Novartis takes legal action over trusts’ advice to use bevacizumab for wet AMD

BMJ 2012; 344 doi: (Published 24 April 2012) Cite this as: BMJ 2012;344:e2959
  1. Ingrid Torjesen
  1. 1London

The drug company Novartis is taking a primary care trust cluster on the south coast of England to court over its decision to give NHS ophthalmologists the option to use the cheaper bevacizumab (marketed as Avastin) for wet age related macular degeneration (AMD) rather than the considerably more expensive ranibizumab (Lucentis).

Bevacizumab and ranibizumab are derived from the same antibody and work by blocking vascular endothelial growth factor. In the United Kingdom they are both marketed by Novartis. Ranibizumab costs £890 (€1090; $1440) a dose, is licensed for injection into the eye specifically to treat macular degeneration, and has been recommended by the National Institute for Health and Clinical Excellence (NICE) for the treatment of wet AMD. Avastin is licensed for treating cancer and costs between £50 and £100 a dose.

In September last year the board of the Southampton, Hampshire, Isle of Wight, and Portsmouth primary care trust (PCT) cluster agreed to fund bevacizumab to treat wet AMD by NHS ophthalmologists to save money. The cluster estimated that a switch could save £5m a year. Novartis has asked for a judicial review of that decision.

The outcome could have massive financial implications for the NHS and Novartis because many other cash strapped PCT clusters, including North Yorkshire and York, have been considering allowing the use of bevacizumab but have been deterred by the threat of legal action. A decision against Novartis would lose it millions of pounds and would be likely to give many other trusts the confidence to also opt to use bevacizumab.

A spokesman for the south coast PCT cluster 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.”

A number of eye conditions, including diabetic macular oedema and retinal vein occlusion, have no NICE recommended treatment. Vascular endothelial growth factor blockers are effective for these conditions, but last year NICE rejected bevacizumab for diabetic macular oedema on the grounds that it was too expensive.

The PCT cluster spokesman added: “The PCTs have always made it clear that if NHS ophthalmologists prescribed Lucentis in clinically appropriate cases this drug would be funded by the NHS.

“Under this policy the choice of drug is a matter for individual patients and their NHS clinicians.”

Current General Medical Council guidelines on good practice in prescribing medicines state that to use a drug off label doctors must “be satisfied that it would better serve the patient’s needs than an appropriately licensed alternative.”

Revised GMC guidelines, expected to allow doctors to be able to take the cost of the drug into account for the benefit of the wider health system, were due to be published last week. They will now be published in June but without the controversial chapter on off-label and unlicensed prescribing, on which the GMC is seeking legal advice.

Novartis argues that ranibizumab is safer for patients. A spokesman said that “there is emerging evidence of potential safety concerns with the use of unlicensed bevacizumab when used to treat eye conditions.”

Before any drug is licensed for use by the public it is normally assessed by the Medicines and Healthcare Products Regulatory Agency for safety, effectiveness, and quality profile. “This assessment has not been conducted for bevacizumab for use in the eye,” the spokesman added. “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.”

First year data from a US trial, the comparison of age related macular degeneration treatments trial (CATT), indicated that bevacizumab may be associated with a higher risk of stroke and death. Second year data from that trial and the UK inhibit VEGF in age related choroidal neovascularisation (IVAN) trial are due to be unveiled at the Association for Research in Vision and Ophthalmology meeting in Florida next month.

There is also an infection risk whenever any drug is injected into the eye. Novartis argues that the risk is greater with bevacizumab because it distributes the drug in quantities that are much too large for injection, so special compounding pharmacies have to split it into smaller doses.

The judicial review will examine whether the south coast PCT cluster followed the correct procedures in its decision rather than whether it was right to allow bevacizumab to be used for wet AMD. A decision is not expected for at least six months.

John Harris, of the University of Manchester’s Institute for Science Ethics and Innovation, said: “Companies like Novartis should not be in the position to block moves to more cost effective treatments in order to maximise their profits. It is legitimate for healthcare providers to appraise and approve off-label treatments which are significantly more cost effective than those that pharma are prepared to license.

“Industry should recognise and be responsive to the social and economic context in which they operate. Health systems in some countries may be able to afford treatment at the higher cost; this will inevitably divert resources from other areas, with negative results for patients and the system as a whole.”


Cite this as: BMJ 2012;344:e2959