PCTs back down in Lucentis row

Four PCTs have scrapped a policy of using a cheaper cancer drug in place of a licensed wet age-related macular degeneration (AMD) treatment after a legal challenge from a pharmaceutical company.

Macular degeneration: treatment row (photo: SPL)
Macular degeneration: treatment row (photo: SPL)

The Southampton, Hampshire, Isle of Wight and Portsmouth (SHIP) PCT cluster said it has abandoned its policy of using bowel cancer drug bevacizumab in an unlicensed way ahead of ranibizumab (Lucentis), which is licensed for wet AMD and approved by NICE.

The PCT cluster implemented the policy in September 2011 to save costs, but then faced a legal challenge by Novartis, which markets the drug in the UK.

In a statement, the SHIP board said the legal challenge and other factors had made the policy 'difficult to implement'. Most consultant opthalmologists in the region had refused to prescribe bevacizumab for wet AMD, in line with guidance from the Royal College of Opthalmologists, which supported the continued use of Lucentis.

The board said that, until the Novartis legal challenge had finished, the PCT cluster was 'unable to exert its policy with commissioning providers'. Until this happened, which may take a long time, it would be 'increasingly difficult to commit CCGs to the policy', it said.

The board added that it has since worked with Novartis to lower the cost of Lucentis through a national patient access scheme.

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.'

The SHIP PCT cluster originally said that published evidence showed bevacizumab is 'as clinically effective as Lucentis and is far more cost effective'. It anticipated large savings from switching to the unlicensed drug.

Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry (ABPI) welcomed the decision: '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.

'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.'

A study in the BMJ in June 2010 suggested bevacizumab is safe and effective at preventing wet age-related AMD. But experts warned that the study did not directly compare bevacizumab with ranibizumab.

In May, preliminary results from the IVAN study, a RCT comparing the two drugs, showed the drugs had similar effects on wet AMD. Further results from the trial are due in 2013.

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