Comparative cost analysis of management of secondary hyperparathyroidism with paricalcitol or cinacalcet with low-dose vitamin D in hemodialysis patients

Abstract

Objective:

The objective of this analysis was to compare costs of paricalcitol or cinacalcet plus low dose vitamin D, and of phosphate binders, in patients in the IMPACT SHPT study; and to extrapolate those to estimate expected annual maintenance costs.

Methods:

IMPACT SHPT was a 28-week, randomized, open-label trial. Subjects from 12 countries received intravenous (IV) or oral paricalcitol, or oral cinacalcet plus fixed IV doxercalciferol or oral alfacalcidol. The primary end-point was the proportion of subjects who achieved a mean intact parathyroid hormone (iPTH) value of 150–300 pg/mL during weeks 21–28 (evaluation period). This study compares the costs of study drugs and phosphate binders among participants during the study and annualized. This analysis includes only those subjects that reached the evaluation period (134 in each group).

Results:

The mean total drug costs over the study period were €2606 (SD = €2000) in the paricalcitol group and €3034 (SD = €3006) in the cinacalcet group (difference €428, p = 0.1712). The estimated annualized costs were €5387 (SD = €4139) in the paricalcitol group and €6870 (SD = €6256) in the cinacalcet group (difference €1492, p = 0.0395). In addition, a significantly greater proportion (p = 0.010) of subjects in the paricalcitol arm (56.0%) achieved an iPTH of 150–300 pg/mL during the evaluation period compared to the cinacalcet arm (38.2%).

Limitations:

This was a secondary analysis of the IMPACT SHPT study which was not designed or powered for costs as an outcome. The dosing of study drugs and phosphate binders in the IMPACT study may not reflect actual practice, and patients were followed for 28 weeks, while the treatment of SHPT is long-term.

Conclusion:

Patients with SHPT requiring hemodialysis who were treated with a paricalcitol-based regimen for iPTH control had lower estimated annual drug costs compared to those treated with cinacalcet plus low-dose vitamin D.

Keywords::

• Secondary hyperparathyroidism
• Costs
• Paricalcitol
• Cinacalcet

Transparency

Declaration of funding

This and the IMPACT SHPT study were funded by AbbVie Inc.

Declaration of financial/other relationships

TM and SK are employees of Abbvie Inc. and owners of AbbVie, Inc. stock. AS has received support in the form of grant/research, consultant/advisor, or speakers bureau from AbbVie, Amgen, AMAG Pharmaceuticals, Affymax and Keryx Biopharmaceuticals. MK has received support in the form of grant/research, consultant/advisor, or speakers bureau from AbbVie, Amgen, Fresenius Medical Care, Medice, Misubishi, Sanofi, Shire, and Vifor. GS has received sponsorship from AbbVie and consulted for Merck. AbbVie, Inc. is the manufacturer of Zemplar® (paricalcitol) and Amgen is the manufacturer of Sensipar® (cinacalet). AbbVie contributed to the study design, research, and interpretation of data, writing, reviewing, and approving the publication.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors wish to acknowledge Beverly Johns and Naijun Chen, employees of AbbVie, Inc. for assistance with statistical analyses. Glen Schumock, who is an author, is a partner in Second City Outcomes Research LLC which received payment from AbbVie Inc. to assist with manuscript preparation.