An economic comparison of surgical and medical therapy in patients with secondary hyperparathyroidism—the German perspective

Ralph Schneider, MD,a Georgios Kolios, MD,b Benjamin M. Koch,a Emilio Domınguez Fernandez, MD,c Detlef K. Bartsch, MD,a and Katja Schlosser, MD,a Marburg, Bremen, and Hannover, Germany

Background. Treatment options for secondary hyperparathyroidism were significantly amended with the introduction of cinacalcet and paricalcitol. Limitations of resources in public health systems demand detailed analyses of accruing costs. The aim of this study was to compare the costs of these new treatment modalities to surgery. Methods. Patients who underwent initial parathyroidectomy (n = 91) and patients treated with cina- calcet or paricalcitol (n = 100) at an ambulatory dialysis center between 01/2003 and 12/2006 were analyzed. The revenues of both therapies for the funding agencies were calculated by a cost-cost analysis. The real arising costs of the supplier were analyzed and compared to the revenues. Results. Treatment costs for cinacalcet (60 mg/day/year) were 5828.40V and 4485.20V for paricalcitol (15 mg/week/year). Revenues for inpatient surgical treatment according to the German DRG system were 3755.38V/case. Additionally, costs for postoperative ambulatory therapies were 545.05V for the first year and 384.97V for the following. Conclusion. Due to linearly increases, expenses of medical treatment with cinacalcet for more than 9 months or paricalcitol for more than 12 months exceeded the costs of surgical therapy. The indication of these new medical therapies should be restricted to patients as an interim solution ahead of surgery or in patients considered unfit for surgery. (Surgery 2010;148:1091-9.)

From the Department of Visceral, Thoracic and Vascular Surgery,a Philipps University, Marburg, Department of Plastic, Reconstructive and Aesthetic Surgery,b University of Bremen, and Department of General, Visceral and Vascular Surgery,c Clinical Centre Nordstadt, Hannover, Germany

2 SECONDARY HYPERPARATHYROIDISM (sHPT) is a common metabolism. However, limited availability of kidney sequel of chronic kidney disease (CKD) developing transplants or high comorbidities preventing trans- in response to high phosphate, low calcium and low plantation led to a high percentage of patients 1,25-dihydroxyvitamin D3 (calcitriol) levels. High requiring operative intervention with total parathy- levels of parathyroid hormone (PTH) accelerate roidectomy (PTX) with autotransplantation or subtotal bone turnover, with efflux of calcium and phosphate PTX, both worldwide accepted equivalent standard leading to vascular calcifications and renal osteopathy.1 procedures in the surgical treatment of sHPT.3 Until the beginning of this century, the medical treat- The introduction of vitamin D analogs and ment of sHPT comprised the application of calcitriol calcimimetics in 2004 and 2005 was considered as a and calcium-based phosphate binders. A successful ‘‘breakthrough’’ in the medical treatment of sHPT.4 kidney transplantation is the only causal treatment Vitamin D analogs such as paricalcitol (ZemplarÒ) available to correct the abnormalities in mineral inhibit PTH gene transcription and parathyroid hyperplasia and have the advantage of a reduced R.S. and G.K. contributed equally to this work. calcemic activity when compared to vitamin D. Sev- Accepted for publication December 18, 2010. eral such analogs are now in use, and analogs with even greater selectivity than those currently available Reprint requests: Ralph Schneider, MD, Philipps University 5 Marburg, Department of Visceral, Thoracic and Vascular Sur- are in development. However, the role of vitamin D gery, Baldingerstrasse, 35043 Marburg, Germany. E-mail: analogs and PTX needs to be re-evaluated in the [email protected]. calcimimetic era.6 0039-6060/$ - see front matter Cinacalcet (SensiparÒ/MimparaÒ) is the first of Ó 2010 Mosby, Inc. All rights reserved. the new class of calcimimetic drugs approved for the doi:10.1016/j.surg.2010.09.009 treatment of sHPT. Calcimimetics suppress the

SURGERY 1091 1092 Schneider et al Surgery December 2010 secretion of PTH by sensitizing the parathyroid sHPT who underwent initial PTX between January calcium receptor to extracellular calcium.2 Com- 2003 and January 2006 at a tertiary referral surgical bined with higher doses of calcium-based oral phos- center (n = 91). The standard surgical procedure phate binders, it is mostly well tolerated and already was a total PTX with a parathyroid autotransplanta- considered as an effective alternative to standard tion into the forearm. medical treatments such as vitamin D derivatives to- The costs of surgical therapy comprised inpa- gether with non--calcium-based oral phosphate tient costs, as well as costs for special postoperative binders.2 Clinical trials demonstrated cinacalcet to ambulatory measures including blood examina- be effective in suppressing PTH secretion in uremic tions and calcium and calcitriol supplementation. patients with severe sHPT in whom formerly PTX The revenues were calculated on the basis of the might have been considered. Therefore, calcimi- German diagnosis related grouping (DRG) calcu- metics were claimed to be an alternative to PTX.2 lation system, where base-case values are multi- However, evidence for an impact on clinical events plied with a relative weight. To find out if the such as mortality, cardiovascular events or fractures inpatient surgical therapy can be performed cost- is based on short-term post hoc analyses7 and most covering, the real arising costs for the supplier of the trials with cinacalcet are supported by the in- (hospital) were analyzed and compared to the dustry merchandising this drug. Whether the appli- revenues. An activity-based costing approach based cation of cinacalcet will translate in improved on clinical pathways, which allocated the individ- outcomes remains to be demonstrated and ade- ual and overhead costs to processes, was chosen for quately powered prospective controlled random- an appropriate real cost accounting. Therefore, ized studies independently performed from primary, secondary, and tertiary processes were industrial influence are needed.6 Reports about defined. PTX rates before and after the introduction of ei- Primary processes comprised main activities ther one of these new drugs are unavailable and including personal and material costs, which the rate of patients requiring PTX after unsuccess- were directly related to the treatment. The nursing ful treatment with either calcimimetics or vitamin related activity was calculated summarizing the D analogs needs to be evaluated.8 At present, the ris- daily allocation of each patient with correlated ing costs of vitamin D analogs and cinacalcet are re- working minutes. Nursing related activities funded without any restrictions in Germany, and comprised admission examinations, transport of consecutively decision-making between medical or patients (x-ray, electrocardiogram, operation thea- surgical therapy often depends on personal inter- ter), preoperative preparation of patients as well as ests and experiences of both patients and documentation and other nursing activities on the nephrologists. ward. Nursing efforts in the operation theater were To the best of our knowledge, no analysis is defined in a special ‘‘operation pathway’’ including available comparing the costs of the surgical treat- the efforts of 1 anesthetic and 2 surgical nurses. ment and the costs of these new medical treat- The personnel costs of the nurses were calculated ments with either cinacalcet or paricalcitol. on the basis of the salaries and the working The aim of this study was to obtain objective minutes at 0.50V per minute. The physician re- information allowing a transparent estimation of lated activity was calculated on the working min- costs associated with cinacalcet or paricalcitol utes for every process per patient on the ward medication as well as with surgical therapy to (interviews, examinations, ward rounds, documen- find out which therapy is more cost effective. tations). In the operation theater, the efforts of 2 Consequently, the results should facilitate the surgeons and 1 anesthetist were taken into consid- decision-making process in reference to resources, eration. The calculated minutes were multiplied regulations, and developmental processes. with personnel costs on the basis of the mean salaries of 2 residents (1 surgeon and 1 anesthetist) MATERIALS AND METHODS and 1 consultant of 1.05V per minute. Material Data of the present study refer to a retrospective costs were calculated considering wound dressing analysis of a prospective database regarding the materials, surgical drapes, anesthetic materials, patients who underwent surgery and to a retro- and drugs and disposable items like clips and spective review of outpatient files of patients who sutures, as well as costs for sterilization of surgical received a medical therapy with either cinacalcet instruments. The working minutes of physicians or paricalcitol in 2 dialysis centers. and nurses on the ward were extrapolated from The inpatient surgical sector taken for economic estimates based on interviews to all nurses and evaluation comprised all patients with advanced physicians involved in the care of patients with Surgery Schneider et al 1093 Volume 148, Number 6 sHPT. The working minutes in the operation 40 theater were extrapolated as the mean of the 35 precise data provided by both the surgical and anesthetic protocols of all 91 patients who under- 30 went a PTX. 25 Secondary processes comprised personal and material costs provided by other departments of 20 the hospital. The costs of medical functional ser- vices such as laboratory, radiology, pathology, 15 nuclear medicine, and others were calculated 10 according to a catalog listing the equivalence- numeral-calculations of the German Hospital So- 5 ciety (DKG-NT-table), where a point system of sHPT for PTX initial undergoing patients of Number 0 inpatient and outpatient services for hospitals is 2003200420052006200720082009 depicted. Every department is given a score which Years is calculated on the total costs for the department Fig 1. Number of patients undergoing initial PTX for divided by the sum of all scores provided over a sHPT per year. period of 1 year. Afterwards this score is mul- tiplied with the points of the DKG-NT-table. The files of all patients who underwent surgery The ambulatory medical sector comprised all were screened for these services, and the costs patients who were treated with cinacalcet or for every service in each patient were calcu- paricalcitol in 2 dialysis centers (n = 100) between lated. The mean costs were used for the final January 2003 and January 2006. The costs of both calculation. medical therapies for the funding agencies were Tertiary processes were defined as activities of calculated depending on their dosage and on costs the hospital infrastructure without direct relation for laboratory measures. Considering a typical dis- to the treatment (technical service, kitchen, clean- count of 5% for funding agencies, the costs were ing service, energy costs). These estimates refer to correspondingly reduced. The dosages per patient the costs which arise for any patient admitted to were analyzed, leading to a mean dosage of 60mg/ the hospital per treatment day independently day for cinacalcet and of 3 ml/week for paricalci- from the reason of admission. The sum of all tol. The costs were summarized per month over a overhead costs of 2006 was divided by the sum of time period of 2 years. Physical or other examina- all treatment days of 2006 and multiplied by the tions which were necessary due to dialysis were individual hospital stay of each of the 91 patients not taken into consideration. who underwent surgery. The mean costs were used An analysis comparing the costs for surgical and for the final calculation. the costs for medical therapies was then performed These primary, secondary, and tertiary processes (cost-cost analysis). were summarized for every individual patient in order to optimally display the clinical pathways and RESULTS then to calculate the real costs for the inpatient Ninety-one patients with sHPT who underwent therapy. initial PTX between January 2003 and January 2006 Costs for reoperations due to postoperative com- were analyzed. Of these 91 patients, 29 had a failed plications or recurrent/persistent disease were treatment attempt with cinacalcet or paricalcitol added into the calculation. A reoperation rate of prior to surgery. The number of patients who 5% was chosen as a result of a follow-up study not yet underwent initial parathyroid surgery for sHPT published concerning 479 patients who underwent decreased from 37 in 2003 to 28 in 2004, 21 in surgery at our department between the years 1976 2005, and 5 in 2006. The number of initial PTX for and 2003. This study revealed a rate of persistent sHPT increased thereafter with 12, 13, and 20 sHPT of 0.6% and a rate of recurrent sHPT of 4.6% patients in the years 2007, 2008 and 2009, respec- after a mean follow-up of 57.6 months. tively (Fig 1). The mean duration of hospital stay of Patients who underwent initial PTX for sHPT in the patients considered for economic evaluation the following years (2007--2009) were counted to was 7.3 ± 4.31 days. One patient had to undergo a achieve information about the trend in the cervical revision for persistent sHPT due to a missed numbers of PTX performed in the era after the fifth gland within the carotid sheath. Within a initiation of vitamin D analogs and calcimimetics. follow-up period of 3 years after surgery, 2 patients 1094 Schneider et al Surgery December 2010

Table I. Revenues for our hospital for the treatment of sHPT Relative Base-case- Revenue/ Number Overall Year DRG text DRG code weights value (V) case (V) of patients revenue (V) 2003 ‘‘Parathyroid surgery’’ or ‘‘other K05Z 1.179 3169.83 3737.23 35 130 830.03 disorders resulting from impaired 901Z 1.479 4688.18 1 4 688.18 renal tubular function’’ or L09B 2.137 6773.93 1 6 773.93 ‘‘secondary hyperparathyroidism of renal origin’’ Average revenue per case (2003) 3 845.00 2004 ‘‘Procedures on the thyroid the L09B 1.405 3054.43 4291.47 8 34 331.79 parathyroids or the thyroglottic duct’’ K12Z 1.390 4245.66 20 84 913.15 or ‘‘other procedures for kidney and urinary tract disorders’’ Average revenue per case (2004) 4 258.75 2005 ‘‘Parathyroid disorders’’ or ‘‘Procedures K11Z 1.257 2954.71 3714.07 6 22 284.42 on the thyroid the parathyroids or L09B 1.169 3454.06 11 37 994.62 the thyroglottic duct’’ or ‘‘Other L18Z 1.331 3932.72 1 3 932.72 disorders resulting from impaired K64C 0.676 1997.38 1 1 997.38 renal tubular function’’ or 901D 1.879 5551.90 2 11 103.80 ‘‘secondary hyperparathyroidism of renal origin’’ Average revenue per case (2005) 3 681.57 2006 ‘‘Parathyroid disorders’’ or ‘‘procedures K11Z 1.217 2806.35 3415.33 2 6 830.66 on the thyroid the parathyroids or L09B 1.285 3606.16 2 7 212.32 the thyroglottic duct’’ or X06B 1.146 3216.08 1 3 216.08 ‘‘parathyroid procedures’’ Average revenue per case (2006) 3 451.81 Mean revenues per case for the whole period, calculated from the mean annual revenues and 3 559.79 the number of patients treated per year ± 484.22 developed recurrent sHPT at the parathyroid auto- were 545.05V for the first and maximum 384.97V graft and had to undergo an autograft reduction. for the following year. The sensitivity analyses con- The ambulatory medical sector comprised 50 sidering the different base-case values estimated a patients who were treated with cinacalcet and 50 ‘‘worst-case’’ revenue of 3589.77V and a ‘‘best- patients who were treated with paricalcitol in 2 case’’ revenue of 3983.96V. dialysis centers (n = 100) between 01/2003 and Costs of primary processes arising from nursing 01/2006. An interview with the nephrologists in related activities were 571.50V per case assuming charge addressing the outcome of these 100 pa- 663 working minutes per patient on the ward and tients revealed a high lost to follow-up rate of 480 minutes per surgery in the operation theater. 18%, another 13% underwent PTX after a mean Time for physician related work was 243 minutes per medical treatment duration of 25.6 months with ei- patient on the ward and 541 minutes in the oper- ther cinacalcet or paricalcitol, 38% achieved a sig- ation theater resulting in a total amount of 823.20V nificant (>50%) reduction in PTH levels, and 31% per case (Fig 2). Material costs were 643.66V per patients exhibited minor or no response regarding case. Costs of 1118.27V ± 650.40V per case were PTH. The latter are considered unfit for surgery, calculated for secondary processes and of 685.89V refuse surgical intervention, or are already sched- ± 407.45V per case for tertiary processes. The sum- uled for PTX in the meantime. mation of the costs for primary, secondary and The calculation of the mean annual inpatient tertiary processes revealed 3842.52V per case as revenues is shown in Table I. The mean revenues the real arising costs for the inpatient surgical per case for the whole period, calculated from the treatment. mean annual revenues and the number of patients The mean revenues from the agencies for our treated per year, were 3559.79V ± 484.22V. Consid- hospital were 3912.99V per case, leading to a cost- ering a reoperation rate of 5% due to postoperative covering situation with a mean benefit of 70.47V complications or recurrent/persistent disease the per case over all years analyzed (Table II). Neither revenues increased to 3755.38V for Germany. Addi- the costs of the operative treatment nor the costs tional costs for postoperative ambulatory therapies of the medical therapy varied over the years Surgery Schneider et al 1095 Volume 148, Number 6

Fig 2. Timeline of primary processes to physician and nurse related activities to estimate the real arising costs. analyzed. However, the revenues decreased over the sensitivity analysis considering different dosages of years mainly attributed to a reduction of the base- the drugs to differentiate between best and worst- case values. The cost-revenue relation per case for case scenarios. In the worst case scenarios all pa- every year analyzed is depicted in Table II. However, tients were treated with the highest dosage of each the cost-revenue analysis per year observed revealed drug (cinacalcet 180 mg, paricalcitol 3 3 2 ml). In an increasing unprofitable relation between these contrast, the best case scenario was based on the low- measures, leading to resumed negotiations between est dosages of each drug (cinacalcet 30mg, paricalci- the hospital, the funding agencies, and the nephrol- tol 1 3 1-ml). The costs of surgical therapy were ogists in charge to compile a treatment plan in the exceeded by the costs for cinacalcet in the worst aim to regain a cost-covering situation. case scenario after 3 months (Fig 4, A) and for par- The costs of the ambulatory medical therapies icalcitol after 6 months (Fig 4, B). Based on the best mainly depended on the dosages of the drugs. case scenario surgical therapy has to be preferred Cinacalcet (28 tablets/package) was offered with from an economic point of view after 16 months 30, 60, and 90 mg at 232.72V, 421.47V, and (C) treatment with cinacalcet and after 31 months 627.39V, respectively. Paricalcitol was offered in (D) treatment with paricalcitol. packages containing 5 3 1-ml (5 mg/ml) at 130.47V and 5 3 2ml(5mg/ml) at 251.29V. DISCUSSION Monthly and yearly costs for cinacalcet and par- According to the third National Health and icalcitol are displayed in Tables III and IV. Nutrition Examination Survey, CKD affected as The cost-intensive inpatient hospital stay caused many as 19 million adults in the U.S. in 2003, with higher expenses for the surgical therapy within the 20 million more at risk.9 The economic burden first months. Due to linearly rising costs and lifelong associated with CKD was recently analyzed in an application of the drugs the surgical expenses were observational study of 13,796 predialytic pa- exceeded by cinacalcet after 9 months and by tients,10 the determined costs to treat CKD related paricalcitol after 12 months (Fig 3). The postopera- comorbidities were almost twice of those treating tive costs remained almost constant within the out- CKD alone ($14,000 vs $8,000) and the cumulative patient period. These costs were depended on the costs of CKD plus comorbidities were greater than dosages of calcium and vitamin D supplementation their simple sum ($26,000 vs $22,000). However, and the numbers of laboratory measures needed to these findings underscored the importance of an control calcium and PTH levels and are displayed in active treatment of underlying risk factors for Tables V and VI. We additionally performed a comorbidities.10 1096 Schneider et al Surgery December 2010

Table II. The cost-revenue relation per case for every year analyzed 2003--2006 2003/2004 2005 2006 Mean revenue per case 3912.99 4258.75 3681.57 3451.81 Mean cost per case 3842.52 3842.52 3842.52 3842.52 Mean cost-revenue relation per case 70.47 416.23 À160.95 À390.71

All costs are in Euros.

Table III. Dosage dependent costs of medical treatment with cinacalcet Dose/day cinacalcet 30 mg 60 mg 90 mg 180 mg Medical/month 240.17 434.96 647.46 1 294.93 Laboratory/month 50.70 50.70 50.70 50.70 Total therapy/month 290.87 485.66 698.16 1 345.63 Total therapy/year 3 490.44 5 827.92 8 377.92 16 147.56

All costs are in Euros.

Table IV. Dosage dependent costs of medical decreasing frequency of surgical interventions for treatment with paricalcitol sHPT in the years 2003--2006, the numbers of sur- Dose/week paricalcitol geries increased thereafter. The decreasing num- (5 mg/ml) 1 3 1ml 33 1ml 33 2ml ber of surgeries within the study period at our hospital can be explained by the introduction of ci- Medical/month 107.42 322.26 620.69 nacalcet and paricalcitol into the armamentarium Laboratory/month 50.70 50.70 50.70 of the medical treatment options in patients with Total therapy/month 158.12 372.96 671.39 sHPT and the increased usage of these new drugs Total therapy/year 1 897.44 4 475.52 8 056.68 during that time. Due to the first studies pub- All costs are in Euros. lished, which reported excellent results for both ci- nacalcet and paricalcitol, and to an aggressive advertisement of the pharmaceutical industry Prior to the development of newer drugs such as merchandising these drugs, many nephrologists vitamin D analogs and calcimimetics, medical considered the new medical treatments as alterna- treatment results of sHPT as the most important tives to the surgical treatment of sHPT. The clinical sequela of CKD remained inadequate. Less than courses and results of laboratory measures in the 30% of all patients achieved 3 and only 5% of all following years demonstrated a treatment failure patients all 4 Kidney Disease Outcomes and Initia- in some of the patients who received either cinacal- tive (KDOQI) target ranges (phosphate, calcium, cet or paricalcitol or both which consecutively led PTH, calcium-phosphate product)11 leading to a to an increased assignment of patients for surgery. high rate of PTX over time. The introduction of ci- Almost all of the patients who underwent surgery nacalcet and vitamin D analogs into clinical prac- at our hospital within the last 3 years had under- tice opened a novel pathway in the treatment of gone an attempt to treat sHPT with cinacalcet, patients with sHPT.12,13 vitamin D analogs, or both for several years (un- Cinacalcet acts as an allosteric activator of the published data), and therefore, had undergone calcium-sensing receptor of parathyroid cells and an unnecessary and costly medical therapy. Thus, therefore represents an appealing molecular target drug resistances to cinacalcet or vitamin D analogs for therapeutic agents designed to control sHPT.14 are possible, already described in the literature Paricalcitol as a new analog of vitamin D sup- and usually attributed to either nodular hyperpla- presses synthesis and secretion of PTH as effec- sia or patient incompliance.18 tively as calcitriol but has a lower tendency to In a recent large observational study patients raise serum calcium and phosphorus.15,16 with mild disease prior to treatment with cinacalcet Several retrospective studies reported a signifi- (PTH 300--500 pg/ml) were more likely to achieve cant reduction in the need to undergo PTX in the KDOQI PTH target ranges than those with patients receiving either cinacalcet or vitamin D more severe disease (PTH >800 pg/ml).19 More- analogs or both.17 Although we experienced a over, patients with nodular hyperplasia have been Surgery Schneider et al 1097 Volume 148, Number 6

7.000 €

6.500 € Surgery (average base-case-value nationwide) 6.000 € Paricalcitol (5μg/ml) 3 x 1ml/week 5.500 € Cinacalcet 60mg/day 5.000 € 4.500 € 4.000 € 3.500 € costs 3.000 € 2.500 € 2.000 € 1.500 € 1.000 € 500 € - € 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 months

Fig 3. Average treatment costs of treatment modalities over time.

possible surgical costs and minimum cinacalcet Table V. Costs for calcitriol and calcium 23 supplementation within the postoperative costs. To the best of our knowledge, this is the ambulatory setting first study which provides a detailed cost-cost anal- ysis together with an estimate of the real arising Drug Costs Calcitriol (vitamin D) Calcium costs concerning the treatment options in patients Per day .53 .19 with sHPT. Based on our results one has to suggest Per week 3.73 1.33 that medical therapy may be optimal in patients Per month 16.18 5.78 with an anticipated short time on dialysis therapy Per year 194.18 69.35 (<12 months) and mild sHPT. This group includes All costs are in Euros. patients with a high expected mortality due to co- morbid illness or poor general health, patients reported to have a higher risk for cinacalcet resis- who expect to undergo transplantation in less tance.20 Thus, the severity of sHPT and the degree than 1 year, dialysis patients with living donors, of nodular transformation potentially induce the and those who do decline operative therapy, development of resistance to the new drugs. respectively. However, it is not known whether con- Very few reports exist about the proposed length trol of PTH will be sustained after cessation of cina- of treatment and dosage titration for cinacalcet or calcet or paricalcitol. It is possible that underlying paricalcitol to achieve KDOQI targets.17 These arti- disease progression still occurs or that effectiveness cles report successful reductions in PTH already af- may not be sustained over the long-term.24 More- ter 3 months of treatment.11,19-21 Accordingly, the over, cinacalcet is not approved in patients after National Institute for Health and Clinical Excel- kidney transplantation and it needs to be eluci- lence of the United Kingdom recommended a con- dated how many of those requiring pretransplant tinuation of medication only in patients who cinacalcet will have to undergo PTX or necessitate achieved a reduction in PTH levels of 30% or ongoing costly off-label administered cinacalcet more within 4 months of treatment, including therapy thereafter. dose escalation if appropriate.22 Because our study referred to 2 different med- Our study demonstrated that the costs for sur- ical treatment arms, the group of patients observed gical therapy were exceeded by the linearly rising was unfortunately too small and heterogeneous to costs for medical therapy already after a 9-month gain reliable data about the treatment successes. treatment with cinacalcet and after a 12-month To evaluate the outcome of these treatments, treatment with paricalcitol. Our findings are in prospective randomized multicenter trials with a accordance to those of Narayan et al who found structured follow-up protocol have to be con- the surgical intervention to be more cost effective ducted. However, the wise use of medical resources after 8 months when compared to a treatment with is paramount to delivering cost-effective care and cinacalcet.23 In addition, Narayan showed that our study adds a helpful piece of information to PTX was more cost effective after 16 to 19 months enable the development of a reasonable duration even after calculating a combination of maximum and dosage recommendation for the medical 1098 Schneider et al Surgery December 2010

Table VI. Costs for laboratory measures within the postoperative ambulatory setting Laboratory parameters Calcium PTH Total Costs/laboratory measure (V) 2.76 33.12 35.88 Number of laboratory measures in the 1st year postsurgery 78 2 80 Total costs for laboratory measures in the 1st year 215.28 66.24 281.52 postsurgery (V) Number of laboratory measures in the 2nd year 20 2 22 postsurgery Total costs for laboratory measures in the 2nd year 55.20 66.24 121.44 postsurgery (V)

Fig 4. Sensitivity analysis considering different dosages of the drugs compared to costs for surgical therapy over time. therapies. A combination of our results and the vitamin D analogs, a prolongation of medical results of future prospective trials comparing the therapy over the recommended length of 4 success of medical and surgical treatments will months seems to be unjustifiable and should not help to facilitate the ever pressing challenge to be remunerated by the funding agencies. Random- surgeons in choosing the right patient to undergo ized studies are needed to predict which patients surgery, choosing the right surgical technique, and will most likely gain benefit from early parathyroid then making the operative treatment more suc- surgery in order to avoid unnecessary, prolonged, cessful, less complicated, and less expensive. and costly medical therapy. In conclusion, sHPT is an important sequela of CKD. The treatment options of sHPT have ex- panded substantially in the last years, with vitamin REFERENCES D analogs and calcimimetics being the most recent 1. Schlieper G, Floege J. Calcimimetics in CKD-results from re- addition. From an economic point of view surgical cent clinical studies. Pediatr Nephrol 2008;23:1721-8. 2. Lewin E, Wang W, Olgaard K. Reversibility of experimental therapy should be preferred whenever possible. secondary hyperparathyroidism. Kidney Int 1997;52:1232-41. Especially in patients with only little effect on 3. Schlosser K, Veit JA, Witte S, Fernandez ED, Victor N, Knae- improving mineral balance by cinacalcet or bel HP, et al. Comparison of total parathyroidectomy Surgery Schneider et al 1099 Volume 148, Number 6

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