Where I live doctors are only allowed to give prescriptions for the generic chemical compound and are forbidden to give prescriptions for specific brands. They may suggest the use of a particular brand if they know of a benefit over others but the one who decides is the patient.
Of course this is not very useful when the drug is patented or if there is only one laboratory producing it, but none the less it seems like a sane default. And this is in a private healthcare system, it is surprising that the NHS doesn't have a rule like this when is their taxpayer's money being used.
this is a more complicated situation. First, for biologics, there are rarely equivalent generics (context: https://www.jhsph.edu/news/news-releases/2016/generic-biolog...). Second, this is a case where Genentech (the maker of Avastin and Lucentis) is basically trying to prevent people from prescribing a cheaper drug that can be substituted. Genentech's made the argument that Lucentis is specifically designed for this use, while Avastin has issues (safety and efficacy). Doctors have some latitude to prescribe off-label drugs where there is an indication it's safe and effective. In this case, doctors are basically subdividing avastin packets (which has a risk).
The cheaper alternative that the NHS wants to offer is not actually the same as the more expensive drug that's licensed to treat wet age-related macular degeneration. It's related and there's every reason to believe it's as safe and effective as the licensed drug, but it's still not the same stuff.
The cheaper one is 3.5% and 5% the price of the other two and is recommended by WHO and used widely around the world, including the US. As always the decision as to what will be appropriate will lie with the doctor but at least they have the option now.
I expect that the price of the other two will mysteriously drop quite dramatically now ...
I don't understand their arguments. Do they have proof that their licensed drugs are safer and/or more effective than the replacement?
The article says "In January, the National Institute for Health and Care Excellence (NICE) concluded that Avastin was as safe and effective as the two licensed drugs, Lucentis and Eylea."
No. The issue is different. You see, the government demands drugs are proven to be safe before use, and safe for specific purposes, specific treatments.
Now I say "demands" because the government does zero research on the subject, zero testing. Rather, the government demands that the pharmaceutical companies do this, at great expense, by third parties, extensively regulated, involving at least hundreds of UK patients, ... a total maze (that somehow seems to provide excellent, HIGHLY paid jobs for ex-government regulatory doctors in these pharmaceutical companies). Also, this has to be done on a per-country basis.
Now there was an issue. These companies had done that for one drug for this specific treatment, this was the more expensive drug. They hadn't done it for the "cheaper" alternative they used elsewhere in the world for that treatment, but that drug was being used for another treatment. Note: this makes it highly illegal for these companies to suggest using that drug.
(so the accusation made that these companies were preventing the use of the cheaper drug is ... evil. I don't know another word for it. They refused to allow prescription of that drug for the eye problem because the government forces them to refuse that. And now the government also decided it's illegal as well. Great. If we're unlucky they'll just withdraw the drug altogether. Then eye and cancer patients are fucked, but hey, the government won't have to pay. Hurray !)
Also cheaper is between quotes because it's only cheaper because they never went through the governments' expensive approval process, which would have added to the cost and therefore changed the picture. Furthermore it would have factored in the pricing decisions made by the companies.
So now we have established that the government gets to completely disregard it's own safety rules to save a buck (no worries "it's safe" because it's proven to be safe elsewhere with a differently manufactured pill with the same active substance ... except ... no it isn't, or at least, you can't be sure). And if, for some reason, there is a difference between the drug when using it for cancer and using it for eye treatment ... who will pay for the damage caused to patients ? Because does this now also mean the government assumes responsibility for this drug (which they did in the past (not for this drug), then when it cost them money ...).
The issue with drugs "having issues" is that generally patients die or develop a very serious health issue when drugs have unanticipated side effects. This whole safety regulation is setup to avoid that and to make sure pharmaceutical companies never take too much risk, and can be forced to carry the cost of fucking up.
I would argue that even if this turns out to be safe, sooner or later letting the government just bypass drug safety rules will cause very severe issues (or should I say, will cause very severe issues again), and then these people are going to find out that not only does the government not take care of them ... well ... read the above link and then read the next paragraph:
> In October 1979, three judges at Birmingham Magistrates' Court dismissed the prosecution's evidence that the University of Birmingham had contravened the Health and Safety at Work Act.
(Just so we're clear, at this point it was clear that the government had not only failed to provide adequate isolation to a lethal disease, but gotten a report that it had failed to do so BEFORE any actual harm, THEN the government lab accidentally infected someone working above the laboratory, imprisoned her and most of her family and colleagues immediately (with zero compensation), ... and then decided the government had zero culpability in all this. Why ? Because it was impossible that this woman was infected with a lethal disease that didn't exist anywhere in the country except in that lab, but she had not gotten it from that lab, so ... no compensation ... yes, really. To add extreme insult to very severe injury and death, the queen granted honors to the witness that exonerated the government later that year ...
So to say that I don't think the UK government should be trusted to make medical decisions like this is a vast understatement. We are all going to die)
Where I live doctors are only allowed to give prescriptions for the generic chemical compound and are forbidden to give prescriptions for specific brands. They may suggest the use of a particular brand if they know of a benefit over others but the one who decides is the patient. Of course this is not very useful when the drug is patented or if there is only one laboratory producing it, but none the less it seems like a sane default. And this is in a private healthcare system, it is surprising that the NHS doesn't have a rule like this when is their taxpayer's money being used.
this is a more complicated situation. First, for biologics, there are rarely equivalent generics (context: https://www.jhsph.edu/news/news-releases/2016/generic-biolog...). Second, this is a case where Genentech (the maker of Avastin and Lucentis) is basically trying to prevent people from prescribing a cheaper drug that can be substituted. Genentech's made the argument that Lucentis is specifically designed for this use, while Avastin has issues (safety and efficacy). Doctors have some latitude to prescribe off-label drugs where there is an indication it's safe and effective. In this case, doctors are basically subdividing avastin packets (which has a risk).
More reading: https://www.nih.gov/news-events/news-releases/avastin-lucent...
https://www.bmj.com/bmj/section-pdf/187523?path=/bmj/344/785...
The cheaper alternative that the NHS wants to offer is not actually the same as the more expensive drug that's licensed to treat wet age-related macular degeneration. It's related and there's every reason to believe it's as safe and effective as the licensed drug, but it's still not the same stuff.
The cheaper one is 3.5% and 5% the price of the other two and is recommended by WHO and used widely around the world, including the US. As always the decision as to what will be appropriate will lie with the doctor but at least they have the option now.
I expect that the price of the other two will mysteriously drop quite dramatically now ...
Yes but there's 2 issues:
1) not in the same concentration/dose (patient will need to change the dose by breaking pills)
2) not according to the UK government (which has never approved the cheaper drug)
So now the big question is, suppose this goes very wrong for a patient, who is responsible ? The doctor ? The patient ? The government ?
>1) not in the same concentration/dose (patient will need to change the dose by breaking pills)
Specifically I don't think they are using pills (untouched or broken) to make intraocular injections.
I don't understand their arguments. Do they have proof that their licensed drugs are safer and/or more effective than the replacement?
The article says "In January, the National Institute for Health and Care Excellence (NICE) concluded that Avastin was as safe and effective as the two licensed drugs, Lucentis and Eylea."
If they have no proof, they should stfu.
No. The issue is different. You see, the government demands drugs are proven to be safe before use, and safe for specific purposes, specific treatments.
Now I say "demands" because the government does zero research on the subject, zero testing. Rather, the government demands that the pharmaceutical companies do this, at great expense, by third parties, extensively regulated, involving at least hundreds of UK patients, ... a total maze (that somehow seems to provide excellent, HIGHLY paid jobs for ex-government regulatory doctors in these pharmaceutical companies). Also, this has to be done on a per-country basis.
Now there was an issue. These companies had done that for one drug for this specific treatment, this was the more expensive drug. They hadn't done it for the "cheaper" alternative they used elsewhere in the world for that treatment, but that drug was being used for another treatment. Note: this makes it highly illegal for these companies to suggest using that drug.
(so the accusation made that these companies were preventing the use of the cheaper drug is ... evil. I don't know another word for it. They refused to allow prescription of that drug for the eye problem because the government forces them to refuse that. And now the government also decided it's illegal as well. Great. If we're unlucky they'll just withdraw the drug altogether. Then eye and cancer patients are fucked, but hey, the government won't have to pay. Hurray !)
Also cheaper is between quotes because it's only cheaper because they never went through the governments' expensive approval process, which would have added to the cost and therefore changed the picture. Furthermore it would have factored in the pricing decisions made by the companies.
So now we have established that the government gets to completely disregard it's own safety rules to save a buck (no worries "it's safe" because it's proven to be safe elsewhere with a differently manufactured pill with the same active substance ... except ... no it isn't, or at least, you can't be sure). And if, for some reason, there is a difference between the drug when using it for cancer and using it for eye treatment ... who will pay for the damage caused to patients ? Because does this now also mean the government assumes responsibility for this drug (which they did in the past (not for this drug), then when it cost them money ...).
The issue with drugs "having issues" is that generally patients die or develop a very serious health issue when drugs have unanticipated side effects. This whole safety regulation is setup to avoid that and to make sure pharmaceutical companies never take too much risk, and can be forced to carry the cost of fucking up.
Note: this is an example of the UK government "taking responsibility" for it's own medical fuckups: https://www.bbc.com/news/uk-england-birmingham-45101091
I would argue that even if this turns out to be safe, sooner or later letting the government just bypass drug safety rules will cause very severe issues (or should I say, will cause very severe issues again), and then these people are going to find out that not only does the government not take care of them ... well ... read the above link and then read the next paragraph:
> In October 1979, three judges at Birmingham Magistrates' Court dismissed the prosecution's evidence that the University of Birmingham had contravened the Health and Safety at Work Act.
(Just so we're clear, at this point it was clear that the government had not only failed to provide adequate isolation to a lethal disease, but gotten a report that it had failed to do so BEFORE any actual harm, THEN the government lab accidentally infected someone working above the laboratory, imprisoned her and most of her family and colleagues immediately (with zero compensation), ... and then decided the government had zero culpability in all this. Why ? Because it was impossible that this woman was infected with a lethal disease that didn't exist anywhere in the country except in that lab, but she had not gotten it from that lab, so ... no compensation ... yes, really. To add extreme insult to very severe injury and death, the queen granted honors to the witness that exonerated the government later that year ...
So to say that I don't think the UK government should be trusted to make medical decisions like this is a vast understatement. We are all going to die)
Suddenly drug companies don't want off-label use when it doesn't suit them...
This debate has happened in the US for many years. Here is a wsj article from 2011 https://www.wsj.com/articles/SB10001424052748704463804576291...