FAQs
CBRAD (Comparative Benefit-Risk Assessment of Drugs) is the process of engaging experts, prescribers, and patients in constructing the ranks of prescription drugs for a medical condition. DrugRanks brings these participants together in a facilitated workshop called a ‘decision conference’.
The group establishes the key favourable and unfavourable effects of the drugs, considers the available evidence, and judges the clinical relevance of the effects. Software based on decision theory combines the data and judgements, enabling the overall benefit-risk ratings to be displayed graphically. The clarity of the results makes it possible to create brief written descriptions of the relative advantages and disadvantages of each individual drug.
The group establishes the key favourable and unfavourable effects of the drugs, considers the available evidence, and judges the clinical relevance of the effects. Software based on decision theory combines the data and judgements, enabling the overall benefit-risk ratings to be displayed graphically. The clarity of the results makes it possible to create brief written descriptions of the relative advantages and disadvantages of each individual drug.
Doesn’t the British National Formulary (BNF), which anyone can purchase, already do this?
Not really. Although it is an impressive and useful document, providing convenient summaries of drugs in the UK along with guidance on best practice, much of it from NICE and the MHRA, nearly everything is described in words.
There is hardly any numerical data about the magnitude and likelihood of favourable effects, or the severity and incidence of unfavourable effects. Few data tables and no graphical summaries are given, forcing users to trawl through an often-considerable amount of text before deciding.
Most of the text focuses on individual drugs, with little guidance for choosing among the alternatives.
Isn’t information about individual drugs sufficient for most clinical interventions?
Yes, in deciding the approach to take for a given patient, but not necessarily which drug to prescribe.
For example, in the section on antidepressant drugs, the BNF points out that ‘SSRIs are better tolerated and are safer in overdose than other classes of antidepressants and should be considered first-line for treating depression’.
In the section on SSRIs, a page of general comments is followed by descriptions of six non-proprietary drugs, but there is no comparative assessment of the six.
What would a comparative assessment add?
First, an ordering of the drugs based on their overall benefit-risk balances, accompanied by text describing the key advantages and disadvantage of each drug compared to the other alternatives; second, the benefit-risk profile of each drug; third, a table showing the definitions of all the effects, the input data and the weights assigned to each of the effects.
Eventually it will be possible to provide a fourth analysis: the ranking of the drugs based on the ratio of cost to their overall benefit-risk balance, an index of cost-effectiveness.
How would that assist decision making?
The benefit-risk profiles of available drugs identify the favourable and unfavourable effects that are characteristic of each drug, which enables decisions that are clinically relevant for a given patient.
The text enables a quick comparative survey of the alternatives. The effects table provides decision makers with the evidence, the favourable and unfavourable effects, enabling them to apply with confidence their own clinical judgements in making a decision.
Ranking by cost-effectiveness could aid any decision in which cost is an important consideration.
What are the expected impacts of this project?
Discussions and interviews with several interested health professionals suggest that an understanding of the relative benefit-risk balance of drugs could become a useful input to the many joint formulary committees in the UK, enabling them to create formularies that are based on hard comparative evidence and the judgements of experts and clinicians.
Cost saving would be an obvious impact. Another possibility is the saving of hospital admissions by prescribing drug A instead of drug B.
The availability of easily-accessed CBRAD information (app, computer program, publication, magazine-style report) would enable prescribers to quickly choose a cost-effective drug, providing possible cost savings at no loss in effectiveness.
Patients, especially, would welcome the non-technical descriptions describing the benefits and harms of each drug. CBRAD rankings would contribute to the ‘optimal prescribing’ initiative of NHS England, by providing guidance on the best drug for an individual patient.
The ready availability of CBRAD information could impact drug development as a pharmaceutical company uses the model to test the benefit-risk balance of a drug under development, possibly helping to allocate its limited resources to more promising opportunities.
This will become increasingly possible as the Effects Tables in the European Public Assessment reports for new drugs continue to become available. Those tables facilitate the rapid construction of quantitative models and provide a framework for obtaining assessments by patients of the trade-off weights associated with the favourable and unfavourable effects.
Adding a drug that is currently being fast-tracked by the MHRA in an existing CBRAD model could speed up approval. Other impacts may well emerge during the feasibility study and in any subsequent implementation.
Not really. Although it is an impressive and useful document, providing convenient summaries of drugs in the UK along with guidance on best practice, much of it from NICE and the MHRA, nearly everything is described in words.
There is hardly any numerical data about the magnitude and likelihood of favourable effects, or the severity and incidence of unfavourable effects. Few data tables and no graphical summaries are given, forcing users to trawl through an often-considerable amount of text before deciding.
Most of the text focuses on individual drugs, with little guidance for choosing among the alternatives.
Isn’t information about individual drugs sufficient for most clinical interventions?
Yes, in deciding the approach to take for a given patient, but not necessarily which drug to prescribe.
For example, in the section on antidepressant drugs, the BNF points out that ‘SSRIs are better tolerated and are safer in overdose than other classes of antidepressants and should be considered first-line for treating depression’.
In the section on SSRIs, a page of general comments is followed by descriptions of six non-proprietary drugs, but there is no comparative assessment of the six.
What would a comparative assessment add?
First, an ordering of the drugs based on their overall benefit-risk balances, accompanied by text describing the key advantages and disadvantage of each drug compared to the other alternatives; second, the benefit-risk profile of each drug; third, a table showing the definitions of all the effects, the input data and the weights assigned to each of the effects.
Eventually it will be possible to provide a fourth analysis: the ranking of the drugs based on the ratio of cost to their overall benefit-risk balance, an index of cost-effectiveness.
How would that assist decision making?
The benefit-risk profiles of available drugs identify the favourable and unfavourable effects that are characteristic of each drug, which enables decisions that are clinically relevant for a given patient.
The text enables a quick comparative survey of the alternatives. The effects table provides decision makers with the evidence, the favourable and unfavourable effects, enabling them to apply with confidence their own clinical judgements in making a decision.
Ranking by cost-effectiveness could aid any decision in which cost is an important consideration.
What are the expected impacts of this project?
Discussions and interviews with several interested health professionals suggest that an understanding of the relative benefit-risk balance of drugs could become a useful input to the many joint formulary committees in the UK, enabling them to create formularies that are based on hard comparative evidence and the judgements of experts and clinicians.
Cost saving would be an obvious impact. Another possibility is the saving of hospital admissions by prescribing drug A instead of drug B.
The availability of easily-accessed CBRAD information (app, computer program, publication, magazine-style report) would enable prescribers to quickly choose a cost-effective drug, providing possible cost savings at no loss in effectiveness.
Patients, especially, would welcome the non-technical descriptions describing the benefits and harms of each drug. CBRAD rankings would contribute to the ‘optimal prescribing’ initiative of NHS England, by providing guidance on the best drug for an individual patient.
The ready availability of CBRAD information could impact drug development as a pharmaceutical company uses the model to test the benefit-risk balance of a drug under development, possibly helping to allocate its limited resources to more promising opportunities.
This will become increasingly possible as the Effects Tables in the European Public Assessment reports for new drugs continue to become available. Those tables facilitate the rapid construction of quantitative models and provide a framework for obtaining assessments by patients of the trade-off weights associated with the favourable and unfavourable effects.
Adding a drug that is currently being fast-tracked by the MHRA in an existing CBRAD model could speed up approval. Other impacts may well emerge during the feasibility study and in any subsequent implementation.
