Avastin and Lucentis: what a glorious tale!

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.\”

6 thoughts on “Avastin and Lucentis: what a glorious tale!”

  1. “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.””

    If by ‘the media’ you mean the usual suspects like the ‘Guardian’ and ‘Indy’, then yes…

  2. Going back to my initial ignorant reaction (which you were expecting…)
    A clinical trial answers two questions:
    Does is do any good for the condition?
    Does it do very little harm? (Side effects.)
    If we confined clinical trials to just question 2 then we’d have any drug for anything, an universal panacea ever one, and a sovereign remedy for hypochondria.
    Going forward, £800M does seem an awful lot and I wonder if the insurance industry could help out and make a buck.
    Doctors who wished to prescribe the cheap drug could get malpractice insurance, or patients who wanted it could insure themselves and give doctors a waiver declaring their informed consent.

    Which reminds me. Must go to the pharmacy to renew my baldness prescription. Can’t say it works, but the wife is happy.

  3. I had an Avastin injection in my eye to retard diabetes-related proliferative retinopathy. The drug licensing regime is much more liberal here in Costa Rica, which obviously in my case is a good thing. Only cost $400, too, and believe it or not, having a hypodermic needle stuck in your eyeball doesn’t hurt a bit.

  4. My father had a shot of Avastin injected in his right eye. Got the feared Endoftalmitis and ended up losing his right eye due to it. Going through a legal battle now. Any ideas?

  5. Spending the money to get a drug called AVASTON approved for use in wet macular degeneration that costs £25 a dose, is perhaps less attractive than spending the money to obtain approval for an identical supposedly ‘new’ drug called LUCENTIS approved, that the same drug company produces for £2000 a dose? (Lucentis is molecularly smaller but there is no difference in the results).

    At Kings College Hospital Eye Department they have been told to cut costs by 20% and the nurses jobs will be culled.

    Millions have been spent from the National Health Budget on this ‘look-a-like’ drug. A test case should be made (as happens in the States) and the drug company should be fined, and the money returned to the health service budget.

    Has it happened with other drugs?

    How big a criminal fraud is this?

    Who was responsible for approving LUCENTIS? Did any eye specialists working in the National Health receive financial inducement to back it?

    Currently they are seeking approval to use LUCENTIS for treating Diabetic related back of the eye bleeding problems. That will cost the Health Service £2000 a dose, insteat of £25 a dose unless AVASTIN is approved. Some eye specialists are concerned LUCENTIS (or AVASTIN for that matter) may cause strokes or heart attacks in young Type 1 diabetics but the drug companies will make a fortune if it is approved for use on Diabetics, so I wonder if there will be inducements to quiet those concerns?

  6. What a biased article! It fails to mention that, when Novartis realized Avastin worked in the treatment of an eye condition, they altered it oh so slightly, patented the new adaptation and then tried to force the NHS to use the new (but virtually the same) drug at 10x the cost.

    They never bothered to get Avastin approved because they wouldn’t be able to change the price of the drug upwards (this is regulated). So, they created a new drug (that was actually the same… the differences are very, very small) in order to go on and rip off the NHS under the guise of safety. Mugs like the author of this article clearly fell for it. This is the most blatant example of profiteering I’ve ever seen in my life.

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