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A longer view: Moving from a thrice-weekly to weekly or biweekly erythropoiesis-stimulating agent dose
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For many years, dialysis providers in the United States had only one choice for erythropoiesis-stimulating agents to treat anemia in the end-stage renal disease patient: Epogen by Amgen Inc. Today, other options include longer-titrating formulas from Amgen and Mircera from Roche Pharmaceuticals. Nancy Pelfrey, MSN, ACNP-BC, CNN-NP, has many years of experience in pharma management in the renal care specialty. She talks about the change from Epogen’s thrice-weekly regimen to the longer-titrating Aranesp.
NN&I: Your experience is with moving patients from Amgen’s Epogen to Aranesp. What were the challenges in making the switch?
Nancy Pelfrey, MSN, ACNP-BC, CNN-NP: The dosing conversion tables offer a range in the number of units for Epogen vs. the micrograms for Aranesp. But there is no specific value; rather a range is suggested. Every patient is unique and each will respond in their own way. Some respond quickly, some slowly and then for a given patient, his/her response may vary depending on other comorbid factors.
NN&I: So is it better to estimate that a higher dose is needed for the longer-titrating regimen?
Pelfrey: It is probably better to use the higher end of the conversion dose range to avoid hemoglobins (hgb) below 10 g/dL and then back off on a higher dose once there is a positive response. The anemia manager becomes adept at following trends of hgbs and doses. Persistent and timely observation and assessment are needed.
NN&I: How much time do you give to make sure you selected the right dosing to create a steady hgb value?
Pelfrey: Patience is a virtue with anemia management. The response time for both Epogen and Aranesp is 2 to 6 weeks. There is a tendency to want to adjust a dose when the hgb doesn’t respond or the response is not quick enough. Take time to watch the patient carefully. My experience is that the time needed to get to the expected stability point when the drug manufacturer indicates that most patients are converted and at what hgb value is longer than expected. This may take up to 3 months. It is sometimes longer for an individual patient.
NN&I: What is the target you are aiming for in the conversion?
Pelfrey: The target should be in alignment with the CMS Core Survey Clinical Thresholds, product information from the FDA, the facility goal and target, and what the patient needs for their individual hgb. Have a plan and be consistent in the measurement factors, such as whether the hgb used is the one that is measured at the end of the month, whether it is the average of the hgbs recorded during the month or whether the hgb is included from the first 90 days of dialysis. Reporting entities for patients receiving dialysis vary in how hgb is reported, ie, the Dialysis Outcomes Practice Pattern Study methods and how CMS’ Quality Incentive Program chooses different measurements of hgbs and what time period is covered.
NN&I: Is there a cost savings for the clinic in switching to the longer-titrating erythropoiesis-stimulating agent (ESA)?
Pelfrey: Yes, but manufacturers can manipulate pricing by making the older drug more expensive to use. The longer-titrating drug did become more financially attractive. We thought we would see more staffing time-savings, freeing up the [registered nurse] RN to do more care management/coordination; this was difficult to quantify.
NN&I: What about overall better outcomes in terms of anemia management? Are longer titrating drugs a clear-cut winner?
Pelfrey: Taking everything together, I would say that 1) patient outcomes are similar; 2) pricing for longer-acting drugs is better; and 3) the RN time-savings part of the equation, the longer-titrating drugs are an improvement. When I was the virtual outcomes manager at Reliant Renal Care, the conversion from Epogen to Aranesp occurred at the same time as our target hgb changed. Initially, it was 10 g/dL to 12 g/dL but changed to 10 g/dL to 11 g/dL. We continued to use the 10 g/dL to 11 g/dL as the target and incorporated the concept of minimizing sub 10s.
NN&I: What did going to a longer-titrating ESA do to your iron protocol?
Pelfrey: Overall, there was less iron used but the reasons were multifaceted, including:
Our iron protocol allowed dosing of iron up to a ferritin level of 1,200 ng/dL. This was in alignment with the [Dialysis Patients’ Response to IV Iron with Elevated Ferritin] DRIVE study. When the iron controversies report was published in 2016 some MDs then limited iron to patients with ferritin less than 800 ng/mL.
We started using the iron-based phosphate binders and this had an impact on IV iron usage.
Overall, fewer loading doses were needed; weekly or biweekly maintenance doses provided enough iron.
NN&I: What do you think is a healthy hgb to shoot for and maintain?
Pelfrey: You know you have the ideal hemoglobin when your patient doesn’t experience signs and symptoms of anemia. A hemoglobin measurement may be one that provides a bumper when the patient has worsening of chronic comorbid conditions or becomes hospitalized, but how to tell which signs and symptoms are attributable to anemia or to any of the other conditions that patients with ESRD exhibit, is the question. For example, shortness of breath could be from worsening anemia or from volume overload.
The best approach is to avoid hemoglobin in the sub 10s. Shoot for high 10s and low 11s. Try to predict hgb changes that may occur with blood loss events, infection, etc.
NN&I: In what type of patient is this more challenging?
Pelfrey: Your dosing regimen gets thrown out of kilter when the patient is hospitalized. It’s not always clear if the patient received ESAs of any kind while hospitalized and if they did, when the last dose was received. Was Epogen or Aranesp used? We also don’t always know if a blood transfusion was performed and, if so, when, and how many units. Gather as much timely information as available; it is usually a challenge to obtain records from outside the facility.
NN&I: What scenarios are also challenging for longer-titrating regimens?
Pelfrey: This is most likely the same for any ESA, but always consider these scenarios as challenging to maintain a steady hgb:
- Patients residing in nursing homes or undergoing rehabilitation service;
- The impact of missed treatments;
- The use of anti-coagulant medications;
- Patients with infection;
- Patients with cognitive dysfunction — They can’t always tell you things like GI/GU blood loss or what medications they are actually taking;
- Patients with catheters for their vascular access;
- Patients who are malnourished;
- Patients with myelodysplastic syndromes;
- Hereditary hemolytic anemias;
- Patients with diabetes, mineral bone disease, myeloid-suppressive medications or side effects; and
- Patients with aberrant iron utilization.
- References:
- CMS, ESRD Core Survey. Version 1.0-1.8
- Coyne DW, et al. J Am Soc Nephrol. 2007;doi:10.1681/ASN.2006091034.
- Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Kid Int. Suppl. 2012;279-335.
- Macdougal IC, et al. Conclusions from a “Kidney Disease: Improving Global Outcomes” Controversies Conference. Kid Int. 2016;89, 28-39.
- For more information:
- Nancy Pelfrey, MSN, ACNP-BC, CNN-NP, was most recently the Virtual Outcomes Manager for Reliant Renal Care, based in Media, Pa.
Disclosure: Pelfrey has no relevant financial disclosures.