Germany says Otezla gives no benefit to psoriasis patients

[Fred]

This isn't good news for new psoriasis treatment Otezla (apremilast), The German Institute for Quality and Efficiency in Health Care (IQWiG) has said after checking two dossier evaluations that there is no relevant data to say Otezla gives any benefit to psoriasis and psoriatic patients.

I have had to Google translate this so I'm not sure if the wording or spelling is correct, I will show both versions and if anyone can translate better please let me know. But you will get the gist of what has been said.

Quote:

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Google Translation:

Apremilast (trade name: Otezla) is since January 2015 available adults who either participated in a moderate to severe plaque suffering -Psoriasis or active psoriatic arthritis and where certain preliminary activities not sufficiently effective or are not suitable. The Institute for Quality and Efficiency in Health Care (IQWiG) has checked in two dossier evaluations, whether this drug compared to the respective appropriate comparator therapies provides an additional benefit. Such added value is, however, none of the dossiers derivable because they do not contain relevant information.

Producers themselves claimed no added value
The manufacturer must present for any of the two indications prior studies in which Apremilast has been tested against the respective appropriate comparator therapy. He only describes data from placebo-controlled trials, but uses these non for indirect comparisons.

Also, a systematic search for studies with the appropriate comparator therapy is missing that would be possibly suitable for an indirect comparison with apremilast. Therefore, it remains unclear whether an indirect comparison would have been possible and if Apremilast in this comparison an additional benefit or lesser benefit would have shown as the preparations already available. Consequently, claims the manufacturer itself for any of the two indications of additional benefit for the new active substance.

G-BA decides on the extent of the value added
This dossier evaluation is part of the early benefit assessment pursuant Pharmaceutical Market Restructuring Act (AMNOG), which is responsible for the G-BA. After publication of the dossier evaluation of the G-BA performs a commenting procedure and shall take a final decision on the extent of added benefit.

An overview of the results of the benefit assessment IQWiG following summary. In addition to the published by IQWiG website find generally understandable information.

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Original German statement:

Apremilast (Handelsname: Otezla) steht seit Januar 2015 Erwachsenen zur Verfügung, die entweder an einer mittelschweren bis schweren Plaque-Psoriasis oder an einer aktiven Psoriasis-Arthritis erkrankt sind und bei denen bestimmte Vorbehandlungen nicht ausreichend wirken oder nicht geeignet sind. Das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) hat in zwei Dossierbewertungen überprüft, ob dieser Wirkstoff gegenüber den jeweiligen zweckmäßigen Vergleichstherapien einen Zusatznutzen bietet. Ein solcher Zusatznutzen ist jedoch aus keinem der Dossiers ableitbar, da sie keine relevanten Daten enthalten.

Hersteller selbst beansprucht keinen Zusatznutzen
Der Hersteller legt für keine der beiden Indikationen Studien vor, in denen Apremilast gegen die jeweilige zweckmäßige Vergleichstherapie getestet wurde. Er beschreibt lediglich Daten aus placebokontrollierten Studien, nutzt diese aber nicht für indirekte Vergleiche.

Auch eine systematische Recherche nach Studien mit der zweckmäßigen Vergleichstherapie fehlt, die sich gegebenenfalls für einen indirekten Vergleich mit Apremilast eignen würden. Deshalb bleibt offen, ob ein indirekter Vergleich möglich gewesen wäre und ob Apremilast in diesem Vergleich einen Zusatznutzen oder einen geringeren Nutzen als die bereits verfügbaren Präparate gezeigt hätte. Konsequenterweise beansprucht der Hersteller selbst für keine der beiden Indikationen einen Zusatznutzen für den neuen Wirkstoff.
G-BA beschließt über Ausmaß des Zusatznutzens

Diese Dossierbewertung ist Teil der frühen Nutzenbewertung gemäß Arzneimittelmarktneuordnungsgesetz (AMNOG), die der G-BA verantwortet. Nach Publikation der Dossierbewertung führt der G-BA ein Stellungnahmeverfahren durch und fasst einen abschließenden Beschluss über das Ausmaß des Zusatznutzens.

Einen Überblick über die Ergebnisse der Nutzenbewertung des IQWiG gibt folgende Kurzfassung. Auf der vom IQWiG herausgegebenen Website finden Sie zudem allgemein verständliche Informationen.

Source: iqwig.de/

[jiml]

Ooh I'll have a look at the translation later, but it's not looking good for otezla in Germany
And yet there have been successes

[Fred]

Ooh I'll have a look at the translation later, but it's not looking good for otezla in Germany
And yet there have been successes

I didn't know you knew German Jim.

The way I have read it is that the successes you mention are not facts according to what the Germans want, they say "the dossier evaluations don't contain relevant information", and I think it's saying the mentions of the the success story's are based on placebo trails and not on actual comparisons against another treatment.

By what I have read elsewhere it looks like Germany may not prescribe it.

[jiml]

Ooh I'll have a look at the translation later, but it's not looking good for otezla in Germany
And yet there have been successes

I didn't know you knew German Jim.

The way I have read it is that the successes you mention are not facts according to what the Germans want, they say "the dossier evaluations don't contain relevant information", and I think it's saying the mentions of the the success story's are based on placebo trails and not on actual comparisons against another treatment.

By what I have read elsewhere it looks like Germany may not prescribe it.

Yes I understand that it has only been trailed against Placebo, so the Germans wont accept that although there is evidence in the trials of a better outcome on the drug than the placebo.
Are Celgene planning any trials against bio drugs like stelara or in your opinion are they fearful they may not come out on top ( do you think they may have already done trials and as the results were not as good as they hoped for have not published them ?)

[Fred]

Yes I understand that it has only been trailed against Placebo, so the Germans wont accept that although there is evidence in the trials of a better outcome on the drug than the placebo.
Are Celgene planning any trials against bio drugs like stelara or in your opinion are they fearful they may not come out on top ( do you think they may have already done trials and as the results were not as good as they hoped for have not published them ?)

The French are much the same, I suppose they are right really. If it's no better than other treatments then why use it?

I don't know Jim, you never know with these big pharma's. My personal opinion is I don't think it will be around long, I'm only saying this as we don't (as far as a I know) have any members using it so as patients we have little to go on. But for me there is nothing better than getting it from the horses mouth so to speak, if everyone on Psoriasis Club said a particular drug was no good I would probably believe them over the pharma results.

Usually in these cases they either come up with what is asked, or they just stop offering it to that country. I doubt it will do them much harm loosing one country, but if others followed it could spell the end.

But by Germany saying this, it does make you think are we getting fed misleading information. We have lot's of successful reports posted on here in news from celgene, but we've yet to see anything else from people actually using it, or a study putting up against a competitor.

I don't know Jim, I could be reading it wrong but it doesn't look good by the way I have understood it. Having said that if nothing else was available to me I would give it a try if offered, as it has gone through rigorous testing to get this far so why not give it a go.  

 

[mataribot]

Otezla has shown to be effective for Plaque Psoriasis, but does do much of anything for arthritis. It took three phase III trials in USA to get approved in the USA. Just a waste of time, to be honest.

[D Foster]

Looked on the USA P site and it does not seem to get a very good response from users at all ,very mixed comments and results especially when you compare with ones like Stelara ,lots of side effects plus most who are on it seem to be taking other drugs as well.

[Quest4Cure]

Looked on the USA P site and it does not seem to get a very good response from users at all ,very mixed comments and results especially when you compare with ones like Stelara ,lots of side effects plus most who are on it seem to be taking other drugs as well.

Lets not even go into the many times they were sued in the state of NY for false misrepresentation of their many products and payoffs......

[D Foster]

Looked on the USA P site and it does not seem to get a very good response from users at all ,very mixed comments and results especially when you compare with ones like Stelara ,lots of side effects plus most who are on it seem to be taking other drugs as well.

Lets not even go into the many times they were sued in the state of NY for false misrepresentation of their many products and payoffs......

I thought that was FIFA ?

[mataribot]

Looked on the USA P site and it does not seem to get a very good response from users at all ,very mixed comments and results especially when you compare with ones like Stelara ,lots of side effects plus most who are on it seem to be taking other drugs as well.

Otezla is used as an add on for people whose arthritis is controlled by anti tnfs, but psoriasis is not.