More recent trials using esa doses with hgb targets similar to current goal levels in ckd have not confirmed this increased risk of. It is expected that patients medical records reflect the need for careservices provided. Erythropoiesis stimulating agents esas, administered to esrd patients receiving dialysis in a renal dialysis facility. Erythropoietin stimulating agent esa documentation requirements. Erythropoietin german erythropoietine french eritropoyetina spanish erythropoiesis stimulating factor is hemopoietine is erythropoietin ph. Glycoprotein hormone which stimulates red blood cell formation in higher organisms. Erythropoiesis stimulating agents esas blue cross nc. Erythropoietinstimulating agents in anemia of chronic. Epoetin alfa, darbepoetin alfa, methoxy polyethylene glycolepoetin beta brand name. Clinical effectiveness and safety of erythropoietin. Recombinant erythropoietin is a manmade version of natural erythropoietin. Erythropoietin stimulating agents esas 3 erythropoietin directly and other causes of anemia have been ruled out.
Pdf anemia is a very common clinical problem in patients with chronic kidney disease ckd and is associated with increased morbidity and mortality in. 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. The median duration of response is 23 years, with patients responding for more than a decade. Treatment with erythropoiesisstimulating agents esas is firstline treatment for the anemia of most patients with mds.
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. Erythropoietin acts synergistically with gcsf to inhibit erythroid apoptosis and promote erythrocyte production. The role of erythropoietin and erythropoiesis stimulating agents in tumor progression. In these situations they decrease the need for blood transfusions. Erythropoiesis stimulating agents esa are medications which stimulate the bone marrow to make red blood cells. Low versus high dose erythropoiesisstimulating agents in.
Application for erythropoietinstimulating agents world health. Request pdf types of erythropoietinstimulating agents and mortality among patients undergoing hemodialysis background. Feb 08, 2019 in controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis stimulating agents esas to target a hemoglobin level of greater than 11 gdl see warnings and precautions 5. Epoetin beta is an erythropoiesisstimulating agent esa indicated for the. Therapeutic class overview erythropoiesis stimulating agents therapeutic class overviewsummary. Chronic kidney diseaseerythropoiesisstimulating agents. Epo is a protein hormone 165 amino acids primarily synthesized by the kidneys that contains 3 n glycan and 1 o.
The anemia of cancer not related to cancer treatment. Erythropoiesis stimulating agents esas are produced using recombinant dna technologies. 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. Internal only renal department, revised 20 page 1 of 4 erythropoietin stimulating agents indications for use. Dec 23, 2016 erythropoietin stimulating agents esa request form instructions. The original rhuepos epoetin alfa and epoetin beta have now been. Aetna medicare form erythropoiesis stimulating agents. 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. History of erythropoiesisstimulating agents, the development of. To determine the effect of esas on hrqol at different hemoglobin targets in adults with ckd who were receiving or not receiving dialysis. Among the misuse of erythropoietic stimulating agents, t he application of substances that induce epo gene expression by stabilizing hif 1 as cobalt.
Erythropoietin acts on the erythroid progenitor cells in the bone marrow to cause late differentiation and maturity of the rbcs. Erythropoiesisstimulating agents esas are produced using recombinant dna. Patterns of erythropoiesisstimulating agent use among. Endogenous erythropoietin stimulation by cobreathing and by. It differs from rhuepo by having 2 additional nglycosylation sites which slow its clearance. 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. Anemia secondary to myelodysplastic syndrome mds o treatment of lower risk disease associated with symptomatic anemia. Erythropoietin is an endogenous glycoprotein which stimulates red blood cell production.
Pdf erythropoietin stimulating agents in the management. Erythropoiesis stimulating agents esas stimulate the bone marrow to make more red blood cells and are united states food and drug administration fda approved for use in reducing the need for blood transfusion in patients. 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 hb concentration. Alaska, arizona, idaho, montana, north dakota, oregon, south dakota, utah, washington, wyoming. Increasing incidence of chronic diseases such as endstage renal diseases, cancer, and hiv is expected to accelerate demand for epo stimulating agents as these diseases may cause anemia. The expression is indicated of the different surface markers commonly used to characterise the different erythroidprecursors. Reimbursement policy erythropoietin stimulating agent esa level of less than 500 muml are more likely to respond to erythropoiesis stimulating agent esa therapy.
But, if the hemoglobin level approaches or goes over 11 gdl, the dose of the drug should be. The increased risks of death and adverse events with erythropoiesis stimulating agent esa therapy targeting a higher hemoglobin level are established. Erythropoiesisstimulating agent species route frequency duration of study dose mortalityanimals in dose group a thrombotic event and valvulopathy rat onlyanimals in dose group b organ location of thrombotic event c. Screening and confirmation strategies were developed. The efficacy of erythropoietinstimulating agents esas for improving healthrelated quality of life hrqol in anemia of chronic kidney disease ckd is unclear. Erythropoietin german erythropoietine french eritropoyetina spanish generic names. Trends in the utilization of erythropoiesisstimulating.
Among 407 patients listed for transplant, 84 received a deceased donor kidney during a median followup of 26. Thi form must be submitted obtain a prior authorization for an erythropoietin stimulating agent epogen, procrit or aranesp. 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. Erythropoiesis stimulating agents injectable medication precertification request aetna precertification notification 503 sunport lane, orlando, fl 32809. Erythropoiesis stimulating agents esas will be considered for coverage under the pharmacy benefit program when the following criteria are met. Erythropoiesisstimulating agents in the management of. Hyporesponsiveness to erythropoietin stimulating agents occurs frequently, and may be observed at initiation of treatment or during maintenance therapy. Medicare cd medical coverage policy erythropoietin. There are many glycoproteins which can activate the synthesis of anticarbohydrate antibodies.
Erythropoiesis stimulating agents and other growth factors in. Treatment with erythropoiesis stimulating agents european school. Pdf erythropoietin stimulating agents in the management of. Therapeutic class overview erythropoiesisstimulating agents. Dosing, uses, side effects, interactions, patient handouts, pricing and more from medscape reference. Prior authorization approval criteria fallon health. Bcbsa medical policy reference manual electronic version. Erythropoiesisstimulating agents esas are a group of medicines that help take the place of a hormone called erythropoietin epo. In order to make red blood cells, the body maintains an adequate supply of. Erythropoiesis stimulating agents esas boost the production of red blood cells and as.
Erythropoietin stimulating agents market 2019 with top. Cms has policies that effect the use of erythropoietin stimulating agents in esrd facilities. 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 patient has adequate iron stores confirmed by ferritin levels greater than100 mcgl or serum transferrin. Covered chronic diseases include, rheumatoid arthritis, systemic lupuserythematosis, chronic hepatitis c, crohns disease and ulcerative colitis. Pdf the four currently available erythropoiesisstimulating agents esas, the main drugs for correcting anemia in patients with chronic kidney. The requirement for erythropoietin starts at mature bfue and stops after the proerythroblasts stage. Erythropoietin stimulating agents market global countries. Erythropoietin analogs contain the identical amino acid sequence as naturally occurring erythropoietin, and have the same biological effect. Erythropoiesisstimulating agent esa nova scotia health authority. The global erythropoietin epo drugs market size was valued at usd 7.
The global erythropoietin stimulating agents market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status. Complications associated with erythropoietin stimulating. Prophylactic use to prevent chemotherapyinduced anemia. Further increases may be made at 4week intervals until the specified hemoglobin is obtained. Erythropoietic stimulating agents esa are recombinant and synthetic erythropoietin epo. The medicare advantage policy guideline documents are generally used to. Erythropoiesis stimulating agents injectable medication. Reimbursement policy erythropoietin stimulating agent esa. Point of view about new guidelines on esas erythropoiesis stimulating agents l. Guiding principles for the quality use of offlabel. Erythropoietin epo is a hormone with a glycoprotein structure and is immunogenic 64. An erythropoietin stimulating agent esa is an analog of erythropoietin. All area s must be completed in order to proces the request. They are used to treat anemia due to end stage kidney disease, chemotherapy, major surgery, or certain treatments in hivaids.
Erythropoetin stimulating agents are used often for people with longterm kidney disease and anemia. Darbepoetin aranesp is an erythropoiesis stimulating agent similar to rhuepo. January 1, 2020 page 2 of 6 aranesp is covered for the following indications. Erythropoiesisstimulating agents pharmacy coverage policy. Erythropoietinstimulating agents casebook in clinical.
Esas are biologically engineered hormones produced by recombinant dna technology. Erythropoietin induces cancer cell resistance to ionizing radiation and to cisplatin. 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. Patients who have cancer, particularly those undergoing chemotherapy, frequently become anemic. The last two have much longer halflives, which means they can be administered less frequently. Therapy with erythropoiesis stimulating 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, and quality of life. Anemia is common in patients with cancer or with chronic kidney disease ckd. The erythropoiesisstimulating agents esas currently available are darbepoetin alfa aranesp, epoetin alfa epogen, procrit and peginesatide omontys. Esas include recombinant human erythropoietin epo derivatives. Plawny recent concerns about the safety of erythropoietin stimulating agents esas in cancer patients have led to a reformulation of the guidelines issued by. Claims processing manual, chapter 8 outpatient esrd hospital.
Erythropoiesis stimulating agents esas are commonly used to treat anemia associated with chronic kidney disease ckd. Erythropoiesis stimulating agents fdaapproved uses. Endogenous erythropoietin is a glycoprotein hematopoietic growth factor that regulates hemoglobin levels in response to changes in the blood oxygen concentration. Erythropoiesis stimulating agents with preclinical toxicology studies that reported mortality andor thrombotic events. Although the introduction of erythropoiesisstimulating agents esas has. Erythropoiesis stimulating agents aetna precertification notification 503 sunport lane, orlando, fl 32809 injectable medication precertification request phone. Recombinant erythropoietin epo and its analogues have been frequently misused in sports as doping agents. Epoetin alfa and darbepoetin alfa are erythropoiesis stimulating agents esas, approved for the treatment of anemia low red blood cells resulting from chronic kidney disease, chemotherapy. The erythropoiesis stimulating agents esas, erythropoietin and darbepoetin, have been widely used to increase hemoglobin values and reduce transfusion requirements in cancer patients 1 3. Drugs in this class are epoetin alfa, darbepoetin alfa, and peginesatide. 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. Despite the widespread use of erythropoietin stimulating agents esas.
They are structurally and biologically similar to endogenous epo and are used in the management of various types of anemia. Anemia associated with treatment of acute and chronic myelogenous leukemias, i. Information on erythropoiesisstimulating agents esa. 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. There is a lack of relliable evidence that one brand of erythropoietin alpha procrit or epogen. In an adjusted cox proportional hazards model, with erythropoiesis stimulating agent and. Erythropoietin stimulating agents esa request form instructions. Dec 23, 2019 profound via comtex the report provides rational insights along with historical and forecast data to aid in better understanding of the. Cox proportional hazards were used to model time to deceased donor kidney transplant. Therapeutic class overview erythropoiesisstimulating agents therapeutic class overviewsummary. Who eml 20162017 erythropoietinstimulating agents december 2016.
Erythropoiesis stimulating agents esas in cancer and. 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. January 1, 2020 unless otherwise specified, the effective date is the date of service. An inverse relationship between hyporesponsiveness and incident cardiovascular events has been reported. 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 analyst elizabeth.
A wide range of erythropoiesis stimulating agents to stimulate red blood cell production are currently in clinical use, but advances in our understanding of erythropoiesis have provided an ever. 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. Providers must ensure all necessary records are submitted to support services rendered. Erythropoiesisstimulating agents in renal medicine. It is produced by cloning the gene for erythropoietin.
Red blood cells are produced in the bone marrow the spongy tissue inside the bone. Erythropoiesisstimulating agents esas are produced using recombinant dna technologies. Ep is erythropoiesis stimulating factor is esf is hemopoietine is rhuepo is. Pdf erythropoiesisstimulating agents in renal medicine. Types of erythropoietinstimulating agents and mortality. Endogenous erythropoietin stimulation by cobreathing and by stabilizing hif1 by oral cobalt application pr. If approved, authorizations will be valid for a time period of up to 12 months. We conducted a multicenter, prospective randomized openlabel, blindedendpoint probe trial to evaluate fixed. Erythropoietin stimulating agents in the management of anemia of chronic kidney disease article pdf available in patient preference and adherence 2. Erythropoietin, glucoamylase a, myeloma protein, tumor, monoclonal.
Recombinant erythropoietin drugs are known as erythropoietinstimulating agents esas. Dailymed procrit erythropoietin injection, solution. Prior authorization approval criteria erythropoiesis stimulating agents generic name. Erythropoietin epo is produced by the kidney and used to make red blood cells. Point of view about new guidelines on esas erythropoiesis. Despite the findings of valuable benefits and limited risks, there is inconsistent use of esas among practitioners in nicus. Fdas announcement applies to patients with earlystage kidney. It is produced primarily in the kidney and is an essential hormone for initiating and. Transfusion, erythropoiesisstimulating agent therapy, and. These drugs are given by injection shot and work by stimulating. Erythropoietin stimulating agents in the management of anemia of chronic kidney disease.