After a long legal fight with Bayer and Novartis, England’s National Health Service has won the right to use a compounded form of Roche’s Avastin off-label in patients with wet age-related macular degeneration over much more expensive drugs Eylea and Lucentis.
Even though Avastin is only approved in England to treat certain cancers, clinicians in the country can now use a compounded version of the drug to treat AMD. In the Friday decision, a judge ruled that a practice by 12 clinical commissioning groups to use Avastin instead of more expensive meds from Novartis and Bayer is legal, rejecting arguments from the pharma companies.
The drugmakers argued the policy was illegal under EU law because Avastin isn’t approved to treat AMD.
In the end, the court ruled that the European Medicines Agency “does not have exclusive competence to determine whether Avastin is clinically effective and safe for ophthalmic use,” according to a summary of the decision. The court said NICE and clinical consulting groups can also weigh in.
With the ruling, NHS’ use of the cheaper drug could enable savings of more than £100 million per year, The Guardian reports. Bayer’s Eylea costs £816 per injection and Novartis’ Lucentis costs about £551, both before discounts, according the court. A dose of compounded Avastin costs £28.
Following the decision, Dr. Sheuli Porkess, deputy chief scientific officer of the British pharma trade group ABPI, said the “extraordinary judgement potentially undermines the regulation of all medicines and by doing that, neither patients nor doctors have clarity on what information to trust.” The confusion is "deeply unhelpful" amid Brexit talks, Porkess added.
The ruling follows years of arguments in the case after regional NHS officials started approving the off-label use of Avastin back in 2011. The drugmakers have also fought the battle elsewhere. In 2012, a National Institutes of Health study found the two drugs essentially equivalent.