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. Clarity of results is achieved by showing more and more information as the user moves down each Medicinal Product's page through the five steps common to all descriptions.
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. Clarity of results is achieved by showing more and more information as the user moves down each Medicinal Product's page through the five steps common to all descriptions.
iDoesn’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 individual 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, second, the benefit-risk profile of each drug accompanied by graphs that aid interpretation; and third, an Effects Table showing the definitions of all the effects, the input data and the relative importance weights assigned to each of the effects.
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 enable decisions that are clinically relevant for an individual patient.
The tables and graphs enable 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 and providing advice about trade-offs.
Why aren't costs included in CBRAD?
Because there are no 'true' costs for a given drug. The British National Formulary only give costs for a single dose or multiple doses. However, the costs for a maximum daily dose for some over-the-counter pain-killers were higher than the purchase price offered to shoppers at some UK supermarkets. Costs can also differ across different regions or countries, while the benefit-safety profile may remain unchanged.
Other sources quote costs for a fixed time, like the maximum time for which the drug should be taken. In some cases the total costs for a single time period are given. For example, one source lists costs for a year's treatment of overactive bladder drugs, without regard for the average number days of actual treatment.
If treatment costs could be established, the CBRAD benefit-safety figure for a drug should be divided by the treatment cost to give a value-for-money figure known as a Performance Index. That might result in a useful but different ordering of the drugs. It is, of course, the task of Health Technology Assessment organisations, like the UK's NICE, to determine costs of treatment. CBRAD results might by of interest to HTA organisations.
What are the expected impacts of this project?
Enabling precision prescribing: choosing the best drug for an individual patient, reducing the need for trying another drug when the one prescribed doesn't work or causes unacceptable side effects, and reducing numbers of hospital admissions for patients who have been prescribed the wrong drug.
Providing joint formulary committees with the information needed to create stocks of drugs that are based on hard comparative evidence and the judgements of experts and clinicians.
Providing easy access to CBRAD information, like the Medical Condition pages here, enables prescribers to choose quickly a drug that is high in benefits and safety, providing possible cost savings at no loss in effectiveness.
Providing patients with non-technical descriptions describing the benefits and harms of each drug, and with hard evidence of expected benefits and side-effects so they can consider the trade-off between favourable and unfavourable effects.
Speeding up drug development in pharmaceutical companies by their using a CBRAD model to test the benefit-risk balance of a drug under development compared to similar marketed drugs, possibly helping to allocate its limited resources to more promising opportunities.
Ability quickly to add a new drug into a previous CBRAD model as soon as it is approved. There is no need to redo the model; DrugRanks adds the new data required for its approval, as reported in the European Public Assessment Report, and the new drug will take its place compared to others for the same medical condition.
Speeding up approval of a drug that is currently being fast-tracked by the MHRA if the new drug is incorporated into an existing CBRAD model to determine its relative benefit-safety balance.
Not really. Although it is an impressive and useful document, providing convenient summaries of individual 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, second, the benefit-risk profile of each drug accompanied by graphs that aid interpretation; and third, an Effects Table showing the definitions of all the effects, the input data and the relative importance weights assigned to each of the effects.
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 enable decisions that are clinically relevant for an individual patient.
The tables and graphs enable 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 and providing advice about trade-offs.
Why aren't costs included in CBRAD?
Because there are no 'true' costs for a given drug. The British National Formulary only give costs for a single dose or multiple doses. However, the costs for a maximum daily dose for some over-the-counter pain-killers were higher than the purchase price offered to shoppers at some UK supermarkets. Costs can also differ across different regions or countries, while the benefit-safety profile may remain unchanged.
Other sources quote costs for a fixed time, like the maximum time for which the drug should be taken. In some cases the total costs for a single time period are given. For example, one source lists costs for a year's treatment of overactive bladder drugs, without regard for the average number days of actual treatment.
If treatment costs could be established, the CBRAD benefit-safety figure for a drug should be divided by the treatment cost to give a value-for-money figure known as a Performance Index. That might result in a useful but different ordering of the drugs. It is, of course, the task of Health Technology Assessment organisations, like the UK's NICE, to determine costs of treatment. CBRAD results might by of interest to HTA organisations.
What are the expected impacts of this project?
Enabling precision prescribing: choosing the best drug for an individual patient, reducing the need for trying another drug when the one prescribed doesn't work or causes unacceptable side effects, and reducing numbers of hospital admissions for patients who have been prescribed the wrong drug.
Providing joint formulary committees with the information needed to create stocks of drugs that are based on hard comparative evidence and the judgements of experts and clinicians.
Providing easy access to CBRAD information, like the Medical Condition pages here, enables prescribers to choose quickly a drug that is high in benefits and safety, providing possible cost savings at no loss in effectiveness.
Providing patients with non-technical descriptions describing the benefits and harms of each drug, and with hard evidence of expected benefits and side-effects so they can consider the trade-off between favourable and unfavourable effects.
Speeding up drug development in pharmaceutical companies by their using a CBRAD model to test the benefit-risk balance of a drug under development compared to similar marketed drugs, possibly helping to allocate its limited resources to more promising opportunities.
Ability quickly to add a new drug into a previous CBRAD model as soon as it is approved. There is no need to redo the model; DrugRanks adds the new data required for its approval, as reported in the European Public Assessment Report, and the new drug will take its place compared to others for the same medical condition.
Speeding up approval of a drug that is currently being fast-tracked by the MHRA if the new drug is incorporated into an existing CBRAD model to determine its relative benefit-safety balance.