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Abstract
Aims: Patients with chronic kidney disease (CKD) not on dialysis frequently have vitamin D insufficiency (VDI) and secondary hyperparathyroidism (SHPT), which are associated with an increased risk of cardiovascular (CV) disease, fracture, CKD progression, and death. This study estimated the cost-effectiveness of extended-release calcifediol (ERC) vs paricalcitol for the treatment of patients with CKD stages 3–4 that have SHPT and VDI.
Materials and methods: An economic analysis of SHPT treatments among a hypothetical cohort of 1,000 patients with CKD Stage 3 and 4 with SHPT and VDI was developed to estimate differences in the rates and costs of CV events, fractures, CKD stage progression, and mortality in patients treated with ERC and paricalcitol. A Markov model was developed with 1-year cycles and a 5-year time horizon from a US Medicare payer perspective with costs valued in 2017 US dollars.
Results: The outcomes of the model were rates of clinical events, total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER). Across a 1,000-person cohort, ERC was the dominant (less costly, more effective) treatment strategy when compared with paricalcitol. Treatment with ERC resulted in cost savings of $14.8 M (95% CI = –$10.0 M–$45.2 M) and an incremental gain of 340 QALYs (95% CI = 200–496) compared to treatment with paricalcitol.
Limitations: Bridging biochemical levels to clinical outcomes may not represent real-world risk of the clinical events modeled. Future real-world outcomes of patients treated with ERC and paricalcitol may be used to evaluate the model results.
Conclusions: This model demonstrated favorable short- and long-term clinical benefits associated with the use of ERC in patients with CKD Stage 3 and 4 with SHPT and VDI, suggesting ERC may be cost-effective from the Medicare perspective compared to paricalcitol.
Transparency
Declaration of funding
OPKO Health, Inc. funded the model development upon which this manuscript was based, as well as manuscript development. The funder had a role in the study design, collection of data, and the decision to submit the report for publication
Declaration of financial/other interests
Akhtar Ashfaq is an employee of OPKO Health, Inc. Sophie Snyder and Roy Arguello are employees of BluePath Solutions.
A peer reviewer on this manuscript has disclosed that they have received advisory and lecture honoraria as an expert on vitamin D in CKD from both Vifor Fresenius Medical Care Renal Pharma (extended release calcifediol) and AbbVie (paricalcitol). The peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.
Acknowledgements
No assistance in the preparation of this article is to be declared.
Previous presentations
The manuscript is a sub-analysis of a model that was presented as a poster at the National Kidney Foundation (NKF) Clinical Meeting in May 2019.
Data availability
The data to support our model and conclusions can be made partially available upon request. The proprietary modeling code and some of the data are confidential and cannot be made fully available.