Management of Anemia: Final Thoughts

The editors hope that this issue of ASN Kidney News focusing on anemia and its management will allow readers to review lessons learned from our use of rEPO and to take pause as we thoughtfully embark on anemia treatment strategies utilizing newer agents that may soon be available.

CKD affects over 10% of the US population, with anemia being present as this disorder progresses, ultimately terminating in ESKD, preemptive kidney transplantation, or conservative management. Even with these clinical endpoints, anemia often remains a critical comorbidity. With increased focus on value-based payment and most important, patient-centered care, the management of this population cannot and should no longer be delivered in a fragmented manner.

Hypertension control, management of metabolic bone disease, nutritional support, fluid optimization, and other co-morbidity control will be delivered in an integrated fashion more so than ever. The management of anemia in this environment must be completely reevaluated. Front and center are the recurrent questions: How do my patients feel when their anemia is managed? Is hemoglobin of 9–11 g adequate to suppress symptoms? Are there advantages to higher hemoglobin levels with newer agents? HIFs are not erythropoietin; how will the FDA view the labeling for them? Will there be restrictions? What are their short- and long-term safety profiles?

As physician-scientists we all must get comfortable reliving many of the same issues we now understand of earlier agents but answer them in an accelerated manner, not over a 30-year period.

Finally, understanding our payment systems and how they drive pharmaceutical utilization cannot be underestimated. I spoke with Dr. Jay Wish, one of the authors in this special section, and he passionately believes no discussion of pharmacotherapy can occur without consideration of cost and payment. The pricing of HIF stabilizers has yet to be determined, so a value proposition cannot be quantified.

Because HIF stabilizers will be approved by the FDA during or after 2020, their use in ESKD patients will qualify for the “transitional drug add-on payment adjustment (TDAPA)” to the ESKD prospective payment system. Each HIF stabilizer will be paid for by the Centers for Medicare and Medicaid Services (CMS) outside the dialysis payment “bundle” for two years following its approval by the FDA. In other words, for those two years the HIF stabilizer with be paid for through Medicare Part D or Medicaid and will not cost the dialysis provider anything. The bundled payment for patients using a HIF stabilizer through TDAPA will be reduced by the average cost of ESA per treatment, which is about $30. Thus, if a patient’s ESA dose costs more than an average of $30/treatment, the dialysis facility will save money if a HIF stabilizer is used rather than an ESA. This provides a perverse economic, non-clinical, non-patient–centered incentive to use HIF stabilizers, which, it is hoped, will be resisted. After its 2-year TDAPA period, each HIF stabilizer will not go into the dialysis payment bundle, but will rather be charged to CMS by the dialysis provider as an “outlier payment” that is not fully reimbursed. At that point, there may again be a perverse economic incentive to return to ESAs, which remain in the bundle, or there may be competition, which brings the price of all anemia treatments down.

Phase 3 trial results for HIFs will be available soon and will answer some, but not all, the questions posited here. In anticipation of the many additional questions bound to be generated from these trials, the National Kidney Foundation empaneled some of the world experts March 22–23, 2019, in Philadelphia, PA, to review all available data and ask, where do we go next? Their white paper will be available soon in the American Journal of Kidney Diseases.

In closing, we hope this series of articles by industry experts and your colleagues, has helped educate and shape your understanding of the next generation of agents available for anemia management.

May 2019 (Vol. 11, Number 5)