NICE to review wider use of off-label prescribing
pharmafile | October 5, 2011 | News story | Sales and Marketing | off label, off label prescribing
The government has asked NICE to review its plans to give doctors greater freedom for ‘off-label’ prescribing.
It wants NICE, through its NHS Evidence arm, to provide expert assessments of the evidence on the off-label use of medicines where there is no appropriate licensed alternative to treat a particular condition.
These assessments are intended to “inform” doctors’ decision-making and patients’ choices, but “will not provide a yes or no recommendation”, the Department of Health said.
NICE’s review will focus on conditions such as rarer cancers and autoimmune diseases that currently have few or no licensed treatments, but the government said off-label prescribing for more common conditions would also be reviewed.
Health secretary Andrew Lansley said: “The NHS we want to create is one where doctors and patients at local level have the power to take the best clinical decisions together.
“Wherever possible we should apply common sense solutions – especially to longstanding problems such as this – to ensure that patients can access the treatment they and their doctor think best for them.”
Andrew Wilson, chief executive of the Rarer Cancers Foundation, said: “The objective should always be to develop licensed drugs for rare diseases, but this is not always possible.
“When there are no licensed drugs available for a condition, it can be difficult to know how best to treat it. It is important that doctors are able to use their clinical judgement.
“In order to support them, they need to have access to advice and information on what works best.”
Wilson added that this was a “common sense move”, which will make a big difference to patients and to doctors.
Around 1,000 patients could benefit from off-label drugs
The DH said most drugs are licensed for use in conditions where the drug manufacturers are able to recruit enough patients into clinical trials and where they will yield enough sales to justify running the trial.
This presents a long-standing problem for patients with rare diseases, whose access to medication is limited because not enough patients are available for a clinical trials to be run.
NICE is also unable appraise drugs outside their licenced indication, which means they cannot be recommended for use on the NHS.
Evidence on the scale of the problem is limited, but the DH estimates that around 1,000 specific requests for off-label drug use are made to NHS in England every year.
Controversial practice
Off-label prescribing could also prove a much cheaper option for the NHS, as many drugs that might be considered for use outside their licensed indications are older medicines without patent protection.
The practice of off-label prescribing is becoming more commonplace, but its use among doctors has proved controversial.
The General Medical Council is currently conducting its own review and looking to make specific changes to its ethical guidelines in an effort to make the rules on off-label use clearer for doctors.
Their review was prompted by the ongoing debate over the off-label use of Roche’s cancer drug Avastin (bevacizumab) for wet age-related macular oedema.
Even though Novartis’ Lucentis (ranibizumab), which is co-marketed with Roche, is licensed to treat wet AMD, doctors have been prescribing Avastin because it is chemically similar to Lucentis, but much cheaper.
Ben Adams
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