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Emerging Evidence on Anemia

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Emerging Evidence on Anemia Provided by the Society for the Advancement of Blood Management, Inc., a nonprofit corporation. 350 Engle Street, Englewood, NJ 07631 [email protected] CONTRIBUTORS Michael Auerbach M.D. Aryeh Shander M.D. Private Practice, Baltimore Maryland Chief, Department of Anesthesiology, Clinical Professor of Medicine Critical Care Medicine, Pain Management & Georgetown University School of Hyperbaric Medicine Medicine Englewood Hospital & Medical Center Washington DC Englewood, NJ Clinical Professor of Anesthesiology, Irwin Gross M.D. Medicine and Surgery Senior Medical Advisor, Accumen, Inc. Icahn School of Medicine San Diego, CA New York, NY EMERGING EVIDENCE ON ANEMIA EVIDENCE, EDUCATION, AND BETTER PATIENT OUTCOMES EVOLVING EVIDENCE ON ANEMIA, TRANSFUSION, INTRAVENOUS IRON AND ITS IMPACT ON PATIENT OUTCOMES THE NEED FOR UPDATED INTRAVENOUS IRON COVERAGE IS ANEMIA REALLY A PROBLEM? RECOGNIZING THE PREVALENCE What is the evidence? What are the OF ANEMIA AND NEED FOR barriers? IMPROVED MANAGEMENT Anemia is under-recognized as a ANEMIA IS A WIDELY UNDER-RECOGNIZED condition CONDITION THAT IS: EPIDEMIC • Epidemic. • Often accepted or ignored as a harmless Anemia and iron deficiency are extremely problem. common. It is estimated that greater than one third of adults over the age of 65 have unexplained • Associated with poor medical and surgical anemia, defined as a hemoglobin less than 12 g/ outcomes. dL. Seventeen percent (17%) of adults over the age • Independent risk factor for morbidity and of 65 have been shown to have iron deficiency mortality. and of those with iron deficiency anemia, only 50% normalized their hemoglobin with oral iron ANEMIA DIAGNOSIS AND TREATMENT therapy. IS POORLY UNDERSTOOD BY MANY Iron deficiency in the hospitalized patient PRACTICING CLINICIANS population, both functional and true iron • Common treatment modalities can be deficiency, is also extremely common. ineffective and even harmful. • There is lack of awareness of established science PREVALENCE OF IRON DEFICIENCY in various disease states. ANEMIA F1 CURRENT TREATMENT IS LIMITED BY: MINIMUM MAXIMUM TOTAL • Physician knowledge of and comfort with new intravenous iron therapies. Chronic Kidney 40-60% Disease • Medicare Administrative Contractor’s (MAC’s) Diabetes w/o overt 20-40% limitations on (Medicare) coverage. renal failure Chronic Heart Failure 30-50% HOW CAN THE PROBLEM BE Inflammatory 30-50% FIXED? Bowel Disease 1. Broaden clinical application of new evidence. Rheumatoid Arthritis 30-60% 2. Create universal inclusion criteria for coverage 0 20 40 60 80 100 across all MAC’s. 3. Add qualifying diagnosis codes for coverage. References for charts and graphs can 4. Promote education and awareness of anemia. be found on page 7 2 SABM Copyright 2019 Hospital acquired anemia is prevalent and has a ASSOCIATED WITH POOR SURGICAL significant impact on clinical outcomes with major OUTCOMES health care implications. The association of preoperative anemia with postoperative mortality is a compelling reason HOSPITAL ACQUIRED ANEMIA to manage anemia in the perisurgical patient population. F2 10 hospitals, from 1/2009 – 08/2011 188,447 Hospitalizations Endpoints: Mortality, Charges and LOS PREOPERATIVE ANEMIA IS ASSOCIATED WITH POSTOPERATIVE MORTALITY F4 N – 7759 2003 – 2006 MILD MODERATE SEVERE HB<12 G/DL FOR WOMEN AND <13 G/DL FOR MEN >11-12F > 3.5% Definition 9.1 < 11 < 9.0 11-13M PREOPERATIVE ANEMIA 3.0% HAA (74%) 29% 41% 30% 2.5% Mort RR 1.0 1.51 3.28 2.0% LOS 1.08 1.28 1.88 1.5% NO ANEMIA MORTALITY CHARGES 1.06 1.18 1.80 1.0% 0.5% 0.0% OFTEN ACCEPTED OR IGNORED AS A 0 30 60 90 HARMLESS PROBLEM POSTOPERATIVE DAY Anemia has become a “normalized deviation” with a long tradition of acceptance as a harmless problem that can be ignored in most cases or The impact of preoperative anemia on colon easily corrected with transfusion. and rectal surgery outcomes in 23,000 patients selected from the National Surgical Quality Improvement Program (NSQIP) database was ANEMIA: A POTENT MULTIPLIER OF reported as shown in Figure 5. MORTALITY F3 N = 1.1 MILLION (5% MEDICARE SAMPLE, 1996-1997) DOES PREOPERATIVE ANEMIA ADVERSELY AFFECT COLORECTAL F5 No HF, No CKD, No Anemia 1 SURGERY OUTCOMES? 2005-2008 - NSQIP (251 HOSPITALS) Anemia Only 1.9 CO – MI, CVA, AKI, MORTALITY AND HLOS N – 23,348 – 47.4 % ANEMIC CKD Only 2.05 UNI, MULTI, LOGISTIC REGRESSION AND PROPENSITY SCORING HF Only 2.86 CKD, Anemia 3.37 ANEMIA HCT N CO-OR HLOS HF, Anemia 3.78 None (>38%) 12,281 1.0 - HF, CKD 4.86 Mild (30-37%) 9037 1.47 - HF, CKD, Anemia 6.07 Moderate (26-29%) 1726 1.87 1.2 0 1 2 3 4 5 6 7 RELATIVE RISK OF 2-YEAR MORTALITY Severe (21-25%) 304 2.1 1.6 SABM Copyright 2019 3 Anemia diagnosis and treatment is poorly The addition of IV iron to erythropoietin when understood by many practicing clinicians treating patients with cancer-associated anemia results in a statistically significant increase in the percentage of patients who respond to treatment. ENTERIC IRON THERAPY IS INEFFECTIVE AND MAY BE HARMFUL ADDITION OF IV IRON TO EPO Side effects associated with oral iron are well INCREASES HGB RESPONSE IN CANCER- known. These complications often lead to non- F7 ASSOCIATED ANEMIA compliance with as many as 40 to 50% of patients unable to tolerate enteric iron therapy. IV IRON GROUP (N=27) NO IRON GROUP (N=30) Costly For much of the medical community, 93% transfusion as treatment for anemia remains 100 (95% CI: 76%-99%) the default position. Knowing that significant morbidity and mortality is independently associated with anemia, a new clinical paradigm 80 is needed where anemia is managed regardless of the level of hemoglobin. 53% 60 Transfusion as a treatment of anemia compounds (95% CI: 34%-72%) the problem and increases costs. Activity based HGB RESPONDERS (%) cost analysis shows that the cost of transfusion 40 independent of complications associated with the transfusion range from $800 per unit to over $1200 per transfused unit. Anemia recognition, 20 diagnosis and treatment will reduce the cost and complications of transfusion. 0 LACK OF AWARENESS OF EMERGING 0 4 8 12 16 SCIENCE BY MEDICARE ADMINISTRATIVE TIME (WKS) CONTRACTORS The superiority of intravenous iron over enteric iron In patients treated with an erythropoietic is demonstrated in this study of intravenous iron in stimulating agent (ESA), intravenous iron is much women with anemia secondary to menorrhagia. more efficacious than is enteric iron in ensuring an adequate response to the ESA at the lowest possible dose. IV IRON IMPROVES ANEMIA IN WOMEN In a study published in the mid-1990s, the target WITH MENORRHAGIA F8 hemoglobin level is achieved with significantly PROPORTION OF 477 PATIENTS ACHIEVING AN lower doses of erythropoietin when intravenous HGB INCREASE OF 2 G/DL OR 3 G/DL AFTER FERRIC iron is used as opposed to enteric iron. CARBOXYMALTOSE MAINTENANCE THERAPY WITH IV VS. 3g/dl INCREASE 2 g/dl INCREASE ORAL IRON IN EPO-TREATED PATIENTS? IV IRON F6 60 ORAL IRON 40 IV IRON BASELINE 2 MONTHS 4 MONTHS ORAL IRON 20 HCT, IV Iron 32.5 ±0.6 33.6 ±0.9* 34.4 ±0.7* % ACHIEVED PO Iron 31.8 ±0.3 32.1 ±0.3 31.8 ±0.4 0 0 14 28 42 EPO, U/RX IV Iron ENDPOINT (%) ACHIEVING 9037 1.47 - TIME AFTER INITIATING TREATMENT (DAYS) REQUIRED PO Iron Proportion of patients achieving an Hgb increase of PO IRON = 200-300 MG/D; IV IRON = 200 MG/WK. more than 2.0 g/dL or 3.0 g/dL according to treatment *P<.05 COMPARED TO PO IRON GROUP. assignment; significant between-group differences. 4 SABM Copyright 2019 A high percentage of patients with inflammatory Factors that limit expanded evidence- bowel disease (IBD) have significant iron based treatment of anemia with deficiency anemia. Moreover, there is a relative contraindication for enteric iron in patients with intravenous iron active IBD due to the potential for a direct toxic effect by enteric iron on the gastrointestinal PHYSICIAN KNOWLEDGE AND COMFORT mucosa. The superiority of an intravenous iron WITH NEW INTRAVENOUS IRON THERAPIES preparation, ferric carboxymaltose, over oral Adverse events (AE) with intravenous iron therapy ferrous sulfate was demonstrated, with a higher vary with the type of preparation. (Fig. 10) percentage of patients achieving the target hemoglobin. AES AND IV IRON THERAPY FERRIC CARBOXYMALTOSE IN IBD F10 PATIENTS F9 FCM (N=136) FERROUS SULPHATE (N=60) FCM (N=136) FERROUS SULPHATE (N=60) 12 100 10 HMWID 80 8 60 RESPONDERS (%) 6 RESPONDERS (%) 4 LMWID 40 2 FERRIC GLUCONATE 20 IRON SUCROSE 0 0 0 2 4 6 8 10 12 FDA MedWatch reports (2001-2003) show HMWID was associated with a 3.4-fold increase in odds of life- STUDY WEEK threatening AEs. DOSING Ferric carboxymaltose: The median calculated This analysis likely overestimates AEs with LMWID (all iron deficit was 1405.5 mg (range 937–2102 mg), AEs reported by generic name only where attributed to requiring 1–3 administrations on an individual basis LMWID). at 1 week intervals. In tens of thousands of patients in Ferrous sulfate: 2x100 mg/day for 12 weeks (total prospective studies SAEs with IV iron are 16,800 mg). Non-inferiority of ferric carboxymaltose confirmed in primary endpoint. vanishingly rare. MAC LIMITATIONS ON MEDICARE COVERAGE A number of the Medicare Administrative Contractors (MAC) limit reimbursement of intravenous iron through the use of medical policy articles. Restriction 1: Requirement that Problem: Intravenous iron is known to have superior efficacy patients first fail a trial of enteric and is associated with fewer adverse events than is the use iron due to either intolerance or of enteric iron. This requirement imposes an unnecessary lack of efficacy before intravenous and ineffective treatment, increasing cost, risk and adverse iron will be covered.
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