Volume 40, Issue 3 , Pages 662-663, September 2002
Preaching and practice: Evidence-based medicine and the accountability of nephrologists within the health care system. The implications of the findings of the cost-saving potential of subcutaneous versus intravenous epoetin therapy☆
Article Outline
Related Article, p. 439
Erythropoietin therapy is the single most important breakthrough in the treatment of the anemia of end-stage kidney disease, and apart from improvements in dialysis and transplantation technologies, it has had a most profound impact on patients and outcomes.
In this edition of the journal, Besarab et al1 report the results of a meta-analysis comparing subcutaneous (SQ) versus intravenous (IV) erythropoietin in the treatment of anemia in maintenance hemodialysis patients. They systematically evaluate the studies reviewing IV versus SQ erythropoietin to assess the relative costs of the administration routes. The investigators demonstrate that a reduction in dosage of approximately 50 U/kg/wk is possible when stable patients are switched from IV to SQ. The average cost savings per year of drug alone was approximately 30%, or $1,761USD per patient year. In the meta-analysis, there is variation in the absolute dose reduction, but on balance, the SQ route offers substantial financial savings without reduction in effectiveness. This meta-analysis is well done and thorough.
The authors do not address the potential issue of differential pain of SQ versus IV injections and patience acceptance and do not address any other reasons for lack of administration of SQ injections in the United States. The focus of the article is primarily on the efficacy of the two modes of administration.
In the current era of evidence-based guideline proliferation, it is interesting to reflect on the need for such an evaluation as this: all current guidelines, including the US-generated K/DOQI guidelines and the European and the Canadian national guidelines for anemia management, have recommended SQ administration, based on best evidence.2, 3 Nonetheless, in the United States, there is continued discrepancy between current clinical practice and the published guidelines, such that 90% of patients still receive erythropoietin through the IV route. It is possible that patient acceptance of SQ injections may be less and that nephrologists and/or dialysis units may be reluctant to implement this strategy, fearing that patients might switch dialysis units if they were to do so. Comparison with international practices and patient acceptance of SQ injections would suggest that this is a minor problem. Nonetheless, the implications of this study are immense in terms of potential cost savings (if even 25% of the patients switched their route of administration from IV to SC, the savings would approximate $47 million per year) and underscore the discordance between what is evidence and what is practice.
Perhaps this article by Besarab et al1 highlights the importance of critical analysis of existing data, despite guidelines, to further “substantiate” published guidelines (the recommendation to administer the drug subcutaneously) when practice does not reflect current guidelines. The question as to why the United States lags behind its own guidelines and behind most of the rest of the western world with respect to route of administration of an expensive medication remains to be answered.
Perhaps more importantly, the findings in this article by Besarab et al1 and their implications bring into focus a broader question: what is the accountability of clinicians and health organizations relative to health care expenses?
With the exponential growth of patients on dialysis, the total costs of care are in the billions of dollars in the United States. With the cost to Medicare of this drug alone quoted to be over $600 million in 1998,4 a reduction in costs would be substantial. As defined in the article by Besarab et al,1 between $150 and $200 million could ultimately be translated into either putting more patients on erythropoietin therapy (and reaping all of the benefits thereof) or using those “savings” towards offsetting other Medicare costs of dialysis treatments. If one considers the total Medicare budget for end-stage renal disease (ESRD), annual savings could be substantial, especially as hemoglobin targets are rising, potentially requiring more erythropoietin therapy. The complete studies with newer molecules, such as darbapoietin, comparing IV versus SQ have not been of long enough duration or of the same magnitude as the current number of studies with erythropoietin. While it may be that the doses of darbapoietin are equivalent, given known pharmacokinetics of IV versus SC administration of most drugs, this may need to be proven more definitively than has been to date. Importantly, SQ administration of drugs may also foster patient independence, is less resource intensive with respect to nursing time, and is a practical route of administration for both home-based patient groups (Stages 1-4 CKD, and peritoneal dialysis or posttransplant patients). Thus, whether the drug is erythropoietin or darbapoietin, the message about ensuring cost effectiveness and cost savings remains important.
In the United States, current reimbursement policies favor the IV over the SQ route, and one needs to ask whether or not these policies are defensible in the current health care climate. If there is substantial evidence to support similar efficacy, as this meta-analysis demonstrates, and if there are potential cost savings with SQ administration, why would the drug continue to be prescribed IV? As scrutiny regarding evidence-based care, clinical performance measures, and clinical guidelines increases, clinicians need to engage in more critical reflection regarding current practices. When lobbying government and funding agencies for increases in clinical, research, and educational dollars to ensure the appropriate care of patients with ESRD and kidney disease in general, it may be wise for US nephrologists to contemplate the value of “best demonstrated practices” as an indicator of commitment to their share of responsibility for health care costs.
Anemia management is expensive in ESRD; however, appropriate therapy and achievement of target hemoglobin translates into reduced morbidity and mortality, reduced transfusion costs and consequences, and improved quality of life and exercise capacity.5, 6, 7 Attempts to reduce the total cost of anemia therapy in the United States, thereby allowing more patients to access those benefits for the same health care dollar, are of tantamount importance. Nephrologists need to seriously consider changes in current prescribing practices in order to demonstrate responsibility and maintain credibility within an ever more scrutinized health care system.
References
- . Meta-analysis of subcutaneous versuss intravenous epoetin in maintenance treatment of anemia in hemodialysis patients. Am J Kidney Dis. 2002;40:439–446
- . European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant. 1999;14:1–50
- Clinical practice guidelines for the management of anemia coexistent with chronic renal failure. Canadian Society of Nephrology. J Am Soc Nephrol. 1999;10(suppl 13):S292–S296
- United States Renal Data System 1999 Annual Data Report. Am J Kidney Dis. 1999;34(suppl 1):S1–S176
- . Hematocrit level and associated mortality in hemodialysis patients. J Am Soc Nephrol. 1999;10:610–619
- Alterations of left ventricular hypertrophy in and survival of patients receiving hemodialysis: Follow-up of an interventional study. J Am Soc Nephrol. 2001;12:2759–2767
- . Increasing the hematocrit has a beneficial effect on quality of life and is safe in selected hemodialysis patients. Spanish Cooperative Renal Patients Quality of Life Study Group of the Spanish Society of Nephrology. J Am Soc Nephrol. 2000;11:335–342
☆ 0272-6386/02/4003-0035$35.00/0
PII: S0272-6386(02)00095-1
doi:10.1053/ajkd.2002.35898
© 2002 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.
Refers to article:
- Meta-analysis of subcutaneous versus intravenous epoetin in maintenance treatment of anemia in hemodialysis patients
Volume 40, Issue 3 , Pages 662-663, September 2002
