The UK High Court on Friday ruled that 12 NHS bodies in the north-east of England can continue to use Roche’s Avastin (bevacizumab) for the treatment of wet age-related macular degeneration (AMD) after dismissing a challenge by Bayer and Novartis. In the case, Bayer and Novartis, which market the respective AMD therapies Eylea (aflibercept) and Lucentis (ranibizumab), argued that Avastin should not be used as it is not licensed in this indication.
However, the judge rejected all four grounds of Bayer and Novartis’ challenge, noting that “treating clinicians can lawfully choose Avastin for ophthalmic use on grounds of cost.” Lucentis costs 551 pounds ($727) per injection, while Eylea costs 816 pounds ($1076) per injection. Meanwhile, compounded Avastin costs 28 pounds ($37) per injection for use in wet AMD.
The drugmakers had previously criticized the clinical commissioning groups (CCGs) for moving to make Avastin the treatment of choice for wet AMD despite only being licensed in the UK for the treatment of certain cancers. Meanwhile, the National Institute for Health and Care Excellence (NICE) concluded in January that Avastin had similar efficacy and safety as Eylea and Lucentis for treating wet AMD.
Commenting on the decision, David Hambleton, chief executive officer of NHS South Tyneside CCG, who descried the ruling as “a victory for common sense over commercial interests,” stated “we’ve always said we think that it’s important that patients should have the choice of a very effective treatment for wet AMD, and it’s actually a fraction of the cost of the other alternatives.” According to Hambleton, the decision will save “in excess of 13.5 million pounds ($17.7 million) per year for the 12 CCGs involved in this litigation alone, and hundreds of millions of pounds across the country.”
In response to the ruling, a Novartis spokesperson said the drugmaker “is deeply disappointed in this decision and remains of the opinion that the policy undermines the well-established legal and regulatory framework that is there to protect both patients’ safety and to ensure health care professionals can prescribe with confidence.”
Meanwhile, Sheuli Porkess, deputy chief scientific advisor to The Association of the British Pharmaceutical Industry, remarked “this extraordinary judgement potentially undermines the regulation of all medicines and by doing that, neither patients nor doctors have clarity on what information to trust.” However, Hambleton said “I think at least we’ve got some real legal clarity now, so both of the bodies – NICE and the [Medicines and Healthcare products Regulatory Agency] – will need to look at what their guidance says.” Hambleton added “now they have the option of allowing the use of so-called ‘off-label’ drugs.”