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. Local coverage determination for erythropoiesis stimulating agents l29168 subject. Office notes, labs and medical testing relevant to request showing medical justification are required to support diagnosis. Erythropoiesisstimulating agents esas are produced using recombinant dna technologies. 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. However, a large pivotal outcome trial found that the esa darbepoetin alfa did not improve longterm outcomes in patients with hf with reduced ejection fraction, and instead was associated with adverse effects. They are used to treat anemia due to end stage kidney disease, chemotherapy, major surgery, or certain treatments in hivaids. Overview of erythropoiesisstimulating agents for anemia of chronic kidney disease. The risks versus benefits of these options should be carefully considered as each has limitations. Erythropoiesisstimulating agents esa are medications which stimulate the bone marrow to make red blood cells. 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.
Haemoglobin profile during the 6 months before initiation of dialysis kazuhiko kawahara. Original investigation spectrum and burden of erythropoiesis stimulating agent hyporesponsiveness among contemporary hemodialysis patients jiacong luo, md, ms, mph,1 donna e. Covered chronic diseases include, rheumatoid arthritis, systemic lupuserythematosis, chronic hepatitis c, crohns disease and ulcerative colitis. An independent licensee of the blue cross and blue shield association erythropoiesisstimulating agents esas red blood cell rbc transfusion is the traditional approach to quickly ameliorate anemia symptoms. Erythropoiesisstimulating agents epoetin alfa, beta. Aetna medicare form erythropoiesis stimulating agents injectable medication precertification request aetna erythropoiesis stimulating agents injectable medication precertification request. Luspatercept in patients with lowerrisk myelodysplastic. Therapeutic class overview erythropoiesisstimulating agents. Erythropoiesis stimulating agents esas blue cross blue shield. Specialty pharmaceuticals service specialty pharmaceuticals.
Treatment with imetelstat provides durable transfusion. Erythropoiesis stimulating agents esa are medications which stimulate the bone marrow to make red blood cells. Erythropoietin and longacting erythropoiesis stimulating. Steensma 2, koen van eygen 3, azra raza 4, valeria santini 5, ulrich germing 6, patricia font 7, maria diezcampelo 8, sylvain thepot 9, edo vellenga 10, mrinal m. Thus, patients receiving erythropoiesis stimulating agents will require iron supplementation, often intravenously, in order to produce additional red blood cells. Erythropoiesisstimulating agent esa therapy and chronic. Small studies showed that erythropoiesis stimulating agents esas improve subjective measures of hf. Although the introduction of erythropoiesisstimulating agents esas has. In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Use of erythropoiesis stimulating agents esas in patients with left ventricular assist devices lvads may minimize blood transfusions and decrease allosensitization.
Hedenus m, osterborg a, tomita d, bohac c, coiffier b. Erythropoiesisstimulating agents in the management of anemia in. Pdf erythropoiesisstimulating agents in renal medicine. Trends in the utilization of erythropoiesisstimulating. Frequency of administration of erythropoiesis stimulating agents for the anaemia of endstage kidney disease in dialysis patients. Pdf the four currently available erythropoiesisstimulating agents esas, the main drugs for correcting anemia in patients with chronic kidney. Efficacy estimation of erythropoiesisstimulating agents. Erythropoiesisstimulating agents esas are a group of medicines that help take the place of a hormone called erythropoietin epo.
Erythropoiesisstimulating agents for anemia of chronic kidney disease. Application for erythropoietinstimulating agents world health. Medicare cd medical coverage policy erythropoietin. Shingo fukuma, md,1 takuhiro yamaguchi, phd,2 seiji hashimoto, md, phd,3. Therapeutic class overview erythropoiesisstimulating agents therapeutic class overviewsummary. In these situations they decrease the need for blood transfusions.
Epoetin alfa, darbepoetin alfa, methoxy polyethylene glycol. Corporate medical policy page 1 of 10 an independent licensee of the blue cross and blue shield association erythropoiesis stimulating agents esas file name. Erythropoiesisstimulating agents in the management of. An erythropoietin stimulating agent esa is an analog of erythropoietin. Erythropoiesisstimulating agent responsiveness and. Erythropoiesisstimulating agent responsiveness and mortality in hemodialysis patients. Then, they are engulfed by macrophages in the bone marrow, and possibly also in the spleen and the liver. Nih funding opportunities and notices in the nih guide for grants and contracts. There is insufficient evidence to support a conclusion concerning the health outcomes or. Local coverage determinations, lcd, local policies, local coverage determination for erythropoiesis stimulating agents l29168, l29168 created date. Erythropoiesis stimulating agents esas boost the production of red blood cells and as. Chronic kidney diseaseerythropoiesisstimulating agents.
Erythropoietin analogs contain the identical amino acid sequence as naturally occurring erythropoietin, and have the same biological effect. The reason for withdrawal and previous versions are archived and accessible within the withdrawn record in the cochrane library. Final page is signature page and is kept on file, but not issued with policy. Information on erythropoiesisstimulating agents esa epoetin alfa. After the initial 4 weeks of rhuepo, if the hb increases by less than 1 gdl and remains erythropoiesisstimulating agents esas fda alert on march, 2008, an fda advisory committee recommended that erythropoiesis stimulating agent esas not be used in patients with metastatic breast cancer, head and neck cancer, or the treatment of cancers with curative potential.
Epo is a hormone released by the kidneys to tell your bone marrow to make more red blood cells. Erythropoietin and longacting erythropoiesis stimulating agent ameliorate nonalcoholic fatty liver disease by increasing lipolysis and decreasing lipogenesis via eporstat pathway. Thiscellularprocess is characterised by commitment and differentiation steps that restrict the differentiation potential and the proliferative capacity. January 1, 2020 page 3 of 6 o hemoglobin hb erythropoiesis stimulating agents esas, administered to esrd patients receiving dialysis in a renal dialysis facility.
The production of red blood cells rbcs is regulated by the hormone erythropoietin epo, which maintains the blood hemoglobin hb concentration constant under normal conditions. Erythropoiesis stimulating agents esas will be considered for coverage under the pharmacy benefit program when the following criteria are met. 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. Erythropoiesisstimulating agents esas are produced using recombinant dna. Erythropoiesisstimulating agent esa nova scotia health authority. Esas are biologically engineered hormones produced by recombinant dna technology. Erythropoiesisstimulating agents for myelodysplastic. Ythropoiesisstimula er ting agents erythropoietin epo is a 30. Results from a cohort study from the dialysis registry in japan. Use this page to view details for the local coverage determination for erythropoiesis stimulating agents. 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. Any person who knowingly files a request for authorization of coverage of a medical procedure or service with the intent to injure, defraud or deceive. History of erythropoiesisstimulating agents, the development of. Technical document for the harmonization of analysis and reporting of erythropoiesis stimulating agents esas by electrophoretic techniques.
Hemodialysis patients with erythropoiesis stimulating agent esa hyporesponsiveness have. Spectrum and burden of erythropoiesisstimulating agent. How i treat anemia in heart failure blood american. The patient has adequate iron stores confirmed by ferritin levels greater than100 mcgl or serum transferrin. Erythropoiesis is the pathway that produces mature red blood cells from haematopoieticstemcells. Erythropoiesis stimulating proteins therapeutic class. Notably, the use of esas to target high hemoglobin levels in ckd patients has been associated with adverse. Any person who knowingly files a request for authorization of coverage of a medical procedure or service with the intent to. Esas include recombinant human erythropoietin epo derivatives. Esas increase thrombotic events which is concerning as lvads are sensitive to pump thrombosis pt. Erythropoiesisstimulating agents epoetin alfa, beta, theta and zeta. Patients with anemia and lowerrisk myelodysplastic syndromes in whom erythropoiesis stimulating agent therapy is not effective generally become dependent on redcell transfusions. Epoetin alfa and darbepoetin alfa are erythropoiesisstimulating agents esas, approved for the treatment of anemia low red blood cells.
Corporate medical policy erythropoiesisstimulating agents. Who eml 20162017 erythropoietinstimulating agents december 2016. Clinical outcomes with use of erythropoiesis stimulating. Bcbsa medical policy reference manual electronic version. Has received an erythropoiesis stimulating agent esa or any chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior. Erythropoiesis stimulating agents esas have black box warnings for an increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. Duringmammaliandevelopment, erythropoiesisoccurs successivelyintheyolksac,thefoetalliverandthebonemarrow. Erythropoiesis stimulating agents and tumor progression r21 pa09024.
The criteria listed above applies to fallon health plan and its subsidiaries. Erythropoiesis stimulating agents injectable medication. However, it is not risk free, with several potential associated adverse events. Open access research comparative effectiveness and safety. Comparative effectiveness and safety of erythropoiesis stimulating agents biosimilars vs originators in clinical practice. In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion.
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