Off-label use and reimbursement of contrast media in MR

Runge, Val M.; Knopp, Michael V.

doi:10.1002/(sici)1522-2586(199909)10:3<489::aid-jmri35>3.0.co;2-1

Cited by 25 publications

(5 citation statements)

References 42 publications

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“…21 Based on its FDA approval for high dose central nervous system MRI, Omniscan may be preferentially utilized for high-risk, high contrast dose MRI applications, which would explain a disproportionate association with NSF. 30 Definitive data to refute this possibility are currently unavailable.…”

Section: Pathophysiologic Basis For Gadolinium Induced Nsfmentioning

confidence: 99%

Association of Gadolinium Based Magnetic Resonance Imaging Contrast Agents and Nephrogenic Systemic Fibrosis

2008

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Purpose To investigate the recently discovered association between gadolinium based MRI contrast agents and the development of nephrogenic systemic fibrosis (NSF) in patients with chronic kidney disease or acute kidney injury. Materials and Methods A systematic review of the PubMed database and publicly available patient databases was performed to characterize NSF and its possible association with exposure to gadolinium based MRI contrast agents. Results Data from case series reports, NSF patient databases, NSF case reporting to the Federal Drug Administration (FDA) after gadolinium contrast agent exposure, and retrospective case-control studies suggest a strong association between the use of gadolinium based MRI contrast agents and the subsequent development of NSF in patients with renal disease. These data also suggest that the risk of NSF depends on the degree of renal dysfunction, dose of contrast agent, gadolinium contrast agent stability, and severity of concomitant illness. Thus, the occurrence of NSF after gadolinium contrast agent exposure may vary from negligible up to 2–5% in select high-risk clinical situations. Conclusions MRI utilizing gadolinium based contrast agents must be undertaken judiciously in patients with renal dysfunction carefully weighing, on a case by case basis, the benefits of MRI and the risk of NSF as well as the disadvantages of undergoing alternative imaging studies or foregoing imaging studies.

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Section: Pathophysiologic Basis For Gadolinium Induced Nsfmentioning

confidence: 99%

Association of Gadolinium Based Magnetic Resonance Imaging Contrast Agents and Nephrogenic Systemic Fibrosis

2008

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“…This reflects standard practice as much of GBCA utilization is off-label, most notably MR angiography. This study was conducted in an independent medical program without financial support from industry, and the FDA judges this situation as acceptable for off-label use [35]. Off-label use promotes advances in medical imaging since there is little incentive for the pharmaceutical manufacturers to seek FDA approval for additional indications once a contrast agent has been approved [35].…”

Section: Discussionmentioning

confidence: 99%

“…This study was conducted in an independent medical program without financial support from industry, and the FDA judges this situation as acceptable for off-label use [35]. Off-label use promotes advances in medical imaging since there is little incentive for the pharmaceutical manufacturers to seek FDA approval for additional indications once a contrast agent has been approved [35]. This current study also serves as a contrast agent postmarketing surveillance and works to supplement the data of phase III trials [31].…”

Section: Discussionmentioning

confidence: 99%

Objective evaluation of acute adverse events and image quality of gadolinium-based contrast agents (gadobutrol and gadobenate dimeglumine) by blinded evaluation. Pilot study

Semelka

Hernandes

Stallings

et al. 2013

Magnetic Resonance Imaging

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“…Off-label use is daily routine in hospitals with up to 23% of the prescriptions identified as off-label in a French study [11]. Numerous reports from different specialities identify off-label applications [2,7,10,[13][14][15][16][17][18][19][20][21][22][23][24][25][26][27]. Off-label use may thus represent standard practice in a paediatric population.…”

Section: Clinical Relevance Of Off-label Usementioning

confidence: 99%

“…Since clinical trials and approval of new contrast agents and/or indications have become a financial burden; new strategies include obtaining a label for a single indication in order to control expenses and leave off-label applications to the medical community [1]. However, safety issues, legal issues and reimbursement for contrast agents are factors that need to be considered when using a contrast agent for an off-label indication [2].…”

Section: Introductionmentioning

confidence: 99%

Off-label use of contrast agents

Reimer

Vosshenrich²

2008

Eur Radiol

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When contrast agents are approved, the label describes the approved indications and particular circumstances of use such as age, organ function or pregnancy. The use of contrast agents outside their labelled indications is increasing, namely with contrast agents used for MRI. The aim of this paper is to improve the knowledge about this topic. The basis for off-label use is the physician's prerogative, which finds its basis in the "Declaration of Helsinki". Off-label use is allowed under special conditions and might be even the medical state of the art. The necessity for off-label use will continue to increase for MR-contrast agents, as the regulatory requirements for approval of new indications continuously increase, and clinical trials for registration purposes are quite costly and time consuming. As a consequence, manufacturers will concentrate on clinical studies for the essential indications.

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Off-label use and reimbursement of contrast media in MR

Cited by 25 publications

References 42 publications

Association of Gadolinium Based Magnetic Resonance Imaging Contrast Agents and Nephrogenic Systemic Fibrosis

Association of Gadolinium Based Magnetic Resonance Imaging Contrast Agents and Nephrogenic Systemic Fibrosis

Objective evaluation of acute adverse events and image quality of gadolinium-based contrast agents (gadobutrol and gadobenate dimeglumine) by blinded evaluation. Pilot study

Off-label use of contrast agents

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