Book Reviews

Louis Baeck. The Mediterranean Tradition in Economic Thought. London and New York: Routledge, 1994. Pp. IX, 241. £40. ISBN 0–415–09301–5.

Vivienne Brown. Adam Smith's Discourse. Canonicity, Commerce and Conscience. London and New York: Routledge, 1994. Pp. 243. £13.99. ISBN 0–415–09593.

Peter Groenewegen (ed.). Feminism and Political Economy in Victorian England. Aldershot: Edward Elgar, 1994. Pp. 208. £39.95. ISBN 1–85278–928‐X.

Terence Hutchison. The Uses and Abuses of Economics. Contentious Essays on History and Method. London and New York: Roudedge, 1994. Pp. XIII, 314. £45. ISBN 0–415–09404–6.

Jan Keppler. Monopolistic Competition Theory. Origins, Results, and Implications. Baltimore and London: The Johns Hopkins University Press, 1994. Pp. x, 220. US$45. ISBN 0–8018–4813‐X.

Lars Magnusson (ed.). Evolutionary and Neo‐Schumpeterian Approaches to Economics. Boston, Dordrecht, London: Kluwer Academic Publishers, 1994. Pp. VIII, 326. £74.95. ISBN 0–7923–9385–6.

Alessandro Marzola and Francesco Silva (eds). John Maynard Keynes. Language and Method. Aldershof. Edward Elgar, 1994. Pp. XY 247. £39.95 ISBN 1–85278–923–9.

Ferdinando Meacci. Luigi Einaudi e i Principi del Capitate. Turin: Giappichelli, 1993. Pp. x, 176. IL. 28,000. ISBN 88–348–3093–8.

Gerald M. Meier (ed.). From Classical Economics to Development Economics. New York: St Martin's Press, 1994. Pp. xiii, 262. US$45. ISBN 0–312–12033–8.

Takashi Negishi. The History of Economics. The Collected Essays of Takashi Negishi, vol. 2. Aldershot: Edward Elgar, 1994. Pp. XXIV, 242. £45. ISBN 1–85278–938–7.

Cosimo Perrota and Vitantonio Gioia (eds). Where is Economics Going? Historical Viewpoints. Lecce: Università degli Studi di Lecce and Congedo Editore, 1994. Pp. 131. Price not indicated. ISBN 88–808–6079–8.

Warren J. Samuels, Jeff Biddle and Thomas W. Patchak‐Schuster. Economic Thought and Discourse in the 20th Century. Aldershot: Edward Elgar, 1993. Pp. x, 288. £45. ISBN 1–85278–724–4.

Mario Sebastiani. Kalecki and Unemployment Equilibrium. London: Macmillan, 1994. Pp. 213, ISBN 0–312–10585–1

John Vint. Capital and Wages. A Lakatosian History of the Wages Fund Doctrine. Aldershot: Edward Elgar, 1994. Pp. x, 278. £45. ISBN 1–85278–864‐X.     

Techno‐cultural integration

K. Kelly, New Rules for the New Economy (NY: Viking 1998 ISBN 014028060 X, pp.179).

D. Morris, Vote.com: How Big‐Money Lobbyists and the Media are Losing Their Influence, and the Internet is Giving Power Back to the People (LA: Renaissance Books 1999 ISBN 158063163 0, pp.236).

G. Rochlin, Trapped in the Net: The Unanticipated Consequences of Computerization (Princeton, NJ: Princeton University Press 1997, ISBN 0691002479, pp.310).     

Book reviews

Powering Apollo: James E. Webb of NASA W. Henry Lambright Baltimore, MD, The Johns Hopkins University Press, 1995, 271 pp, £30.00 (hbk), ISBN 0-8019-4902-0.

Managers and Innovation: Strategies for a Biotechnology John Howells London, Routledge, 1994, £40, ISBN 0-415-08590-X.

Mastering the Dynamics of Innovation James Utterback Boston, MA, Harvard University Press, 1994, $24.95, ISBN0-87584-342-5.

Leadership in Action Helmut Mauche McGraw Hill, 1994, £19.95, ISBN 0-07-041041-0.

International Business: Environments and Operationsf John D. Daniels &; Lee H. Readbaugh Addison-Wesley, 7th Edn, 1995, 788 pp, £25.95, ISBN 0-201-59293-2.

Intenational Business: A Strategic Managment Approach Alan M. Rugman &; Richard M. Hodgetts McGraw-Hill, 1995, 630 pp, £21.95, ISBN 0-07-113635-5.

International Business: Competing in the Global Marketplace Charles W.L. Hill Irwin, 1994, 615 pp, £ 26.95, ISBN 0-256-15682-4.     

Middle eastern Hydropolitics: Interpreting constructed knowledge

D. Hillel, Rivers of Eden: the Struggle for Water and the Quest for Peace in the Middle East (Oxford: Oxford University Press 1994).

N. Kliot, Water Resources and Conflict in the Middle East (London: Routledge 1994).

G. Shapland, Rivers of Discord: International Water Disputes in the Middle East. (London: Hurst & Company 1997).

M. Sherman, The Politics of Water in the Middle East: An Israeli Perspective on the Hydro‐Political Aspects of the Conflict (London: MacMillan Press 1999).

A. Soffer, Rivers of Fire (Rowman & Littlefield 1999).

A. Wolf, Hydropolitics along the Jordan River: Scarce Water and its Impact on the Arab‐Israeli Conflict (Tokyo: United Nations University Press 1995).     

Jousting with Malthus’ ghost: Environment and conflict after the cold war

G. Baechler, Violence through Environmental Discrimination: Causes, Rwanda Arena, and Conflict Model, Dordrecht: Kluwer 1999.

A. Carius and K.M. Lietzmann (eds), Environmental Change and Security: A European Perspective, Berlin: Springer 1999.

T. Homer Dixon, Environment, Scarcity and Violence, Princeton, NJ: Princeton University Press 1999.

K.M. Lietzmann and G.D. Vest (eds), Environment and Security in an International Context, Bonn: North Atlantic Treaty Organization Committee on the Challenges of Modern Society 1999, Report No. 232.

S.C. Lonergan (ed.), Environmental Change, Adaptation and Security, Dordrecht, Kluwer 1999.

L. Ohlsson, Environment, Scarcity and Conflict: A Study of Malthusian Concerns, Department of Peace and Development Research, Goteburg University 1999.

M. Suliman (ed.), Ecology, Politics and Violent Conflict, London: Zed 1999.     

News and notes

New Perspectives on Technology and Organization.

Innovative Banking: Competition and the Management of a New Networks Technology J. Howells &; J . Hines Eds) Ldon, Routledge, 1992, 252pp., £40.00 (hbk), ISB-V 0-415-05941-0. Technology and Organization: Power, Meaning and Design H. Scarborough &; J.M. Corbett London. Routledge. 1992, 178pp., ,£15.00, (pbk), ISBN 0-415-05941-0.

Beyond Partnership-Strategies for Innovation &; Lean Supply Richard Lamming Hemel Hempstead, Prentice-Hall International, 1993, ix + 299pp., £19.95 (hbk).

From Anticipation to Action: A handbook of Strategic Perspective Michel Godet.     

A systematic literature review of utility weights in wet age-related macular degeneration

Abstract

Objective:

The objective of the study was to conduct a systematic review of utility weight estimates relevant to economic models for wet age-related macular degeneration (wAMD).

Methods:

A systematic literature search of PubMed, Embase, the Cochrane Library, and EconLit was performed (January 1995–December 2010) and then updated (October 2010–May 2012; February 2012–July 2013) identifying articles reporting utilities in patients with wAMD and visual impairment. Extracted studies were also assessed for compliance with the NICE reference case.

Results:

Of 2415 articles identified from the searches, 212 articles were reviewed in full, and 17 selected for data extraction. Most studies used time trade-off (TTO) techniques to estimate utilities; other methods included standard gamble, EuroQoL Health Questionnaire 5 Dimensions (EQ-5D); Short-Form 6D Health Status Questionnaire (SF-6D); and Health Utilities Index Mark III (HUI3). Correlation between utility estimates and visual acuity (VA) differed between the instruments. Time trade-off methods were more sensitive to VA changes than standard gamble methods. HUI3 estimates were most highly correlated with VA changes, followed by TTO; no trend was observed between VA and EQ-5D or SF-6D utility weights. Six of the 17 studies complied with the NICE reference case.

Conclusions:

Several instruments have been used to elicit utilities from patients with wAMD. Because TTO methods were more sensitive to VA changes than standard gamble and HUI3 estimates were most highly correlated with VA changes, TTO and HUI3 may be suitable methods for economic evaluations in these patients. The EQ-5D and SF-6D were poor indicators of the impact of VA on HRQL.     

Book reviews

Routledge Series in Analytical Management Series Editor: D.C. Wilson London and New York, Routledge.

Strategues fir Growth; Maturuity, Recovery and Internationalisation Peter McKiernan London and New York, Routledge, 1992, £35.00. (hbk), ISBN 0-415-07383-9.

Technology and Organisation: Power, Meaning and Design Harry Scarborough & F. Martin Corbett London and New York, Routledge, 1992, £35.000 (hbk), ISBN 0-415-07384-7.

A Strategy of Change; Concepts and Controversies in the Management of Change D. C. Wilson London and New York, Routledge, 1992, £10.99 (pbk), ISBN 0-415-09773-8.

Human Resource Strategies for International Growth Chris Hendry London and New York, Routledge, 1994, £35.00. (hbk), ISBN 0-415-09773-8.

What is Strategy and Does it Matter? Richard Whittington London and New York, Routledge, 1993, £35.00. (hbk), ISBN 0-415-07385-5.

Technological Collaboration in Industry Mark Dodgson London, Routledge, 1993, £40.00 (hbk), ISBN 0-415-08230-7.

Corporate Vision and Rapid Technological Change Peter Swann & Jas Gill London, Routledge, 1993, £37.50 (hbk), ISBN 0-415-09135-7.

Internal Merkets: Bringing the Power of Free Enterprise Inside your Organisation W.E. Halad, A. Germanmayeh and J. Pourdenhad (eds) New York, Wiley, 1993, 301 pp., US$ 34.95.

Strategic Management: A Methodological Approach, 4th edition A.J. Rowe, R.O. Mason, K.E. Dicker, R.B. Mann & R.J. Mocler New York, Addison-Wesley, 1994, ISBN 0-201-58638-X.

The Management of Scale (Big Organizations, Big Decisions, Big Mistakes) David Collingridge London, Routledge, 1992, £35.00 (hbk), £12.99 (pbk), ISBN 0-415-07856-3.

The Intelligent Enterprise James B. Quinn New York, Free Press, 1992, ISBN 0-02-925615-1.     

Economic benefits of adequate molecular monitoring in patients with chronic myelogenous leukemia

Objective:

Molecular monitoring of chronic myeloid leukemia (CML) has been associated with improved clinical outcomes during tyrosine kinase inhibitor therapy (TKI), yet recent studies have demonstrated its use is far below published guidelines. This study sought to determine frequencies of molecular monitoring and its impact on resource utilization and medical costs.

Methods:

A retrospective US claims administrative database (IMS LifeLink Health Plan Claims and Truven Health Analytics MarketScan databases, 11/2007–06/2012) was used to analyze the economic impact of qPCR testing in CML patients on first-line TKIs during the initial 12-months of treatment.

Results:

One thousand two hundred and five adult CML patients met the sample selection criteria. Among these, 41.0% had no qPCR tests, 31.9% had 1–2 tests, and 27.1% had 3–4 tests; 88.9% were initiated on imatinib; 47.7% were female. Patients in the 3–4 tests cohort incurred 44% (p?p?=?0.005) lower for the 3–4 tests cohort than the 0-tests cohort. Adjusted progression-related IP cost was $4132 (p?=?0.013) lower for the 3–4 tests cohort than the 0-tests cohort. Adjusted medical service cost was $5997 (p?=?0.049) lower for the 3–4 tests cohort than the 0-tests cohort.

Limitations:

Claims databases did not include information on the primary cause of hospitalizations.

Conclusions:

Among CML patients in two large claims databases, nearly three-quarters did not receive adequate molecular monitoring per published guidelines. Those who were more frequently monitored incurred lower medical service costs, with the majority of the difference in costs being related to disease progression. These findings underscore the clinical and economic values of molecular monitoring in CML.     

Role of transfusion in stem cell transplantation: a freedom-from-transfusion (FFT), cost and survival analysis

Abstract

Background: Transfusion of blood products is often necessary for patients undergoing stem cell transplantation (SCT). The need for red cell and platelet transfusion may vary significantly depending on the type of transplantation and underlying disease.

Methods: In an attempt to evaluate the need and volume of transfusions in patients undergoing SCT at University of Kansas Medical Center, the authors retrospectively evaluated the transfusion data of all patients who received SCT between 2000 and 2005.

Results: A total of 138 (90%) out of 154 patients undergoing autologous SCT and 24 (43%) out of 56 patients with allogeneic SCT exhibited total hematopoietic engraftment and freedom from transfusion (FFT). Time to achieve FFT (median; range) for RBC units for autologous SCT (12; 0–183) was significantly shorter compared with allogeneic SCT (16.5; 0–373). Number of RBC units (median; range) transfused were significantly less in patients undergoing autologous SCT (4; 0–26) compared to patients undergoing allogeneic SCT (6.5; 0–54). The median cost of transfusion was significantly higher in patients undergoing allogeneic SCT (red cell: $2,015; platelet: $4,480) compared to patients undergoing autologous SCT (red cell: $1,240; platelet: $2,520). The authors recognize that this was a retrospective single-center study and practice guidelines may vary from center to center.

Conclusion: Authors conclude that transfusion of blood products is an expensive but integral part of SCT, more so for allogeneic SCT than for patients undergoing autologous SCT. Total FFT is a desirable long-term goal of successful marrow transplantation.     

Book reviews

Powering Apollo: James E. Webb of NASA W. Henry Lambright Baltimore, MD, The Johns Hopkins University Press, 1995, 271 pp, £30.00 (hbk), ISBN 0-8019-4902-0.

Managers and Innovation: Strategies for a Biotechnology John Howells London, Routledge, 1994, £40, ISBN 0-415-08590-X.

Mastering the Dynamics of Innovation James Utterback Boston, MA, Harvard University Press, 1994, $24.95, ISBN0-87584-342-5.

Leadership in Action Helmut Mauche McGraw Hill, 1994, £19.95, ISBN 0-07-041041-0.

International Business: Environments and Operationsf John D. Daniels & Lee H. Readbaugh Addison-Wesley, 7th Edn, 1995, 788 pp, £25.95, ISBN 0-201-59293-2.

Intenational Business: A Strategic Managment Approach Alan M. Rugman & Richard M. Hodgetts McGraw-Hill, 1995, 630 pp, £21.95, ISBN 0-07-113635-5.

International Business: Competing in the Global Marketplace Charles W.L. Hill Irwin, 1994, 615 pp, £ 26.95, ISBN 0-256-15682-4.     

The economic impact of galantamine vs placebo: An analysis based on functional capacity in a Swedish cohort study

Abstract

Objective:

To analyse the economic impact of galantamine, based on basic activities of daily living (ADL).

Methods:

Data were derived from Swedish patients enrolled in a 6-month placebo-controlled trial of galantamine (GAL-INT-1; n?=?80), and from the Kungsholmen–Nordanstig Project, a longitudinal study of 919 elderly persons in Sweden. Basic ADL were assessed using the Katz’ Index of Independence in Activities of Daily Living (ADL) (number of ADL lost [dependency in 0, 1–2, 3–4, or 5–6 ADL]). Costs were appraised based on regression analysis and on costs directly linked to ADL. Six-month costs for galantamine and placebo were calculated.

Results:

In the regression analyses, each increase in a Katz stage was associated with an annual cost increase of SEK 81,415–83,683 (～€8000). Results were similar using stage-specific costs. Overall, there was a small, non-significant numerical cost benefit for galantamine indicating cost neutrality.

Limitations:

The small number of Swedish patients in the GAL-INT-1 study, which was not powered for economic outcomes, limits the statistical power of the analysis. In addition, long-term outcomes are difficult to assess in persons with dementia because of practical and logistical problems.

Conclusions:

The benefits of galantamine in patients with AD can be achieved with no increase in cost. Combined with positive effects in terms of outcome, treatment with galantamine can be regarded as cost-effective using a cost–consequence approach.     

Treatment experience,burden, and unmet needs (TRIBUNE) in Multiple Sclerosis study: the costs and utilities of MS patients in The Netherlands

Abstract

Background:

Multiple sclerosis (MS) is an important, highly disabling neurological disease, common among young adults in The Netherlands. Nevertheless, only a few studies to date have measured the burden imposed by MS on society in The Netherlands.

Objectives:

To estimate the cost and quality-of-life associated with MS in The Netherlands, while focusing on the burden of relapses and increasing disease severity.

Methods:

MS patients in The Netherlands (n?=?263) completed a web-based questionnaire which captured information on demographics, disease characteristics and severity (Expanded Disability Status Scale [EDSS]), co-morbidities, relapses, resource consumption, utilities, fatigue and activities of daily living (ADL).

Results:

Most patients included in the study were receiving treatment for MS (76% of the sample). The mean cost per patient per year increased with worsening disability and was estimated at €30,938, €51,056, and €100,469 for patients with mild (EDSS 0–3), moderate (EDSS 4–6.5), and severe (EDSS 7–9) disability, respectively. The excess cost of relapses was estimated at €8195 among relapsing-remitting patients with EDSS score ≤5. The quality-of-life of patients decreased with disease progression and existence of relapses.

Conclusions:

The cost of MS in The Netherlands was higher compared to the results of previous studies. The TRIBUNE study provides an important update on the economic burden of MS in The Netherlands in an era of more widespread use of disease-modifying therapies. It explores the cost of MS linked to relapses and disease severity and examines the impact of MS on additional health outcomes beyond utilities such as ADL and fatigue.

Conclusions:

Study limitations:     

Health status,function, productivity,and costs among individuals with idiopathic painful peripheral neuropathy with small fiber involvement in the United States: results from a retrospective chart review and cross-sectional survey

Objective:

To characterize the burden of idiopathic painful peripheral neuropathy with small fiber involvement (idiopathic SFN) by pain severity in the US.

Methods:

One hundred previously diagnosed idiopathic SFN subjects were enrolled during routine office visits. Subjects completed a one-time questionnaire, and investigators reported clinical characteristics and healthcare resource use, based on 6 month retrospective chart review. Annualized direct and indirect costs were estimated. Results were stratified across pain severity groups.

Results:

Mean age was 63.5 years; 53.0% were female; 76.0% had moderate or severe pain. Most common comorbidities were sleep disturbance/insomnia (37.0%), anxiety (34.0%), and depressive symptoms (33.0%). Overall mean health status (0.59; ?0.11–1.00 scale), physical and mental health (31.7 and 45.6, respectively, 0–100 scale), sleep index (45.1; 0–100 scale), and pain interference with function (5.0; 0–10 scale) differed by pain severity, with worse outcomes among those with greater pain (all p?Conclusions:

Idiopathic SFN subjects with pain experience moderate or severe pain, which negatively impacts health status, function, and productivity, and leads to substantial direct and indirect costs.     

The societal burden of pain in Germany: Health-related quality-of-life,health status and direct medical costs

Abstract

Objectives:

The purpose of this paper is to estimate the impact of the severity and frequency of pain on health-related quality-of-life (HRQoL), self-reported health status, and direct medical costs in Germany.

Methods:

Data are from the internet-based 2010 National Health and Wellness Survey (NHWS). Estimates of the impact of pain experience are generated by a series of regression models. In the case of HRQoL the physical and mental summary scores from the SF-12, together with SF-6D utilities, are evaluated within an ordinary least squares framework. Health status is assessed through an ordered logit model. Direct medical costs are estimated through a semi-logarithmic healthcare cost function. Socioeconomic characteristics, health risk behaviors, and the Charlson Comorbidity Index (CCI) are introduced as control variables in all regressions.

Results:

An estimated 23.96% of the adult German population (16.39 million) reported experiencing pain in the last 30 days. Of these 13.16% reported severe pain. The experience of frequent severe and moderate pain has a significant deficit impact on HRQoL. For those experiencing severe daily pain, the deficit in the SF-12 physical component score (PCS) is ?17.930 (95% CI: ?18.720 to ?17.140), the SF-12 mental component score (MCS) is ?8.787 (05% CI: ?9.857 to ?7.716), and SF-6D absolute utilities ?0.201 (95% CI: ?0.214 to ?0.188); with self-reported health status the deficit impact of severe daily pain is also substantial (OR?=?29.000; 95% CI: 23.000–36.580). In the case of direct medical costs severe daily pain increases healthcare provider costs by 101.6% and total direct costs by 123.9%.

Limitations:

The NHWS is an internet survey. The principal limitation is that as a self-report there is no separate validation of pain severity or chronicity.

Conclusions:

The experience of pain has a substantial negative impact on HRQoL, health status, and resource utilization in Germany. If pain is considered as a disease in its own right, the experience of chronic pain presents policy-makers with a major challenge.     

Comparing the effectiveness of rosuvastatin and atorvastatin in preventing cardiovascular outcomes: estimates using the Archimedes model

Abstract

Objective:

This study used simulation to compare the effectiveness of rosuvastatin 20?mg vs atorvastatin 40?mg, and rosuvastatin 40?mg vs atorvastatin 80?mg in preventing MACE in a range of patient populations with varying baseline cardiovascular risk.

Research design and methods:

The Archimedes Model was used to simulate head-to-head clinical trials in nine patient populations: Framingham Risk Score (FRS)?≥?5%, 5–10%, 10–20%,?>?20%, EURO-SCORE?≥?5% and >10%, diagnosed diabetes, secondary prevention (history of myocardial infarction or stroke, CVD), and acute coronary syndrome (ACS). Simulated patients, aged 45–70 at trial start, were based on the NHANES 1999–2006. Treatments were modeled using results from the STELLAR, JUPITER, CARDS, ASCOT-LLA, and TNT trials. Treatment models were confirmed using trial validations.

Results:

Comparing rosuvastatin 20?mg vs atorvastatin 40?mg, the 5-year numbers needed to treat to prevent one MACE event (NNT) were 525, 70, and 55 for the FRS?≥?5%, CVD, and ACS groups, respectively. Comparing rosuvastatin 40?mg vs atorvastatin 80?mg the corresponding NNT values were 468, 63, and 51. The 20-year relative risks of MACE in the FRS?≥?5% population were 0.907 (0.901–0.913) for rosuvastatin 20?mg vs atorvastatin 40?mg and 0.892 (0.884–0.901) for rosuvastatin 40?mg vs atorvastatin 80?mg. The relative risks were similar for the remaining populations.

Conclusions:

This study found that rosuvastatin 20?mg and 40?mg lowers the risk of MACE more than atorvastatin 40?mg and atorvastatin 80?mg. While simulation models cannot replace real-world clinical trials, this study bridges gaps in the evidence, and identifies high risk cohorts that would likely see additional benefit from treatment with rosuvastatin rather than atorvastatin.     

Pediatric gastroesophageal reflux disease and acid-related conditions: trends in incidence of diagnosis and acid suppression therapy

Abstract

Objective: To describe the incidence of diagnosis of gastroesophageal reflux disease and acid-related conditions (GERD/ARC) throughout childhood and characterize patterns of diagnosis and treatment with proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H₂RAs).

Methods: Cohorts of GERD/ARC children (age 0–18 years) were identified from a large US administrative claims database covering 1999–2005 using ICD-9 codes. Incidence, healthcare utilization (HCU), costs, therapy discontinuation and switching rates were compared between various age and patient groups.

Results: Between 2000 and 2005 annual incidence of GERD/ARC diagnosis among infants (age ≤1 year) more than tripled (from 3.4 to 12.3%) and increased by 30% to 50% in other age groups. Patients diagnosed by GI specialists (9.2%) were more likely to be treated with PPIs compared to patients diagnosed by primary care physician (PCP). PPI-initiated patients doubled (from 31.5% in 1999 to 62.6% in 2005) and, when compared with H₂RA-initiated patients, were associated with 30% less discontinuation and 90% less therapy switching in the first month, and with higher comorbidity burden and pre-treatment total HCU and costs when diagnosed by GI specialists.

Limitations: The use of an exploratory definition for GERD/ARC, administrative claims data and potential coding errors in diagnosis codes used in selection process may limit the generalizability of the results.

Conclusions: GERD/ARC incidence increased for children of all ages between 2000 and 2005. PCPs made the majority of diagnoses. PPI initiations have now surpassed H₂RA initiations.     

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.