GMC halts prescribing overhaul as Lucentis legal challenge begins

The GMC has halted a planned overhaul of its guidance on prescribing cheap off-label and unlicensed drugs as it seeks legal advice.

PCTs’ use of unlicensed bevacizumab for wet age-related macular degeneration is being challenged (Photograph: SPL)
PCTs’ use of unlicensed bevacizumab for wet age-related macular degeneration is being challenged (Photograph: SPL)

The move comes as PCTs’ use of unlicensed bevacizumab for wet age-related macular degeneration, in the place of the licensed drug ranibizumab (Lucentis), is being challenged by the pharmaceutical company Novartis.

Last year, the GMC issued draft guidance to support use of off-label or unlicensed drugs when a prescriber is satisfied that such treatment is as safe and effective as a licensed alternative.

The GMC has decided not to revise its guidance and will revert to its original wording. This states that, in prescribing an unlicensed medicine, doctors must be satisfied that no licensed medicine would meet the patient’s need.

The GMC is now seeking further advice and said it 'may revise this part of the guidance when we have resolved the remaining legal questions'.

The GMC said it had been advised by lawyers that its proposed change would breach requirements of the EU directive on medicinal products for human use. These state that unlicensed medicines can only be prescribed when there is a ‘special need’. A ‘special need’ could not include commissioning bodies failing to support funding of a licensed medicine, the GMC’s legal advisers said.

Novartis has commenced judicial review proceedings to seek to prevent the Southampton, Hampshire, Isle of Wight and Portsmouth (SHIP) PCT Cluster from being able to fund bevacizumab (licensed under the brand name Avastin for the treatment of cancer) as well as Lucentis.

A spokeswoman for the SHIP PCT Cluster Board said: ‘The PCTs have reached the view that the published evidence suggests that Avastin is as clinically effective as Lucentis and is far more cost effective.

‘If clinicians choose to prescribe Avastin for wet AMD patients the cost savings will result in the PCTs being able to fund other eye-related treatments for NHS patients.

‘The PCTs consider that, in a time of substantial financial pressure on the NHS, this is a responsible as well as lawful approach.’

A spokeswoman for Novartis said there was emerging evidence of potential safety concerns with the use of unlicensed bevacizumab when used to treat eye conditions.

‘Before any medicine is determined appropriate to be licensed for use with the public, it is assessed by a regulatory body that performs a risk/benefit assessment based on the drug’s safety, efficacy and quality profile,’ she said. ‘This assessment has not been conducted for bevacizumab for use in the eye.

She added: ‘Novartis is worried that the principle of patient safety is being undermined by the current SHIP policy. It is unacceptable to put the safety of patients at risk through the widespread use of an unlicensed treatment when a licensed medicine is available. It undermines the regulatory process that was introduced to safeguard patients.'

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