New Rituximab ME/CFS open-label phase II study with rituximab maintenance treatment

[Snow Leopard]

$11,643.80 is a two dose start dose, i.e 2 grams. Standard schedule is up to 1 grams on day 0 and day 14. Then 500 mg every 3 months.

Either way, depressingly expensive for those of us who don't have piles of cash laying around (especially those of us who have never been well enough to work).

 

[greeneagledown]

$11,643.80 is a two dose start dose, i.e 2 grams. Standard schedule is up to 1 grams on day 0 and day 14. Then 500 mg every 3 months.

I don't think that's right. At least, that's not what the Norwegians did. From this latest study:

"The induction treatment, rituximab 500 mg/m2 (maximum 1000 mg)... was administered twice with two weeks interval... The patients then received rituximab maintenance infusions, 500 mg/m2 (maximum 1000 mg) at 3, 6, 10 and 15 months follow-up."

So every single dose is the same size. It's just that you get two doses in a really short period of time in the beginning. Leaving aside the body surface area issue, you would get 1000 mg (or slightly less) in each of the six doses.

Right? Or am I missing something?

 

[deleder2k]

Yes, but isn't health care mainly free in AUS? We would probably have to wait some time though. I assume no one pays the full price for Rituximab R.A treatment?

 

[greeneagledown]

Either way, depressingly expensive for those of us who don't have piles of cash laying around (especially those of us who have never been well enough to work).

Very true, but biosimilars are coming!! Plus, Rituximab will get cheaper when it starts competing against the newer b-cell depleting agents. And insurers and government payers will eventually pay for Ritux if the phase 3 trial is effective. Not sure if it will take additional trials for that to happen or not.

 

[Sasha]

I see on PLoS ONE, BTW, that Fluge & Mella's 2011 paper on rtx had over 66,000 views.

 

[Snow Leopard]

Yes, but isn't health care mainly free in AUS? We would probably have to wait some time though. I assume no one pays the full price for Rituximab R.A treatment?

Hardly anyone gets it for RA because they fob you off with steroids and TNF-alpha inhibitors first.

Some drugs are subsidised by the PBS (govt subsidy scheme, with fairly low price caps), but it has to be approved first and Australians tend to follow, rather than lead when it comes to such decisions. (read: it will be a political shitstorm to get the drug subsidised)

Does anyone in Norway want to marry me?

 

[deleder2k]

I don't think that's right. At least, that's not what the Norwegians did. From this latest study:

"The induction treatment, rituximab 500 mg/m2 (maximum 1000 mg)... was administered twice with two weeks interval... The patients then received rituximab maintenance infusions, 500 mg/m2 (maximum 1000 mg) at 3, 6, 10 and 15 months follow-up."

So every single dose is the same size. It's just that you get two doses in a really short period of time in the beginning. Leaving aside the body surface area issue, you would get 1000 mg (or slightly less) in each of the six doses.

Right? Or am I missing something?

I am very sorry. This baffled me. It seems that they did 1 gram max for every infusion in this trial. In the current phase 3 study they use 500mg fixed maintenance dose:

Induction with two infusions two weeks apart, rituximab 500 mg/m2 (max 1000 mg).

Maintenance with rituximab infusions (500 mg fixed dose) at 3, 6, 9 and 12 months.

Source: https://clinicaltrials.gov/ct2/show/NCT02229942

I don't know why they have changed the maintenance dose. I was simply un aware of it. The normal dosing regime is 1g max start dose x2 then 500 mg (at least for R.A).

@Jonathan Edwards, would you care to comment on this? Do you know why they decreased maintenance dose?

And I'd also like you to comment on the study. I don't know if you've read the study earlier - but what was your first impression of the study?

 

[Kati]

Hardly anyone gets it for RA because they fob you off with steroids and TNF-alpha inhibitors first.

Some drugs are subsidised by the PBS (govt subsidy scheme, with fairly low price caps), but it has to be approved first and Australians tend to follow, rather than lead when it comes to such decisions. (read: it will be a political shitstorm to get the drug subsidised)

Does anyone in Norway want to marry me?

Here is a great opoortunity to leverage this paper globally.

We need to share this paper, we need to mainstream the disease. We need to ask our governments to participate in multi-centers clinical trials.

We need to put this paper in the hands of the medical authorities around the world.

We can't just say 'oh man I can't afford it'. We need to tell the folks at the NIH. At the CDC . We need to demand serious research, and access to clinical trials. We need to mobilize (no pun intended) So much work that needs to be done.

It doesn't have to stay in Norway.

 

[deleder2k]

Hardly anyone gets it for RA because they fob you off with steroids and TNF-alpha inhibitors first.

Some drugs are subsidised by the PBS (govt subsidy scheme, with fairly low price caps), but it has to be approved first and Australians tend to follow, rather than lead when it comes to such decisions. (read: it will be a political shitstorm to get the drug subsidised)

Does anyone in Norway want to marry me?

If the results from the study is right, and that only 39% relapses it is actually quite cheap. There are so many drugs that are used daily that are much more expensive. And as I previously have mentioned, biosimilars are launching in few years. That would lower the price substantially.

Remember that they're also doing a study on cyclophosphamide which will be ready before phase 3 RTX. Cyclophosphamide costs around $20-30 AUD per infusion.

I wouldn't worry much about PBS not paying for it. The thing I would worry about is time.

If you are a gambler maybe this could be an option for you: Rituximab in India

 

[Esther12]

Either way, depressingly expensive for those of us who don't have piles of cash laying around (especially those of us who have never been well enough to work).

You should be relishing the sick role while it lasts SL. Sounds like some of us might soon be expelled from this joyous, responsibility-free state.

 

[Nielk]

Yes, but isn't health care mainly free in AUS? We would probably have to wait some time though. I assume no one pays the full price for Rituximab R.A treatment?

I got Rituximab for my RA in the US. My insurance covered it in full.

 

[greeneagledown]

I am very sorry. This baffled me. It seems that they did 1 gram max for every infusion in this trial. In the current phase 3 study they use 500mg fixed maintenance dose:



Source: https://clinicaltrials.gov/ct2/show/NCT02229942

I don't know why they have changed the maintenance dose. I was simply un aware of it. The normal dosing regime is 1g max start dose x2 then 500 mg (at least for R.A).

@Jonathan Edwards, would you care to comment on this? Do you know why they decreased maintenance dose?

And I'd also like you to comment on the study. I don't know if you've read the study earlier - but what was your first impression of the study?

Whoa, that's interesting. I did not catch that change in the phase 3 protocol. I would also be interested in hearing @Jonathan Edwards 's take on this. Cutting the maintenance doses in half without testing that lower dosage in a smaller study first seems potentially ill-advised. If something has worked in a smaller trial, shouldn't the large trial use the same protocol rather than experiment with a new one?

 

[greeneagledown]

And @deleder2k, that would seem to clear up the cost confusion. You're right -- under the phase 3 regimen, maintenance doses would cost half of what I posted.

 

[deleder2k]

Whoa, that's interesting. I did not catch that change in the phase 3 protocol. I would also be interested in hearing @Jonathan Edwards 's take on this. Cutting the maintenance doses in half without testing that lower dosage in a smaller study first seems potentially ill-advised. If something has worked in smaller trials, shouldn't the large trial use the same protocol rather than experiment with a new one?

I agree. I thought this was a typo from Simmaron Research, but it is not. I don't get it.

 

[deleder2k]

And @deleder2k, that would seem to clear up the cost confusion. You're right -- under the phase 3 regimen, maintenance doses would cost half of what I posted.

Yup!

Regarding India: Ikgdar is Roche's Rituximab version in India

Looks like the price is 37,500 indian rupee, or $585/£376 for 10 mg x 1 mL x 50ml.

Maybe some Indian doctor should start a ME/CFS facility there. I don't know nothing about Indian doctors and hospitals, but there must be some decent ones.

The price in US was $11,643.80 for 2g. That is $2915 for 0.5 g, compared to $585 in India. Not sure if I am doing the arithmetics correct or not. This looks to good to be true! Infusion related costs would also be much cheaper! Kogelnik charges minimum $2000 for each RTX infusion

 

[alex3619]

It would be economically viable. No doubt about that.

What we need is someone to do an economic analysis. I am sure that some political, accounting and economic beancounters will want to say its not economically viable and totally ignore the other benefits.

 

[alex3619]

Yes, but isn't health care mainly free in AUS?

Only for treatments that go through an extensive approval process, and this usually means subsidized treatment not free treatment, though we do have many free hospitals. Many treatments are not subsidized and are not available free.

 

[deleder2k]

What we need is someone to do an economic analysis. I am sure that some political, accounting and economic beancounters will want to say its not economically viable and totally ignore the other benefits.

Can't one base an analysis on other diseases? What about R.A? Myasthenia Gravis? It should be easy to find out how much one person on benefits costs society; benefit payments, no tax income for the state +++ (the list is long). Then we would need to know how likely it is for a person with ME to return to work after receiving RTX. Say that 30% can return to work (part time or full time). Add in the RTX costs and we're getting there. Then one should also say that even more people would get their life back (even though some can't work). They would also be relieved of pain.

 

[alex3619]

Can't one base an analysis on other diseases?

You can make a comparison, but the naysayers will still try to dispute that. We need a proper economic analysis, by a medical economics team, which is then published. I am fairly sure this will happen after the phase 3 trial is done. It just might take a while. Somebody, somewhere, is likely to write such a paper.

Naysayers tend to ignore pain and other personal and social costs. Far too many of them focus on the economics, and ignore the other issues.

 

[deleder2k]

That sounds like a good idea.

If personal and social costs are excluded the study will still conclude it is economically viable. If everyone agreed that this was a real illness I don't think we would have needed a report like that.. Bah! We will probably have to wait until the phase 3 study is released before sh** hits the fan.