Nearly two decades ago, recombinant human erythropoietin transformed the management of chronic kidney disease anemia by allowing a more sustained increase in hemoglobin than was possible by intermittent blood transfusion. More recent trials using esa doses with hgb targets similar to current goal levels in ckd have not confirmed this increased risk of. The maximum dosage of erythropoietin should not exceed a total of 60,000 units per week 5. Erythropoiesisstimulating agents esas have been used to manage anemia in chronic kidney disease ckd to reduce transfusion requirements and anemia symptoms. Who eml 20162017 erythropoietinstimulating agents december 2016. Erythropoietin acts synergistically with gcsf to inhibit erythroid apoptosis and promote erythrocyte production. Decision memo for erythropoiesis stimulating agents esas.
Erythropoietinstimulating agents erythropoietin epo is produced by the kidney and used to make red blood cells. Aranespti is a 165amino acid protein that differs from recombinant human erythropoietin in containing 5 nlinked oligosaccharide. Chronic kidney diseaseerythropoiesisstimulating agentsbiosimilar. February 16, 2010 erythropoiesisstimulating agents esas. Further increases may be made at 4week intervals until the specified hemoglobin is obtained. Recombinant human erythropoietin rhuepo and other erythropoiesisstimulating agents esa were synthesized after the initial cloning of the human erythropoietin epo gene sequence discovered in 1985 and have provided an alternative to transfusion for increasing red blood cell mass and treating anemia. More recent trials using esa doses with hgb targets similar to current goal levels in ckd have not confirmed this increased. Background despite the widespread use of erythropoietinstimulating agents esas to treat anemia in patients undergoing hemodialysis, the relative mortality. Therapeutic class overview erythropoiesisstimulating agents therapeutic class overviewsummary.
Arterial hypertension induced by erythropoietin and erythropoiesisstimulating agents esa reto krapf, henry n. Dosing, uses, side effects, interactions, patient handouts, pricing and more from medscape reference. Pdf erythropoietin stimulating agents in the management. This policy addresses the following erythropoiesisstimulating agents esas. In these situations they decrease the need for blood transfusions. Are all erythropoiesisstimulating agents created equal. Erythropoetinstimulating agents are used often for people with longterm kidney disease and anemia. The safety of erythropoiesisstimulating agents in cancer. January 1, 2020 page 2 of 6 aranesp is covered for the following indications. Erythropoiesisstimulating agents prices and information. Anemia is common in patients with acute neurological disorders and may be a cause of secondary insults. Erythropoietin stimulating agents in the management of anemia of chronic kidney disease.
They are used to treat anemia due to end stage kidney disease, chemotherapy, major surgery, or certain treatments in hivaids. Erythropoiesisstimulating agents esas have been implicated in causing cancer progression. It is produced by cloning the gene for erythropoietin. Cms has policies that effect the use of erythropoietin stimulating agents in esrd facilities. Erythropoiesisstimulating agents esas are effective drugs that correct and maintain haemoglobin hb at an appropriate level in the majority of anaemic patients with chronic kidney disease ckd, thus reducing fatigue, increasing quality of life and decreasing the need for blood transfusions. Covered chronic diseases include, rheumatoid arthritis, systemic lupuserythematosis, chronic hepatitis c, crohns disease and ulcerative colitis. The role of erythropoietin and erythropoiesisstimulating agents in tumor progression benjamin d. An inverse relationship between hyporesponsiveness and incident cardiovascular events has been reported.
Information on erythropoiesisstimulating agents esa. Medicare cd medical coverage policy erythropoietin. History of erythropoiesisstimulating agents, the development of. Erythropoietin epo is an amino acid glycoprotein hormone synthesized and secreted by interstitial cells to stimulate the production of red blood cells in the bone marrow in response to falling levels of oxygen in the tissues. Erythropoietin stimulating agents esas 3 erythropoietin directly and other causes of anemia have been ruled out. Therapeutic class overview erythropoiesisstimulating agents. 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. Erythropoiesisstimulating agents esas are produced using recombinant dna technologies. Epo is a protein hormone 165 amino acids primarily synthesized by the kidneys that contains 3 n glycan and 1 o glycan side chain. Erythropoietin and erythropoiesis stimulating agents.
The median duration of response is 23 years, with patients responding for more than a decade. Esa monitoring policy, effective october 1, 2006 pdf. Erythropoiesisstimulating agents page 1 of 14 unitedhealthcare commercial medical benefit drug policy effective 01012020. Erythropoiesisstimulating agents are used to treat anemia and kidney disease. 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. The use of erythropoiesisstimulating agents in patients with ckd. These drugs are given by injection shot and work by stimulating the production of more red blood cells. There is a lack of relliable evidence that one brand of erythropoietin alpha procrit or epogen. Capitals indicate lifethreatening, underlines indicate most frequent. Erythropoietinstimulating agents in anemia of chronic. The role of erythropoietin and erythropoiesisstimulating. Erythropoietin stimulating agents are similar to erythropoietin, as it stimulates the growth of red blood cells.
The erythropoiesisstimulating agents esas currently available are darbepoetin alfa aranesp, epoetin alfa epogen. Epoetin alfa and darbepoetin alfa are erythropoiesisstimulating agents esas, approved for the treatment of anemia low red blood cells resulting from chronic kidney disease, chemotherapy. Erythropoiesisstimulating agents esas came into widespread use after they became available in the late 1990s, especially in the metastatic cancer setting. They work by increasing red blood cells in the blood.
Treatment with erythropoiesisstimulating agents esas is firstline treatment for the anemia of most patients with mds. Recombinant erythropoietin is a manmade version of natural erythropoietin. Reimbursement policy erythropoietin stimulating agent esa level of less than 500 muml are more likely to respond to erythropoiesisstimulating agent esa therapy. Subsequently, in may 2007, fda convened another odac meeting to reassess the safety and effectiveness of esas in patients with cancer. This belief has been largely based on trials in the early 2000s of esa use in malignancy with high hemoglobin hgb targets and large esa doses to attain the targets. Patients receiving zidovudine with endogenous serum erythropoietin levels 500 munitsml may not respond. 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.
Erythropoiesis stimulating agents esas have been implicated in causing cancer progression. Erythropoiesisstimulating agents esas have been used to manage anemia in chronic kidney disease. Aetna medicare form erythropoiesis stimulating agents. Benefits and risks in supportive care of cancer article pdf available in current oncology 15suppl 1. Erythropoietin analogs contain the identical amino acid sequence as naturally occurring erythropoietin, and have the same biological effect. The treatment was highly effective, but because of the fairly short halflife of the molecule at approximately 6 to 8 h. Erythropoietin stimulating agents in the management of anemia of chronic kidney disease article pdf available in patient preference and adherence 2. Epo, also known as erythropoetin, haematopoietin, or haemopoietin, is a glycoprotein cytokine secreted mainly by the kidney in response to cellular hypoxia. Types of erythropoietinstimulating agents and mortality. The use of erythropoiesisstimulating agents in patients. Anemia secondary to myelodysplastic syndrome mds o treatment of lower risk disease associated with symptomatic anemia.
Lack of objective benefit of normalizing hemoglobin hb levels and increased evidence of esainduced complications in persons with anemia has resulted in clinicians generally attempting to. Endogenous erythropoietin is a glycoprotein hematopoietic growth factor that regulates hemoglobin levels in response to changes in the blood oxygen concentration. In the neuro icu, there are two potential uses for treatment with epo. Unitedhealthcare medicare advantage policy guideline.
Recombinant erythropoietin drugs are known as erythropoietinstimulating agents esas. 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. Hyporesponsiveness to erythropoietin stimulating agents occurs frequently, and may be observed at initiation of treatment or during maintenance therapy. Erythropoiesis stimulating agents esa are considered experimental, investigational or unproven for any other indication including the following. Erythropoietin and erythropoiesisstimulating agents. Effective april 1, 2006 pdf chapter 11 end stage renal disease esrd pdf chapter 8 outpatient esrd hospital, independent facility, and physiciansupplier claims pdf. Esas are biologically engineered hormones produced by recombinant dna technology. An erythropoietin stimulating agent esa is an analog of erythropoietin. The efficacy of erythropoietinstimulating agents esas for improving healthrelated quality of life hrqol in anemia of chronic kidney disease ckd is unclear.
Erythropoiesis stimulating agents esas are abused by athletes because they increase the oxygencarrying capacity of the blood by stimulating red blood cell production 25. Arterial hypertension induced by erythropoietin and. Esas have been approved for the treatment of anemia, due to chronic kidney failure, chemotherapy, hiv, and also for reduced red blood cells. Epoetin alfa epogen, procrit, epoetin alfa epbx retacrit are considered medically necessary. 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. Food and drug administration fda and amgen notified healthcare professionals and patients that all erythropoiesisstimulating agents esas must be used under a risk evaluation and mitigation strategy rems risk management program. To determine the effect of esas on hrqol at different hemoglobin targets in adults with ckd who were receiving or not receiving dialysis. Allan2,3,4, and anargyros xenocostas1,2,4,5 abstract over the past few decades, understanding of the physiologic function of. Erythropoietin epo is an approved drug that is used in the treatment of chronic anemia associated with chronic renal failure. Reimbursement policy erythropoietin stimulating agent esa. Erythropoiesis stimulating agents and other growth factors. Erythropoiesis stimulating agents esa are medications which stimulate the bone marrow to make red blood cells. Erythropoiesis stimulating agents esa includes the following products.
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. Application for erythropoietinstimulating agents world health. Erythropoietin stimulating agents market growth, trends. Bl the usefulness of esas in improving quality of life has been shown in multiple studies around the world.
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