Journal of Pharmacoeconomics and Pharmaceutical Management 2016. 2(1/2):9-18.

Assessment of criteria influencing on judicious selection of new drug in Iran’s health insurances
Amir Viyanchi, Ali Rajabzadeh-Ghatari


Background: This study aimed to analyze hypotheses underlying the assumption that more criteria about clinical, managerial, and economic assessment have a positive impact on the judicious decisions of new drug coverage in public health insurance.
Methods: We developed a structural equation model in which the process components were considered latent constructs and operationalized by a set of proposed criteria. The dependent variable “judicious decision” was defined by the relevance of clinical, economic criteria (Ec.c), and other managerial criteria (Ma.c) in new drug appraisal for reimbursement (as opposed to appraisal based on stakeholder lobbying). We conducted a direct and email survey among individuals familiar with coverage decisions of third-party payers in Iran health system in 2013. Data on 14 decisions’ criteria from 8 locations and 202 experts in Iran health system were used for model estimation.
Results: Ma.c [regression coefficient (RC) = 0.235; P < 0.001) and clinical criteria (RC = 0.424; P < 0.001) had a significant influence on the construct of judicious decision. The path from Ec.c to judicious decision was not significant (RC = 0.103; P = 0.182). For the judicious decision construct, a considerable share of the variance was explained (R2 = 0.350). Biases were assessed through sensitivity analyses.
Conclusion: Clinical assessment and intense Ma.c appeared effective in promoting judicious decision-making, whereas the influence of Ec.c was not significant.


Decision-making; Pharmaceutical coverage policy; Partial least square methods; Iran

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(1) Taylor RS, Drummond MF, Salkeld G, Sullivan SD. Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle. BMJ 2004; 329(7472): 972-5.

(2) Sorenson C. Use of comparative effectiveness research in drug coverage and pricing decisions: a six-country comparison. Issue Brief (Commonw Fund) 2010; 91: 1-14.

(3) Kanavos P, Nicod E, den Aardweg S, Pomedli S. The impact of health technology assessments: an international comparison. Euro Observer 2010; 12(4): 1-7.

(4) Ansaripour A, Uyl-de Groot CA, Steenhoek A, Redekop WK. The Drug Reimbursement Decision-Making System in Iran. Value Health Reg Issues 2014; 3: 174-81.

(5) Eddy D. Reflections on science, judgment, and value in evidence-based decision making: a conversation with David Eddy by Sean R. Tunis. Health Aff (Millwood ) 2007; 26(4): w500-w515.

(6) Eddy DM. Clinical decision making: from theory to practice. Anatomy of a decision. JAMA 1990; 263(3): 441-3.

(7) Velasco Garrido M, Kristensen FB, Nielsen CP, Busse R. Health Technology Assessment and Health Policy-making in Europe: Current Status, Challenges and Potential. Geneva, Switzerland: WHO Regional Office Europe; 2008.

(8) Hutton J, McGrath C, Frybourg JM, Tremblay M, Bramley-Harker E, Henshall C. Framework for describing and classifying decision-making systems using technology assessment to determine the reimbursement of health technologies (fourth hurdle systems). Int J Technol Assess Health Care 2006; 22(1): 10-8.

(9) Persad G, Wertheimer A, Emanuel EJ. Principles for allocation of scarce medical interventions. The Lancet 2009; 373(9661): 423-31.

(10) Cookson R, Dolan P. Principles of justice in health care rationing. J Med Ethics 2000; 26(5): 323-9.

(11) Daniels N, Sabin J. The ethics of accountability in managed care reform. Health Aff (Millwood) 1998; 17(5): 50-64.

(12) Friedman A. Beyond accountability for reasonableness. Bioethics 2008; 22(2): 101-12.

(13) Marckmann G. Health and justice. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2008; 51(8): 887-94.

(14) Claxton K. The irrelevance of inference: a decision-making approach to the stochastic evaluation of health care technologies. J Health Econ 1999; 18(3): 341-64.

(15) Rogowski WH. An economic theory of the fourth hurdle. Health Econ 2013; 22(5): 600-10.

(16) Fischer KE. A systematic review of coverage decision-making on health technologies-evidence from the real world. Health Policy 2012; 107(2-3): 218-30.

(17) Morgan SG, McMahon M, Mitton C, Roughead E, Kirk R, Kanavos P, et al. Centralized drug review processes in Australia, Canada, New Zealand, and the United kingdom. Health Aff (Millwood) 2006; 25(2): 337-47.

(18) Fischer KE, Leidl R, Rogowski WH. A structured tool to analyse coverage decisions: development and feasibility test in the field of cancer screening and prevention. Health Policy 2011; 101(3): 290-9.

(19) Mitton CR, McMahon M, Morgan S, Gibson J. Centralized drug review processes: are they fair? Soc Sci Med 2006; 63(1): 200-11.

(20) Luce BR, Drummond M, Jonsson B, Neumann PJ, Schwartz JS, Siebert U, et al. EBM, HTA, and CER: clearing the confusion. Milbank Q 2010; 88(2): 256-76.

(21) Baltussen R, Niessen L. Priority setting of health interventions: the need for multi-criteria decision analysis. Cost Eff Resour Alloc 2006; 4: 14.

(22) Sibbald SL, Singer PA, Upshur R, Martin DK. Priority setting: what constitutes success? A conceptual framework for successful priority setting. BMC Health Serv Res 2009; 9: 43.

(23) Dakin HA, Devlin NJ, Odeyemi IA. "Yes", "No" or "Yes, but"? Multinomial modelling of NICE decision-making. Health Policy 2006; 77(3): 352-67.

(24) Devlin N, Parkin D. Does NICE have a cost-effectiveness threshold and what other factors influence its decisions? A binary choice analysis. Health Econ 2004; 13(5): 437-52.

(25) Erntoft S. Pharmaceutical priority setting and the use of health economic evaluations: a systematic literature review. Value Health 2011; 14(4): 587-99.

(26) Hair JF, Black WC, Babin BJ. Multivariate Data Analysis: A Global Perspective. 7th ed. Hoboken, NJ: Pearson Education; 2010.

(27) Henseler J, Ringle CM, Sinkovics RR. The use of partial least squares path modeling in international marketing. In: Sinkovics RR, Ghauri PN, editors. New Challenges to International Marketing. Bingley, UK: Emerald Group Publishing; 2009. p. 277-320.

(28) Rogowski WH, Hartz SC, John JH. Clearing up the hazy road from bench to bedside: a framework for integrating the fourth hurdle into translational medicine. BMC Health Serv Res 2008; 8: 194.

(29) Stafinski T, Menon D, Philippon DJ, McCabe C. Health technology funding decision-making processes around the world: the same, yet different. Pharmacoeconomics 2011; 29(6): 475-95.

(30) Ibrahimipour H, Maleki MR, Brown R, Gohari M, Karimi I, Dehnavieh R. A qualitative study of the difficulties in

reaching sustainable universal health insurance coverage in Iran. Health Policy Plan 2011; 26(6): 485-95.

(31) Reinartz W, Haenlein M, Henseler J. An empirical comparison of the efficacy of covariance-based and variance-based SEM. INT J MARKET RES 2009; 26(4): 332-44.

(32) Hair JF, Ringle CM, Sarstedt M. PLS-SEM: Indeed a Silver Bullet. Journal of Marketing Theory and Practice 2011; 19(2): 139-52.

(33) Esposito Vinzi V, Trinchera L, Amato S. PLS path modeling-from foundations to recent developments and open issues for model assessment and improvement. In: Esposito Vinzi V, Chin WW, Henseler J, Wang H, editors. Handbook of Partial Least Squares: Concepts, Methods and Applications. Berlin, Germany: Springer Science & Business Media; 2010. p. 47-82.

(34) Fischer KE. Decision-making in healthcare: a practical application of partial least square path modelling to coverage of newborn screening programmes. BMC Med Inform Decis Ma 2012; 12(1): 83.

(35) Hair JF. SmartPLS [Online]. [cited 2005]; Available from: URL:

(36) Hair JF, Sarstedt M, Ringle CM, Mena JA. An assessment of the use of partial least squares structural equation modeling in marketing research. J of the Acad Mark Sci 2012; 40: 414-33.

(37) Tenenhaus M, Esposito Vinzi V, Chatelin YM, Lauro C. "PLS Path Modeling". Comput Stat Data An 2005; 48(1): 159-205.

(38) Culyer AJ. Hic sunt dracones: the future of health technology assessment--one economist's perspective. Med Decis Making 2012; 32(1): E25-E32.

(39) Haghparast-Bidgoli H, Kiadaliri AA, Skordis-Worrall J. Do economic evaluation studies inform effective healthcare resource allocation in Iran? A critical review of the literature. Cost Eff Resour Alloc 2014; 12: 15.

(40) Viyanchi A, Rasekh H, Safikhani H, Rajabzadeh A. Drug Insurance Coverage in Iran and Some Selected Countries: A Comparative Study. J Health Adm 2015; 18(60): 7-23. [In Persian].


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