Swiss drug giant Novartis is taking the National Health Service to court because it is allowing the use of an unlicensed, cheaper alternative to its eye drug Lucentis in some hospitals.
Specifically, the drugmaker said it is seeking a judicial review of the Southampton, Hampshire, Isle of Wight and Portsmouth Primary Care Trust (SHIP) cluster board's decision to allow the off-label use of Roche's cancer drug Avastin (bevacizumab) to treat wet age-related macular degeneration (AMD).
Lucentis (ranibizumab), which is also owned by Roche but marketed by Novartis in the UK, is the only antivascular endothelial growth factor (Anti-VEGF) treatment option approved to treat wet AMD in the UK.
The drug is recommended by the National Institute for Health and Clinical Excellence as a cost-effective use of NHS resources, and Novartis argues that the SHIP policy is essentially asking patients and doctors to save money by using Avastin instead, a much cheaper alternative but unlicensed for eye conditions.
Lucentis costs around £750 a shot while Avastin comes in much, much cheaper at about £60. But notwithstanding the fact that patients' medical needs could be met with the use of an approved medicine, there are growing safety concerns over the use of Avastin for wet AMD, Novartis said.
The drugmaker insists that the principle of patient safety is being undermined by the current SHIP policy. "It is unacceptable to put the safety of patients at risk through the widespread use of an unlicensed treatment when a licensed medicine is available," it said, adding that it "undermines the regulatory process that was introduced to safeguard patients".
In an emailed statement to PharmaTimes UK News, Roche confirmed that it has no plans to seek a license for Avastin in wet AMD "and does not promote its use in the area".
Overhaul of system?
However, experts from the Institute of Science, Ethics, and Innovation have this week called for a fundamental overhaul of drug research and development, marketing and licensing systems, as they say drug companies should not be able to prevent access to cheaper alternatives in order to boost their profits.
In the paper, published in the Journal of Medical Ethics, the authors argue that "it should not be left to companies to decide whether a particular product is submitted for licensing as this can clearly operate against the public and patients' interest".
In cases where there is a treatment that is "vastly more cost-effective, with a similar safety profile to an existing licensed treatment, there is no good reason that those in charge of resource allocation decisions within healthcare systems (be they public, private, or mixed) and those responsible for delivering treatment, should not be able to opt for the cheaper alternative," they say.
But Novartis maintains that the safety profile of Avastin in the eye setting remains unproven. In the first instance, it is a cancer drug that is being repackaged for use in eye conditions, not in single-use vials but often in plastic syringes, which may leave patients exposed to a higher risk of contamination and therefore infection/inflammation.
And crucially, while Avastin and Lucentis are both anti-VEGF drugs, it is incorrect to assume they have the same safety and efficacy profile. For one, Lucentis stays in the body for around 10 hours while unlicensed Avastin hangs around for 100 days, and the impact of this on patient safety is still unknown, the drugmaker stressed.