New Intravenous Calcimimetic Agents: New Options, New Problems. An Example on How Clinical, Economical and Ethical Considerations Affect Choice of Treatment

Giorgina Barbara Piccoli, Tiziana Trabace, Antoine Chatrenet, Carlos Alberto Carranza de La Torre, Lurlinys Gendrot, Louise Nielsen, Antioco Fois, Giulia Santagati, Patrick Saulnier and Nicola Panocchia
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Giorgina Barbara Piccoli: Department of Clinical and Biological Sciences, University of Torino, 10124 Torino, Italy
Tiziana Trabace: Nephrologie, Centre Hospitalier Le Mans, 72037 Le Mans, France
Antoine Chatrenet: Nephrologie, Centre Hospitalier Le Mans, 72037 Le Mans, France
Carlos Alberto Carranza de La Torre: Nephrologie, Centre Hospitalier Le Mans, 72037 Le Mans, France
Lurlinys Gendrot: Nephrologie, Centre Hospitalier Le Mans, 72037 Le Mans, France
Louise Nielsen: Nephrologie, Centre Hospitalier Le Mans, 72037 Le Mans, France
Antioco Fois: Nephrologie, Centre Hospitalier Le Mans, 72037 Le Mans, France
Giulia Santagati: Nephrologie, Centre Hospitalier Le Mans, 72037 Le Mans, France
Patrick Saulnier: Statistical laboratory, University of Angers, 49035 Angers, France
Nicola Panocchia: Nephrology Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00168 Roma, Italy

IJERPH, 2020, vol. 17, issue 4, 1-21

Abstract: Background. Dialysis treatment is improving, but several long-term problems remain unsolved, including metabolic bone disease linked to chronic kidney disease (CKD-MBD). The availability of new, efficacious but expensive drugs (intravenous calcimimetic agents) poses ethical problems, especially in the setting of budget limitations. Methods. Reasons of choice, side effects, biochemical trends were discussed in a cohort of 15 patients (13% of the dialysis population) who stared treatment with intravenous calcimimetics in a single center. All patients had previously been treated with oral calcimimetic agents; dialysis efficacy was at target in 14/15; hemodiafiltration was employed in 10/15. Median Charlson Comorbidity Index was 8. The indications were discussed according to the principlist ethics (beneficience, non maleficience, justice and autonomy). Biochemical results were analyzed to support the clinical-ethical choices. Results. In the context of a strict clinical and biochemical surveillance, the lack of side effects ensured “non-maleficence”; efficacy was at least similar to oral calcimimetic agents, but tolerance was better. Autonomy was respected through a shared decision-making model; all patients appreciated the reduction of the drug burden, and most acknowledged better control of their biochemical data. The ethical conflict resides in the balance between the clinical “beneficience, non-maleficience” advantage and “justice” (economic impact of treatment, potentially in attrition with other resources, since the drug is expensive and included in the dialysis bundle). The dilemma is more relevant when a patient’s life expectancy is short (economic impact without clear clinical advantages), or when non-compliance is an issue (unclear advantage if the whole treatment is not correctly taken). Conclusions. In a context of person-centered medicine, autonomy, beneficence and non-maleficence should weight more than economic justice. While ethical discussions are not aimed at finding “the right answer” but asking “the right questions”, this example can raise awareness of the importance of including an ethical analysis in the choice of “economically relevant” drugs.

Keywords: principlist ethics; drug choice; hemodialysis; calcimimetic agents; non-compliance; economic aspects of drug choice (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2020
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