NICE bends to pressure over Lucentis

pharmafile | December 14, 2007 | News story | Sales and Marketing AMD, Lucentis, NICE 

NICE is set to change its guidance for blindness treatment Lucentis following a barrage of complaints over its failure to approve the drug in June.

The Institute said Lucentis (ranibizumab) could become available to more patients with wet age-related macular degeneration (AMD) on the NHS, though it is still consulting on the proposal.

Lucentis is injected into the vitreous humour of the eye once a month. It was previously recommended for use in just 20% of AMD patients, but not until both eyes are affected and then only in the healthier one.

The new draft guidance suggests a dose-capping scheme to treat patients with one affected eye, and states the NHS would pay for a maximum 14 injections of Lucentis per eye.

NICE said the manufacturer would pay for any further doses, though this agreement will be developed between Novartis, which markets the drug in the UK, and the Department of Health.

NICE chief executive Andrew Dillon said: “The manufacturer of Lucentis has proposed a scheme in which the number of injections paid for by the NHS could be capped, with any remaining injections paid for by the manufacturer.”

Wet AMD is the leading cause of sight loss in the UK and affects a quarter of a million people. The condition can lead to sight loss in as little as three months and requires prompt treatment if sight is to be saved.

NICE believes 14 doses will make a marked improvement in vision for most patients.

Mr Dillon added: “This proposal therefore represents a good use of NHS resources.”

Macugen

But NICE has not swayed its position on Pfizer’s Macugen, also an anti-VEGF drug, which is still blocked altogether.

NICE recognises the benefit of both treatments, but maintains that Lucentis, which is the more expensive of the two, has greater clinical benefit and therefore represents better cost-effectiveness.

Pfizer has expressed its acute disappointment that the new review decision fails to recommend use of Macugen.

The company’s UK medical director Dr David Gillen said: “Throughout the appraisal process Pfizer’s position has been clear – patients and their physicians should have a choice over which anti-VEGF treatment is appropriate for individual patients – one treatment does not fit all.

“Macugen has been shown to maintain vision in patients with all types of wet AMD and has a licence to reflect this.”

Doctors and leaders of patient groups have welcomed the promise of new guidance for Lucentis, but are disappointed it still means clinicians are unable to present a choice of treatment to their patients.

The guidance again reinforces the difference in drug access within Britain, as both Lucentis and Macugen have been widely available to AMD patients in Scotland for a year now.

Dr Gillen added: “It is unacceptable that patients in England and Wales should still be denied the choices that patients in Scotland have.”

Consultation on the draft recommendations will begin today and conclude on 14 January 2008.

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