Drug regulator withdraws alert on Avastin injection for ophthalmic usage

Expert panel says the drug is cheaper than alternatives and its safety and efficacy is "stated to be proven" globally

The drug regulator in the country has withdrawn an alert it issued on usage of bevacizumab injection, a cancer drug, in the treatment of eye disease. The medicine, which is known under the brand name Avastin and sold by Swiss pharma major Roche, has been used by eye doctors to treat ophthalmic conditions such as age-related macular degeneration (ARMD).

The decision comes after an expert committee recommended the Office of Drug Controller General (India), [DCGI] to withdraw the alert notice. The committee observed that the safety and efficacy of the medicine in its use intravitreal (inside the eye) has been proven in over 2,500 independent studies published globally and that it is 40 times cheaper than the other available drug for the same use.

"The Ministry of Health and Family Welfare, Government of India has accepted recommendations of the Committee," said G N Singh, DCGI in a notice issued.

The DCGI, on January 21, this year, has issued an alert notice as a precautionary measure in the light of the incidences of blindness reported in Gujarat following the use of medicine allegedly for Ophthalmic conditions. According to reports, the injections has damaged the vision of 15 patients in Gujarat, following which the State drug control office put its sales on hold. The expert committee was formed to look into the issue and it has submitted its report on February 8, 2016.

"The Bevacizumab Injection is 40 times cheaper than other available drug (Renibizumab Injection) for same use and equally effective in India. This would put less financial burden on patients and prevent blindness of many," says the directive from DCGI quoting the committee. Renibizumab Injection is sold by Novartis in various countries under the brand name Lucentis and Accentrix.

Off-label use is the use of a medicine for an therapeutic indication for which the originator company has not sought approval from the regulatory authorities, but has been proven by repeated use by the practitioners, said experts.

The committee proposed that All India Ophthalmological Society (AIOS) and Vitreo Retinal Society of India (VRSI) will formulate guidelines for safe and effective use of the medicine for ophthalmic purpose based on the written-informed consent as practiced globally for off-label use under appropriate environmental conditions by skilled ophthalmic surgeons based on risk-benefit analysis. These organisations would also further ensure that appropriate training and awareness may be imparted to its members.

The AIOS, in tune with the recommendation, has already formulated guidelines and communicated it with its members along with details of the consent format, said D Ramamurthy, president of AIOS.

According to him, a vial of bevacizumab injection is priced at Rs 25,000-27,000, which could be used in around 15 patients. "Lucentis was priced at around Rs 45,000 a vial earlier, but in the last one month, the price was dropped on par with Accentrix, to around Rs 15,000-17,000 a vial," he said. These vials contain quantity only for a single injection, he added.

The medicine is used for various treatment, including diabetic retinopathy, age related macular degeneration (ARMD) and others, mainly for the aged population, for preventing blindness. It may also have to be used almost on a monthly basis on some of the patients. According to a rough calculation by the AIOS, around 4,000 injections of Avastin are being performed across the country a day on an average.

The committee, which deliberated on the use of the injection in ophthalmic conditions as an off-label indication, commented that while it is not approved by global regulator authorities to be delivered into the eye since the innovator company has not applied for it, it has been recommended for use in eye by the World Health Organisation (WHO) last year.

It observed that the WHO in April, 2015, has recommended the medicine by including it in the list of essential medicines prepared as anti-vascular endothelial growth factor (anti-VEGF) in ophthalmic section based on the recommendation of International Council of Ophthalmology (ICO). Regulatory agencies of France and Italy have allowed the off-label use of the medicine as a Temporary Recommended Use (TRU).

The safety and efficacy of the medicine intravitreal use is stated to be proven by various independent studies (over 2,500 studies published) conducted globally. It was discussed that rate of endophthalmitis is significantly lower after the injection of bevacizumab injection as compared to standard cataract surgery, it added.