This policy describes when the use of esas may be considered medically necessary. Erythropoiesisstimulating agents and anemia in patients with non. To improve blood cell counts and reduce the need for blood transfusions. The higher risk for vtes associated with the use of erythropoiesisstimulating agents esas appears to be a class effect but may be particularly pronounced when these agents are used in patients. Erythropoiesisstimulating agent resistance and mortality in. Esa resistance has been associated with mortality in hemodialysis hd patients, but in peritoneal dialysis pd patients data is limited. Erythropoiesisstimulating agent esa nova scotia health authority. New dosing guidelines for erythropoiesisstimulating agents. They are used to treat anemia due to end stage kidney disease, chemotherapy, major surgery, or certain treatments in hivaids. 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. When administering erythropoiesisstimulating agents, it is important for the nurse to. Erythropoiesisstimulating agents esas ask attorney. Listing a study does not mean it has been evaluated by the u. Erythropoiesisstimulating agents time for a reevaluation.
Treatment with erythropoiesis stimulating agents has been used for the anemia of mds for almost 25 years. Erythropoiesis stimulating agents 2 reduce the need for allogeneic blood transfusions. Evidencerecommendations on erythropoiesisstimulation agents epoetin alfa, beta, theta and zeta and darbepoetin. Cms issued a national coverage decision for esas for nonesrd use. Introduction erythropoiesis is the pathway that produces mature red blood cells from haematopoieticstemcells. Use this page to view details for the decision memo for erythropoiesis stimulating agents esas for nonrenal disease indications cag00383n. Administration of erythropoiesisstimulating agents has become standard therapy for patients with erythropoietindeficient anemia who are receiving dialysis. Erythropoiesisstimulating agents esas have been shown to steadily increase hemoglobin levels, reduce the need for blood transfusions, and improve overall quality of life. National institute for health and care excellence nice 26 november 2014. Duringmammaliandevelopment,erythropoiesisoccurs successivelyintheyolksac,thefoetalliverandthebonemarrow. Receipt of sample product does not satisfy any criteria requirements for coverage.
Erythropoiesisstimulating agents for the treatment of. The risks versus benefits of these options should be carefully considered as each has limitations. Erythropoiesisstimulating agents esa are commonly used to treat human patients, dogs, and cats with chronic renal failure or other chronic or neoplastic disease. Many patients with autoimmune hemolytic anemia aiha do not respond to standard therapy andor may develop severe complications which can be of fatal outcome. Erythropoiesis stimulating agents in the treatment of anaemia in cancer patients. A method for detection of erythropoietin stimulating agents esas abuse using dried blood spots dbs has been validated in agreement with the current world anti. Although the introduction of erythropoiesisstimulating agents esas has. The erythropoiesisstimulating agents esas currently available are darbepoetin alfa aranesp, epoetin alfa epogen, procrit and peginesatide omontys. Treatment with erythropoiesisstimulating agents has been used for the anemia of mds for almost 25 years.
The erythropoiesisstimulating agents esas epoetin alfa and darbepoetin are indicated for the treatment of anemia caused by endstage renal disease esrd, zidovudine therapy in patients with hiv, chemotherapy in cancer patients, and also to reduce transfusion need in patients scheduled for noncardiac major surgery. June 24, 2011 the us food and drug administration fda today urged more conservative dosing guidelines for erythropoiesisstimulating agents. Who eml 20162017 application for erythropoietinstimulating agents erythropoietin type blood factors pdf. Necosad is a dutch multicenter prospective cohort study of incident. Iron supplements enhance the absorption of erythropoiesis stimulating agents. The goal of the present study was to explore the differences in effects between erythropoiesis stimulating agent esa types on hemoglobin hb level at the initiation of maintenance dialysis. 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. Erythropoiesis stimulating agents work effectively when iron stores in the body are adequate. 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. The advisory noted these drugs had a higher chance of serious and lifethreatening side effects andor death.
Erythropoiesis is the pathway that produces mature red blood cells from haematopoieticstemcells. In these situations they decrease the need for blood transfusions. Erythropoiesisstimulating agents esas are produced using recombinant dna technologies. Erythropoiesisstimulating agents, including epoetin alpha epogen, procrit, and darbepoeitin aranesp medical policy rx501. Drugs called esas erythropoiesisstimulating agents are similar to our own erythropoietin. These drugs can be used to stimulate the bone marrow to make more red blood cells. Thiscellularprocess is characterised by commitment and differentiation steps that restrict the. To protect the kidney from further hypoxic damage during anemia episodes. Comparison among erythropoietin stimulating agents the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Seventynine patients who switched from epoetin beta to darbepoetin alfa group 1, and 82 patients who switched from darbepoetin alfa to epoetin beta pegol. Aranesp epogen procrit erythropoiesisstimulating agents esas 9. Romiplostim is a novel thrombopoieticstimulating agent for use in patients with chronic itp who have not responded to other therapies. Responsiveness to erythropoiesisstimulating agents esas varies widely among dialysis patients. The role of erythropoietin stimulating agents in anemic.
This funding opportunity announcement foa issued by the national institute of diabetes and digestive and kidney diseases niddk and the national heart, lung, and blood institute nhlbi, national institutes of health, encourages investigatorinitiated r01 applications that propose hypothesisdriven research using erythroid cells. Necosad is a dutch multicenter prospective cohort study of. The effect of erythropoiesisstimulating agents in patients. Although epoetin alfa and darbepoetin alfa, a related erythropoiesisstimulating agent esa approved in 2001, have been widely accepted for this indication, optimal hemoglobin targets have never.
When administering erythropoiesis stimulating agents, it is important for the nurse to. Esa monitoring policy, effective october 1, 2006 pdf. Local coverage determination for erythropoiesis stimulating. Drugs called esas erythropoiesis stimulating agents are similar to our own erythropoietin. Clinicians who manage anemia in patients with chronic kidney disease, both on and off dialysis therapy, face several challenges.
Comparison among erythropoietin stimulating agents full. Effect of longacting erythropoiesisstimulating agents on. Erythropoiesis stimulating agents esas in cancer and. 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. Fda approved indications, fda recommended dosing and drug availability. Effects of three kinds of erythropoiesisstimulating agents. Therapeutic class overview erythropoiesisstimulating agents therapeutic class overviewsummary. An external file that holds a picture, illustration, etc. Erythropoiesisstimulating agents market global industry. Feb 26, 2010 2262010 the fda is requiring all drugs called erythropoiesis stimulating agents esas to be prescribed and used under a risk management program, known as a risk evaluation and mitigation. 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 thrombopoiesisstimulating agents should be restricted to clinical trials. The maximum dosage of erythropoietin should not exceed a total of 60,000 units per week 5. Pdf erythropoiesisstimulating agents in renal medicine. Erythropoiesisstimulating agents work effectively when iron stores in the body are adequate. Erythropoiesisstimulating agents in the management of. Erythropoietin stimulating agents esas 3 erythropoietin directly and other causes of anemia have been ruled out. Medicare cd medical coverage policy erythropoietin. The goal of the present study was to explore the differences in effects between erythropoiesisstimulating agent esa types on hemoglobin hb level at the initiation of maintenance dialysis.
No data are available on the combined use of epo, gcsf and tpo in mds and should not be used in routine daily practice. These agents are given as subcutaneous injections or as intravenous injections. Application for erythropoietinstimulating agents world health. The erythropoiesis stimulating agents esas epoetin alfa and darbepoetin are indicated for the treatment of anemia caused by endstage renal disease esrd, zidovudine therapy in patients with hiv, chemotherapy in cancer patients, and also to reduce transfusion need in patients scheduled for noncardiac major surgery. Erythropoiesis stimulating agents esas prior authorization. Erythropoiesisstimulating agents esas are standard therapy for chronic kidney disease ckd patients with renal anemia.
Erythropoiesis stimulating agents esas in cancer and related neoplastic conditions ncd 110. Erythropoiesisstimulating agents esa are medications which stimulate the bone marrow to. Why are erythropoiesis stimulating agents esas prescribed for. There is some evidence that erythropoiesisstimulating agents esas may be helpful in the management of such patients. Erythropoiesisstimulating agents esa are medications which stimulate the bone marrow to make red blood cells. Pdf erythropoeisisstimulating agents esas in cervix. National coverage analysis nca for erythropoiesis stimulating agents esas for nonrenal disease indications cag00383n select the print complete record, add to basket or email record buttons to print the record, to add it to your basket or to email the record. The higher risk for vtes associated with the use of erythropoiesis stimulating agents esas appears to be a class effect but may be particularly pronounced when these agents are used in patients. Iron does not affect the elimination of erythropoiesis stimulating agents from the body but helps in their absorption. Erythropoiesisstimulating agents in the management of anemia in. Why are erythropoiesisstimulating agents esas prescribed for patients with chronic kidney disease.
June 24, 2011 the us food and drug administration fda today urged more conservative dosing guidelines for erythropoiesisstimulating agents esas when used to treat anemia in patients with. Notably, the use of esas to target high hemoglobin levels in ckd patients has been associated with adverse. Possible reasons for switching a patient between erythropoiesis stimulating agents may include patient preference, injection site pain, hypersensitivity to one of the erythropoiesis stimulating agents, stabilitystorage, dosing interval, lack of response to one of the erythropoiesis stimulating agents and the support provided by the manufacturer. However, few studies have compared the effects of different esas on anemia in identical predialysis ckd patients. The role of erythropoietin stimulating agents in anemic patients with heart failure. Therapeutic class overview erythropoiesisstimulating agents. Office notes, labs and medical testing relevant to request showing medical justification are required to support diagnosis.
There is some evidence that erythropoiesis stimulating agents esas may be helpful in the management of such patients. What links here related changes upload file special pages permanent link page information. Erythropoiesis stimulating agents pharmacy prior authorization request form do not copy for future use. From january 2006 to october 2012, 2920 patients with endstage kidney disease commenced hemodialysis hd at nine participating hospitals. Iron supplements enhance the absorption of erythropoiesisstimulating agents. Erythropoiesis stimulating agents and other growth factors in. Increasing incidence of anemia cases worldwide is driving the growth of the global erythropoiesisstimulating agents market. Though erythropoiesisstimulating agents esas have been strongly endorsed in.
Erythropoiesisstimulating agents clinical criteria information included in this document erythropoiesisstimulating agents aranesp drugs requiring prior authorization. Food and drug administration fda today issued a public health advisory outlining new safety information, including revised product labeling about erythropoiesisstimulating agents esas, widelyused drugs for the treatment of anemia. Who eml 20162017 erythropoietinstimulating agents december 2016. Possible reasons for switching a patient between erythropoiesisstimulating agents may include patient preference, injection site pain, hypersensitivity to one of the erythropoiesisstimulating agents, stabilitystorage, dosing interval, lack of response to one of the erythropoiesisstimulating agents and the support provided by the manufacturer. Pharmacology chapter 54, anemia drugs flashcards quizlet. Erythropoiesisstimulating agents in the treatment of anaemia in cancer patients. 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. The dose frequency, depending on the patients condition, can vary from once in a week or once every two weeks. Erythropoiesis stimulating agents esa are medications which stimulate the bone marrow to make red blood cells. Increasing incidence of anemia cases worldwide is driving the growth of. Sep 25, 20 responsiveness to erythropoiesis stimulating agents esas varies widely among dialysis patients. Aetna medicare form erythropoiesis stimulating agents. To prevent vein thromboembolism during periods of dehydration. Erythropoiesis stimulating agents esas, administered to esrd patients receiving dialysis in a renal dialysis facility.
Sep 15, 2014 many patients with autoimmune hemolytic anemia aiha do not respond to standard therapy andor may develop severe complications which can be of fatal outcome. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 gdl. 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. Clinical information continued required clinical information must be completed in its entirety for all precertification requests. Erythropoiesisstimulating agents use the lowest dose of aranesp. Covered chronic diseases include, rheumatoid arthritis, systemic lupuserythematosis, chronic hepatitis c, crohns disease and ulcerative colitis. Iron does not affect the elimination of erythropoiesisstimulating agents from the body but helps in their absorption. In the case of anaemia caused by anticancer chemotherapy, research in the late 1990s and subsequently has suggested that the risks associated with such treatment include thromboembolic disease and promotion. Should erythropoiesisstimulating agents be used in predialysis. Therefore we assessed the relation between esa resistance in both hd and pd patients.
Erythropoiesis stimulating agents esas are produced using recombinant dna technologies. Erythropoietin stimulating agent esa page 2 of 5 unitedhealthcare medicare advantage policy guideline approved 112019 proprietary information of unitedhealthcare. Challenge of effectively using erythropoiesisstimulating. The use of thrombopoiesis stimulating agents should be restricted to clinical trials. Decision memo for erythropoiesis stimulating agents esas. Erythropoietins, erythropoietic factors, and erythropoiesis.
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