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