scholarly journals A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate design trials

2016 ◽  
Vol 81 (4) ◽  
pp. 667-678 ◽  
Author(s):  
Yang Yu ◽  
Steven Teerenstra ◽  
Cees Neef ◽  
David Burger ◽  
Marc Maliepaard
Keyword(s):  
Retrospective Analysis ◽  
Drug Exposure ◽  
Brand Name ◽  
Brand Name Drugs ◽  
Replicate Design

Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling

2022 ◽  
Author(s):  
Bryan S. Walsh ◽  
Aaron S. Kesselheim ◽  
Ameet Sarpatwari ◽  
Benjamin N. Rome
Keyword(s):  
Patent Protection ◽  
Cross Sectional Study ◽  
Myelogenous Leukemia ◽  
Brand Name ◽  
Generic Competition ◽  
Cross Sectional ◽  
The Us ◽  
Lower Drug ◽  
The Impact ◽  
Brand Name Drugs

PURPOSE Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. METHODS In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020. Generic versions were introduced with skinny labels that included indications covering treatment of chronic myelogenous leukemia (CML) but excluded treatment of gastrointestinal stromal tumors (GISTs) because of remaining patent protections. Logistic regression was used to determine whether use of generic versus brand-name imatinib differed between patients with a diagnosis of CML or GIST, adjusting for demographics, insurance type, prior use of brand-name drugs, and calendar month. RESULTS Among 2,000 initiators, 934 (47%) had CML and 686 (34%) had GIST. Within 3 years after generics entered the market, more than 90% of initiators in both groups used generic imatinib. Initiation of generic imatinib was slightly lower among patients with GIST than among patients with CML (85% v 88%; adjusted odds ratio 0.56; 95% CI, 0.39 to 0.80; P ≤ .001). CONCLUSION Generic versions of imatinib were dispensed frequently for indications both included (CML) and excluded (GIST) from the skinny labeling, although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.

Regulating Conflicts of Interest in Medicine Through Public Disclosure: Evidence from a Physician Payments Sunshine Law

2021 ◽  
Author(s):  
Matthew Chao ◽  
Ian Larkin
Keyword(s):  
Conflicts Of Interest ◽  
Healthcare Management ◽  
Public Disclosure ◽  
Brand Name ◽  
Data Set ◽  
Pharmaceutical Firms ◽  
Drug Classes ◽  
Healthcare Administrators ◽  
The Many ◽  
Brand Name Drugs

Hospital and healthcare administrators name high prescription drug costs as one of their largest problems. A significant body of research demonstrates that meals and honoraria from pharmaceutical firms to physicians leads to higher prescribing of expensive, brand name drugs, despite little difference in efficacy. Some administrators and scholars have advocated for mandatory disclosure of these payments in order to reduce this conflict of interest, but many practitioners believe disclosure has little effect on prescribing, and the empirical evidence is mixed. This paper uses a quasi-experiment of a 2009 payment disclosure policy in Massachusetts to estimate the causal impact of public disclosure on prescribing. The comprehensive data set includes all retail prescriptions for 262 drugs in nine drug classes written by 5,730 physicians in five states over 48 months. We show a significant postdisclosure reduction in brand name drug prescriptions by Massachusetts physicians, relative to control physicians in other states. These effects are driven by heavy prescribers of brand name drugs in the prepolicy period, particularly for drugs with large prepolicy sales forces. Effects are also detected before the first data were released, implying that the effects are not because patients or administrators responded to the disclosed payments. Instead, some physicians may have changed their payments and prescriptions behavior to avoid appearing biased. Taken in tandem with the many studies showing that pharmaceutical industry payments influence prescribing, this study suggests a strong role for mandatory public disclosure in reducing conflicts of interest in medicine and costly prescribing of brand name drugs. This paper was accepted by Stefan Scholtes, healthcare management.

scholarly journals Novelty of Active Ingredients in High-Cost Brand-Name Drugs

2020 ◽  
Vol 35 (7) ◽  
pp. 2219-2221 ◽  
Author(s):  
Emily H. Jung ◽  
Ameet Sarpatwari ◽  
Aaron S. Kesselheim
Keyword(s):  
Brand Name ◽  
Active Ingredients ◽  
Brand Name Drugs

scholarly journals Can income-based co-payment rates improve disparity? The case of the choice between brand-name and generic drugs

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Yuki Ito ◽  
Konan Hara ◽  
Byung-Kwang Yoo ◽  
Jun Tomio ◽  
Yasuki Kobayashi
Keyword(s):  
Generic Drugs ◽  
Income Group ◽  
High Income ◽  
Medical Expenditure ◽  
High Income Group ◽  
Brand Name ◽  
Income Groups ◽  
Additional Payment ◽  
Brand Name Drugs ◽  
Payment Rate

Abstract Background Higher income population tend to prefer brand-name to generic drugs, which may cause disparity in access to brand-name drugs among income groups. A potential policy that can resolve such disparity is imposing a greater co-payment rate on high-income enrollees. However, the effects of such policy are unknown. We examined how patients’ choice between brand-name and generic drugs are affected by the unique income-based co-payment rates in Japan; 10% for general enrollees and 30% for those with high income among the elderly aged 75 and over. Methods We drew on cross-sectional price variation among commonly prescribed 311 drugs using health insurance claims data from a large prefecture in Japan between October 2013 and September 2014 to identify between-income-group differences in responses to differentiated payments. Results Running 311 multivariate logistic regression models controlling individual demographics, the median estimate indicated that high-income group was 3% (odds ratio = 0.97) less likely to choose a generic drug than the general-income group and the interquartile estimates ranged 0.92–1.02. The multivariate feasible generalized least squares model indicated high-income group’s higher likelihood to choose brand-name drugs than the general-income group without co-payment rate differentiation (p < 0.001). Such gap in the likelihood was attenuated by 0.4% (p = 0.027) with an US$1 increase in the difference in additional payment/month for brand-name drugs between income groups — no gap with US$10 additional payment/month. This attenuation was observed in drugs for chronic diseases only, not for acute diseases. Conclusions Income-based co-payment rates appeared to reduce disparity in access to brand-name drugs across income groups, in addition to reducing total medical expenditure among high-income group who shifted from brand-name drugs to generic ones due to larger drug price differences.

scholarly journals Comparison of the Properties of Brand-Name and Generic Nadifloxacin Creams

Medicina ◽  
2011 ◽  
Vol 47 (11) ◽  
pp. 89
Author(s):  
Yutaka Inoue ◽  
Miruto Matsumoto ◽  
Masayuki Kimura ◽  
Toru Tanaka ◽  
Ikuo Kanamoto
Keyword(s):  
Water Content ◽  
Absorption Spectroscopy ◽  
Infrared Absorption ◽  
Near Infrared ◽  
Generic Drugs ◽  
Infrared Absorption Spectroscopy ◽  
Brand Name ◽  
Yield Value ◽  
Lower Viscosity ◽  
Brand Name Drugs

Background and Objective. In external preparations, types and ratios of additives are not necessarily the same for brand-name drugs and generic drugs. Thus, the physicochemical properties of preparations may differ despite the fact that they contain the same ingredients or additives. This study examined differences in brand-name and generic versions of nadifloxacin (NFX) creams. Material and Methods. Three types of NFX creams (NFX-A, NFX-B, and NFX-C) were used. The viscosity of each preparation was determined, its yield value was calculated, and each preparation was subjected to light microscopy, x-ray powder diffraction, and near-infrared absorption spectroscopy. Results. Comparison of viscosity of different preparations revealed that NFX-B had a lower viscosity than NFX-A and NFX-C (14.5 vs. 24.6 and 17.9 Pa·s). NFX-B also had a lower yield value than NFX-A and NFX-C. Microscopy revealed that NFX-A and NFX-B had satisfactory emulsification although crystallization was observed with NFX-C. Near-infrared absorption spectroscopy revealed changes in the absorption spectra of NFX-B in comparison with those of NFX-A and NFX-C that were due to differences in water content and differences in fat and oil content. Conclusions. These findings confirmed that there were differences in the viscosity and flattening of NFX-A, NFX-B, and NFX-C. In addition, microscopy revealed differences in emulsification and it revealed the precipitation of NFX crystals in NFX-C. Near-infrared absorption spectroscopy revealed that differences in the type and amount of additives and water content in the creams had contributed to differences in the preparations.

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