scholarly journals Insight into reimbursement decision-making criteria in Bulgaria: implications for orphan drugs

Folia Medica ◽  
2013 ◽  
Vol 55 (3-4) ◽  
pp. 80-86 ◽  
Author(s):  
Georgi G. Iskrov ◽  
Ralitsa D. Raycheva ◽  
Rumen S. Stefanov
Keyword(s):  
Decision Making ◽  
Clinical Effectiveness ◽  
Orphan Drugs ◽  
Scenario Planning ◽  
Life Assessment ◽  
Reimbursement Decision ◽  
Therapeutic Alternative ◽  
Societal Value ◽  
Hypothetical Scenario ◽  
Decision Making Criteria

ABSTRACT OBJECTIVE: This article’s objective is to critically assess the Bulgarian legislation on health technology assessment (HTA). It analyses how innovative therapies and orphan drugs in particular would respond to the regulators’ decision-making criteria for reimbursement. MATERIALS AND МETHODS: The study features critical analysis of current decision-making criteria for drug reimbursement in Bulgaria, as well as hypothetical scenario planning for orphan medicinal products. RESULTS: The approval for inclusion into the Positive Drug List (PDL) (which is a must for reimbursement) has been reorganised into an assessment scoring system with decisionmaking criteria (presence of therapeutic alternative, clinical effectiveness, safety, pharmacoeconomics and societal value) divided into weighted indicators. An explicit threshold has been set - a medicinal product must score 60 points at least to be included in PDL. Under the currently defined reimbursement decision-making criteria a hypothetical middle- of-the-road scenario planning shows that an orphan drug would score 20 points for therapeutic alternative, 28 for clinical effectiveness and 12 for safety. It would take no points for pharmacoeconomics and societal value. This leaves the orphan drugs with a total score of 60 points, making the final outcome of real-life assessment and decision-making heavily dependent on small fluctuations. CONCLUSIONS: The current reimbursement decision-making framework in Bulgaria seems to be generalised and not sufficiently transparent. It is unable to precisely assess innovative health technologies. The availability of a therapeutic alternative emerges as a key reimbursement decision-making criterion for orphan drugs, as these innovative products nominally provide the first medicinal therapy alternative to rare diseases.

scholarly journals PHP76 Evidence Requirements for Pricing and Reimbursement Decision Making for Orphan Drugs in Asia

2012 ◽  
Vol 15 (7) ◽  
pp. A621-A622
Author(s):  
S. Tan ◽  
H. Dummett ◽  
S. Kirpekar ◽  
Q. Guan ◽  
V.L. Priest
Keyword(s):  
Decision Making ◽  
Orphan Drugs ◽  
Reimbursement Decision ◽  
Pricing And Reimbursement

Research and analysis of business management processes implemented under conditions of incomplete certainty

2020 ◽  
Author(s):  
Igor Klimenko ◽  
A. Ivlev
Keyword(s):  
Decision Making ◽  
A Priori ◽  
Business Management ◽  
Statistical Uncertainty ◽  
Management Processes ◽  
Classical Decision ◽  
Decision Making Criteria

The study carried out in this work made it possible to expand the rank scale for a priori assessment of the chosen strategy in terms of increasing the sensitivity of assessing the caution / negligence ratio using risky, as well as classical decision-making criteria under conditions of statistical uncertainty.

The impact of a physician’s recommendation and gender on informed decision making: A randomized controlled study in a simulated decision situation

2020 ◽  
Author(s):  
Marie Eggeling ◽  
Anna Meinhardt ◽  
Ulrike Cress ◽  
Joachim Kimmerle ◽  
Martina Bientzle
Keyword(s):  
Decision Making ◽  
Cruciate Ligament ◽  
Treatment Options ◽  
General Information ◽  
Treatment Preference ◽  
Controlled Study ◽  
Treatment Preferences ◽  
Hypothetical Scenario ◽  
And Gender ◽  
The Impact

Objective: This study examined the influence of physicians’ recommendations and gender on the decision-making process in a preference-sensitive situation. Methods: N = 201 participants were put in a hypothetical scenario in which they suffered from a rupture of the anterior cruciate ligament (ACL). They received general information on two equally successful treatment options for this injury (surgery vs. physiotherapy) and answered questions regarding their treatment preference, certainty and satisfaction regarding their decision, and attitude toward the treatment options. Then participants watched a video that differed regarding physician’s recommendation (surgery vs. physiotherapy) and physician’s gender (female vs. male voice and picture). Afterward, they indicated again their treatment preference, certainty, satisfaction, and attitude, as well as the physician’s professional and social competence.Results: Participants changed their treatment preferences in the direction of the physician’s recommendation (P<.001). Decision certainty (P<.001) and satisfaction (P<.001) increased more strongly if the physician’s recommendation was congruent with the participant’s prior attitude than if the recommendation was contrary to the participant’s prior attitude. Finally, participants’ attitudes toward the recommended treatment became more positive (surgery recommendation: P<.001; physiotherapy recommendation: P<.001). We found no influence of the physician’s gender on participants’ decisions, attitudes, or competence assessments.Conclusion: This research indicates that physicians should be careful with recommendations when aiming for shared decisions, as they might influence patients even if the patients have been made aware that they should take their personal preferences into account. This could be particularly problematic if the recommendation is not in line with the patient’s preferences.

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