Win for the NHS

Not quite as simple as that.

Avastin (bevacizumab) is licensed for oncology indications as per its EMA license. Therefore anything outside of that license is regarded as unlicensed which means it has been tested through clinical trials in that indication. That isnt to say it is not safe as this has been proven through the phase II and III trials for it to get its license in the first. it just hasnt been studied "officially" for treating wAMD. There is anecdotal evidence of it being of benefit in wAMD as it is from the same class of drugs as Lucentis (ranibizumab) and Eylea (alfibercept) so the mechanism of action will be similar and they would expect similar efficacy. The only difference in this is that Roche who manufacture Avastin have not applied to have this indication licensed. Add into that the fact Lucentis and Eylea are still within their protected patent and you can see why the drug companies want to protect the patent for their brands. They are allowed a 15 year patent from the year of approval by EMA and this allows them to generate the profit to pay for the R&D in bringing the drug to market. This cost can run into £/$billions so there has to be some incentive for drug companies to develop drugs.

They were obviously unhappy that Avastin was being used for an unlicensed indication hence the court case. They will have argued the point of patent protection and also potential harm to patients as to make Avastin available for patients some aseptic manipulation is required. Aseptic manipulation is common place and shouldnt really raise too many concerns but it will have been a point they used. They quote rightly will argue there is patent issues by using and unlicensed drug when a licensed alternative is available.

Its not capitalism but enshrined in law regarding patents and this decision is a little suprising so expect to see an appeal of they have been given that option.

There is likely to be no change of position from the current situation unless this has ran its course, which no doubt they will try and do.

One of the medications I have taken for my Episodic Cluster Headache condition (suicide headaches) was unlicensed for that condition - verapamil. It is licensed as a medication to reduce high blood pressure in doses of 100mg-360mg per day but wasn't licensed at the time for ECH (don't know if it has been licensed properly yet). I had to self-ramp-up the dosages until it was effective for me and it only became effective at reducing the pain levels of my attacks sufficiently when I went over 1000mg per day.

At the time it was the only known preventive medication for ECH (and I think it's still thought to be the most effective) so I don't think they will have had this same problem about other manufacturers getting arsey about it being used. Just guessing there, like.

I did have to sign a disclaimer though, with it not yet being licensed for my condition. I had to have an ECG before they would give it to me too.

The other medication I use is sumatriptan subcutaneous injections as an abortive, but you can only inject yourself 3 times per day, whereas at the peak of my cycle I have days where I have 5 or 6 attacks. That one really fucks you up if you take more than the recommended dose, hence why I needed to get the unlicensed verapamil as a preventive.
 
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Not quite as simple as that.

Avastin (bevacizumab) is licensed for oncology indications as per its EMA license. Therefore anything outside of that license is regarded as unlicensed which means it has been tested through clinical trials in that indication. That isnt to say it is not safe as this has been proven through the phase II and III trials for it to get its license in the first. it just hasnt been studied "officially" for treating wAMD. There is anecdotal evidence of it being of benefit in wAMD as it is from the same class of drugs as Lucentis (ranibizumab) and Eylea (alfibercept) so the mechanism of action will be similar and they would expect similar efficacy. The only difference in this is that Roche who manufacture Avastin have not applied to have this indication licensed. Add into that the fact Lucentis and Eylea are still within their protected patent and you can see why the drug companies want to protect the patent for their brands. They are allowed a 15 year patent from the year of approval by EMA and this allows them to generate the profit to pay for the R&D in bringing the drug to market. This cost can run into £/$billions so there has to be some incentive for drug companies to develop drugs.

They were obviously unhappy that Avastin was being used for an unlicensed indication hence the court case. They will have argued the point of patent protection and also potential harm to patients as to make Avastin available for patients some aseptic manipulation is required. Aseptic manipulation is common place and shouldnt really raise too many concerns but it will have been a point they used. They quote rightly will argue there is patent issues by using and unlicensed drug when a licensed alternative is available.

Its not capitalism but enshrined in law regarding patents and this decision is a little suprising so expect to see an appeal of they have been given that option.

There is likely to be no change of position from the current situation unless this has ran its course, which no doubt they will try and do.
Their patents having been infringed in any way.
 
Good explanation mate but at the same time why are the nhs not allowed to use whatever drugs they see fit.
Because you should (in 99%) of the cases use licensed drugs which have been assessed as safe and efficacious

Their patents having been infringed in any way.
No that's right. It's patent protection by encouraging prescribing of drugs licensed for that indication.

It's good that it has been deemed a clinical decision and not a commercial one. That's if they don't fanny on with appeals dragging the whole thing out
 
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