Dec 23, 2019 profound via comtex the report provides rational insights along with historical and forecast data to aid in better understanding of the. Erythropoiesis stimulating agents esa are used commonly to reduce symptomatic anemia in patients with myelodysplastic syndromes mds. Following input from the esrd community, cms implemented the first iteration of the national esa monitoring policy emp, effective for dates of service april 1, 2006, and later change request cr 45 dated november 10, 2005. Decision memo for erythropoiesis stimulating agents esas. Product variations n no product variation, policy applies as stated. Covered chronic diseases include, rheumatoid arthritis, systemic lupuserythematosis, chronic hepatitis c, crohns disease and ulcerative colitis. Chronic kidney diseaseerythropoiesisstimulating agents.
It is produced by cloning the gene for erythropoietin. Erythropoietin stimulating agents market by current industry status,growth opportunities, top key players, target audience and forecast to 2026. Erythropoietin induces cancer cell resistance to ionizing radiation and to cisplatin. Erythropoiesisstimulating agents esas have been used to manage anemia in chronic kidney disease. In cancer patients, anemia is multifactorial, resulting from cancer treatment, anemia of malignancy, blood loss, impaired production of or response to erythropoietin, and dysregulation of iron metabolism decreased dietary iron intake, absorption, and utilization. Corporate medical policy erythropoiesisstimulating agents. Description of procedure or service endogenous erythropoietin epo is a glycoprotein hematopoietic growth factor synthesized at the. Erythropoietin definition of erythropoietin by the free. At this meeting, the results of study n93004 the agreedon postmarketing study, the best study, 2 and the enhance study 3 were discussed. Epoetin beta is an erythropoiesisstimulating agent esa indicated for the. Claims processing manual, chapter 8 outpatient esrd hospital. Glycoprotein hormone which stimulates red blood cell formation in higher organisms. Esa resistance, or hyporesponsiveness, is a term used to describe patients who do not achieve the desired hemoglobin hb concentration despite higher than usual doses of esas or who require increasingly higher esa doses to maintain an. Jacques, md director, coverage and analysis group tamara syrek jensen, jd deputy director, coverage and analysis group james rollins, md, phd division director kimberly long lead.
Drug administration fda for the treatment of anemia in patients with. Recombinant erythropoietin epo and its analogues have been frequently misused in sports as doping agents. Because of the confounding interaction of its risk factors, initial evaluation should include nutrition. Erythropoiesisstimulating agents are used to treat anemia and kidney disease. Erythropoietin stimulating agents esa are drugs used for anemia management for patients with renal disease. Routine clinical and laboratory assessments facilitate diagnosis of erythropoietin epo resistant anemia by allowing early identification of patients with nonadherence. Erythropoietin stimulating agents esas for endstage renal disease related anemia in a renal dialysis facility. Patterns of erythropoiesisstimulating agent use among. Recent studies from a variety of sources would seem to establish the existence of a humoral substance capable of stimulating erythropoiesis and, under certain experimental conditions, even producing a polycythemic state. Medicare cd medical coverage policy erythropoietin. As a result, the alleged erythropoietins tissue protective potential has already been investigated in clinical trials, for example, in brain and heart diseases. Esas are unproven to treat anemia of ckd in patients on dialysis for a. Epoetin alfa epogen, procrit, epoetin alfa epbx retacrit are considered medically necessary.
Erythropoiesisstimulating agents esas are commonly used to treat anemia associated with chronic kidney disease ckd. Erythropoiesisstimulating agents esas, such as recombinant human epoetin rhepo and darbepoetin, are recombinant glycosylated analogs of erythropoietin epo that have been used to relieve chemotherapyinduced anemia in cancer patients glaspy, 2009a, sytkowski, 2007. Erythropoiesis stimulating agents esa includes the following products. The efficacy of erythropoietinstimulating agents esas for improving healthrelated quality of life hrqol in anemia of chronic kidney disease ckd is unclear. Dosing, uses, side effects, interactions, patient handouts, pricing and more from medscape reference. Effects of the dose of erythropoiesis stimulating agents. Anemia is common in patients with cancer or with chronic kidney disease ckd.
Subsequently, in may 2007, fda convened another odac meeting to reassess the safety and effectiveness of esas in patients with cancer. It is uncertain whether the adverse effects of esa therapy are related to dose and are mitigated when a fixed low esa dose is used. Types of erythropoietinstimulating agents and mortality. Documentation to support coverage requirements as indicated in erythropoiesis stimulating agents local coverage determination lcd and national coverage determination ncd 110. Esas are biologically engineered hormones produced by recombinant dna technology.
Transfusion, erythropoiesisstimulating agent therapy, and. Aranesp darbepoetin alfa, also known as novel erythropoiesis stimulating protein nesp, is an erythropoiesis stimulating protein closely related to erythropoietin that is produced in chinese hamster ovary cells by recombinant dna technology. The role of erythropoietin and erythropoiesisstimulating agents in tumor progression. Final page is signature page and is kept on file, but not issued with policy. Aranesp darbepoetin alfa epogen, procrit epoetin alfa mircera methoxy polyethylene glycolepoetin beta retacrit epoetin alfaepbx i. Background despite the widespread use of erythropoietinstimulating agents esas to treat anemia in patients undergoing hemodialysis, the relative mortality. Study n93004, conducted in patients with smallcell lung cancer undergoing treatment with chemotherapy and radiotherapy, was terminated early by the sponsor, due to slow accrual rates. An erythropoietin stimulating agent esa is an analog of erythropoietin. Erythropoiesisstimulating agents in renal medicine article pdf available in the oncologist 16 suppl 3suppl 3.
We assessed populationbased patterns of esa use relative to treatment guidelines using data from the surveillance, epidemiology, and end results seer registries, with linked medicare claims providing detailed treatment data from. Recombinant erythropoietin drugs are known as erythropoietinstimulating agents esas. Pdf erythropoiesisstimulating agents in renal medicine. Application for erythropoietinstimulating agents world health. Help with file formats and plugins home a federal government website managed and paid for by the u. Evaluations of possible indicators of response to these agents have included serum erythropoietin levels, ferritin levels, and change in hemoglobin levels or reticulocyte count in the first four weeks of therapy but demonstrated weak associations across the board. Effect of erythropoiesisstimulating agents on blood pressure in predialysis patients, plos one, 20, volume 8, issue 12, doi. The purpose of this study was to examine the impact of blood transfusion and erythropoiesis stimulating agent therapy on renal transplant wait time. They are indicated in end stage renal disease esrd patients and approved by the. They work by increasing red blood cells in the blood. Clinical outcomes with use of erythropoiesis stimulating. Low versus high dose erythropoiesisstimulating agents in.
Listing a study does not mean it has been evaluated by the u. Guiding principles for the quality use of offlabel. They are used to treat anemia due to end stage kidney disease, chemotherapy, major surgery, or certain treatments in hivaids. We conducted a multicenter, prospective randomized openlabel, blindedendpoint probe. Use of erythropoiesis stimulating agents esas in patients with left ventricular assist devices lvads may minimize blood transfusions and decrease allosensitization. Erythropoiesisstimulating agents esas are produced using recombinant dna technologies. This article provides information on new erythropoieticstimulating agents that aim to meet one or more of these criteria. Use of erythropoietinstimulating agents in breast cancer. Comparison among erythropoietin stimulating agents. These drugs are given by injection shot and work by stimulating the production of more red blood cells. Esas will be used to refer to all erythropoiesis stimulating agents. Comparison among erythropoietin stimulating agents full. Although the introduction of erythropoiesisstimulating agents esas has transformed the management of anemia, their use has been complicated by a number of factors including frequent guideline updates, safety concerns and, in the united states, a risk evaluation and mitigation strategy. Erythropoiesis stimulating proteins epoetin alfa epo.
History of erythropoiesisstimulating agents, the development of. Erythropoiesis stimulating agents esas, administered to esrd patients receiving dialysis in a renal dialysis facility. See the medicare benefit policy manual, chapter 15, 50. The data considered at this meeting included a mix of published studies, summary results from closed studies provided to the us fda by the sponsors or others, and primary data from closed studies data provided to the us.
Erythropoietin german erythropoietine french eritropoyetina spanish erythropoiesis stimulating factor is hemopoietine is erythropoietin ph. The increased risks of death and adverse events with erythropoiesisstimulating agent esa therapy targeting a higher hemoglobin level are established. Fc, a fusion protein consisting of erythropoietin and the fc region of human igg 1, interacts with the neonatal fc receptor fcrn on lung epithelial cells and hence enables simple administration of epo by inhalation. In these situations they decrease the need for blood transfusions. The effect of erythropoietinstimulating agents on healthrelated. Erythropoiesisstimulating agents prices and information. Group service agreement, evidence of coverage, certificate of.
Full text the role of erythropoietin stimulating agents. Erythropoietin stimulating agents market by current. Therapeutic class overview erythropoiesisstimulating agents. Internal only renal department, revised 20 page 1 of 4 erythropoietin stimulating agents indications for use. Patients who have cancer, particularly those undergoing chemotherapy, frequently become anemic. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The role of erythropoietin stimulating agents in anemic patients with heart failure. Therapy with erythropoiesisstimulating agents esas is associated with an increase in hemoglobin levels, a reduction in transfusion requirements, and, according to many clinical trialists and experienced clinicians, an improvement in functional status, productivity. The use of erythropoiesisstimulating agents in patients with ckd. Clinical studies have found that erythropoietin stimulating agents esas increase. Effect of erythropoiesisstimulating agents on blood.
Information on erythropoiesisstimulating agents esa epoetin alfa marketed as procrit, epogen, darbepoetin alfa marketed as aranesp aranesp medication guide pdf 210kb darbepoetin alfa. To determine the effect of esas on hrqol at different hemoglobin targets in adults with ckd who were receiving or not receiving dialysis. Erythropoiesisstimulating agents esa are medications which stimulate the bone marrow to make red blood cells. Clinical trial results indicate that approximately 40% of selected patients have a clinically meaningful hemoglobin response to esas, with a median twoyear response 5 7. They were initially developed as replacement therapy to treat anemia due to endogenous erythropoietin deficiency that commonly occurs in individuals with chronic renal failure crf secondary to ckd. Erythropoietin analogs contain the identical amino acid sequence as naturally occurring erythropoietin, and have the same biological effect. Esa monitoring policy, effective october 1, 2006 pdf. Erythropoiesis stimulating agents esas this article contains instructions for coding medical necessity in accordance with both the national coverage determination ncd and local coverage determination lcd and other cms instructions on darbepoetin alfa aranesp, dpa and epoetin alfa epogen, procrit, epo. Recombinant erythropoietin is a manmade version of natural erythropoietin. Erythropoietin stimulating agents esa are commonly used to increase hemoglobin levels in this population. Erythropoietin stimulating agents market 2019 with top. Patterns of erythropoiesis stimulating agent use among.
A glycoprotein hormone that stimulates the production of red blood cells by stem cells in bone marrow. Before the introduction of esas, the only treatment option for cancerrelated. Erythropoietinstimulating agents in anemia of chronic. Anemia is a risk factor for death, adverse cardiovascular outcomes and poor quality of life in patients with chronic kidney disease ckd. We advocate the inclusion of erythropoietinstimulating agents in the.
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