Nip in the bud for drug substitute

Former ophthalmologist and international drug policy expert argues the Italian government should reconsider the decision to substitute AMD drug for the safety of patients and out of respect to other EU member nations

Dr Steven Bradshaw, a drug policy expert and former ophthalmologist, is disappointed at the news of the Italian government’s decision to substitute wet age-related macular degeneration (AMD) treatment drug, from Lucentis to Roche’s Avastin.

Dr Bradshaw understands the Italian health care system increasingly concerns about the cost of medicines, and have pressured drug makers to lower prices, or at least higher rebates, for many years. But this has caused concerns to Dr Bradshaw - the fears 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

Wet AMD is the leading cause of blindness in developed countries. With just over 10 years ago there was not anything 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) came along to save and restore sight, many patients who would otherwise have gone blind. However, the off-label use of Avastin among many clinicians in many countries is causing concerns as the drug is only licensed for the treatment for various cancers, which to be given intravenously. 

In the UK, 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 per cent 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 data indicate that, in term 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.

“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.” 

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