Germany says Cosentyx shows no added benefit for psoriatic arthritis.

[Fred]

This is a bit of a knock for Cosentyx as Institute for Quality and Efficiency in Healthcare (IQWiG) says an added benefit of Cosentyx in comparison with the appropriate comparator therapies is not proven.

Quote:

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Secukinumab (trade name: Cosentyx) has been approved since November 2015 for adults with active ankylosing spondylitis or psoriatic arthritis. For patients with plaque psoriasis, the drug already underwent an early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) in 2015.

The Federal Joint Committee (G-BA) now commissioned the German Institute for Quality and Efficiency in Health Care (IQWiG) to conduct a dossier assessment also for the new therapeutic indications. Since the manufacturer cited no suitable studies in its dossier, an added benefit of secukinumab in comparison with the appropriate comparator therapies is not proven.
No studies for direct comparison

According to the G-BA, the monoclonal antibody secukinumab had to be compared with one of four TNF? inhibitors.

Since the manufacturer presented no studies on these comparisons in its dossier, an added benefit of secukinumab in comparison with the appropriate comparator therapies for patients with active ankylosing spondylitis or psoriatic arthritis is not proven. This result concurs with the assessment of the manufacturer.
Indirect comparison: Manufacturer referred to unpublished analyses

Since studies of direct comparisons were lacking, the manufacturer conducted an unsystematic literature search for both therapeutic indications to find out whether an indirect comparison would be possible. According to the manufacturer, no relevant data from studies on the appropriate comparator therapy were found in this search. This approach cannot be checked because the manufacturer did not disclose the inclusion criteria, the search itself or its results.

In addition, the manufacturer enclosed two unpublished indirect comparisons (network meta-analyses) in its dossier. Based on these analyses, the manufacturer also stated that no indirect comparison was possible. However, it did not process the analyses for the present benefit assessment and therefore did not present them in the publicly available part of the dossier.

Overall, it remained unclear whether an indirect comparison would have been possible and suitable for the derivation of greater or lesser benefit.
G-BA decides on the extent of added benefit

This dossier assessment is part of the early benefit assessment according to AMNOG supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.

Source: iqwig.de

[mataribot]

This is a bit of a knock for Cosentyx as Institute for Quality and Efficiency in Healthcare (IQWiG) says an added benefit of Cosentyx in comparison with the appropriate comparator therapies is not proven.

Quote:

---

Secukinumab (trade name: Cosentyx) has been approved since November 2015 for adults with active ankylosing spondylitis or psoriatic arthritis. For patients with plaque psoriasis, the drug already underwent an early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) in 2015.

The Federal Joint Committee (G-BA) now commissioned the German Institute for Quality and Efficiency in Health Care (IQWiG) to conduct a dossier assessment also for the new therapeutic indications. Since the manufacturer cited no suitable studies in its dossier, an added benefit of secukinumab in comparison with the appropriate comparator therapies is not proven.
No studies for direct comparison

According to the G-BA, the monoclonal antibody secukinumab had to be compared with one of four TNF? inhibitors.

Since the manufacturer presented no studies on these comparisons in its dossier, an added benefit of secukinumab in comparison with the appropriate comparator therapies for patients with active ankylosing spondylitis or psoriatic arthritis is not proven. This result concurs with the assessment of the manufacturer.
Indirect comparison: Manufacturer referred to unpublished analyses

Since studies of direct comparisons were lacking, the manufacturer conducted an unsystematic literature search for both therapeutic indications to find out whether an indirect comparison would be possible. According to the manufacturer, no relevant data from studies on the appropriate comparator therapy were found in this search. This approach cannot be checked because the manufacturer did not disclose the inclusion criteria, the search itself or its results.

In addition, the manufacturer enclosed two unpublished indirect comparisons (network meta-analyses) in its dossier. Based on these analyses, the manufacturer also stated that no indirect comparison was possible. However, it did not process the analyses for the present benefit assessment and therefore did not present them in the publicly available part of the dossier.

Overall, it remained unclear whether an indirect comparison would have been possible and suitable for the derivation of greater or lesser benefit.
G-BA decides on the extent of added benefit

This dossier assessment is part of the early benefit assessment according to AMNOG supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.

Source: iqwig.de

There isn't a drug on the market that has statistical met their secondary goal for PsA or AS. Sounds like to me that someone is tight wad and doesn't want to pay for the cost.

[Caroline]

This is a bit of a knock for Cosentyx as Institute for Quality and Efficiency in Healthcare (IQWiG) says an added benefit of Cosentyx in comparison with the appropriate comparator therapies is not proven.

Quote:

---

Secukinumab (trade name: Cosentyx) has been approved since November 2015 for adults with active ankylosing spondylitis or psoriatic arthritis. For patients with plaque psoriasis, the drug already underwent an early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) in 2015.

The Federal Joint Committee (G-BA) now commissioned the German Institute for Quality and Efficiency in Health Care (IQWiG) to conduct a dossier assessment also for the new therapeutic indications. Since the manufacturer cited no suitable studies in its dossier, an added benefit of secukinumab in comparison with the appropriate comparator therapies is not proven.
No studies for direct comparison

According to the G-BA, the monoclonal antibody secukinumab had to be compared with one of four TNF? inhibitors.

Since the manufacturer presented no studies on these comparisons in its dossier, an added benefit of secukinumab in comparison with the appropriate comparator therapies for patients with active ankylosing spondylitis or psoriatic arthritis is not proven. This result concurs with the assessment of the manufacturer.
Indirect comparison: Manufacturer referred to unpublished analyses

Since studies of direct comparisons were lacking, the manufacturer conducted an unsystematic literature search for both therapeutic indications to find out whether an indirect comparison would be possible. According to the manufacturer, no relevant data from studies on the appropriate comparator therapy were found in this search. This approach cannot be checked because the manufacturer did not disclose the inclusion criteria, the search itself or its results.

In addition, the manufacturer enclosed two unpublished indirect comparisons (network meta-analyses) in its dossier. Based on these analyses, the manufacturer also stated that no indirect comparison was possible. However, it did not process the analyses for the present benefit assessment and therefore did not present them in the publicly available part of the dossier.

Overall, it remained unclear whether an indirect comparison would have been possible and suitable for the derivation of greater or lesser benefit.
G-BA decides on the extent of added benefit

This dossier assessment is part of the early benefit assessment according to AMNOG supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.

Source: iqwig.de

There isn't a drug on the market that has statistical met their secondary goal for PsA or AS. Sounds like to me that someone is tight wad and doesn't want to pay for the cost.

Looks very much like that Matari.
Basically P and PSA are the same disease. The chance that cosentyx will work for PSA is very high.

[jiml]

It doesn't say it doesn't work, just that it's not proven to work

[Caroline]

It doesn't say it doesn't work, just that it's not proven to work

True but the effect of such a statement, allthough it is true, is often that derms will not try it but avoid it. People are very quickly influenced by apparent correct statements and will not step out of their comfort zone.

[Fred]

I think it's a matter of governments making the pharma's work harder. They couldn't supply the data requested showing that is as good as or better than a TNF for psoriatic arthritis.

They asked for comparison tests, they didn't get them. So they are saying to pharma's give us what we ask for and we will give you approval, don't come up with the goods and we won't approve.

Sounds fair to me.  

[Caroline]

I think it's a matter of governments making the pharma's work harder. They couldn't supply the data requested showing that is as good as or better than a TNF for psoriatic arthritis.

They asked for comparison tests, they didn't get them. So they are saying to pharma's give us what we ask for and we will give you approval, don't come up with the goods and we won't approve.

Sounds fair to me.  

No, it is stupid.
You close doors that, if open, could help people.
It is called a tunnel vision.

[Fred]

I think it's a matter of governments making the pharma's work harder. They couldn't supply the data requested showing that is as good as or better than a TNF for psoriatic arthritis.

They asked for comparison tests, they didn't get them. So they are saying to pharma's give us what we ask for and we will give you approval, don't come up with the goods and we won't approve.

Sounds fair to me.  

No, it is stupid.
You close doors that, if open, could help people.
It is called a tunnel vision.

Well I still would rather a drug manufacturer show the evidence that has been asked for. If not what is the point in having a regulatory body.

The drug manufacturer has failed to give what was asked for, it may be a pointless exercise in our opinion but if they let them get away with it then others will try it on too.

All they want is a simple study to show that Cosentyx is as good as TNFs for treating psoriatic arthritis. If it's not then what is the point in them giving approval for such.

[mataribot]

Politics as usual. The manufacturer doesn't need to spend millions USD to figure out where consentyx stands with PsA. It's no better than the TNfs if you consider the current standard. However, there isn't a drug that has statistically shown superiority over TNFs. What we do know is the TNFs have a high rate of failure or reduced benefit over a prolonged period of time. It's nice to give another option for those people.

[Caroline]

Politics as usual. The manufacturer doesn't need to spend millions USD to figure out where consentyx stands with PsA. It's no better than the TNfs if you consider the current standard. However, there isn't a drug that has statistically shown superiority over TNFs. What we do know is the TNFs have a high rate of failure or reduced benefit over a prolonged period of time. It's nice to give another option for those people.

Matari, I don't think this will cost millions of USD.
You hire an administrative force, or even a student, and let him search through the database with PSA sufferers. Then he should send requests to them if they are willing to have part in the investigation.
A planner has to write a plan. Not so difficult. Its only minor timing.
Someone has to make some questionnaires, you can do that in one day.
A pharmacist has to make the placebo's, will take him two days.
The manufacturer has to provide for the stuff.., may take a week in passing time, the work connected is nothing.
An IT-guy has to make a database for recording the results. 4 hours work.
Than a projectleader has to start and coordinate the plan. He will be connected to the project for one day a week during the time of the test. This may be the most costly part of the project. A few thousands of dollars.
In the end someone has to interpret the results and make a report. Also one week of work.

Most costly will be the management involved as they cost a lot of money compared to practical work, still they are necessary because of their networking possibilities.

Certainly, I cannot find Millions anywhere in any trial, that is a myth that manufactures will want us to believe in order to increase the price of the medication.