NICE looking into unlicensed and off-label drug use
pharmafile | March 26, 2012 | News story | Sales and Marketing | DoH, NICE, off label, off-label, postcode, unlicensed
NICE is reviewing the use of off-label and unlicensed medicines across the NHS in England.
This follows a pilot project carried out in 2010 that identified 41 unlicensed and off-label drugs for review, which included Roche’s Avastin and Allergan’s Botox.
The watchdog said it is looking to end the postcode prescribing of these drugs, as some NHS regions are more likely to use these drugs more often than others.
The Department of Health has asked NICE to review these drugs and produce guidance on their use, in order to create a more uniform approach to the practice.
As part of the process NICE is now asking front line clinicians and decision-makers their opinions of its original list of 41 drugs, and whether it should be added to.
NICE said it would be working with these stakeholders to: “Identify topics within this category to ensure those selected are appropriate to support decision-making by clinicians and commissioners, and help to reduce variation in access to medicines for patients”.
Respondents have until the end of March to submit their top five drugs to NICE – based on this consultation, the watchdog will then consider adding more medicines to its list later this year.
A drug is considered to be used off-label when it is prescribed for a disease outside the scope of its indication.
This usually occurs in rare diseases where there are no existing treatments, but it is also being used to cut costs, as off-label drugs can be much cheaper than their licensed alternatives.
An unlicensed medicine simply means a drug does not have a licence to treat a particular disease, or to treat a disease within a certain patient population.
The use of unlicensed medicines is frequently used in children, as most drugs are not licensed to treat patients less than 18 years of age.
NICE’s list of medicines
NICE’s current list of 41 drugs include using Roche’s Avastin (bevacizumab), in combination with a chemotherapy agent, to treat malignant gliomas.
The drug has a licence for this type of cancer in the US, but Europe has never been convinced by the data for the drug, and it remains unlicensed for this indication across the continent.
NICE also identified Allergan’s Botox (botulinium toxin) as a drug that could be used for “a long list of often related unlicensed uses,” but added that this needs to be scoped properly.
Botox is currently licensed as an anti-wrinkle treatment, and in 2010 the Medicines and Healthcare Products Regulatory Agency approved it for use as a headache prophylaxis.
It also has a number of US licenses to treat urinary incontinence in certain patients and spasticity in the arms – these indications are currently under review by the EMA.
Takeda’s Velcade (bortezomib) is also on the list for the off-label use in relapsed mantle cell or follicular lymphomas.
It currently only has a European licence to treat multiple myeloma, a rare cancer of the plasma cells in the bone marrow.
GMC to report on off-label use
The General Medical Council told Pharmafocus last week that it would be publishing its draft guidance on doctors’ prescribing off-label medicines on 17 April.
The doctors’ regulator said this guidance has been delayed, as they have been unable to reach a decision on the key points surrounding the issue.
This practice has been brought to a head by the off-label use of Avastin to treat the eye disease wet age-related macular oedema.
Novartis’ Lucentis (ranibizumab) is already licensed to treat the disease, but Avastin is being used as an alternative as its acquisition cost is much lower.
Prescribing drugs off-label to cut costs has been criticised by the pharma industry, and the GMC is looking to clarify its ethical guidelines on the issue with this new guidance.
Ben Adams
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