By John Miller
ZURICH (Reuters) – Drug giants Novartis, Bayer and Roche on Friday lost a bid to stop British doctors from recommending a cheaper drug option for people with an eye disease that causes blindness, the High Court in London ruled.
A drug industry group said the decision was “extraordinary” and was bad news for future regulatory cooperation between Britain and the European Union after Britain’s exit from the bloc next year.
The companies had sought to block doctors from 12 health groups in the north of England from making Roche’s cancer therapy Avastin the preferred option for wet age-related macular degeneration (AMD), even though it is not licensed for this use.
Avastin works similarly to Bayer’s Eylea and Roche’s and Novartis’s Lucentis, but those drugs were made specifically for the eye.
“Treating clinicians can lawfully choose Avastin for opthalmic use on grounds of cost,” according to the ruling. It added that NICE, the UK’s drug cost effectiveness agency, had concluded that using Avastin for AMD was safe.
Avastin costs around 28 pounds ($37) per injection, according to the judgment, while Eylea costs around 816 pounds per injection and Lucentis costs around 551 pounds per injection. The actual prices vary, however, based on confidential discounts.
Bayer said it was disappointed, adding the ruling puts up roadblocks for companies trying to develop new medicines if off-label uses of older drugs win official sanction.
“Bayer is currently considering all of its options, including the possibility of an appeal,” it said.
While Roche makes Avastin, it wants to sell the more expensive Lucentis for eye patients and said prescribing medicines for off-label use merely based on cost was illegal.
“We believe the unapproved use of medicines for purely economic reasons breaches established laws governing the unapproved or unlicensed use of medicines,” according to a statement from the Basel-based company.
UK drug industry lobby ABPI said it would examine the ruling carefully. “This extraordinary judgment potentially undermines the regulation of all medicines and by doing that, neither patients nor doctors have clarity on what information to trust.”
Eylea and Lucentis, like Avastin, reduce new blood vessel growth that contributes to AMD, which occurs when the macula is unable to function properly.
Bayer and Novartis have argued Avastin had not undergone the same regulatory scrutiny for use in AMD as Lucentis and Eylea.
The doctors group has said using Avastin rather than Eylea or Lucentis could save the regional National Health Service (NHS) 13.5 million pounds a year. Across England, savings from using Avastin could total more than 500 million pounds, the British Medical Journal has reported.
According to the policy sought by the doctors, patients will be told Avastin is the preferred choice, although they are still free to choose Eylea or Lucentis.
($1 = 0.7606 pounds)($1 = 0.8516 euros)
(Reporting by John Miller in Zurich, Kate Kelland in London and Ludwig Burger in Frankfurt)