Out-Law News 2 min. read
07 Apr 2015, 10:53 am
Documents obtained by the British Medical Journal (BMJ) following a freedom of information request showed that "lobbying by the Medicines and Healthcare Products Regulatory Agency [MHRA] and industry" may have affected a decision by the General Medical Council (GMC) to abandon proposed changes to its guidance on the use of unlicensed drugs in 2011, according to an article in the latest issue of the publication. The BMJ said that the UK's legal and regulatory rules about unlicensed drugs had "skewed clinical practice, fuelled drug costs for the NHS, and left doctors confused about what they can and can't prescribe".
"At least six" trials comparing the use of Avastin and Lucentis for the treatment of 'wet' age-related macular degeneration (AMD) have found "no difference in efficacy" between the two drugs, according to the BMJ. However, the BMJ said that it had found evidence of a "campaign by the drug manufacturers" to "undermine and divert attention" from the results of these trials. AMD is an age-related eye condition which, if left untreated, can lead to blindness.
The BMJ's intervention follows that of representatives from over 100 clinical commissioning groups (CCGs) in England, who wrote to the health secretary, GMC and NHS leaders in February urging the GMC to make changes to its guidance. Allowing the use of Avastin instead of Lucentis in wet AMD cases could free up £102 million for patient services each year, according to the letter.
GMC guidance states that drugs should only be prescribed for purposes for which they are not licensed "where there is no suitably licensed medicine that will meet the patient's need". In its response to the CCGs' letter, the GMC said that EU law prevented the adoption of "blanket" policies permitting the use of unlicensed medicines on the grounds of costs. Either EU law had to be changed or Roche, which manufactures Avastin, could "seek an appropriate licence to use Avastin for this purpose", it said.
Lucentis and Avastin have similar chemical compositions and act in similar ways. Both drugs are manufactured by Roche, although Novartis has the right to market Lucentis in the UK. Both companies have argued that Avastin has not been manufactured to treat eye disease, and that its unlicensed use raises product liability and health and safety issues. Large vials of the drug have to be broken down into smaller amounts for injection into the eye, and this introduces a risk of infection, they said.
In 2012, the manufacturers attempted to take four NHS Primary Care Trusts to court over their decision to promote the off-label use of Avastin. The challenge was settled after the trusts agreed to use Lucentis instead, and Novartis agreed to lower the price of the drug.
The World Health Organisation (WHO) has backed the use of Avastin for the treatment of eye conditions, as have the French and Italian courts. Last month, French medical products regulator the Agence Nationale de Securité du Médicament et des Produits de Santé (ANSM) made a 'temporary use recommendation' in favour of the use of Avastin in wet AMD cases, while Italy changed its rules on off-label drug use last year.