This is really rather funny, at least for those who have my own rather lugubrious sense of humour about matters economic.
So there\’s two drugs, Avastin and Lucentis. They\’re really rather similar: almost exactly the same you might say.
However, Avastin is the one licensed for use on bowel cancer and Lucentis the one licenced for use on blindness (wet eye advanced macular degeneration, AMD).
Doctors have noted that you can in fact use the Avastin to treat wet eye AMD. And that doing so is about one tenth of the cost of using Lucentis.
However, the drug company that makes both refuses to take part in the clinical trials (either Phase III or Phase IV) to prove that Avastin works just as well as Lucentis.
Now, at this point, opinions can differ. On the one side we\’ll have the pretty usual screams of bloodthirsty profiteers trying to make a fortune out of those going blind, the rapine of the NHS drugs budget and so on.
On the other might be those who stop and think for a moment.
For you are allowed to use drugs \”off licence\”. If you note that sticking a bowel cancer drug into eyeballs stops people going blind then as far as the licence for the drug is concerned, go right ahead. But, and here\’s the point, no Phase III or Phase IV trials will have been done on how well this works and what the long term effects on lots of people are.
And this is the very expensive part of drug testing. This costs the lion\’s share of the $800 million it takes to get a drug approved and to market.
But here we\’re in a very interesting situation: for the drug manufacturers have actually gone and spent this $800 million (or the lion\’s share of it) in doing Phase III and IV trials on Lucentis. They must have done for they now have formal approval for using it to treat wet eye AMD.
So the current situation is that NICE is asking them to take part in Avastin trials for wet eye AMD: when they\’ve already done that, spending all that money to get Lucentis approved.
Note that this is nothing at all to do with drugs coming from universities, from various forms of the public sector. This is all about the regulatory costs, costs imposed by government, on bringing a drug to market for an approved use.
So, what they\’re really being asked to do is to help NICE make that $800 million (or lion\’s share of it) an entire waste of money because NICE now wants Avastin approved for eye care, despite the fact they\’ve already done this by getting Lucentis approved.
This might be best described as NICE both wanting their cake and eating it. If NICE actually wanted Avastin to be so used they could have turned around years ago and said so, before all that cash was used to get Lucentis approved.
And the real bottom line is that this is all an artefact of how the drugs licencing regime works. And yes, this does mean the blame is on the regulatory regime. Currently one must show that a new drug is both safe (to a certain level of safety: no one worries about heart attacks in 30 years if it cures terminal cancer today) and effective in order to get a licence.
And effectiveness of course depends upon which disease or problem the drug is being aimed at. If we changed the system to showing only safety then we wouldn\’t have this problem at all. Avastin could be used on eyeballs and the drug company would never have spent the money on trying to get Lucentis approved for eyeballs.
But I\’ll bet you that the way this plays out in the media is the \”usual screams of bloodthirsty profiteers trying to make a fortune out of those going blind, the rapine of the NHS drugs budget and so on.\”