Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population

Kesselheim, Aaron S.; Franklin, Jessica M.; Kim, Seo Young; Seeger, John D.; Solomon, Daniel H.

doi:10.1007/s11606-015-3285-7

Cited by 20 publications

(13 citation statements)

References 15 publications

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“…The continuing decline in NSAID use observed in our study was contrasted by a modest increase in both colchicine and glucocorticoid use among gout patients over the study period. By comparison, a recent US-based study reported an increasing trend of colchicine initiation among those with newly diagnosed gout until the medication's substantial price increase in the US, after which colchicine initiation declined [42, 43]. Meanwhile, such a decline was not observed in the current Canadian setting where colchicine remains at its original low cost.…”

Section: Discussionmentioning

confidence: 99%

The rising prevalence and incidence of gout in British Columbia, Canada: Population-based trends from 2000 to 2012

Sharan

Aviña‐Zubieta

McCormick

et al. 2017

Seminars in Arthritis and Rheumatism

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Objectives Gout is increasingly recognized as the most common form of inflammatory arthritis worldwide; however, no Canadian data on the disease burden of gout are available. We estimated the prevalence, incidence, prescription patterns, and comorbidity burden of gout in an entire Canadian province (British Columbia [BC]) over the last decade. Methods We utilized PopulationData BC, a province-wide database, to estimate temporal trends in the prevalence and incidence of gout from 2000-2012, as well as according to age category. Annual estimates were age-sex-standardized using 2012 as the reference. We also examined annual trends in prescription patterns of common gout medications and assessed the comorbidity burden among gout patients in 2012. Results The 2012 prevalence of gout was 3.8% among the overall population, and the incidence rate was 2.9 per 1,000 person-years. Both gout prevalence and incidence increased substantially over the study period. This burden additionally increased according to age category, affecting over 8% of those ages 60-69 years in 2012. Approximately 22% of gout patients received a prescription for urate-lowering therapy (ULT), which remained stable over the study period, while colchicine and oral glucocorticoid use both increased modestly. By 2012, 72%, 52%, and 18% of prevalent gout patients had been diagnosed with hypertension, hyperlipidemia, and diabetes, respectively. Conclusions The burden of gout in BC, Canada, is substantial, and both the prevalence and incidence have increased over the past decade, while prescription of ULT remains low. These data support the need to improve gout prevention and care.

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Section: Discussionmentioning

confidence: 99%

The rising prevalence and incidence of gout in British Columbia, Canada: Population-based trends from 2000 to 2012

Sharan

Aviña‐Zubieta

McCormick

et al. 2017

Seminars in Arthritis and Rheumatism

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“…We extracted population-level data on prevalent statin use from the Optum Clinformatics research database, which covers 14 mil-lion current beneficiaries insured under UnitedHealth Group. [7][8][9][10] Eligible patients were 18 years or older, had at least 180 days of continuous enrollment, and had filled a prescription for at least 1 statin (atorvastatin, simvastatin, rosuvastatin, fluvastatin, pitavastatin, lovastatin, pravastatin, combined amlodipine besylate and atorvastatin, combined ezetimibe and simvastatin, combined atorvastatin and ezetimibe, combined niacin and simvastatin, or combined niacin and lovastatin) from December 1, 2010 (1 calendar year before the first generic entry), to May 31, 2013 (1 calendar year after full generic competition). This study was approved by the institutional review board of Brigham and Women's Hospital and Harvard Medical School, which waived the need for informed consent for the deidentified patient data.…”

Section: Data Source and Patient Populationmentioning

confidence: 99%

Effect of Generic Competition on Atorvastatin Prescribing and Patients’ Out-of-Pocket Spending

et al. 2016

Self Cite

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, the cholesterol level-lowering medication atorvastatin calcium became available in the United States as a generic drug. However, only a single generic form (from a manufacturer that qualified for market exclusivity by challenging several of Pfizer's patents) and an authorized generic form (a brand-name drug sold as a generic) were available for the first 180 days. OBJECTIVE To describe trends in the prescribing of generic atorvastatin after expiration of market exclusivity for the brand-name medication and the effect on patients' out-of-pocket spending. DESIGN, SETTING, AND PARTICIPANTS A US population-based study used commercial claims data from the Optum Clinformatics research database (UnitedHealth Group) from December 1, 2010, to May 31, 2013. Participants were 1 968 709 adults with commercial insurance who had been prescribed 1 or more statins (13 285 223 statin prescriptions). An interrupted times series model was used to examine the effect of limited and full generic competition on brand-name and generic atorvastatin prescriptions. Data were analyzed from December 1, 2010, to May 31, 2013. EXPOSURES Prescription of brand-name atorvastatin, generic atorvastatin, and authorized generic atorvastatin were distinguished using National Drug Codes. MAIN OUTCOMES AND MEASURES Total number of prescriptions dispensed per month and out-of-pocket expenditures for a typical 30-day supply of 20-mg atorvastatin during the periods of brand-name availability only, limited generic competition (lasting 180 days after market exclusivity ended), and full generic competition. RESULTS Of the 1 968 709 beneficiaries, 1 483 066 (58.8% male and 41.2% female; mean [SD] age, 55.6 [10.2] years) received a prescription for a single statin and were included in the analysis. The introduction of the first generic competitor was associated with a reduction in monthly brand-name atorvastatin fills by 20 896 prescriptions (level change, P = .001), an 18.1% change compared with the month preceding loss of exclusivity. Full generic competition reduced brand-name fills by 54 944 prescriptions (level change, P < .001), a 47.6% change relative to the month preceding loss of exclusivity. During the first 180 days of generic competition, no meaningful difference in monthly out-of-pocket spending was found between brand-name

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“…Previous articles have explored the historical background for the UDI 3,8,9 and characterized the experience of individual unapproved drugs, 3,[8][9][10][11][12] including the finding that prices and shortages of specific drugs increased after they were targeted by the UDI. [13][14][15][16][17] However, to…”

Section: Clinical Evidencementioning

confidence: 99%

The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States

Gupta

Dhruva

Fox

et al. 2017

JMCP

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This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholars program. Ross reports receiving research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing; from Medtronic and the FDA to develop methods for postmarket surveillance of medical devices; from the FDA to establish the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency at Yale. Fox reports travel support from Oklahoma Society of Health System Pharmacists, Premier Oncology Hematology Management Society, and SEHA-United Arab Emirates. Vizient provides some financial support to the University of Utah Drug Information Service to provide summaries of drug shortage information. Gupta and Ross were responsible for the conception and design of this work, drafted the manuscript, and conducted the statistical analysis. Gupta and Fox were responsible for acquisition of data. Ross provided supervision. All authors participated in the analysis and interpretation of the data and critically revised the manuscript for important intellectual content.

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Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population

Cited by 20 publications

References 15 publications

The rising prevalence and incidence of gout in British Columbia, Canada: Population-based trends from 2000 to 2012

The rising prevalence and incidence of gout in British Columbia, Canada: Population-based trends from 2000 to 2012

Effect of Generic Competition on Atorvastatin Prescribing and Patients’ Out-of-Pocket Spending

The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States

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