UK Court Ruling Ends Novartis/Bayer Crusade Against Avastin In AMD
Off-Label Use Does Not Undermine Licensing System
AMD patients in the UK can legitimately be given compounded bevacizumab (Roche’s Avastin) after the appeals court said NHS trusts could offer a drug off-label for economic reasons where there were no safety or efficacy concerns.
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The UK regulator has clarified its guidance on the use of the anticancer Avastin for age-related macular degeneration, saying that reformulating the drug into small vials for ophthalmic injection represents an off-label use of the Roche product and does not create an unlicensed medicine.
In the latest in a string of knockbacks for both Novartis and Roche, the EU’s highest court has said that the Italian authorities are within their rights to reimburse Roche’s Avastin for wet AMD, even though it is not approved for that indication.
The English High Court has rejected attempts by Novartis and Roche to stop clinical commissioning groups from offering Avastin to wet AMD patients in a cost-containment move. In a development that has alarmed pharma firms, the court also questioned the exclusive role of the European Medicines Agency in marketing authorizations, saying that CCGs as well as the health technology assessment body, NICE, have competences in that area, and called on the UK regulator to review its guidance on off-label and unlicensed use.