A primary care trust (PCT) in England has said it will no longer recommend the off-label use of Roche's Avastin to treat wet age-related macular degeneration (AMD) following a legal challenge from Novartis, whose Lucentis is approved to treat the condition.
The Southampton, Hampshire, Isle of Wight and Portsmouth (SHIP) PCT gave several reasons for its decision to abandon its policy, in place since last September, of offering patients the much cheaper alternative of off-label Avastin, but the key factor appears to be Novartis' offer to cut Lucentis' price in the UK.
After discussions with the SHIP PCT the pharma company introduced an NHS-wide patient access scheme that the PCT said offered "significant improvements in the cost of prescribing Lucentis".
Professor Jonathan Montgomery, chairman of the PCT cluster board, said: “We remain of the view that the policy was lawful, sensible and safe for patients. However, in our consideration of the policy today, the board has concluded that given the discount being offered, it will be possible to reduce significantly the £7.5m spent annually on Lucentis in the SHIP area.”
Further details on the discounts involved, which have been agreed nationally as 'commercial in confidence', were not available.
Explaining its decision to change the prescribing policy the PCT also noted that NHS consultant ophthalmologists had largely chosen not to prescribe Avastin, due to guidance from the Royal College of Ophthalmologists supporting Lucentis.
But the PCT remains convinced both Lucentis and Avastin are similar treatments for web AMD, pointing to new research that emerged over the last year showing both were being very effective and broadly equivalent in their efficacy.
Ongoing NHS reforms also influenced the PCT cluster's decision, with SHIP announcing that as it will be handing over commissioning authority to clinical commissioning groups (CCGs) in April 2013 and, given the potential length of time needed to complete legal proceedings, the PCT cluster would find it “increasingly difficult” to commit CCGs to the policy.
The decision was welcomed by chief executive of the Association of the British Pharmaceutical Industry (ABPI) Stephen Whitehead, who had previously publicly backed Novartis' legal challenge.
“It continues to be our view that off-label and unlicensed prescribing should be strictly limited to those circumstances where there is no licensed alternative and where the clinician, in discussion with the patient, decides that this is in their best interests,” he said.
“Loosening the regulations in this area would not only put a patient's safety at risk, it would also undermine the entire regulatory process which is in place to protect public health.”