Avastin bevacizumab regulatory update

Novartis AG (NYSE:NVS; SIX:NOVN, Basel, Switzerland) said a U.K. primary care trust cluster revoked a September 2011 policy and said it will no longer reimburse for off-label use of Avastin bevacizumab to treat wet age-related macular degeneration (AMD). Novartis said the board of the Southampton, Hampshire, Isle of Wight and Portsmouth primary care trust made the decision after considering a number of issues, including new clinical safety data, government reinforcement of the requirement to fund NICE-recommended medicines, and reductions in the cost of prescribing Lucentis. Novartis did not provide more details.

The move comes after Novartis asked for judicial review of the policy in April, arguing that the policy undermines the regulatory process and may compromise patient safety. Novartis' more expensive Lucentis ranibizumab is approved to treat wet AMD and recommended for NHS reimbursement by the U.K.'s NICE. ...