Category: Market/Novel Tech
Month: 01 Jan 2019
Issue: not yet available
Bayer and Novartis may appeal ruling in the UK on lawful use of Avastin (bevacizumab) for wet AMD
Bayer and Novartis may appeal to a UK ruling on how Avastin (bevacizumab) will be allowed for doctors use lawful medication. The main crux of the ruling is that current anti-VEGF treatments for wet AMD are safe and effective for three main drugs – Avastin (estimated £28 per injection), Eylea (estimated £816 per injection) and Lucentis (estimated £551 per injection). The cost between the anti-VEGF treatments are logarithmic despite all of the drugs being comparable for medical use. The only distinction is that Avastin does not have a marketing authorization, while Eylea and Lucentis have marketing authorization. Avastin does not have to obtain a marketing authorization presumably for commercial reasons, for the most part.
The Royal College of Ophthalmologists (RCOphth) and their Scientific Chair, Professor Andrew Lotery, stated: “this is a great day for the NHS and patients. The ruling is extremely welcome as the Royal College has long petitioned on the use of Avastin as an effective treatment for wet AMD. Our members, ophthalmologists overseeing the treatment of patients with eye disease, can now feel assured that they can offer the best treatment for their patient’s individual needs. We expect that the release of funds in the use of Avastin will be secured to improve patient care within the hospital eye service.”
Commercial companies note that Avastin is not “safe when used for ophthalmic purposes”, as identified in a recent High Court Judiciary England and Wales summation however, Mrs. Justice Whipple states that several doctors from 12 health groups in the north of England find Avastin are now be lawful.
Following the High Court ruling, Mrs. Justice Whipple stated that several reasons for the decision were: (i) the European Medicines Agency (EMA) did not have exclusive competence to determine whether Avastin is clinically effective and safe for ophthalmic use and that NICE and other Clinical Commissioning Groups (CCGs) also hold competence on prescribing Avastin; (ii) that clinicians can lawfully choose Avastin for ophthalmic use on grounds of cost; (iii) the drug has been shown to be safe and has supported for NICE to conclude that Avastin is safe; (iv) that Avastin prepared for ophthalmic use is widely available in the UK and elsewhere, and; (v) protects NHS Trusts “does not lead to, permit or encourage unlawful acts” on the care of patients judged by doctors. In a statement, the Association of the British Pharmaceutical Industry (ABPI) said the ruling “potentially undermines the regulation of all medicines.” No doubt, commercial litigation may continue for appeal.Back to previous