The ANSM has just given the green light for the use of Avastin in the treatment of AMD. The drug could replace the Lucentis, thirty times more expensive and as effective.
A crucial step has just been taken in the thorny issue of Avastin. The use of this drug in the treatment of AMD (age-related macular degeneration) has been approved by the French drug agency. The implementation of this measure should be effective “before the summer”, indicates the ANSM in a press release.
Thanks to this decision, doctors will therefore be able to prescribe Avastin to patients suffering from the pathology, even though the drug does not have a Marketing Authorization (marketing authorization) for this application. Ultimately, it could well replace the other drug used for the treatment of AMD, Lucentis. To understand the scope of such an announcement, it is necessary to return to the sprawling history of these two drugs, and to the somewhat dubious arrangements of the laboratories that market them.
Avastin, 30 times cheaper and as effective as Lucentis
Lucentis is the first social security expenditure item: 428 million euros per year (up 40% in two years), for 300,000 people affected. For a long time, this very effective drug, manufactured by the Swiss laboratory Novartis, was the only one authorized in the treatment of AMD. Hence its high price: 800 euros per injection, to be renewed at least three times. A chasm for hospitals, which have for several years found an alternative.
Indeed, there is a much less expensive molecule: Avastin, from the Roche laboratory, also Swiss. Originally, it is an anticancer drug, but many studies have shown equal effectiveness in the treatment of AMD. It costs 30 euros per injection – almost 30 times less than Lucentis! A boon for Health Insurance, which, in 2013, suggested to the Roche laboratory to request an extension of MA for the treatment of AMD. But, surprise: Roche refused. An investigation by the Italian authorities has shown why.
A secret agreement between laboratories
Novartis and Roche are indeed guilty of “criminal association, corruption, swindle, damage to the State, trading”. The two laboratories have made a secret agreement to prevent the use of Avastin in the treatment of AMD. Roche has even gone so far as to ask the European Medicines Agency to modify the Avastin leaflet to add side effects in the case of out-of-frame use, thus denigrating its own medicine for non-cancer treatment!
It turns out that the two laboratories have direct capital links. Novartis owns 33% of Roche’s capital. In addition, Roche receives royalties from the sale of Lucentis by Novartis. The laboratory therefore has no interest in promoting its Avastin. The two laboratories were fined 1.2 billion euros by the Italian courts, a country where Avastin is widely prescribed in the context of AMD.
The state gets involved …
To force the hand of the Roche laboratory, the French government passed an amendment last summer to authorize the prescription of Avastin in the treatment of AMD. The savings for Social Security should amount to 200 million euros per year.
But this legal circumvention is not without its problems. In a liberal economy, a State can hardly force a laboratory to put a molecule on the market… at the risk of being pinned down by Brussels! Moreover, still in 2014, the Council of State canceled a decree drafted by the government to authorize Avastin for the treatment of AMD, recalling that imposing a drug for economic reasons is not authorized in Europe.
… the ANSM has the last word
In October, it was therefore the French drug agency that got involved. “The ANSM asked the laboratory concerned to provide it with all the scientific data relating to the use of this product, in particular in terms of safety, efficacy and ongoing research, in order to assess the use of this product in the context of a possible RTU (temporary recommendation for use), ”said a press release from the agency.
After examining the elements, the ANSM therefore gave the green light. “The various trials and meta-analyzes comparing Avastin and Lucentis (…) have shown the efficacy of Avastin in the treatment of neovascular AMD and non-inferiority compared to Lucentis in terms of functional efficacy”. Hard blow for Roche and Novartis; glory day for Social Security and patients with AMD. The misfortune of some makes the happiness of others …
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