The Experts below are selected from a list of 7587 Experts worldwide ranked by ideXlab platform
Rishi J Desai - One of the best experts on this subject based on the ideXlab platform.
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comparative effectiveness of generic and Brand Name medication use a database study of us health insurance claims
PLOS Medicine, 2019Co-Authors: Rishi J Desai, Sara Z Dejene, Saeid Raofi, Justin Bohn, John G. Connolly, Nazleen F. Khan, James R. Rogers, Susan K Dutcher, Ameet Sarpatwari, Michael A FischerAbstract:Background To the extent that outcomes are mediated through negative perceptions of generics (the nocebo effect), observational studies comparing Brand-Name and generic drugs are susceptible to bias favoring the Brand-Name drugs. We used authorized generic (AG) Products, which are identical in composition and appearance to Brand-Name Products but are marketed as generics, as a control group to address this bias in an evaluation aiming to compare the effectiveness of generic versus Brand medications. Methods and findings For commercial health insurance enrollees from the US, administrative claims data were derived from 2 databases: (1) Optum Clinformatics Data Mart (years: 2004–2013) and (2) Truven MarketScan (years: 2003–2015). For a total of 8 drug Products, the following groups were compared using a cohort study design: (1) patients switching from Brand-Name Products to AGs versus generics, and patients initiating treatment with AGs versus generics, where AG use proxied Brand-Name use, addressing negative perception bias, and (2) patients initiating generic versus Brand-Name Products (bias-prone direct comparison) and patients initiating AG versus Brand-Name Products (negative control). Using Cox proportional hazards regression after 1:1 propensity-score matching, we compared a composite cardiovascular endpoint (for amlodipine, amlodipine-benazepril, and quinapril), non-vertebral fracture (for alendronate and calcitonin), psychiatric hospitalization rate (for sertraline and escitalopram), and insulin initiation (for glipizide) between the groups. Inverse variance meta-analytic methods were used to pool adjusted hazard ratios (HRs) for each comparison between the 2 databases. Across 8 Products, 2,264,774 matched pairs of patients were included in the comparisons of AGs versus generics. A majority (12 out of 16) of the clinical endpoint estimates showed similar outcomes between AGs and generics. Among the other 4 estimates that did have significantly different outcomes, 3 suggested improved outcomes with generics and 1 favored AGs (patients switching from amlodipine Brand-Name: HR [95% CI] 0.92 [0.88–0.97]). The comparison between generic and Brand-Name initiators involved 1,313,161 matched pairs, and no differences in outcomes were noted for alendronate, calcitonin, glipizide, or quinapril. We observed a lower risk of the composite cardiovascular endpoint with generics versus Brand-Name Products for amlodipine and amlodipine-benazepril (HR [95% CI]: 0.91 [0.84–0.99] and 0.84 [0.76–0.94], respectively). For escitalopram and sertraline, we observed higher rates of psychiatric hospitalizations with generics (HR [95% CI]: 1.05 [1.01–1.10] and 1.07 [1.01–1.14], respectively). The negative control comparisons also indicated potentially higher rates of similar magnitude with AG compared to Brand-Name initiation for escitalopram and sertraline (HR [95% CI]: 1.06 [0.98–1.13] and 1.11 [1.05–1.18], respectively), suggesting that the differences observed between Brand and generic users in these outcomes are likely explained by either residual confounding or generic perception bias. Limitations of this study include potential residual confounding due to the unavailability of certain clinical parameters in administrative claims data and the inability to evaluate surrogate outcomes, such as immediate changes in blood pressure, upon switching from Brand Products to generics. Conclusions In this study, we observed that use of generics was associated with comparable clinical outcomes to use of Brand-Name Products. These results could help in promoting educational interventions aimed at increasing patient and provider confidence in the ability of generic medicines to manage chronic diseases.
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Hazard ratios (HRs) and 95% confidence intervals (CIs) comparing outcomes for patients initiating authorized generics (AGs) versus generics, and patients switching from Brand-Name Products to AGs versus generics, after 1:1 propensity score matching in each database.
2019Co-Authors: Rishi J Desai, Sara Z Dejene, Saeid Raofi, Justin Bohn, Nazleen F. Khan, James R. Rogers, Ameet Sarpatwari, Sarah K Dutcher, Joyce Lii, John G. ConnollyAbstract:The outcome for amlodipine tablets, amlodipine-benazepril capsules, and quinapril tablets was a composite endpoint comprising hospitalization for myocardial infarction, ischemic stroke, or coronary revascularization procedures. The outcome for alendronate tablets and calcitonin salmon nasal spray was a composite non-vertebral fracture endpoint comprising humerus, wrist, hip, or pelvis fractures. The outcome for escitalopram tablets and sertraline tablets was hospitalization with a psychiatric condition as the principal discharge diagnosis code. The outcome for glipizide extended release (ER) tablets was initiation of insulin during the follow-up period.
Michael A Fischer - One of the best experts on this subject based on the ideXlab platform.
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comparative effectiveness of generic and Brand Name medication use a database study of us health insurance claims
PLOS Medicine, 2019Co-Authors: Rishi J Desai, Sara Z Dejene, Saeid Raofi, Justin Bohn, John G. Connolly, Nazleen F. Khan, James R. Rogers, Susan K Dutcher, Ameet Sarpatwari, Michael A FischerAbstract:Background To the extent that outcomes are mediated through negative perceptions of generics (the nocebo effect), observational studies comparing Brand-Name and generic drugs are susceptible to bias favoring the Brand-Name drugs. We used authorized generic (AG) Products, which are identical in composition and appearance to Brand-Name Products but are marketed as generics, as a control group to address this bias in an evaluation aiming to compare the effectiveness of generic versus Brand medications. Methods and findings For commercial health insurance enrollees from the US, administrative claims data were derived from 2 databases: (1) Optum Clinformatics Data Mart (years: 2004–2013) and (2) Truven MarketScan (years: 2003–2015). For a total of 8 drug Products, the following groups were compared using a cohort study design: (1) patients switching from Brand-Name Products to AGs versus generics, and patients initiating treatment with AGs versus generics, where AG use proxied Brand-Name use, addressing negative perception bias, and (2) patients initiating generic versus Brand-Name Products (bias-prone direct comparison) and patients initiating AG versus Brand-Name Products (negative control). Using Cox proportional hazards regression after 1:1 propensity-score matching, we compared a composite cardiovascular endpoint (for amlodipine, amlodipine-benazepril, and quinapril), non-vertebral fracture (for alendronate and calcitonin), psychiatric hospitalization rate (for sertraline and escitalopram), and insulin initiation (for glipizide) between the groups. Inverse variance meta-analytic methods were used to pool adjusted hazard ratios (HRs) for each comparison between the 2 databases. Across 8 Products, 2,264,774 matched pairs of patients were included in the comparisons of AGs versus generics. A majority (12 out of 16) of the clinical endpoint estimates showed similar outcomes between AGs and generics. Among the other 4 estimates that did have significantly different outcomes, 3 suggested improved outcomes with generics and 1 favored AGs (patients switching from amlodipine Brand-Name: HR [95% CI] 0.92 [0.88–0.97]). The comparison between generic and Brand-Name initiators involved 1,313,161 matched pairs, and no differences in outcomes were noted for alendronate, calcitonin, glipizide, or quinapril. We observed a lower risk of the composite cardiovascular endpoint with generics versus Brand-Name Products for amlodipine and amlodipine-benazepril (HR [95% CI]: 0.91 [0.84–0.99] and 0.84 [0.76–0.94], respectively). For escitalopram and sertraline, we observed higher rates of psychiatric hospitalizations with generics (HR [95% CI]: 1.05 [1.01–1.10] and 1.07 [1.01–1.14], respectively). The negative control comparisons also indicated potentially higher rates of similar magnitude with AG compared to Brand-Name initiation for escitalopram and sertraline (HR [95% CI]: 1.06 [0.98–1.13] and 1.11 [1.05–1.18], respectively), suggesting that the differences observed between Brand and generic users in these outcomes are likely explained by either residual confounding or generic perception bias. Limitations of this study include potential residual confounding due to the unavailability of certain clinical parameters in administrative claims data and the inability to evaluate surrogate outcomes, such as immediate changes in blood pressure, upon switching from Brand Products to generics. Conclusions In this study, we observed that use of generics was associated with comparable clinical outcomes to use of Brand-Name Products. These results could help in promoting educational interventions aimed at increasing patient and provider confidence in the ability of generic medicines to manage chronic diseases.
Aimee Drolet - One of the best experts on this subject based on the ideXlab platform.
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express your social self cultural differences in choice of Brand Name versus generic Products
Personality and Social Psychology Bulletin, 2009Co-Authors: Aimee DroletAbstract:This research examined cultural differences in the patterns of choices that reflect more social characteristics of a chooser (e.g., social status). Four studies examined the cultural difference in individuals’ tendency to choose Brand-Name Products (i.e., high-status options) over generic Products (i.e., low-status options) and the underlying reasons for these differences. Compared to European Americans, Asian Americans consistently chose Brand-Name Products. This difference was driven by Asian Americans’ greater social status concerns. Self-consciousness was more strongly associated with the Brand-Name choices of Asian Americans (vs. European Americans), and experimentally induced social status led Asian Americans (vs. European Americans) to make more choices concordant with self-perception. These findings highlight the importance of considering external and social motivations underlying the choice-making process.
Aaron S. Kesselheim - One of the best experts on this subject based on the ideXlab platform.
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US Spending Associated With Transition From Daily to 3-Times-Weekly Glatiramer Acetate
JAMA internal medicine, 2020Co-Authors: Benjamin N. Rome, Frazer A. Tessema, Aaron S. KesselheimAbstract:Importance Market exclusivity for daily injections of glatiramer acetate, a disease-modifying therapy for multiple sclerosis, expired in 2015. In 2014, the manufacturer launched an alternate 3-times-weekly version that was widely adopted, sustaining market dominance of Brand-Name glatiramer until late 2017. Objective To estimate excess US spending associated with the transition from daily to 3-times-weekly glatiramer. Design, Setting, and Participants This economic evaluation estimated total US glatiramer spending from January 1, 2011, to June 30, 2019, using a national cohort from 3 data sources that collectively represent approximately 40% of the US glatiramer market: Medicare Part D, Medicaid, and a claims database of commercially insured and Medicare Advantage patients. Exposures Calendar quarter. Main Outcomes and Measures Outcomes were quarterly US glatiramer spending, estimated as price × use. Manufacturer list prices for generic Products and estimates of net (postrebate) prices for Brand-Name Products were used. Linear regression and interrupted time series models were used to compare spending trends in 3 periods: before generic competition (2011-2015), during generic competition for daily glatiramer (2015-2017), and during generic competition for daily and 3-times-weekly glatiramer (2017-2019). Results From 2011 to 2015, US glatiramer spending increased to $962 million per quarter and did not decrease with generic competition of only daily glatiramer (2015-2017). After generic competition began for 3-times-weekly glatiramer in 2017, prices decreased by 47% to 64%, and spending decreased to $508 million per quarter in 2019 (P Conclusions and Relevance These findings suggest that 2.5 years of delayed generic competition related to introduction of a new version of Branded glatiramer acetate was associated with $4.3 billion to $6.5 billion in excess spending. Extended market exclusivity from introducing a new version of an existing Brand-Name drug can yield manufacturer returns out of proportion to the level of investment or risk involved; more limited incentives could encourage incremental innovations to existing drugs at a lower societal cost.
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the international pharmaceutical market as a source of low cost prescription drugs for u s patients
2008Co-Authors: Aaron S. Kesselheim, Niteesh K ChoudhryAbstract:In response to increasing prescription drug costs, more U.S. patients and policymakers are importing less-expensive pharmaceutical Products from other countries. Large-scale prescription drug importation is currently illegal, but the U.S. Food and Drug Administration permits individuals to bring in 90-day supplies of drugs for personal use. As patient use of foreign-bought drugs has increased, federal legislators have continued to debate the full legalization of importation. Three factors help guide whether U.S. patients and policymakers can rely on other countries as sources of imported prescription drugs: whether the safety of the product can be ensured, how the import price compares with domestic prices, and how importation might affect the exporting country's pharmaceutical market. In wealthier countries with active regulatory systems, drug safety can be adequately ensured, and Brand-Name Products are usually less expensive than in the United States (although generic drugs may be more expensive). However, implementing large-scale importation can negatively impact the originating country's market and can diminish the long-term cost savings for U.S. consumers. In low- and middle-income countries, prices may be reduced for both Brand-Name and generic drugs, but the prevalence of unauthorized Products on the market makes ensuring drug safety more difficult. It may be reasonable for individual U.S. consumers to purchase essential medicines from certain international markets, but the most effective way to decrease drug costs overall is the appropriate use of domestic generic drugs, which are available for almost every major therapeutic class.
Philip E Johnson - One of the best experts on this subject based on the ideXlab platform.
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changes in reimbursement rates and rules associated with the medicare prescription drug improvement and modernization act introduction
American Journal of Health-system Pharmacy, 2006Co-Authors: Philip E JohnsonAbstract:PURPOSE Future trends in the Medicare population and drug expenditures, the organizational structure of the Medicare program, and recent changes in Medicare rules and rates for pharmaceutical reimbursement are described. SUMMARY Large increases in the number of Medicare beneficiaries and drug spending are anticipated in the future. Medicare Part A provides insurance benefits for hospital inpatients, nursing home patients, home health care patients, and hospice care patients. Part B provides benefits for physician services, durable medical equipment, oral chemotherapy, and end-stage renal disease services. For hospitals, Part B rules are followed for ambulatory services, but these services are administered through the Part A Outpatient Prospective Payment System. The average sales price plus 6% is now used for pharmaceutical reimbursement, although physician-owned clinics may participate in a competitive acquisition program under Part B. Payments are the same for generic drugs and Brand Name Products, although they differed in the past. Pharmaceutical reimbursement is available for uses listed in compendia approved by the Centers for Medicare & Medicaid Services and possibly some other authoritative sources. CONCLUSION Medicare rules and rates for pharmaceutical reimbursement have undergone substantial changes in recent years and will continue to change in the future, with a potentially large impact on health systems and patients.