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Supplements Issues in Improving the Treatment of Anemia: Negotiating the Shifting Regulatory and Clinical Landsc

The Clinical and Economic Burden of Anemia

Robert E. Smith Jr, MD
After renal transplantation, anemia is associated with poorer graft function14,34 and significantly predicts graft failure.14 In one study of transplant recipients with a serum creatinine greater than 2 mg/dL (indicating poor graft function), 63% had anemia compared with 32% of those with a serum creatinine less than or equal to 2 mg/dL (P <.01).34





Finally, as CKD progresses, anemia contributes to mortality.12,14,15 In a study of dialysis patients, each 1-g/dL decrease in mean Hb was independently associated with increased mortality.15 In another study, anemia significantly predicted mortality in renal transplant recipients.14





HIV/AIDS

Anemia is associated with more rapid disease progression from HI V to AIDS and decreased survival at all CD4 T-lymphocyte counts.7,16,48 The risk of death is up to 70% greater in anemic patients with AIDS compared with their nonanemic counterparts.7 With anemia in HIV, the need for transfusions is greater and QOL poorer, largely due to fatigue.7





Cardiovascular Disease

Anemia is an independent risk factor for death after myocardial infarction (MI).12,17 In a random sample of patients hospitalized with acute MI, those with an Hct value between 30% and 35% had a 1-year mortality of 31%, and those with an Hct value less than 30% had a 1-year mortality of 42%.17 Anemia complicates coronary artery bypass surgery, increasing the risk of postoperative adverse events.18 Anemia also complicates heart failure. A meta-analysis of chronic heart failure studies (n = 153,180) found anemia increased mortality risk.19 A recent study demonstrated that patients with heart failure and anemia had unadjusted survival at 3 years of 50% versus 74% in nonanemic patients (P = .0003).35 Anemia was also a powerful predictor of rehospitalization in heart failure.29 Finally, in heart failure registry outpatients, reduced Hb levels were associated with poorer QOL.8





Inflammatory Bowel Disease

For patients with IBD, chronic fatigue may be as great a concern as abdominal pain or diarrhea.28 As with other conditions in which anemia of chronic disease occurs, anemia may contribute substantially to fatigue.





Chronic Obstructive Pulmonary Disease

In COPD, anemia was associated with several indicators of worse disease. Patients with COPD and anemia have poorer 6-minute walking distance and dyspnea scores and increased hospitalization and mortality rates.1 In the Medicare study by Halpern et al, the mortality rate was 262 deaths per 1000 person-years in those with anemia versus 133 deaths in those without anemia (P <.001).1





Diabetes

As noted earlier, the presence of diabetes increases the risk of anemia. Anemia in diabetes also increases the risks of other morbidity and mortality. Anemia doubles the risk of diabetic retinopathy.20 In patients with diabetes, anemia also contributes to cardiovascular disease,20 which is the leading cause of death in diabetes.20,49





Neurologic Disorders

Secondary cerebral injury from hypoxia increases the importance of addressing anemia in the critical care of neurologic conditions.21 Anemia is consistently associated with worse clinical outcomes in this setting.21







Economic Costs of Anemia

It is difficult to isolate and quantify the economic costs of anemia because of the varied settings in which it occurs. Analyses of the cost of treatment of anemia associated with other disorders must consider drug acquisition expenses, drug administration costs, hospital charges, inpatient physician fees, transfusion costs, laboratory testing costs, and indirect costs.13 The influence of anemia on the cost of treating the associated disease and on disease progression must also be considered. In general, anemia increases the costs of care for patients with associated conditions. Government databases and research studies have provided data for specific situations.





Large claims analyses have demonstrated increased healthcare utilization and expenditures when anemia coexists with several major disorders.1 For example, a 2005 study of approximately 2.3 million health plan members found that patients with a systemic disorder condition (CKD, solid-tumor cancers, HIV, RA, IBD, or congestive heart failure) who were also anemic had twice the average annualized costs of nonanemic patients with the same condition.2 Here again, anemia was a surrogate for more severe disease with consequent higher costs.





Cancer

In a systematic review of 24 studies in patients with cancer and chemotherapy-related anemia, costs attributable to anemia were estimated at $22,775 to $93,454 per year (2006 dollars).50





Chronic Kidney Disease

A study in predialysis patients with CKD found that those with untreated anemia had an unadjusted incremental monthly cost increase of $1089 compared with those who did not have anemia (cost ratio 1.8:1; P <.0001).51 In a 6-month follow-up study in 28,985 patients with end-stage renal disease (ESRD) initiating dialysis, each month that the Hb level was less than 11 g/dL was associated with an incremental increase in medical costs of 8.9%.52 Of course, treatment of anemia alone entails costs. In 2007, costs for intravenous iron supplementation in ESRD were $255 million; costs for treatment with ESAs were $1.8 billion.53





Cardiovascular Disease

A study in patients with symptomatic heart failure found that those with anemia had adjusted total costs of $22,926 per year versus $17,189 in patients without anemia (P = .04).35 In patients undergoing percutaneous coronary interventions, preexisting anemia was the third most powerful predictor of hospital costs.54 An additional $250 in hospital costs was associated with each Hct point below normal range.54





Chronic Obstructive Pulmonary Disease

In the study by Halpern et al, unadjusted analysis found more than twice the average annual Medicare payments for patients with COPD and anemia compared with those without anemia (P <.001).1 After adjustment for markers of disease severity and preceding healthcare utilization, anemia was independently associated with $3582 per patient in annual payments.1 Figure 2 illustrates the impact of anemia on Medicare reimbursements for specific healthcare costs.1





Aging and Falls

Anemia can contribute to the total cost of falls in the elderly. A retrospective analysis of claims for injurious falls from more than 30 health plans (mean patient age, 76 years) found that anemia increased costs by $1855 per patient per month, and $2811 for hip-specific falls.55





Indirect Costs

Fatigue and other limitations related to anemia have untold effects on indirect costs for employed individuals and, in the case of disabled patients, their caregivers.13,36 Indirect costs may include disability payments, lost workdays, reduced productivity at work, and travel expenses for healthcare appointments.36





 
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