The Experts below are selected from a list of 27978 Experts worldwide ranked by ideXlab platform
Saral Mehra - One of the best experts on this subject based on the ideXlab platform.
-
industry payments to physicians and prescriptions of Brand Name proton pump inhibitors
Otolaryngology-Head and Neck Surgery, 2019Co-Authors: Elliot Morse, Rance J T Fujiwara, Saral MehraAbstract:ObjectiveTo characterize the association between industry payments and prescriptions of 2 Brand-Name proton-pump inhibitors (PPIs).Study DesignCross-sectional retrospective.SettingPhysicians nation...
-
the association of industry payments to physicians with prescription of Brand Name intranasal corticosteroids
Otolaryngology-Head and Neck Surgery, 2018Co-Authors: Elliot Morse, Rance J T Fujiwara, Saral MehraAbstract:ObjectivesTo examine the association of industry payments for Brand-Name intranasal corticosteroids with prescribing patterns.Study DesignCross-sectional retrospective analysis.SettingNationwide.Subjects and MethodsWe identified physicians prescribing intranasal corticosteroids to Medicare beneficiaries 2014-2015 and physicians receiving payment for the Brand-Name intranasal corticosteroids Dymista and Nasonex. Prescription and payment data were linked by physician, and we compared the proportion of prescriptions written for Brand-Name intranasal corticosteroids in industry-compensated vs non-industry-compensated physicians. We associated the number and dollar amount of industry payments with the relative frequency of Brand-Name prescriptions.ResultsIn total, 164,587 physicians prescribing intranasal corticosteroids were identified, including 7937 (5%) otolaryngologists; 10,800 and 3886 physicians received industry compensation for Dymista and Nasonex, respectively. Physicians receiving industry payment f...
Aaron S Kesselheim - One of the best experts on this subject based on the ideXlab platform.
-
medicare spending on Brand Name combination medications vs their generic constituents
JAMA, 2018Co-Authors: Chana A Sacks, Aaron S Kesselheim, Jerry AvornAbstract:Importance Brand-Name combination drugs can be more expensive than the sum of their components, especially when the constituent products are available as generic medications. The potential savings that could be achieved using generic components is not known. Objective To estimate the additional cost to Medicare of prescribing Brand-Name combination medications instead of generic constituents. Design, Setting, and Participants Retrospective analysis for 2011 through 2016 using the Medicare data set of Part D beneficiaries prescribed any of the 1500 medications that accounted for the highest total spending in 2015. Brand-Name combination drugs that had identical or therapeutically equivalent generic constituents were included. Exposures Brand-Name, oral combination medications with constituents available either as generic drugs or therapeutically equivalent generic substitutes. Main Outcomes and Measures The estimated difference between the amount spent by Medicare on Brand-Name combination drugs and the estimated amount that would have been spent on substitutable generic components. Results Among the 1500 medications evaluated, 29 Brand-Name combination medications were separated into 3 mutually exclusive categories: constituents available as generic medications at identical doses (n = 20), generic constituents at different doses (n = 3), and therapeutically equivalent generic substitutes (n = 6). For the constituents available as generic medications at identical doses category, total spending by Medicare in 2016 on the Brand-Name combination products was $303 million and the estimated spending for the generic constituents would have been $68 million, which is an estimated difference of $235 million. For the generic constituents at different doses category, total spending by Medicare in 2016 on the Brand-Name combination products was $232 million and the estimated spending for the generic constituents would have been $13 million, which is an estimated difference of $219 million. For the therapeutically equivalent generic substitutes category, total spending by Medicare in 2016 on the Brand-Name combination products was $491 million and the estimated spending for the generic constituents would have been $20 million, which is an estimated difference of $471 million. In 2016, the estimated spending for the generic constituents for these 29 drugs would have been $925 million less than the estimated spending for the Brand-Name combinations. For the 10 most costly combination products available during the entire study period, the listed Medicare spending could have been an estimated $2.7 billion lower between 2011 and 2016 if the generic constituents had been prescribed. Conclusions and Relevance In 2016, the difference between the amount that the Medicare drug benefit program reported spending on Brand-Name combination medications and the estimated spending for generic constituents for the same number of doses was $925 million. Promoting generic substitution and therapeutic interchange through prescriber education and more rational substitution policies may offer important opportunities to achieve substantial savings in the Medicare drug benefit program.
-
association of industry payments to physicians with the prescribing of Brand Name statins in massachusetts
JAMA Internal Medicine, 2016Co-Authors: Jessica M Franklin, Jerry Avorn, Joan Landon, Aaron S KesselheimAbstract:Importance Pharmaceutical industry payments to physicians may affect prescribing practices and increase costs if more expensive medications are prescribed. Objective Determine the association between industry payments to physicians and the prescribing of Brand-Name as compared with generic statins for lowering cholesterol. Design, Setting, and Participants Cross-sectional linkage of the Part D Medicare prescriptions claims data with the Massachusetts physicians payment database including all licensed Massachusetts physicians who wrote prescriptions for statins paid for under the Medicare drug benefit in 2011. Main Outcomes and Measures The exposure variable was a physician’s industry payments as listed in the Massachusetts database. The outcome was the physician’s rate of prescribing Brand-Name statins. We used linear regression to analyze the association between the intensity of physicians’ industry relationships (as measured by total payments) and their prescribing practices, as well as the effects of specific types of payments. Results Among the 2444 Massachusetts physicians in the Medicare prescribing database in 2011, 899 (36.8%) received industry payments. The most frequent payment was for company-sponsored meals (n = 639 [71.1%]). Statins accounted for 1 559 003 prescription claims; 356 807 (22.8%) were for Brand-Name drugs. For physicians with no industry payments listed, the median Brand-Name statin prescribing rate was 17.8% (95% CI, 17.2%-18.4%). For every $1000 in total payments received, the Brand-Name statin prescribing rate increased by 0.1% (95% CI, 0.06%-0.13%; P P = .004); other forms of payments were not. Conclusions and Relevance Industry payments to physicians are associated with higher rates of prescribing Brand-Name statins. As the United States seeks to rein in the costs of prescription drugs and make them less expensive for patients, our findings are concerning.
-
comparative effectiveness of generic versus Brand Name antiepileptic medications
Epilepsy & Behavior, 2015Co-Authors: Joshua J Gagne, Aaron S Kesselheim, Niteesh K Choudhry, Jennifer M Polinski, David Hutchins, Olga S Matlin, Troyen A Brennan, Jerry Avorn, William H ShrankAbstract:Abstract Objective The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a Brand-Name product. Methods We used linked electronic medical and pharmacy claims data to identify Medicare beneficiaries who initiated one of five AEDs (clonazepam, gabapentin, oxcarbazepine, phenytoin, zonisamide). We matched initiators of generic versus Brand-Name versions of these drugs using a propensity score that accounted for demographic, clinical, and health service utilization variables. We used a Cox proportional hazards model to compare rates of seizure-related emergency room (ER) visit or hospitalization (primary outcome) and ER visit for bone fracture or head injury (secondary outcome) between the matched generic and Brand-Name initiators. We also compared treatment persistence, measured as time to first 14-day treatment gap, between generic and Brand-Name initiators. Results We identified 19,760 AED initiators who met study eligibility criteria; 18,306 (93%) initiated a generic AED. In the matched cohort, we observed 47 seizure-related hospitalizations and ER visits among Brand-Name initiators and 31 events among generic initiators, corresponding to a hazard ratio of 0.53 (95% confidence interval, 0.30 to 0.96). Similar results were observed for the secondary clinical endpoint and across sensitivity analyses. Mean time to first treatment gap was 124.2 days (standard deviation [sd], 125.8) for Brand-Name initiators and 137.9 (sd, 148.6) for generic initiators. Significance Patients who initiated generic AEDs had fewer adverse seizure-related clinical outcomes and longer continuous treatment periods before experiencing a gap than those who initiated Brand-Name versions.
-
seizure outcomes following the use of generic versus Brand Name antiepileptic drugs a systematic review and meta analysis
Drugs, 2010Co-Authors: Aaron S Kesselheim, Joshua J Gagne, Jerry Avorn, Alexander S Misono, Margaret R Stedman, Alan M Brookhart, Ellen J Bubrick, William H ShrankAbstract:Background: The automatic substitution of bioequivalent generics for Brand-Name antiepileptic drugs (AEDs) has been linked by anecdotal reports to loss of seizure control.
-
clinical equivalence of generic and Brand Name drugs used in cardiovascular disease a systematic review and meta analysis
JAMA, 2008Co-Authors: Aaron S Kesselheim, Niteesh K Choudhry, Alexander S Misono, Margaret R Stedman, Alan M Brookhart, William H ShrankAbstract:Context Use of generic drugs, which are bioequivalent to Brand-Name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that Brand-Name drugs may be clinically superior to generic drugs. Objectives To summarize clinical evidence comparing generic and Brand-Name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue. Data Sources Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008. Study Selection Studies compared generic and Brand-Name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution. Data Extraction We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral. Results We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of β-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of α-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was −0.03 (95% confidence interval, −0.15 to 0.08), indicating no evidence of superiority of Brand-Name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution. Conclusions Whereas evidence does not support the notion that Brand-Name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs.
William H Shrank - One of the best experts on this subject based on the ideXlab platform.
-
comparative effectiveness of generic versus Brand Name antiepileptic medications
Epilepsy & Behavior, 2015Co-Authors: Joshua J Gagne, Aaron S Kesselheim, Niteesh K Choudhry, Jennifer M Polinski, David Hutchins, Olga S Matlin, Troyen A Brennan, Jerry Avorn, William H ShrankAbstract:Abstract Objective The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a Brand-Name product. Methods We used linked electronic medical and pharmacy claims data to identify Medicare beneficiaries who initiated one of five AEDs (clonazepam, gabapentin, oxcarbazepine, phenytoin, zonisamide). We matched initiators of generic versus Brand-Name versions of these drugs using a propensity score that accounted for demographic, clinical, and health service utilization variables. We used a Cox proportional hazards model to compare rates of seizure-related emergency room (ER) visit or hospitalization (primary outcome) and ER visit for bone fracture or head injury (secondary outcome) between the matched generic and Brand-Name initiators. We also compared treatment persistence, measured as time to first 14-day treatment gap, between generic and Brand-Name initiators. Results We identified 19,760 AED initiators who met study eligibility criteria; 18,306 (93%) initiated a generic AED. In the matched cohort, we observed 47 seizure-related hospitalizations and ER visits among Brand-Name initiators and 31 events among generic initiators, corresponding to a hazard ratio of 0.53 (95% confidence interval, 0.30 to 0.96). Similar results were observed for the secondary clinical endpoint and across sensitivity analyses. Mean time to first treatment gap was 124.2 days (standard deviation [sd], 125.8) for Brand-Name initiators and 137.9 (sd, 148.6) for generic initiators. Significance Patients who initiated generic AEDs had fewer adverse seizure-related clinical outcomes and longer continuous treatment periods before experiencing a gap than those who initiated Brand-Name versions.
-
seizure outcomes following the use of generic versus Brand Name antiepileptic drugs a systematic review and meta analysis
Drugs, 2010Co-Authors: Aaron S Kesselheim, Joshua J Gagne, Jerry Avorn, Alexander S Misono, Margaret R Stedman, Alan M Brookhart, Ellen J Bubrick, William H ShrankAbstract:Background: The automatic substitution of bioequivalent generics for Brand-Name antiepileptic drugs (AEDs) has been linked by anecdotal reports to loss of seizure control.
-
clinical equivalence of generic and Brand Name drugs used in cardiovascular disease a systematic review and meta analysis
JAMA, 2008Co-Authors: Aaron S Kesselheim, Niteesh K Choudhry, Alexander S Misono, Margaret R Stedman, Alan M Brookhart, William H ShrankAbstract:Context Use of generic drugs, which are bioequivalent to Brand-Name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that Brand-Name drugs may be clinically superior to generic drugs. Objectives To summarize clinical evidence comparing generic and Brand-Name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue. Data Sources Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008. Study Selection Studies compared generic and Brand-Name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution. Data Extraction We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral. Results We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of β-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of α-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was −0.03 (95% confidence interval, −0.15 to 0.08), indicating no evidence of superiority of Brand-Name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution. Conclusions Whereas evidence does not support the notion that Brand-Name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs.
Philippe Ravaud - One of the best experts on this subject based on the ideXlab platform.
-
quality of reporting of bioequivalence trials comparing generic to Brand Name drugs a methodological systematic review
PLOS ONE, 2011Co-Authors: Amelie Van Der Meersch, Agnes Dechartres, Philippe RavaudAbstract:Background Generic drugs are used by millions of patients for economic reasons, so their evaluation must be highly transparent. Objective To assess the quality of reporting of bioequivalence trials comparing generic to Brand-Name drugs. Methodology/Principal Findings PubMed was searched for reports of bioequivalence trials comparing generic to Brand-Name drugs between January 2005 and December 2008. Articles were included if the aim of the study was to assess the bioequivalency of generic and Brand-Name drugs. We excluded case studies, pharmaco-economic evaluations, and validation dosage assays of drugs. We evaluated whether important information about funding, methodology, location of trials, and participants were reported. We also assessed whether the criteria required by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) to conclude bioequivalence were reported and that the conclusions were in agreement with the results. We identified 134 potentially relevant articles but eliminated 55 because the Brand-Name or generic drug status of the reference drug was unknown. Thus, we evaluated 79 articles. The funding source and location of the trial were reported in 41% and 56% of articles, respectively. The type of statistical analysis was reported in 94% of articles, but the methods to generate the randomization sequence and to conceal allocation were reported in only 15% and 5%, respectively. In total, 65 articles of single-dose trials (89%) concluded bioequivalence. Of these, 20 (31%) did not report the 3 criteria within the limits required by the FDA and 11 (17%) did not report the 2 criteria within the limits required by the EMA. Conclusions/Significance Important information to judge the validity and relevance of results are frequently missing in published reports of trials assessing generic drugs. The quality of reporting of such trials is in need of improvement.
Joel Lexchin - One of the best experts on this subject based on the ideXlab platform.
-
the effect of generic competition on the price of Brand Name drugs
Health Policy, 2004Co-Authors: Joel LexchinAbstract:Abstract Background: Literature from the US has shown that Brand-Name manufacturers do not compete on price once generic competitors become available. This study was undertaken to investigate if this is also true in Canada. Methods: Editions of the Ontario Drug Benefit Formulary were used to identify Brand-Name drugs that lacked generic competition in July 1990 but had acquired one or more generic competitors by December 1998. Prices of the Brand-Name drugs were compared before generic competition, at the point when generic competition started and subsequent to the initiation of competition. Results: Price changes for 81 different products in 144 separate presentations were analysed. There was no statistically significant change in Brand-Name prices when generic competition started. The movement of Brand-Name prices was not influenced by whether the generic was made by the company producing the Brand-Name product or price freezes imposed by the Ontario government. When generics first became available having four or more generics was associated with a rise in the price of the Brand-Name drugs compared to having one, two or three generic competitor(s). Interpretation: The lack of price competition may lead to increased costs in the private market. Private insurance companies generally do not require generic substitution and some provinces do not require generic substitution for cash-paying customers. Maintaining higher prices on Brand-Name drugs impacts on the prices of new patented medications coming onto the Canadian market under the current pricing guidelines of the Patented Medicine Prices Review Board.