The kidneys make a hormone called erythropoietin that stimulates the bone marrow to make more red blood cells. Erythropoiesisstimulating agents clinical criteria information included in this document erythropoiesisstimulating agents aranesp drugs requiring prior authorization. Download erythropoiesis stimulating agents book pdf free download link or read online here in pdf. When erythropoiesis stimulating agents esas are covered. Medicare cd medical coverage policy erythropoietin. Effect of erythropoiesisstimulating agents on blood pressure. Erythropoiesisstimulating agents pdf book manual free.
Erythropoiesisstimulating agents esa such as recombinant human erythropoietin rhepo and erythropoietin analogues are sometimes used in horses with the intention to enhance athletic performance this form of doping is dangerous and can lead to severe pure red cell aplasia. Pdf erythropoiesisstimulating agents in renal medicine. Final page is signature page and is kept on file, but not issued with policy. Covered chronic diseases include, rheumatoid arthritis, systemic lupuserythematosis, chronic hepatitis c, crohns disease and ulcerative colitis. The gold standard for managing anemia of ckd is the use of erythropoiesisstimulating agents esas. Group service agreement, evidence of coverage, certificate of. The four currently available erythropoiesisstimulating agents esas, the main drugs for correcting anemia in patients with chronic kidney disease ckd, are epoetin alfa, epoetin beta, darbepoetin alfa, and continuous erythropoietin receptor activator. Incomplete forms will be returned for additional information. Pdf erythropoiesis stimulating agents researchgate. A prescription survey on erythropoiesisstimulating agents esa for treatment of anemia associated with chronic kidney disease ckd was conducted in. Effect of erythropoiesisstimulating agents on blood pressure in predialysis patients, plos one, 20, volume 8, issue 12, doi. If you continue browsing the site, you agree to the use of cookies on this website. Esas are biologically engineered hormones produced by recombinant dna technology. When administering erythropoiesis stimulating agents, it is important for the nurse to.
Internal only renal department, revised 20 page 1 of 4 erythropoietin stimulating agents indications for use. The four currently available erythropoiesis stimulating agents esas, the main drugs for correcting anemia in patients with chronic kidney disease ckd, are epoetin alfa, epoetin beta, darbepoetin alfa, and continuous erythropoietin receptor activator. 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 agents injectable medication. Anemia is common in patients with cancer or with chronic kidney disease ckd. The lack of endogenous erythropoietin production in patients with chronic kidney disease ckd results in the development of anemia, which is associated with impaired quality of life, and increased morbidity and mortality. This site is like a library, you could find million book here by using search. Erythropoiesis stimulating agents esa includes the following products. Chronic kidney diseaseerythropoiesisstimulating agents. Erythropoiesis stimulating agents esa cvs caremark. 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. The aim of this study was to identify predictors of esa hyporesponsiveness in patients with chronic kidney disease ckd or cancer in clinical practice.
Information on erythropoiesisstimulating agents esa epoetin alfa. The efficacy of erythropoietinstimulating agents esas for improving healthrelated quality of life hrqol in anemia of chronic kidney disease ckd is unclear. Treatment with esas that resulted in higher hemoglobin levels increased risks for stroke, worsening hypertension, and vascular access thrombosis more than strategies that resulted in lower hemoglobin levels. Treatment is indicated for patients at high risk for perioperative transfusions with significant, anticipated blood loss, for example, for patients expected to lose greater than two units of blood. Concurrent initial use of erythropoiesis stimulating agents and granulocyte colonystimulating factor in medicare beneficiaries with myelodysplastic syndromes, patients initiating esa use after mds diagnosis experienced 11,755 distinct episodes of esa treatment, representing a mean of 3.
Erythropoiesisstimulating agents time for a reevaluation. Although epoetin alfa and darbepoetin alfa, a related erythropoiesis stimulating agent esa approved in 2001, have been widely accepted for this indication, optimal hemoglobin targets have never. If there are not enough red blood cells in the body, a person is said to be anemic. Erythropoiesisstimulating agents are not associated with increased risk of thrombosis in patients with myelodysplastic syndromes by sheila weiss smith, masayo sato, steven d. Therapeutic class overview erythropoiesisstimulating agents therapeutic class overviewsummary. Erythropoiesis stimulating agents esas, developed as replacement therapy for anaemia in cases of epo deficiency, are produced using recombinant dna technology. Erythropoietinstimulating agents in anemia of chronic kidney. An independent licensee of the blue cross and blue shield association. Read online erythropoiesisstimulating agents book pdf free download link book now.
Baer, xuehua ke, diane mcnally, and amy davidoff haematologica 2011 epub ahead of print. Erythropoiesis stimulating agents esas boost the production of red blood cells and as such may play a role in optimising red cell mass pbm pillar 1 in specific groups of patients. This article provides information on new erythropoieticstimulating agents that aim to meet one or more of these criteria. Bcbsa medical policy reference manual electronic version. Erythropoiesis stimulating agents 2 high risk for perioperative transfusions with significant, anticipated blood loss, for example, for patients expected to lose greater than two units of blood. Takeshi nakanishi, hidetomo nakamoto, takao masaki. All structured data from the file and property namespaces is available under the creative commons cc0 license. Erythropoiesis stimulating agents esas will be considered for coverage under the pharmacy benefit program when the following criteria are met. Proposed decision memo for erythropoiesis stimulating agents. Erythropoiesis stimulating agents esas blue cross nc. Erythropoiesis stimulating agents esas boost the production of red blood cells and as such may play a role in optimising red cell mass pbm pillar 1 in specific groups of. Erythropoietinstimulating agents in anemia of chronic. Therapeutic class overview erythropoiesisstimulating agents.
Thiscellularprocess is characterised by commitment and differentiation steps that restrict the. Erythropoiesis stimulating agents esa includes the following. The erythropoiesisstimulating agents esas currently available are darbepoetin alfa aranesp, epoetin alfa epogen, procrit and peginesatide omontys. Key messages y esas are a method of optimising red cell mass pbm pillar 1 y esas are an authority item on the pharmaceutical benefits scheme pbs with a limited. Mar 31, 2007 erythropoiesis stimulating agents article pdf available in bmj online 3347595. Aetna considers erythropoiesis stimulating agents experimental and investigational for all other indications, including the following conditions, because its use in these. The proposed underlying pathophysiologic mechanism is the production of antierythropoietin. Corporate medical policy erythropoiesisstimulating agents esas.
These progenitors develop into recognizable erythroid precursors, which subsequently follow a specific differentiation program that culminates in the emergence of mature erythrocytes. Erythropoiesisstimulating agents are not associated with. In this chapter, the control of epo levels and erythropoiesis, the various forms of esas used commercially, and their physical and biological. Erythropoiesisstimulating agents in renal medicine. The use of epoetin alfa, darbepoetin, or pegylated pegepoetin beta may be considered medically necessary for. History of erythropoiesisstimulating agents, the development of. Information on erythropoiesisstimulating agents esa epoetin alfa marketed as procrit, epogen, darbepoetin alfa marketed as aranesp aranesp medication guide pdf 210kb darbepoetin alfa. When administering erythropoiesisstimulating agents, it is important for the nurse to. Read online erythropoiesis stimulating agents book pdf free download link book now. Erythropoiesis stimulating agents esas are abused by athletes because they increase the oxygencarrying capacity of the blood by stimulating red blood cell production 25.
Description of procedure or service endogenous erythropoietin epo is a glycoprotein hematopoietic growth factor synthesized at the. Oct 18, 2010 successful cloning of the epo gene allowed for the first time production of recombinant human erythropoietin and other erythropoiesis stimulating agents esas, which are used to treat anemia in patients. Dose of erythropoiesisstimulating agents and adverse. Epoetin alfa and darbepoetin alfa are erythropoiesisstimulating agents esas, approved for the treatment of anemia low red blood cells. Epoetin alfa epogen, procrit, epoetin alfa epbx retacrit are considered medically necessary. This publication has been supported by an unrestricted educational grant from. This difference in the marrow reflects the fact that the average life span of white cells is short, whereas that of red. Duringmammaliandevelopment,erythropoiesisoccurs successivelyintheyolksac,thefoetalliverandthebonemarrow. They work by increasing red blood cells in the blood. Effect of erythropoiesis stimulating agents on blood pressure in predialysis patients, plos one, 20, volume 8, issue 12, doi. Erythropoiesisstimulating agents esas have been used to manage anemia in chronic kidney disease.
In these situations they decrease the need for blood transfusions. Drug administration fda for the treatment of anemia in patients with. Higher telomerase activity, overexpression of human telomerase reverse transcriptase htert and shorter telomeres predict for shorter overall survival in lrmds. They are used to treat anemia due to end stage kidney disease, chemotherapy, major surgery, or certain treatments in hivaids. Erythropoiesis stimulating agents article pdf available in bmj online 3347595. When erythropoiesisstimulating agents esas are covered. Drugs called esas erythropoiesisstimulating agents are similar to our own erythropoietin. These socalled recombinant epoetins, first introduced in 1986, are available as epoetins alpha, beta, delta and omega each differing from the endogenous protein, and from each other.
Treatment of anemia associated with chronic kidney disease if. Proposed decision memo for erythropoiesis stimulating. Erythropoietin stimulating agents policies cms has policies that effect the use of erythropoietin stimulating agents in esrd facilities. Controversial postmarketing data exist on the predictors of esa hyporesponsiveness. In search of potential predictors of erythropoiesis. All books are in clear copy here, and all files are secure so dont worry about it. Esa monitoring policy, effective october 1, 2006 pdf esa monitoring policy, effective april 1, 2006 pdf chapter 11 end stage renal disease esrd pdf chapter 8 outpatient esrd hospital, independent. Successful cloning of the epo gene allowed for the first time production of recombinant human erythropoietin and other erythropoiesis stimulating agents esas, which are used to treat anemia in patients. Erythropoiesisstimulating agents pharmacy coverage policy.
Although epoetin alfa and darbepoetin alfa, a related erythropoiesisstimulating agent esa approved in 2001, have been widely accepted for this. The axial skeleton normally, 75% of the cells in the marrow belong to the white blood cellproducing myeloid series and only 25% are maturing red cells, even though there are over 500 times as many red cells in the circulation as there are white cells. In mammals, definitive erythropoiesis first occurs in the fetal liver with progenitor cells from the yolk sac. The patient has adequate iron stores confirmed by ferritin levels greater than100 mcgl or serum transferrin. Apr 05, 2016 the efficacy of erythropoietin stimulating agents esas for improving healthrelated quality of life hrqol in anemia of chronic kidney disease ckd is unclear. Evidences show that around 20% of biosimilar or originator erythropoiesisstimulating agents esas users are hyporesponsive.
Erythropoiesis is the pathway that produces mature red blood cells from haematopoieticstemcells. Patterns of erythropoiesisstimulating agent use among. The use of erythropoiesisstimulating agents in patients with ckd. Aranesp darbepoetin alfa epogen, procrit epoetin alfa mircera methoxy polyethylene glycolepoetin beta retacrit epoetin alfaepbx i. Esas will be used to refer to all erythropoiesis stimulating agents. Download erythropoiesisstimulating agents book pdf free download link or read online here in pdf. Recommended baseline and followup laboratory monitoring check boxes to order desired labs baseline hemoglobin hematocrit on day 1 if not available. Effect of erythropoiesisstimulating agents on blood. Although the introduction of erythropoiesis stimulating 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 rems program, which aimed. Erythropoiesisstimulating agents pdf book manual free download. Epo is a protein hormone 165 amino acids primarily synthesized by the kidneys that contains 3 n glycan and 1 o glycan side chain. An erythropoietin stimulating agent esa is an analog of erythropoietin. Corporate medical policy erythropoiesisstimulating agents. The maximum dosage of erythropoietin should not exceed a total of 60,000 units per week 5.
Erythropoietin analogs contain the identical amino acid sequence as naturally occurring erythropoietin, and have the same biological effect. Erythropoiesis begins with the differentiation of a small pool of multipotent stem cells into the most primitive erythroid progenitors. Cms has policies that effect the use of erythropoietin stimulating agents in esrd facilities. Erythropoiesisstimulating agents aranesp, epogen, procrit preauthorization request physician fax form only the prescriber may complete and fax this form. The following documentation is required for preauthorization.
The last two have much longer halflives, which means they can be administered less frequently. Erythropoiesisstimulating agents esas are produced using recombinant dna technologies. To determine the effect of esas on hrqol at different hemoglobin targets in adults with ckd who were receiving or not receiving dialysis. Dosing, uses, side effects, interactions, patient handouts, pricing and more from medscape reference. Erythropoietin stimulating agents esas 3 erythropoietin directly and other causes of anemia have been ruled out.
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