Genentech agrees to pay for ME/CFS patient's Rituximab

[Gingergrrl]

@debc yes I would love to talk to you about this and will send you a PM. I assume you needed three insurance denials before you could apply to Genentech?

 

[Alvin2]

I am not at all convinced this drug is a good idea but it was approved in 1997, the patent should be expiring soon

 

[Kati]

I am not at all convinced this drug is a good idea but it was approved in 1997, the patent should be expiring soon

We will find out whether if it works or not for our patient population when the Norwegian paper publishes next year. Perhaps the Cyclophosphamide paper will publish first since the trial ends in September. Cyclophosphamide is much cheaper than RItuxan, however presents with serious side effects and should only be infused (and closely monitored) by a knowlegeable professional.

 

[Gingergrrl]

I am not at all convinced this drug is a good idea but it was approved in 1997, the patent should be expiring soon

I think it truly depends on each person's individual medical circumstances. There was a point that I would have agreed with you that it is too dangerous and I still feel that no one should do it unless they have some solid evidence that they could be a responder. My doctors feel that I could be a responder based on having so many autoantibodies and such a positive response to high dose IVIG for autoimmunity. My biggest concern is that I will be allergic to it but am willing to take the risk if I can figure out how to get it covered financially.

 

[TiredSam]

the patent should be expiring soon

I had to read that twice. The first time I thought it said "the patient should be expiring soon".

 

[Alvin2]

I had to read that twice. The first time I thought it said "the patient should be expiring soon".

i LOLed
i certainly feel like i'm expired or at least past my best before date

 

[debc]

@debc yes I would love to talk to you about this and will send you a PM. I assume you needed three insurance denials before you could apply to Genentech?

I did not need three denials, in my case it was based on medical necessity (not FDA approved but is the standard of care for my diagnosis, which is NMO) combined with financial need. The formula is - your out of pocket costs for the drug must be be greater than five percent of your gross adjusted income. Then they will cover it.

And yes, the patent is expiring soon so presumably a generic version or versions will hit the market.

 

[Marc_NL]

Cyclophosphamide is much cheaper than RItuxan, however presents with serious side effects and should only be infused (and closely monitored) by a knowlegeable professional.

If generic versions of Rituximab will be available the price may no longer be an advantage for Cyclophosphamide and might only be worth trying for Rituximab non-responders if I understand it correctly.

Or does Cyclophosphamide have other advantages (besides the price) as far as information is available?

 

[Kati]

If generic versions of Rituximab will be available the price may no longer be an advantage for Cyclophosphamide and might only be worth trying for Rituximab non-responders if I understand it correctly.

Or does Cyclophosphamide have other advantages (besides the price) as far as information is available?

This is only speculation, but pharma being pharma, i would not expect a Rituximab biosimioar to be sold much less than 1000$ per dose.

Again, speculation, but Cyclophosphamide would, I suspect, be effective faster than Rituximab but I have no solid basis to explain. We will find more in the next 12 months.

 

[Jonathan Edwards]

I am not at all convinced this drug is a good idea but it was approved in 1997, the patent should be expiring soon

I think the main patent has expired already. There is ongoing legal activity about dosing but the biosimilar companies are I think geared up to start selling worldwide. I think this means that rituximab is if anything a liability for Genentech. They will want to sell next generation drugs for lymphoma and as many there indications as they can get licenses for. Maybe they think ME/CFS might be a way of sopping up the remaining rituximab production - if they actually think it is worth going on making it.

Companies often make drug available for trials. What is not clear is whether a trial is actually going on at OMI. Provision of free drug for rare diseases is also quite common but ME/CFS does not come in to that category. What is not clear to me here is whether this has been provided as part of a specific company policy or just by someone in a patient support programme being flexible.

It is interesting that someone has had funding. Dr Fluge and Dr Mella have not been keen on usage outside trials but individual physicians have a right to decide what to do.

 

[Gingergrrl]

I did not need three denials, in my case it was based on medical necessity (not FDA approved but is the standard of care for my diagnosis, which is NMO) combined with financial need. The formula is - your out of pocket costs for the drug must be be greater than five percent of your gross adjusted income. Then they will cover it.

@debc I just replied to your PM and want to thank you for all of the info which was incredibly helpful and look forward to chatting with you further. My case is a little different than yours, but we also have some incredible similarities, and you have given me hope that there is a real possibility that I could get Ritux through the Genentech patient assistance program in the future. My doctor is still hoping I will get insurance approval so I am not contacting Genentech yet but will definitely be talking w/you further to gather some more info. Thank you so much and you could not have appeared at a more perfect time .

What is not clear is whether a trial is actually going on at OMI.

There is not a trial for Ritux going on at OMI right now but I do not know if there was one in prior years. My sense is that they really wanted to do one but did not have the funding or staffing and were focused on patient care. They have now split into two separate offices (the original OMI and a newer private practice that does not yet have a name). My doctor is at the new office which is no longer connected to OMI. We are trying to get Ritux approved through my insurance and I would do it at the local infusion center where I have been doing IVIG for 10 months. Technically I am no longer an OMI patient but I still have my same doctor and we still have the same treatment plan based on my total clinical picture which as of now is not ME/CFS (but without a biomarker, there is no way to be 100% sure).

 

[BurnA]

I think this means that rituximab is if anything a liability for Genentech. They will want to sell next generation drugs for lymphoma and as many there indications as they can get licenses for. Maybe they think ME/CFS might be a way of sopping up the remaining rituximab production - if they actually think it is worth going on making it.

Rituxan is one of the top selling drug in the world. I don't see the situation being as dire for Roche/ Rituximab as you are suggesting. They will definitely want to move patients on to newer drugs but the biosimilar take-up is much slower than traditional generics. Rituxan is predicted to be a top seller for many years to come.
And until or unless they can show the newer drugs are better than Rituxan then they won't get approval for them. Obinutuzumab failed in this regard in a trial for DLBCL:

Adding the anti-CD20 agent obinutuzumab (Gazyva) to CHOP chemotherapy (G-CHOP) in the frontline setting did not improve progression-free survival (PFS) compared with the standard regimen of rituximab (Rituxan) plus CHOP (R-CHOP) in patients with diffuse large B-cell lymphoma (DLBCL), according to results from the phase III GOYA trial. - See more here

So i don't think they will be too worried about stopping or sopping up production, any time soon.

 

[Jonathan Edwards]

Rituxan is one of the top selling drug in the world. I don't see the situation being as dire for Roche/ Rituximab as you are suggesting. They will definitely want to move patients on to newer drugs but the biosimilar take-up is much slower than traditional generics. Rituxan is predicted to be a top seller for many years to come.
And until or unless they can show the newer drugs are better than Rituxan then they won't get approval for them. Obinutuzumab failed in this regard in a trial for DLBCL:

Adding the anti-CD20 agent obinutuzumab (Gazyva) to CHOP chemotherapy (G-CHOP) in the frontline setting did not improve progression-free survival (PFS) compared with the standard regimen of rituximab (Rituxan) plus CHOP (R-CHOP) in patients with diffuse large B-cell lymphoma (DLBCL), according to results from the phase III GOYA trial. - See more here

So i don't think they will be too worried about stopping or sopping up production, any time soon.

You may be right but the biosimilar situation will move fast fairly soon. I think the delay has been in sorting out rather complicated legal issues. It may be that Genentech want people to be aware of rituximab original before the others come along.

 

[Gingergrrl]

Rituxan is one of the top selling drug in the world. I don't see the situation being as dire for Roche/ Rituximab as you are suggesting. They will definitely want to move patients on to newer drugs but the biosimilar take-up is much slower than traditional generics. Rituxan is predicted to be a top seller for many years to come.

I agree with you 100% on this and cannot imagine the price of Rituximab going down any time soon and it will remain a major money maker for Genentech (Roche counterpart in the US).

Adding the anti-CD20 agent obinutuzumab (Gazyva) to CHOP chemotherapy (G-CHOP) in the frontline setting did not improve progression-free survival (PFS) compared with the standard regimen of rituximab (Rituxan) plus CHOP (R-CHOP) in patients with diffuse large B-cell lymphoma (DLBCL), according to results from the phase III GOYA trial. - See more here

The Infusion Center where I have done IVIG for 10 mos is a cancer center and they do Ritux as part of R-CHOP for chemo patients all the time. I have never heard of them doing another version than R-CHOP in cancer (separate from using Ritux for RA and autoimmunity patients).

You may be right but the biosimilar situation will move fast fairly soon. I think the delay has been in sorting out rather complicated legal issues. It may be that Genentech want people to be aware of rituximab original before the others come along.

My doctor said that the biosimilar versions are not yet available in the US, which I was very glad to hear, b/c I would not feel comfortable if my insurance tried to force me to do a generic version b/c no way to know what additives are in it vs. the actual brand, Rituximab.

Edit: And no way to know if the biosimilars are equally effective either in my opinion.

 

[Jonathan Edwards]

My doctor said that the biosimilar versions are not yet available in the US, which I was very glad to hear, b/c I would not feel comfortable if my insurance tried to force me to do a generic version b/c no way to know what additives are in it vs. the actual brand, Rituximab.

Edit: And no way to know if the biosimilars are equally effective either in my opinion.

The irony is that Genentech can swap around the additives in rituximab whenever they like and still call it rituximab. They can change the recipe a bit and nobody will know if it is any good any more and call it rituximab. However, whether another company uses an identical process as used to be used for rituximab (even if Genentech does not) or something else they can never call it rituximab because rituximab simply means 'made by Genentech'. I am currently deeply involved in the patent litigation business and it is an eye opener. Companies making other biologics have changed recipes and called the drug the same.

 

[Gingergrrl]

The irony is that Genentech can swap around the additives in rituximab whenever they like and still call it rituximab. They can change the recipe a bit and nobody will know if it is any good any more and call it rituximab.

Wow, I did not know this! So Genentech can currently swap around the additives in Rituximab and still call it Rituximab?!!! The exact ingredients are listed on the package insert and I had assumed that these could not be changed unless they changed the insert? How can they legally change the recipe and not alert the consumers/patients? Do they tell the doctors?

However, whether another company uses an identical process as used to be used for rituximab (even if Genentech does not) or something else they can never call it rituximab because rituximab simply means 'made by Genentech'.

I knew that the biosimilars/generics cannot use the same name and the one I keep hearing about is called "Truxima" which I do not want b/c I didn't know what was really in it.

I am currently deeply involved in the patent litigation business and it is an eye opener. Companies making other biologics have changed recipes and called the drug the same.

I can only imagine what an eye opener the patent litigation process must be! I had no idea that biologics can change recipes or ingredients and still use the same name. How can they get away with this?!!!

 

[Butydoc]

The irony is that Genentech can swap around the additives in rituximab whenever they like and still call it rituximab. They can change the recipe a bit and nobody will know if it is any good any more and call it rituximab. However, whether another company uses an identical process as used to be used for rituximab (even if Genentech does not) or something else they can never call it rituximab because rituximab simply means 'made by Genentech'. I am currently deeply involved in the patent litigation business and it is an eye opener. Companies making other biologics have changed recipes and called the drug the same.

I believe any generic company can call it retuximab but not Retuxan. One is a generic name and the other is the patented name, similar to ibuprofen vs advil.

 

[Jonathan Edwards]

I believe any generic company can call it retuximab but not Retuxan. One is a generic name and the other is the patented name, similar to ibuprofen vs advil.

Yes, absolutely, Gary. That came to me afterwards. Only Genentech can use Rituxan and only Roche can use Mabthera. Other companies can sell rituximab but it has to be called something else.

The point I was making remains that Genentech can change the recipe and still call it Rituxan, because the name Rituxan is theirs to use. Over the years Coca Cola and Kentucky Fried Chicken have probably changed their recipes without telling anyone. So a trade name does not tell us anything specific about quality control or details of preparation.

 

[Jesse2233]

Yes, absolutely, Gary. That came to me afterwards. Only Genentech can use Rituxan and only Roche can use Mabthera. Other companies can sell rituximab but it has to be called something else.

The point I was making remains that Genentech can change the recipe and still call it Rituxan, because the name Rituxan is theirs to use. Over the years Coca Cola and Kentucky Fried Chicken have probably changed their recipes without telling anyone. So a trade name does not tell us anything specific about quality control or details of preparation.

Do you think these changes affect the effectiveness of the drug? And might that explain the good results in Norway vs the poor anecdotal results here?

 

[Jonathan Edwards]

Do you think these changes affect the effectiveness of the drug? And might that explain the good results in Norway vs the poor anecdotal results here?

No, I think it highly unlikely, but equally I think it pretty unlikely that biosimilars will be different. Initially biosimilars were made for local markets but now they are being made for international markets by major companies. It is very unlikely that they will be substandard.