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"off-label uses"

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Comparative Effectiveness of Recombinant Factor VIIa for Off-Label Uses vs. Usual Care in the Hospital Setting This slide set is based on the research presented in a comparative effectiveness review (CER) , Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care, that was developed by the Stanford-UCSF Evidence-based Practice Center for the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0017) and is available online at effectivehealthcare.ahrq.gov. The findings and conclusions in this document are those of the author(s), who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information presented here is intended to help health care decisionmakers—clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This information is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, that is, in the context of available resources and circumstances presented by individual patients. CERs represent systematic reviews of the literature and usually compare two or more types of treatments, such as different drugs, devices, or procedures, for the same disease. The talk will cover data collected from the Perspective Comparative Database of Premier, Inc., in Charlotte, NC (2000 to 2008), as well as the current evidence from 10 electronic databases, grey literature, trial registries, and reference lists that were searched. Finally, the manufacturer’s web site and files supplied by the manufacturer of rFVIIa (Novo Nordisk) were reviewed, bibliographies of identified meta-analyses and systematic reviews were searched, and experts in the field were contacted to uncover studies not already identified by these searches. The methods used to develop this CER followed version 1.0 of the Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews published by AHRQ (draft available at: http://effectivehealthcare.ahrq.gov/repFiles/2007_10DraftMethodsGuide.pdf).
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Comparative Effectiveness of Recombinant Factor VIIa for Off-Label Uses vs. Usual Care in the Hospital Setting

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: hospital setting | off-label | recombinant factor VIIa | systematic review | U.S. Department of Health and Human Services | comparative effectiveness
Off-Label Uses of rFVIIa The use of rFVIIa for off-label clinical indications originates in the ability of rFVIIa to “bypass” multiple defects in the coagulation pathway. These uses are listed by their relative proximity to the FDA approved uses. The following categories suggest increasing extension of rFVIIa use into clinical areas with diminishing similarity to the FDA approved uses. Chronic prophylactic use in hemophilia A and B in the absence of bleeding episodes or procedures. While not approved by the FDA, this form of use has been approved in Australia. Episodic use in other congenital and acquired clotting factor defects, including hemophilia C, von Willebrand’s disease, and factor VII deficiency, as well as in other rare coagulopathies. Episodic use for isolated congenital or acquired clotting defects that arise from deficiency or dysfunction of other components of the coagulation process. This includes platelet dysfunction, such as Glanzmann’s thrombasthenia, which has been approved by the EMEA but not the FDA. Episodic use in disease states where impaired coagulation is but one manifestation. Liver disease is a prominent example, but other conditions include leukemia, lymphoma, and other cancers. Episodic use where anticoagulant therapy contributes to bleeding problems beyond what would exist otherwise. This includes patients on warfarin and those undergoing cardiac surgery with cardiopulmonary bypass that requires heparin anticoagulation. Clinical circumstances where a consumptive coagulopathy has developed as the result of substantial and rapid blood loss. In practice, this often includes trauma patients and those with massive gastrointestinal bleeding. Situations where significant blood loss is anticipated in the absence of pre-existing coagulopathy, as with prophylactic use of rFVIIa in prostatectomy or vascular surgery. Clinical situations requiring prompt cessation of traumatic, surgical, or spontaneous bleeding in non-coagulopathic patients where hemorrhage extension is associated with significant adverse outcomes, as occurs with intracranial hemorrhage, brain surgery, and pulmonary hemorrhage.
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Off-Label Uses of rFVIIa

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: bleeding | clotting factor defects | consumptive coagulopathy | hemophilia | off-label uses | recombinant factor VIIa | comparative effectiveness
The CER Development Process (1) The comparative effectiveness review (CER) topic, Comparative Effectiveness of Recombinant Factor VIIa for Off-Label Uses vs. Usual Care in the Hospital Setting, was nominated in a public process. The nominated topic was reviewed and selected based on need, importance, and feasibility. Sufficient research into the current literature by experts in the field and stakeholders determined that a CER on the off-label usage trends and benefits and harms for select patient populations was needed and would not duplicate existing work. Based on this research, key clinical questions that the report would address were developed and made available for public comment. The Agency for Healthcare Research and Quality (AHRQ) then commissioned the Stanford-UCSF Evidence-Based Practice Center to prepare the CER with input from a Technical Expert Panel. This advisory panel was comprised of experts in different specialties, including anesthesiology, pediatric hematology/oncology, transplantation, pathology, hematology, pharmacology, trauma surgery, and drug risk management. The panel identified important issues, reviewed proposed methods, defined parameters for the review of evidence, and helped develop the draft report.
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The CER Development Process (1)

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | topic nomination | stakeholder | technical expert panel | research process
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Overview of In-Hospital, Off-Label vs. On-Label rFVIIa Use From the Premier Database (2000–2008)

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | Premier Database | adult cardiac surgery | body trauma | spontaneous intracranial hemorrhage
Additional Off-Label Uses of rFVIIa Requiring Future Research Surgery-related uses include: management of abdominal aortic aneurysm (with and without surgical intervention), pediatric cardiac surgery, vascular surgeries (not related to abdominal aortic aneurysm), and surgical procedures beyond cardiac and vascular surgery.
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Additional Off-Label Uses of rFVIIa Requiring Future Research

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | future research
Additional Off-Label Uses of rFVIIa Requiring Future Research Medical conditions include: cancer-related conditions, gastrointestinal bleeding not related to liver disease, hematopoietic stem cell transplantation, liver disease (other than transplantation), neonatal conditions (beyond cardiac surgery), obstetrical conditions, primary clotting disorders (other than hemophilia), pulmonary conditions (e.g., pulmonary hemorrhage, pulmonary transplantation), and secondary clotting disorders (e.g., complications of warfarin anticoagulation).
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Additional Off-Label Uses of rFVIIa Requiring Future Research

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | future research
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Clinical Questions Addressed by the Comparative Effectiveness Review (1 of 2)

Presentation: Off-Label Use of Atypical Antipsychotics: An Update
Keywords: antipsychotics | atypical antipsychotics | off-label | second generation | utilization | comparative effectiveness | efficacy
 
 
 
 
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