Pharmaceutical Benefits Advisory Committee

Glossary of C Terms

Glossary to accompany the 1995 edition of the Guidelines for the Pharmaceutical Industry on Preparation of Submissions to the Pharmaceutical Benefits Advisory Committee

Cardinal data Ordinal data in which the difference between two equi-distant estimates on the ranked scale has the same value irrespective of where the estimates lie on the scale (eg 0.9-0.8 = 0.2-0.1).
Case series with historical controls (see Appendix N) A quasi-experimental study in which the outcomes measured in a group of subjects with a specified indication who are managed with a new therapy (eg involving the proposed drug) are compared with outcomes measured in a similar group of subjects (usually seen previously in the same setting) who are managed with previous therapy (eg involving the main comparator).  
Case-control study (see Appendix N) An observational study in which the past history of exposure to a suspected risk factor (eg therapy involving the proposed drug) is compared proposed drug between cases (who have the outcome or disease) and controls (who resemble the cases but do not have the or outcomed disease).
Categorical data Data in which the variables can only have discrete values.
Causality(see also association) The relating of factors to the effects they produce. Hill (a clinical epidemiologist) proposed eight criteria (not all essential) of a causal association between a factor and an outcome (see reference 9, page 77).
CBA cost-benefit analysis 
CEA cost-effectiveness analysis 
ChanceRandom variation; an explanation of the distribution of variables; an alternative explanation for an apparent treatment effect.
Charge The market price associated with a product or service; does not necessarily reflect the economic or opportunity cost.
Clinical Pertaining to health outcomes rather than economic outcomes, eg clinical performance or clinical comparison; of or by clinicians, eg clinical department, clinical use.
Clinically important The extent to which a treatment effect is considered worth having.
CMA cost-minimisation analysis 
Co-payment A payment made by the user at the time of service as part of the total payment for that service and any associated product.
Cohort study (see Appendix N) An observational study in which two or more sub-sets of defined populations are identified by the presence of a common factor or factors (eg non-randomly assigned to therapy involving the proposed drug or to therapy involving the main comparator(s)) and then followed in time to investigate the influence of the factors on the probability of occurrence of an outcome or outcomes.  
Common reference A drug or therapy to which a proposed drug and its main comparator(s) have been compared in separate comparative randomised trials.  
Confidence interval The computed interval with a specified probability (by convention, usually 95%) that the true value of a population parameter is contained within the interval.
Confounding The distortion of a measure of the effect of an exposure (eg to therapy involving the proposed drug) on the risk of an outcome under investigation brought about by the association of the exposure with other factor(s) that can influence the outcome.  
Consequence (see outcome)
Conservative Resistance to change. A behavioural response to uncertainty involving harm, costs and benefits where the expected rate of harm or costs is given a greater weight than the expected rate of benefits . In practice, this means that where alternative assumptions, estimates or values are available, the conservative assumption, estimate or value for a PBAC submission is the one which is less favourable to the proposed drug. top of page
Continuous data Data with a potentially infinite number of possible values along a continuum (eg age, height).
Contingent valuation A survey-based method to establish individuals' willingness to pay for a therapy.
Control group A group of subjects who are observed but who do not receive therapy involving the proposed drug. They may receive alternative therapy, no therapy or placebo. They provide data on the streams of outcomes (clinical and economic) for comparison with the streams of outcomes observed for subjects who take therapy involving the proposed drug.
Correlation (see association)
Cost analysis A partial economic evaluation that only compares the costs in monetary units of therapy involving the proposed drug with therapy involving its main comparator(s). Cost, financial The monetary value of providing a resource accounted for in the budget of the provider.
Cost, economic or opportunity The value of the best alternative use of a resource that is foregone as a result of its current use.  
Cost-benefit analysis (see Appendix H) An economic evaluation that compares therapy involving the proposed drug with therapy involving its main comparator(s) in which both costs and benefits are measured in monetary terms to compute a net monetary gain/loss or benefit gain/loss. top of page 
Cost-effective A proposed drug is considered cost-effective by the PBAC if the Committee considers that, for a specified main indication, the incremental benefits of therapy involving the proposed drug over therapy involving its main comparator(s) justify its incremental costs and harms.
Cost-effectiveness analysis (see Appendix H) An economic evaluation that compares therapy involving the proposed drug with therapy involving its main comparator(s) having common clinical outcome(s) in which costs are measured in monetary terms and outcomes are measured in natural units.  
Cost-efficacy analysis A cost-effectiveness analysis using the most internally valid data available (ie from adequate randomised trials); if required, a preliminary step to inferring a more externally valid modelled economic evaluation incorporating extrapolations and assumptions.  
Cost-minimisation analysis (see Appendix H) An economic evaluation that finds the least costly alternative therapy after the proposed drug has been demonstrated to be no worse than its main comparator(s) in terms of effectiveness and toxicity.
Cost-utility analysis (see Appendix H) An economic evaluation that compares therapy involving the proposed drug with therapy involving its main comparator(s) in which costs are measured in monetary terms and outcomes are measured in terms of extension of life and the utility value of that extension (eg QALYs or HYEs).
Cross-over (compare with parallel group) A method of comparing two alternative therapies in which the subjects, upon completion of the course of one therapy, are switched to the other therapy.
CUA cost-utility analysis.