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Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
UK chooses to use off-label drug indication to cut healthcare costs. Will others follow suit?
The prices of pharmaceuticals are coming under increasing scrutiny in today's age of cost constraints. Drug development is expensive, but governments and healthcare payers are not always willing to pay the price that pharmaceutical companies are asking.
In the UK, the National Health System (NHS) has taken the controversial step of cutting the cost of treating wet age-related macular degeneration (AMD) by prescribing a cheaper drug over a more expensive one. The controversial element? The cheaper drug isn't licensed for wet AMD.
The approved treatment for AMD is Lucentis (Ranibzumab), which is marketed by Genentech (now owned by Roche) in the US and by Novartis elsewhere. The drug costs around $1190, but has been approved by the UK's cost–effectiveness evaluation agency, NICE.
But according to the NHS, Roche's Avastin (bevacizumab) is just as effective and costs significantly less—around $80. The UK's National Institute for Health Research Health Technology Assessment has even funded a study examining the two drugs. The results, released last month, show that both treatments are equally effective in wet AMD. In addition, it was found that using Avastin in place of Lucentis could save the NHS around $135.9 million annually. A similar study has also been conducted in the US, with both drugs being shown as effective (1).
Novartis has hit back, claiming that the results highlight "serious safety concerns" and a "significantly higher risk of serious systemic adverse events" with Avastin versus Lucentis.
But the US study added, "Although Avastin had a higher rate of serious adverse events, they were distributed across many different conditions, most of which were not associated with Avastin... The number of deaths, heart attacks, and strokes were low and similar for both drugs during the study."
Novartis feels so strongly about the situation that it is taking the case to court by seeking a judicial review of the decision to enable patients to choose between Lucentis and Avastin in the UK. The Association of the British Pharmaceutical Industry is reportedly backing Novartis after speaking out at the association's recent annual conference in London. The backing is based on the fact that NICE has approved the use of Lucentis so it should be made available, as well as the fact that Avastin is unlicensed for treating wet AMD.
Another option is for Roche to seek a license for the use of Avastin in wet-AMD, according to NICE. Roche has said that it is not interested in pursuing this. There's a good reason for this too. Both Lucentis and Avastin were both developed by Genentech, which Roche acquired in 2009. The drugs are similar in that they both act against Vascular Endothelial Growth Factor, but were developed with different specifications. From a cost point of view, why would any pharmaceutical company want to license Avastin for wet AMD when more money can be made from Lucentis? A lot of work also went into developing Lucentis specifically for eye conditions. Pharmaceutical companies are businesses after all and profits have to be considered.
Doctors in Europe and the US have been using Avastin off label for years for wet AMD. It will be interesting to see whether anything changes as the situation with the NHS and Novartis unfolds and as comparative effectiveness studies become the norm.
Stephanie Sutton is community manager for Pharmaceutical Technology.
Read Stephanie's blogs at blog.PharmTech.com.
1. NIH News, "Avastin and Lucentis are Equivalent in Treating Age-Related Macular Degeneration," www.nih.gov, accessed May 17, 2012.