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Why is the Lucentis-Avastin case back in the spotlight?

07 July 2014 Federica Benassi

Is Avastin as safe and effective as Lucentis in an ophthalmology setting? In recent years, many countries have evaluated potential risks posed by off-label use of the cheaper Avastin (bevacizumab) - manufactured by Roche's US subsidiary Genentech and marketed by Novartis outside US - compared to the more expensive Genentech's drug Lucentis (ranibizumab injection) and approved in a number of countries for the treatment of neovascular (wet) age-related macular degeneration (wet-AMD). Lucentis is an anti-vascular endothelial growth factor (anti-VEGF) agent that has brought important improvements in the treatment of wet-ADM, one of the most prevalent causes of blindness among older people. Avastin is also a VEGF inhibitor, but it is licensed for use in inhibiting the growth of blood vessels supporting tumours, with an application across a variety of cancers. The sales generated demonstrate that Lucentis has significantly penetrated the market and has quickly become a blockbuster medicine in the ophthalmology market. However, given the potential for savings, a number of payers worldwide have questioned whether Avastin could not be used instead of Lucentis in the wet-AMD setting.

Italy's Minister of Health seeks compensation from Roche and Novartis However, increasing market shares gained by Lucentis' competitor Eylea, produced by Regeneron in partnership with Bayer, as well as controversies linked to the Avastin-Lucentis case poses risks to overshadow the success of Lucentis. In particular, debate over authorisation for off-label use of Avastin rekindled following to the decision announced by the Italian Minister of Health in May to claim a EUR-1.2 billion (USD1.6-billion) damage compensation from Swiss companies Novartis and Roche. The decision taken by the Minister to file for damages compensation is based on a ruling of the Italian antitrust authority (AGCM) that imposed in March a EUR92-million (USD126.11-million) fine on Roche and Novartis for having allegedly agreed unlawfully to hinder the spread of the use of a cheaper drug in wet-AMD patients, Avastin, in favour of a more expensive product, Lucentis, artificially differentiating the two products. In Italy, Avastin manufacturer price is approximately EUR15 for one dose required for wet-AMD patients whereas Lucentis costs EUR814, according to pricing information from the IHS PharmOnline International database. The AGCM argument is that companies' collusion would be related to a commercialisation agreement signed by Novartis and Genentech which provides the former with rights to commercialise Lucentis outside the United States. In return, Roche obtains through its subsidiary Genentech significant sales royalties from Novartis. Therefore, according to AGCM sentence the licensing agreement would make it profitable for both companies to favour sales of Lucentis over Avastin.

France and EC are keeping an eye on the case Furthermore, the Avastin-Lucentis case is not plaguing the two Swiss pharmaceutical colossuses exclusively in Italy. In fact, the French competition authority and the European Commission are also looking at the case to clarify whether Roche and Novartis breached antitrust regulations. In particular, back in April 2014, the French competition authority conducted a raid in the offices of the two companies in France in relation to an investigation on Roche and Novartis related to use of Avastin for wet-AMD. Furthermore, the European Commissioner for Competition, Joaquín Almunia, recently revealed in early May that the EU antitrust authority is in the process of gathering information concerning alleged collusion between Roche and Novartis, although no formal investigation has been launched so far.

Roche contends that the safety profile of Avastin is not solid to sought marketing approval as eye treatment. Therefore, to go back to the initial question, does Avastin ensure the same efficacy and safety profile as Lucentis? Healthcare systems have been interested in shedding light on the issue, as allowing use of Avastin as off-label drug would allow them to achieve significant savings. The United States and United Kingdom, for instance, have conducted publicly-funded head-to-head studies, the CATT and IVAN trials, comparing Lucentis and Avastin in terms of efficacy, tolerability and safety. Results of the studies have shown that the medicines are equally effective in the treatment of AMD. Furthermore, in terms of their safety profile, although the two drugs have reported differences in the occurrence of adverse events, both drugs are considered safe.

Off-label use authorisations may increase Due to the characteristic of the Italian judicial system, it may to take long time before a judge pronounces a sentence on the request for damages filed by the Italian Minister of Health. However, the controversy in Italy and France over the Lucentis and Avastin case may arise in other countries as a snowball effect, with potential negative reputation impact and financial impacts for the Swiss manufacturers. Furthermore, similarly to the United States, Canada, Australia and United Kingdom, other countries may decide to allow off-label use of Avastin. In Italy, for instance, the Scientific and Technical Committee (CTS) of the Italian Medicines Agency (AIFA) has recently recommended approval for reimbursement for Avastin for off-label use in wet-AMD patients. The recommendation follows the request put forward by the Veneto and Emilia-Romagna regions following a new law passed in May to facilitate off-label use of medicines when the manufacturer does not apply for extension of marketing authorisation. Italy, for instance, has recently passed a law to facilitate off-label use of medicines when the manufacturer does apply for extension of marketing authorisation. The peer-reviewed journal Health Affairs published in June a study which estimates that treating wet-AMD or diabetic macular oedema (DME) with Avastin may allow savings of USD18 million for Medicare part B and USD5million for patients over the next ten years (source: Health Affairs, 2014). With similar perspectives in terms of resource savings, other healthcare systems may be tempted to consider allowing Avastin use in the ophthalmology setting.

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