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Novartis right to challenge NHS on Avastin use – ABPI chief

pharmafile | April 27, 2012 | News story | Sales and Marketing ABPI, Lucentis, Whitehead, avastin, wet AMD 

The ABPI has declared its support for Novartis in its legal challenge against off-label prescribing in England.

The pharma company is challenging the off-label use of Roche’s Avastin in place of its own Lucentis for patients with wet age-related macular oedema, a common eye disease. 

Using Avastin off-label is much cheaper than using Lucentis, but seems to contravene UK regulations. These state that doctors should not use off-label drugs if a licensed alternative exists. Novartis also says that using Avastin for these patients – which entails splitting vials of Avastin to make multiple doses – represents a safety risk for patients.

Speaking at the ABPI annual conference, the UK pharma organisation’s chief executive Stephen Whitehead said Novartis was ‘fundamentally right’ to seek a judicial review.

He added that it was “appropriate for Novartis to draw attention to this complicated issue”, which he said reflects the wider problems for the industry surrounding off-label prescribing. 

Lucentis is chemically similar to Avastin, but costs £740 per injection, much higher than Avastin at around £60. 

Novartis has been granted a judicial review against the SHIP PCT Cluster in southern England, which is encouraging doctors in their region to use Avastin for wet AMD. If the judicial review were to rule in Novartis’ favour, the PCT could be forced to prescribe Lucentis rather than Avastin. This could then force numerous other PCT clusters into following suit.

Whitehead said that since Lucentis (ranibizumab) is licensed for the indication, and recommended by NICE, it should be the drug of choice for these patients.

When asked what would happen if Novartis lost, Whitehead said firmly: “I don’t think they will lose.”

The conference focused on the ongoing Value-Based Pricing debate in the UK, and developing closer relationships with the NHS. 

Nobel prize winner criticises Novartis

Whitehead’s defence of Novartis came on the same day that Sir John Sulston, the 2002 Nobel prize winner in physiology or medicine, said companies should not be able to block access to cheaper alternatives.

Writing in the Journal of Medical Ethics journal, Sir Sulston and several other authors, said: “When there is a treatment that is apparently vastly more cost effective, with a similar safety profile to an existing licensed treatment, there is no good reason that those in charge of resource allocation decisions within healthcare systems […] should not be able to opt for the cheaper alternative.

“Not only is Roche unwilling to submit [Avastin] for licensing for eye conditions, it is also resistant to continued off-label use,” they add.

They conclude that drug companies “should not be able to block access to cheaper alternatives in a bid to maximise their profits”, and call for a “fundamental rethink of the way in which drugs are researched and developed, marketed, and licensed”.

Ben Adams

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