-world setting to assess the safety and efficacy in the treatment of various bacterial infections.
View Article and Find Full Text PDFChallenges of Incorporating Life Cycle Drug Pricing in Cost-Effectiveness Models: A Review of Methods and Modeling Suggestions.
Value Health
July 2024
Bristol Myers Squibb, Uxbridge, England, UK.
Objectives: This study aimed to conduct a review of existing methods used to incorporate life cycle drug pricing (LCDP) in cost-effectiveness analyses (CEAs), identify common methodological challenges, and suggest modeling approaches for prospectively implementing LCDP in CEA.
Methods: Two complementary searches were conducted in PubMed, combined with hand searching and reference mining, to identify English language full-text articles that explored (1) how drug prices change over time and (2) methods used to apply dynamic pricing in cost-effectiveness models (CEMs). Relevant articles were reviewed, and authors discussed the common methodological practices used in the literature and their associated challenges on prospectively implementing LCDP in CEMs.
Exploring the Evolution of Statin Pricing in Australia: Observations of Price Disclosure Effects on Pharmaceutical Benefits Scheme Expenditure.
Value Health Reg Issues
March 2024
Centre for Applied Health Economics, School of Medicine and Dentistry, Griffith University, Southport, Australia.
Objectives: The high cardiovascular disease burden globally and in Australia necessitates attention on statin expenditure, the primary pharmacological intervention for cardiovascular disease risk factors. The Pharmaceutical Benefits Scheme (PBS) subsidies approved statins for Australians. Managing PBS government expenditure occurs through price control strategies of statutory price decreases upon first generic entry and price disclosure.
View Article and Find Full Text PDFNavigating adalimumab biosimilars: an expert opinion.
J Comp Eff Res
November 2023
Université Jean Monnet Saint-Étienne, CHU Saint-Étienne, Service de Rhumatologie, Mines Saint-Etienne, INSERM, SAINBIOSE U1059, Saint-Etienne, 42023, France.
Article Synopsis
- The expiration of Humira's patent in 2018 led to the introduction of eight adalimumab biosimilars in Europe and several in the USA, enhancing treatment options for immune and inflammatory conditions.
- While these biosimilars show similar efficacy and safety to Humira, they may have different excipients and device types, complicating treatment decisions for physicians.
- The article aims to help clinicians understand the distinct characteristics of various biosimilars and emphasizes the importance of clear communication with patients to manage expectations and reduce negative reactions.
Global Barriers to Accessing Off-Patent Endocrine Therapies: A Renaissance of the Orphan Disease?
J Clin Endocrinol Metab
April 2024
Department of Metabolism, Digestion and Reproduction, Imperial College, W12 0NN, London, UK.
Context: Clinical endocrinology encompasses many diseases requiring long-term drug therapy. Prohibitive pricing of some endocrine drugs classified as essential by the World Health Organization has created suboptimal 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.
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