Novartis and Bayer’s case against National Health Services in Northern England has been dismissed by the U.K. High Court. The court ruled that NHS can continue to use Roche’s Avastin (bevacizumab) for the treatment of wet age-related macular degeneration (AMD) despite Novartis and Bayer’s claim that Avastin should not be used by NHS because it is not licensed for this particular indication. Bayer and Novartis market the AMD therapies Eylea (aflibercept) and Lucentis (ranibizumab), respectively.
The Judge rejected the companies’ argument, stating that treating clinicians can lawfully choose Avastin for ophthalmic use on grounds of cost. Avastin, which costs only $37 per injection for use in wet AMD, is a more appealing option for patients when compared to Lucentis, which costs $727 per injection, and Eylea, which costs $1076 per injection.
Chief Executive Officer of NHS South Tyneside CCG, David Hambleton described the ruling as “a victory for common sense over commercial interested.” He added that 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.”
A Novartis spokesperson, however, believes the ruling undermines the established framework for such matters. “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.”
Novartis does not appear to be alone in this opinion. Sheuli Porkess, deputy chief scientific advisor to The Association of the British Pharmaceutical Industry, also noted that the ruling jeopardizes clarity for both patients and doctors.
Hambleton, however, notes the court’s decision could result in a rethink for U.K regulartory agencies, which, he states, will “now […] have the option of allowing the use of so-called ‘off-label’ drugs.”
(Source: BBC News)