Dr Steven Bradshaw, a drug policy expert and former ophthalmologist, is disappointed at the news of the Italian government’s decision to change the wet age-related macular degeneration (AMD) treatment drug, from Lucentis to Roche’s Avastin.
He understands the Italian healthcare system is increasingly concerned about the cost of medicines, and has pressured drug makers to lower prices for many years. But this has caused concerns to Dr Bradshaw: the fear that other EU nations will quickly adopt the substitution practice towards eye drugs and other medicines, undermining the EU regulatory framework.
Wet AMD is the leading cause of blindness in developed countries. Just over 10 years ago, in terms of treatment, there was little that could be done, apart from offering patients multivitamins, referring patients to low-vision aid services and filling a registration form for blind or partial sighted registration.
All of this changed when Lucentis (ranibizumab) and Eylea (aflibercept) were introduced to save and restore sight, many patients would otherwise have gone blind. However, the off-label use of Avastin among many clinicians in many countries is causing concern as the drug is only licensed for the treatment for various cancers, to be given intravenously.
In the UK, the National Institute for Health and Care Excellence (NICE) approved the use of Lucentis for wet AMD in 2008, but there has been much controversy with its price tag of £900 for a single injection, 50 times more than Avastin. Lucentis is manufactured specifically for injection into the eye following many high-quality trials and safety data, and went through a clinical development process for wet AMD. With that, Lucentis is approved by the European Regulators for being effective and safe for this main cause of blindness.
Dr Bradshaw said: “The massive difference in price has led to Avastin being adopted in many parts of the world, especially where there are issues with the affordability of Lucentis.
“However, using Avastin has not given some clinicians 100% satisfaction in evidence of results.”
Although there have been trials to compare Lucentis and Avastin, such as the Comparison of Age-related macular degeneration Treatments Trials (CATT), and the data indicate that, in terms of efficiency, the results were the same. But, the study was not powered to identify meaningful differences in safety profiles.
The manufacturing standards differ for cancer and ophthalmic drugs: particulate matter must be very low in drugs used in the eye, and Avastin is not manufactured with that purpose.
He concluded: “Cost, ethics, safety and purpose of the drugs, and the manufactured methods are some of the aspects to be considered when choosing between Avastin and Lucentis.”
