Health-Economic Comparison of Paricalcitol, Calcitriol and Alfacalcidol for the Treatment of Secondary Hyperparathyroidism during Haemodialysis

Hubertus Rosery; Rito Bergemann; Steven E. Marx; Axel Boehnke; Joel Melnick; Raimund Sterz; Laura Williams

Clin Drug Invest. 2006;26(11):629-638.

4. Discussion

This health-economic analysis investigated the cost, cost-effectiveness and cost-utility of intravenous paricalcitol compared with oral calcitriol and oral and intravenous alfacalcidol. The main finding was that intravenous paricalcitol demonstrated clear advantages with respect to costs, effectiveness and utilities compared with treatment with oral calcitriol and intravenous alfacalcidol (see Table V ).

The unit-cost data were based on German retail pharmacy prices, fixed in a tariff of charges with Germany-wide validity. The alfacalcidol products Doss^® and Bondiol^® and the calcitriol-product Osteotriol^® were not chosen as comparators because of their primary indication for osteoporosis, which might explain the relatively high market share based on 4 million (Doss^®) and 3.6 million (Bondiol^®) defined daily doses (DDD) in 2003.^[44]

For oral alfacalcidol and calcitriol, a constant dosage of 0.5μg per patient per day with 100% compliance and no change in initial doses was assumed. Since intravenous paricalcitol is administered during the dialysis session, compliance with this medication was not an issue. However, the effectiveness of oral calcitriol and alfacalcidol is dependent upon patient compliance, which favours the use of paricalcitol.

The sensitivity analysis showed a strong influence of the G-DRG used. Nevertheless, all suitable G-DRGs associated with secondary hyperparathyroidism resulted in cost savings with use of paricalcitol compared with calcitriol and alfacalcidol, demonstrating the robustness of the results.

Reference to a real-world database, namely 875 million single prescriptions in Germany in 2003, shows that the administration costs per day for alfacalcidol and calcitriol were even higher than those estimated by our analytical approach. Based on 2.5 million DDD of Rocaltrol^® in 2003, the average daily costs for calcitriol were reported as 3.28, which is equivalent to yearly costs of 1197.^[45] If this value were used for one day of treatment or one dialysis session with calcitriol, this would result in even higher benefit ratios for paricalcitol compared with calcitriol and alfacalcidol.

A limitation of this analysis is that the cost of adverse events has not been calculated. However, any additional cost beyond hospitalisations would potentially favour the use of paricalcitol, since a randomised controlled trial of calcitriol and paricalcitol showed a nearly 40% relative increase in the incidence of hypercalcaemia with calcitriol (9.2% and 6.7%, respectively) compared with paricalcitol.^[3,24,45]

The number of hospitalisations per year was obtained from real-world clinical dialysis settings, including 11433 haemodialysis patients treated with paricalcitol (n = 4611) or calcitriol (n = 6832).^[22] As the discharges per 100000 population for Germany are 20% higher than the corresponding rates for the US, a conservative modelling approach was used (i.e. a premium rate was not used).^[46] The study by Dobrez et al.^[22] did not provide any information about disease-specific hospitalisations in the monotherapy subpopulation. Since disease-specific hospitalisations were not reported, all-cause hospitalisations were used in this analysis.

The survival rates of patients treated either with paricalcitol or calcitriol were obtained from patients who received the same therapy for the duration of follow-up. The robustness of these data may offset the uncertainty resulting from missing information regarding patients´ time of entry to the study and withdrawal.

The external validity of the Teng et al.^[23] study is supported by a second retrospective study of haemodialysis patients from a different dialysis facility commenced on either intravenous paricalcitol or intravenous calcitriol between 1999 and 2004. This study found the mortality rate (deaths/100 patient-years) was higher among patients receiving calcitriol than in those receiving paricalcitol, namely 19.6 (95% CI 18.2, 21.1) versus 15.3 (95% CI 13.6, 16.9), respectively (p = 0.0001).^[47] In addition, an international prospective observational study of haemodialysis patients showed a significantly lower mortality rate with vitamin D therapy compared with no vitamin D.^[48] This study also demonstrated that mortality with intravenous paricalcitol compared with no vitamin D was associated with the lowest mortality rate compared with oral vitamin D, intravenous calcitriol or any vitamin D versus no vitamin D, after adjusting for baseline demographics and co-morbidities, and time-varying laboratory values. However, intravenous paricalcitol was not compared with intravenous calcitriol in this study. Furthermore, the US Renal Data System has shown an overall reduction in mortality rates in a current dialysis population, and suggested this phenomenon may be associated with increased use of paricalcitol and other changes in overall medical practice.^[3]

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Cite this: Health-Economic Comparison of Paricalcitol, Calcitriol and Alfacalcidol for the Treatment of Secondary Hyperparathyroidism during Haemodialysis - Medscape - Nov 01, 2006.

Table I. Medication Costs for Alfacalcidol, Calcitriol and Paricalcitol ^a
Medication	Package size	Cost/pack ()	Cost/dialysis^b ()	Cost/day ()	Cost/year ()
Alfacalcidol
Eins Alpha^® capsule	100 × 0.5μg	103.36	2.41	1.03	375.95
Eins Alpha^® injection	10 × 1.0mL(2 μg/mL)	158.46	15.84	6.79	2478.35
Calcitriol
Bocatriol^® capsule	100 × 0.5μg	104.01	2.43	1.04	379.60
Calcitriol-Nephro^® capsule	100 × 0.5μg	100.82	2.35	1.00	365.00
Decostriol^® capsule	100 × 0.5μg	104.01	2.43	1.04	379.60
Rocaltrol^® capsule	100 × 0.5μg	128.67	3.00	1.29	470.85
Intravenous paricalcitol
Zemplar^®	5 × 5μg	127.18	25.44	10.90	3978.50

^aSource: German Red List, January 2005.
^bAssumes three dialysis sessions per week.

Table II. Diagnosis-related Groups (DRGs) for Kidney Disease With Dialysis in Germany ^a
DRG	Description	Points	Base-case value ()	Costs per admissioncase ()
L60A	Kidney disease with dialysis haemolytic-uraemic syndrome or complex diagnosis and extremely severe complications	3.117	2800	8727.60
L60B	Kidney disease with dialysis not haemolytic-uraemic syndrome but complex diagnosis and extremely severe complications	2.277	2800	6375.60
L60C	Kidney disease with dialysis not haemolytic-uraemic syndrome or complex diagnosis or extremely severe complicationsorKidney disease without dialysis with haemolytic-uraemic syndrome or extremely severe complications	1.532	2800	4289.60

^aReference year for DRG values = 2005.

Table III. Published Utility Scores for End-stage Renal Disease and Haemodialysis
Health state	Score	Reference	Year of publication
End-stage renal disease	0.59	Lawrence et al.^[32]	1995
End-stage renal disease	0.61	Eastman et al.^[33]	1997
End-stage renal failure	0.567	Kiberd and Jindal^[34]	1995
End-stage renal failure due to diabetes	0.61	Diabetes Group^[35]	1996
End-stage renal failure	0.61	van Os et al.^[36]	2000
End-stage renal failure	0.576	Kiberd and Jindal^[37]	1998
Patients with end-stage renal disease treated with
full-care centre haemodialysis	0.66	de Wit et al.^[38]	1998
limited-care centre haemodialysis	0.81	de Wit et al.^[38]	1998
Dialysis	0.41	Kiberd^[39]	1994
Dialysis	0.43	Churchill et al.^[40]	1987
Dialysis	0.453	Coffey et al.^[41]	2002

Table I. Medication Costs for Alfacalcidol, Calcitriol and Paricalcitol ^a
Medication	Package size	Cost/pack ()	Cost/dialysis^b ()	Cost/day ()	Cost/year ()
Alfacalcidol
Eins Alpha^® capsule	100 × 0.5μg	103.36	2.41	1.03	375.95
Eins Alpha^® injection	10 × 1.0mL(2 μg/mL)	158.46	15.84	6.79	2478.35
Calcitriol
Bocatriol^® capsule	100 × 0.5μg	104.01	2.43	1.04	379.60
Calcitriol-Nephro^® capsule	100 × 0.5μg	100.82	2.35	1.00	365.00
Decostriol^® capsule	100 × 0.5μg	104.01	2.43	1.04	379.60
Rocaltrol^® capsule	100 × 0.5μg	128.67	3.00	1.29	470.85
Intravenous paricalcitol
Zemplar^®	5 × 5μg	127.18	25.44	10.90	3978.50

^aSource: German Red List, January 2005.
^bAssumes three dialysis sessions per week.

Table II. Diagnosis-related Groups (DRGs) for Kidney Disease With Dialysis in Germany ^a
DRG	Description	Points	Base-case value ()	Costs per admissioncase ()
L60A	Kidney disease with dialysis haemolytic-uraemic syndrome or complex diagnosis and extremely severe complications	3.117	2800	8727.60
L60B	Kidney disease with dialysis not haemolytic-uraemic syndrome but complex diagnosis and extremely severe complications	2.277	2800	6375.60
L60C	Kidney disease with dialysis not haemolytic-uraemic syndrome or complex diagnosis or extremely severe complicationsorKidney disease without dialysis with haemolytic-uraemic syndrome or extremely severe complications	1.532	2800	4289.60

^aReference year for DRG values = 2005.

Table IV. Sensitivity Analysis of Incremental Costs of Intravenous (IV) Paricalcitol Compared With Oral Calcitriol and IV Alfacalcidol Based on German Diagnosis-related Groups (DRG L60A ^a and L60C ^a)
Variable	Oral calcitriol	IV alfacalcidol
Medication costs ()	-3604	-1501
Hospitalisation costs L60A ()	+7384	+7384
Total incremental costs ()	+3780	+5883
Hospitalisation costs L60C ()	+3629	+3629
Total incremental costs ()	+25	+2128

^aSee Table II .

Table V. Incremental Costs, Incremental Survival Rates and Incremental Utilities of Intravenous (IV) Paricalcitol Compared With Oral Calcitriol and IV Alfacalcidol
Variable	IV paricalcitol	Oral calcitriol	IV alfacalcidol
Medication costs ()		-3604	-1501
Hospitalisation costs L60B^a ()		+5394	+5394
Incremental total costs ()		+1790	+3893
Incremental 1-year survival rate	0.04
Incremental utilities	0.030

^aSee Table II .

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Health-Economic Comparison of Paricalcitol, Calcitriol and Alfacalcidol for the Treatment of Secondary Hyperparathyroidism during Haemodialysis

4. Discussion

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