NHS health chiefs facing legal action over eye drug

The controversy surrounding Avastin and Lucentis has reared its head again as it has been revealed that health chiefs may face a legal fight if they go ahead with plans to offer the cheaper drug (Avastin) to patients with wet age-related macular degeneration (AMD) on the NHS.

Reports from multiple news sources state that there are 12 clinical commissioning groups (CCGs) based in the north of England who want to offer the cheaper alternative to the currently administered drug, Lucentis (ranibizumab), to patients suffering from wet AMD. The manufacturers of Lucentis, Bayer and Novartis, have warned that they will seek a judicial review if plans to offer Avastin go ahead.

Avastin (bevacizumab) is licensed by the European Medicines Agency (EMA) as a cancer treatment but it is not specifically indicated for use in wet AMD. However, in other countries, such as the US, it is used as a treatment for wet AMD and may offer significant savings to the NHS if it could be offered as an alternative treatment.

In The Guardian it is reported that the manufacturer of Avastin refused to apply for a licence indicating the drug for use in eyes. However, the IVAN trial, which evaluated the potential efficacy of the treatments in wet AMD patients, demonstrated non-inferiority of Avastin when compared to Lucentis. Although at the two-year follow up of this trial it was noted that there was a higher risk of a systemic serious adverse event in patients receiving Avastin over those receiving Lucentis.

As Avastin is not licensed for use in patients with wet AMD in the UK, it would be considered an ‘off-label’ use of the medication and as such would be against General Medical Council guidance. It is this potential infringement of guidance that Novartis and Bayer have specified as the cause of potential legal action.

Speaking to the BBC, Bayer stated this form of prescribing of Avastin ‘undermines the regulatory framework and NHS constitution’ with Novartis urging that the treatments have ‘not undergone the same regulatory scrutiny…’

In the same BBC report, cost for the drugs were specified as around £70 per injection for Avastin and more than £700 for Lucentis. The chief officer of one of the 12 CCGs requesting to use Avastin for wet AMD, Dr David Hambleton, stressed that by being able to offer the cheaper alternative first while still keeping the option of Lucentis open to patients may save significant amounts of money. “Lots of the decisions and choices we are potentially facing are much less palatable than this one,” he said to The Guardian. “This seems to most people to be a no-brainer.”

Guidance from the National Institute for Health and Care Excellence (NICE) lists Avastin in the pharmacological management options for wet AMD but also asserts the fact that it is unlicensed for intraocular use and should not be prescribed simply because it is cheaper.