A primary care trust cluster under the threat of legal action for recommending the use of an unlicensed drug has revoked the policy after the pharmaceutical company cut the price of the medicine.

Novartis launched judicial review proceedings against the Southampton, Hampshire, Isle of Wight and Portsmouth cluster earlier this year.

The company claimed the cluster’s decision to recommend clinicians use the unlicensed Avastin over its own licensed drug Lucentis for the treatment of age-related macular degeneration was unsafe. However, the cluster insisted there was evidence to show Avastin was just as efficient as Lucentis and was also a tenth of the cost.

Avastin is licensed for the treatment of bowel cancer but not for use in the eye. Studies have shown it to have the same outcomes as Lucentis but there are some concerns about its safety. It is not recommended for the treatment of wet AMD by the National Institute for Health and Clinical Excellence.

However, Novartis has agreed to reduce the price in excess of the discount offered by the existing national patient access scheme. HSJ understands the company is keen to come to similar arrangements with other commissioners provided they have a satisfactory policy regarding the prescription of Lucentis. 

Cluster chair Jonathan Montgomery 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.”

He also noted that clinicians in the area had continued to prescribe Lucentis in line with guidelines from the Royal College of Ophthalmologists and the cluster could not enforce the policy while a legal challenge was outstanding.

Legal proceedings would be likely to drag on beyond the PCT cluster’s abolition in April 2013, Professor Montgomery said, and it would be “difficult” to commit the emerging clinical commissioning groups to the process.

The price cut is part of a national patient access scheme. Such schemes have become increasingly common in the past two years at both local and national level, however pharmaceutical companies closely guard the actual discount from list pric to protect their prices elsewhere in the world.

A spokesman for Novartis said the company was “pleased” by the cluster’s decision.

He said: “Novartis will continue to work together with SHIP as it formulates its new wet AMD policy and hopes to be able to resolve outstanding legal issues.”

The agreement to reduce the price comes as a competitor drug, Bayer’s aflibercept, has been licensed in the US. European licensing is expected to follow.

Simon Kelly, a consultant ophthalmologist at Royal Bolton Foundation Trust, described the decisions by both parties as an “outbreak of common sense”.

“The reduction in price of Lucentis which will benefit the whole of the NHS,” he added.

He called for NICE to look again at the use of Lucentis for treatment of diabetic macular edema in light of the price reduction, another condition that causes blindness.

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