scholarly journals P168 Safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF): one-year data from post-marketing surveillance in the united states

Thorax ◽  
2016 ◽  
Vol 71 (Suppl 3) ◽  
pp. A175.1-A175
Author(s):  
T Maher ◽  
I Noth ◽  
A Allinger ◽  
M Kaul ◽  
CS Conoscenti ◽  
...  
CHEST Journal ◽  
2021 ◽  
Vol 159 (1) ◽  
pp. 228-238 ◽  
Author(s):  
Niranjan Jeganathan ◽  
Rory A. Smith ◽  
Matheni Sathananthan

2021 ◽  
Vol 9 (4) ◽  
pp. 46-52
Author(s):  
Dhruvi B Thakker ◽  
Kalpana G Patel

Prescription medicines, such as analgesics, stimulants, steroids, anti-depressants, psychotropics, and certain antibiotics are commonly mishandled in a variety of ways, including overdosing, abuse, diversion, and drug trafficking. Because of the considerable risk to public health, they are subject to strict regulatory oversight. The drugs possess abuse potential at specific dose and hence prone to abuse therefore they are categorized as Controlled substances. Therefore, they are subject to constant vigilance over the pharmaceutical supply chain. The complete clinical data as well as post marketing surveillance study of such drugs are critical to be in place as per the regulatory requirements. The countries have kept up with the times by constantly updating the system with regulatory laws and strategies to prevent cases of misuse. The current review will give a quick summary of how prescription medications and prohibited substances are regulated in the United States, Europe, and India. It will also emphasize current trends in drug usage, as well as the issues that these countries face and the preventive policies implemented to manage and prevent drug misuse. It will also make recommendations for new regulatory initiatives to address the current drug- misuse-related concerns. As a result, a review of the regulatory system in various countries will present current challenges and new lessons for countries around the globe.


2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Timothy M. Dempsey ◽  
Viengneesee Thao ◽  
James P. Moriarty ◽  
Bijan J. Borah ◽  
Andrew H. Limper

Abstract Background The anti-fibrotic medications nintedanib and pirfenidone were approved in the United States for use in patients with idiopathic pulmonary fibrosis several years ago. While there is a growing body of evidence surrounding their clinical effectiveness, these medications are quite expensive and no prior cost-effectiveness analysis has been performed in the United States. Methods A previously published Markov model performed in the United Kingdom was replicated using United States data to project the lifetime costs and health benefits of treating idiopathic pulmonary fibrosis with: (1) symptom management; (2) pirfenidone; or (3) nintedanib. For the cost-effectiveness analysis, strategies were ranked by increasing costs and then checked for dominating treatment strategies. Then an incremental cost-effectiveness ratio was calculated for the dominant therapy. Results The anti-fibrotic medications were found to cost more than $110,000 per year compared to $12,291 annually for symptom management. While pirfenidone was slightly more expensive than nintedanib and provided the same amount of benefit, neither medication was found to be cost-effective in this U.S.-based analysis, with an average cost of $1.6 million to gain one additional quality-adjusted life year over symptom management. Conclusions Though the anti-fibrotics remain the only effective treatment option for patients with idiopathic pulmonary fibrosis and the data surrounding their clinical effectiveness continues to grow, they are not considered cost-effective treatment strategies in the United States due to their high price.


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