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• W2096146670 abstract "Related Article, p. 262 Related Article, p. 262 Secondary hyperparathyroidism (SHPT) is ubiquitous in patients with chronic kidney failure treated by long-term dialysis and frequently persists after kidney transplant.1Messa P. Sindici C. Cannella G. et al.Persistent secondary hyperparathyroidism after renal transplantation.Kidney Int. 1998; 54: 1704-1713Crossref PubMed Scopus (169) Google Scholar Cinacalcet, a calcium-sensing receptor agonist, is US Food and Drug Administration–approved for use in dialysis patients with SHPT, but not after transplant or in patients with earlier stages of chronic kidney disease.2Sensipar® (cinacalcet) Tablets FDA-approved label, August 1, 2011.http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s017lbl.pdfGoogle Scholar Medical treatment of SHPT is costly. In the United States, 4 of the top 8 prescription drugs used in the end-stage renal disease population (per Medicare Part D) are for SHPT, and the second by cost is cinacalcet ($160 million/y; 323,000 claims),3US Renal Data SystemUSRDS 2011 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States.Am J Kidney Dis. 2012; 59(1): e1-e420Google Scholar with substantial use and cost reflecting off-label prescriptions in kidney transplant recipients.2Sensipar® (cinacalcet) Tablets FDA-approved label, August 1, 2011.http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s017lbl.pdfGoogle Scholar In this issue of the American Journal of Kidney Diseases, Komaba et al4Komaba H. Moriwaki K. Goto S. et al.Cost-effectiveness of cinacalcet hydrochloride for hemodialysis patients with severe secondary hyperparathyroidism in Japan.Am J Kidney Dis. 2012; 60: 262-271Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar report a pharmacoeconomic analysis (Markov model) of the use of cinacalcet as an addition to conventional therapy compared with conventional therapy alone in a theoretical cohort of Japanese hemodialysis patients. Their model uses published data, including a large Japanese prospective cohort study, to populate parameters. In both arms of this simulated cohort, patients underwent parathyroidectomy if their intact parathyroid hormone levels were >500 pg/mL for 6 months and they were eligible for surgery. Patients were followed up for their lifetimes, and dialysis costs (because they applied to the entire cohort) were not assessed. Several other pharmacoeconomic analyses of cinacalcet use in end-stage renal disease have been performed,5Garside R. Pitt M. Anderson R. Mealing S. D'Souza R. Stein K. The cost-utility of cinacalcet in addition to standard care compared to standard care alone for secondary hyperparathyroidism in end-stage renal disease: a UK perspective.Nephrol Dial Transplant. 2007; 22: 1428-1436Crossref PubMed Scopus (45) Google Scholar, 6Narayan R. Perkins R.M. Berbano E.P. et al.Parathyroidectomy versus cinacalcet hydrochloride-based medical therapy in the management of hyperparathyroidism in ESRD: a cost utility analysis.Am J Kidney Dis. 2007; 49: 801-813Abstract Full Text Full Text PDF PubMed Scopus (98) Google Scholar, 7Ray J.A. Valentine W.J. Palmer A.J. Cost-utility analysis of cinacalcet in addition to standard of care in the UK.Nephrol Dial Transplant. 2007; 22 (author reply 3357-3358): 3355-3357Crossref PubMed Scopus (4) Google Scholar, 8Ray J.A. Borker R. Barber B. Valentine W.J. Belozeroff V. Palmer A.J. Cost-effectiveness of early versus late cinacalcet treatment in addition to standard care for secondary renal hyperparathyroidism in the USA.Value Health. 2008; 11: 800-808Abstract Full Text PDF PubMed Scopus (14) Google Scholar, 9Eandi M. Pradelli L. Iannazzo S. Chiroli S. Pontoriero G. Economic evaluation of cinacalcet in the treatment of secondary hyperparathyroidism in Italy.Pharmacoeconomics. 2010; 28: 1041-1054Crossref PubMed Scopus (20) Google Scholar, 10Ravasio R. Giotta N. Marino A. et al.Cost effectiveness analysis of cinacalcet versus conventional care in the treatment of secondary hyperparathyroidism on chronic hemodialysis patients [Italian].Pharmacoeconomics Ital Res Articles. 2008; 10: 13-22Crossref Google Scholar, 11Arenas M.D. Rebollo P. Alvarez-Ude F. et al.[Is cinacalcet a cost-effective treatment in severe secondary hyperparathyroidism in patients on hemodialysis?].Nefrologia. 2008; 28: 511-516PubMed Google Scholar, 12Schneider R. Kolios G. Koch B.M. Fernandez E.D. Bartsch D.K. Schlosser K. An economic comparison of surgical and medical therapy in patients with secondary hyperparathyroidism—the German perspective.Surgery. 2010; 148: 1092-1099Abstract Full Text Full Text PDF Scopus (28) Google Scholar, 13Shireman T.I. Almehmi A. Wetmore J.B. Lu J. Pregenzer M. Quarles L.D. Economic analysis of cinacalcet in combination with low-dose vitamin D versus flexible-dose vitamin D in treating secondary hyperparathyroidism in hemodialysis patients.Am J Kidney Dis. 2010; 56: 1108-1116Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar including 4 cost-utility analyses, and were summarized in a recent review.14Plosker G.L. Cinacalcet: a pharmacoeconomic review of its use in secondary hyperparathyroidism in end-stage renal disease.Pharmacoeconomics. 2011; 29: 807-821Crossref PubMed Scopus (7) Google Scholar Some analyses concluded that cinacalcet, compared with standard medical treatment, could be cost-effective over a lengthy time frame by achieving the National Kidney Foundation's KDOQI (Kidney Disease Outcomes Quality Initiative) targets and decreasing hospitalization and other costs.7Ray J.A. Valentine W.J. Palmer A.J. Cost-utility analysis of cinacalcet in addition to standard of care in the UK.Nephrol Dial Transplant. 2007; 22 (author reply 3357-3358): 3355-3357Crossref PubMed Scopus (4) Google Scholar, 8Ray J.A. Borker R. Barber B. Valentine W.J. Belozeroff V. Palmer A.J. Cost-effectiveness of early versus late cinacalcet treatment in addition to standard care for secondary renal hyperparathyroidism in the USA.Value Health. 2008; 11: 800-808Abstract Full Text PDF PubMed Scopus (14) Google Scholar However, when cinacalcet is compared with parathyroidectomy, as in the article by Komaba et al,4Komaba H. Moriwaki K. Goto S. et al.Cost-effectiveness of cinacalcet hydrochloride for hemodialysis patients with severe secondary hyperparathyroidism in Japan.Am J Kidney Dis. 2012; 60: 262-271Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar it is dominated by parathyroidectomy in patients who are parathyroidectomy candidates. The comparison is striking. In the Komaba et al4Komaba H. Moriwaki K. Goto S. et al.Cost-effectiveness of cinacalcet hydrochloride for hemodialysis patients with severe secondary hyperparathyroidism in Japan.Am J Kidney Dis. 2012; 60: 262-271Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar model, cinacalcet use in patients who were parathyroidectomy candidates was cost-effective in only 0.9% of Monte Carlo simulations, assuming a willingness-to-pay threshold of $50,000 per additional quality-adjusted life-year. By contrast, in those not eligible for parathyroidectomy, cinacalcet was cost-effective in >99.9% of simulations, a dichotomy rare in such studies. Notably, these analyses were remarkably insensitive to the costs of cinacalcet. The cost would have to decrease 95% to change the findings of the Komaba et al4Komaba H. Moriwaki K. Goto S. et al.Cost-effectiveness of cinacalcet hydrochloride for hemodialysis patients with severe secondary hyperparathyroidism in Japan.Am J Kidney Dis. 2012; 60: 262-271Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar model, an event unlikely to occur even if the drug were to become available as a generic. Approximately 20% of dialysis patients are wait-listed for kidney transplant and thus are considered candidates for intermediate-risk surgery. Minimally invasive parathyroidectomy carries lower perioperative risk than vascular access placement per American Heart Association/American College of Cardiologists guidelines,15Fleisher LA, Beckman JA, Brown KA, et al. ACC/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery) [published online before print September 27, 2007]. Circulation. doi:10.1161/CIRCULATIONAHA.107.185699.Google Scholar and even limited 1- to 2-gland resection is adequate in patients considered at high risk for general anesthesia or those of advanced age.16Pitt S.C. Panneerselvan R. Chen H. Sippel R.S. Tertiary hyperparathyroidism: is less than a subtotal resection ever appropriate? A study of long-term outcomes.Surgery. 2009; 146: 1130-1137Abstract Full Text Full Text PDF PubMed Scopus (30) Google Scholar, 17Kebebew E. Duh Q.Y. Clark O.H. Parathyroidectomy for primary hyperparathyroidism in octogenarians and nonagenarians; a plea for early surgical referral.Arch Surg. 2003; 138: 867-871Crossref PubMed Scopus (63) Google Scholar Thus, most dialysis patients likely are eligible for parathyroidectomy. Might cinacalcet have beneficial effects on cardiovascular outcomes in dialysis or transplant patients in addition to controlling SHPT? To date, cinacalcet has been shown to improve overall mortality and major cardiovascular events in only post hoc and observational studies.18Cunningham J. Danese M. Olson K. Klassen P. Chertow G.M. Effects of the calcimimetic cinacalcet HCl on cardiovascular disease, fracture, and health-related quality of life in secondary hyperparathyroidism.Kidney Int. 2005; 68: 1793-1800Crossref PubMed Scopus (430) Google Scholar, 19Block G.A. Zaun D. Smits G. et al.Cinacalcet hydrochloride treatment significantly improves all-cause and cardiovascular survival in a large cohort of hemodialysis patients.Kidney Int. 2010; 78: 578-589Crossref PubMed Scopus (141) Google Scholar Parathyroidectomy has shown a mortality benefit of 10%-15% compared with matched controls.20Kestenbaum B. Andress D.L. Schwartz S.M. et al.Survival following parathyroidectomy among United States dialysis patients.Kidney Int. 2004; 66: 2010-2016Crossref PubMed Scopus (205) Google Scholar A recent systematic review and meta-analysis showed no significant association between all-cause mortality and serum parathyroid hormone and calcium levels.21Palmer S.C. Hayen A. Macaskill P. et al.Serum levels of phosphorus, parathyroid hormone, and calcium and risks of death and cardiovascular disease in individuals with chronic kidney disease: a systematic review and meta-analysis.JAMA. 2011; 305: 1119-1127Crossref PubMed Scopus (533) Google Scholar More definitive cost-effectiveness analysis awaits results of the now completed randomized, double-blind, and placebo-controlled Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events (EVOLVE) trial, for which results are expected later this year.22Chertow G.M. Pupim L.B. Block G.A. et al.Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events (EVOLVE): rationale and design overview.Clin J Am Soc Nephrol. 2007; 2: 898-905Crossref PubMed Scopus (152) Google Scholar We could conclude, despite the findings of the present and multiple previous cost-effectiveness analyses, that the role and optimal use of cinacalcet compared with parathyroidectomy has not been fully resolved. However, how much more definitive will information need to be before practice changes? Even findings of large randomized controlled trials, such as the anticipated EVOLVE trial, may not be definitive. Are we waiting for “perfect” information, and if so, how long and how much would we pay for it? It has been suggested that cost-effectiveness should be a part of the formal curriculum in postgraduate medical training programs,23Weinberger S.E. Providing high-value, cost-conscious care: a critical seventh general competency for physicians.Ann Intern Med. 2011; 155: 386-388Crossref PubMed Scopus (148) Google Scholar but even if this influences new graduates, most of the nephrology workforce will be unaffected. Why has clinical practice not changed in an era in which medical costs are under intense scrutiny and reimbursement is being reduced? Three main factors may present barriers. First, there may be a perception that surgery is an undesirable outcome rather than a medical therapy for SHPT; some cost-utility analyses of cinacalcet model parathyroidectomy as one of the adverse cost outcomes (ie, an outcome to be avoided). Perhaps this attitude is driven by patients' preferences to avoid surgery, but this raises the question of how much society is willing to pay for patient choice if patients do not pay directly themselves. Second, effective marketing of cinacalcet may have kept it in the forefront. Third, the greater complexity, need for multiple encounters and providers, and over-all “hassle factor” of referring a patient for parathyroidectomy as opposed to writing a prescription may discourage surgical treatment, not to mention the potential influence of current reimbursement incentives/disincentives. Such factors are difficult to include in a model. However, faced with prospects of global reduction in reimbursement, nephrologists need to set priorities for reducing expenditures. Establishing the optimal use of cinacalcet would appear to represent a promising opportunity. If we do not pick the low-hanging fruit, one day we may find that the entire orchard has been chopped down. The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Department of the Army, the Department of Defense, or the US Government. Financial Disclosure: The authors declare that they have no relevant financial interests. Cost-Effectiveness of Cinacalcet Hydrochloride for Hemodialysis Patients With Severe Secondary Hyperparathyroidism in JapanAmerican Journal of Kidney DiseasesVol. 60Issue 2PreviewCinacalcet effectively reduces elevated levels of parathyroid hormone (PTH) in patients with secondary hyperparathyroidism (SHPT), even those with severe disease for whom parathyroidectomy can be the treatment of choice. The objective of this study was to estimate the cost-effectiveness of cinacalcet treatment in hemodialysis patients with severe SHPT in Japan. Full-Text PDF" @default.
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• W2096146670 title "Treatment of Secondary Hyperparathyroidism With Parathyroidectomy Instead of Cinacalcet: Time to Pick the Low-Hanging Fruit?" @default.
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