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

[Jesse2233]

From Reddit...

As the researchers in Norway have been showing, Rituxin is becoming pretty much standard treatment for Chronic Fatigue Syndrome. Anyways, I've been seeing a doctor in the US who wanted to treat me with Rituxin, with one problem - it's exorbitantly expensive. So here were the options:

1. Try to get diagnosed with Rheumatoid Arthritis (getting more and more difficult as time goes on)
   
   
2. Try to get insurance to pay for Rituxin (impossible) or get the manufacturer (Genentech) to pay for it (extremely unlikely)
   
   
3. Pay for it out of pocket

The doctor said that he had never had anybody try to get the manufacturer to pay for it, as that would require getting your insurance to reject it, and then if the manufacturer DOESN'T pay for it, you're never going to be able to get the insurance to pay for it, no matter what. So it's a risky situation.

Fortunately, I have very generous family who offered to pay for my treatment, so I thought, yeah we might as well try this. So I asked insurance to pay for it (obviously rejected) and then asked the manufacturer, and they agreed to pay for it!

So, this is possibly a huge step for Chronic Fatigue Syndrome treatment in the United States, as it might be possible for lots of people to get this treatment who otherwise wouldn't be able to afford it. We're still going to have to pay some money for the hospital bills, but that will be closer to $6,000 than the alternative of $60,000.

If you guys have any questions, let me know!

edit: I guess it's spelled Rituxan, oh well

EDIT: he's a patient of Dr Kaufman at OMI

 

[Snow Leopard]

Interesting. Does this mean that if the ongoing Norwegian trials demonstrate efficacy, that they will promptly put in an application to approve the drug for our condition? *speculation*

 

[Jesse2233]

Interesting. Does this mean that if the ongoing Norwegian trials demonstrate efficacy, that they will promptly put in an application to approve the drug for our condition? *speculation*

Not sure but it's certainly promising

 

[Jesse2233]

Tagging a certain someone who might be interested @Gingergrrl

 

[AndyPR]

Why would the drug company decide to give their drug away for free? Does this happen with other treatments do we know? Aren't OMI already treating others with Ritux? If they are then it takes away the only explanation that makes sense to me that they are using it as a loss leader, giving it away now to encourage the OMI to prescribe it in the future.

 

[Jesse2233]

Why would the drug company decide to give their drug away for free? Does this happen with other treatments do we know? Aren't OMI already treating others with Ritux? If they are then it takes away the only explanation that makes sense to me that they are using it as a loss leader, giving it away now to encourage the OMI to prescribe it in the future.

Maybe they want to see more people using it off label in the hopes it will be effective and push the FDA to consider its use

Would be nice for them to have a monopoly on 1-3 million patients without any other FDA approved treatments

 

[AndyPR]

Maybe they want to see more people using it off label in the hopes it will be effective and push the FDA to consider its use

Would be nice for them to have a monopoly on 1-3 million patients without any other FDA approved treatments

Yeah, absolutely, but it seems a haphazard way of doing it. Although thinking about it, obviously they'd much prefer to be paid the full price by insurance, so they wouldn't want to make a lot of noise about being willing to give it away in case people don't even try to get their insurance to pay up. So, in the event that they aren't going to be paid for their product anyway, as far as they know, they decide to give it away to try and build more proof it works, which then has the potential for massive profits in the future. OK, makes more sense to me now.

 

[Jesse2233]

Yeah, absolutely, but it seems a haphazard way of doing it. Although thinking about it, obviously they'd much prefer to be paid the full price by insurance, so they wouldn't want to make a lot of noise about being willing to give it away in case people don't even try to get their insurance to pay up. So, in the event that they aren't going to be paid for their product anyway, as far as they know, they decide to give it away to try and build more proof it works, which then has the potential for massive profits in the future. OK, makes more sense to me now.

That or they're just really nice

 

[Murph]

Yeah, absolutely, but it seems a haphazard way of doing it. Although thinking about it, obviously they'd much prefer to be paid the full price by insurance, so they wouldn't want to make a lot of noise about being willing to give it away in case people don't even try to get their insurance to pay up. So, in the event that they aren't going to be paid for their product anyway, as far as they know, they decide to give it away to try and build more proof it works, which then has the potential for massive profits in the future. OK, makes more sense to me now.

Makes sense to me. nb it seems you can only get the manufacturer to pay after insurance has rejected you.

Also, the price of Rituximab is not equal to the cost of production. They're not really losing thousands, just perhaps the (wild guess here) $10 to $100 it costs to actually make a dose. Most of the price is above the cost to fund the prior research, future research and profits.

 

[adreno]

Well it's an opportunity for an entire new market for them, so why not give away some free samples? Makes sense to me.

 

[Vojta]

It seems they have programe of Patient assistance support for covering their drugs: https://www.gene.com/patients/patient-access
"Patient assistance support is for eligible patients in the United States who don’t have insurance coverage or who can’t afford out-of-pocket co-pay costs."

It seems like very good marketing strategy from them regarding the Rituximab at the moment. But I guess very few patients get it covered from them.

I'm wondering if I could get help when I'm not US citizen but will be under care of US doctor.

 

[Valentijn]

Why would the drug company decide to give their drug away for free? Does this happen with other treatments do we know?

It's done pretty commonly with expensive and necessary drugs in the US. It's only really happening if the patient can't afford it. But I think it's more likely with AIDS drugs, and similar.

It's probably done to avoid the public figuratively taking up their torches and pitchforks to storm the pharmaceutical companies who charge huge amounts for essential meds. There was a company which recently acquired a epinephrine injector, and jacked up the already-high prices to an exorbitant level. The jerk in charge has been in a lot of trouble since then ... both regarding widespread public condemnation, and even legal investigations of him and his company.

If the problem gets too bad, even politicians will have to do something about it. So they hand out a few freebies to placate the masses

 

[Never Give Up]

Most pharmaceutical companies do offer prescription assistance to people who can't afford their medicines, but the patients have to know about it and ask for it. Here is a non profit which claims to help people with the process:

https://www.pparx.org/prescription_assistance_programs/list_of_participating_programs

I don't know anything about the legitimacy of that nonprofit, so use caution.

 

[A.B.]

Why would the drug company decide to give their drug away for free?

My guess: they want to establish it as treatment option if possible, and one way to do that is to just give it to patients.

 

[Diwi9]

Maybe OMI is working is proposing a US-based clinical trial and is working with the manufacturer?

 

[Gingergrrl]

Tagging a certain someone who might be interested @Gingergrrl

Thanks for tagging me, J, and my understanding is that Genentech does have a patient assistance program for patients for Rituximab (like they do for Valcyte) but you have to be rejected by insurance first in order to even apply for it. My doctor is not using ME/CFS as my diagnosis for requesting RTX vs. other multiple other B-cell dependent autoimmune issues combined w/my very positive response to autoimmune dosing of IVIG. I have now done ten months of IVIG (6-7 months at the high dose) and IVIG would be far more expensive, and could be ongoing for years, vs. two infusions of RTX could do the same thing and lead to permanent remission (best case scenario of course)!

We waited to request the Auth so I would not lose my remaining IVIG but now that I only have one cycle of IVIG left (mid-May), we have put in the request. My doctor feels very optimistic that we will get RTX covered but no longer in May and we are now aiming for June b/c many hoops to jump through. I would still pay infusion & hospital co-pays but hoping to get the RTX itself covered. But if we exhaust all options, I will not hesitate to apply for patient assistance from Genentech. I will find a way to try RTX (if it's the last thing I do on earth!), b/c it is the only med I have found that has the possibility to destroy the B-cells and the new ones grow back auto-antibody free (again best case scenario like I said). IVIG is just a temporary fix and no idea what will happen once I stop it.

Thanks to Jesse and all who tag me in these threads re: IVIG or RTX, I truly appreciate it!

 

[Butydoc]

It's done pretty commonly with expensive and necessary drugs in the US. It's only really happening if the patient can't afford it. But I think it's more likely with AIDS drugs, and similar.

It's probably done to avoid the public figuratively taking up their torches and pitchforks to storm the pharmaceutical companies who charge huge amounts for essential meds. There was a company which recently acquired a epinephrine injector, and jacked up the already-high prices to an exorbitant level. The jerk in charge has been in a lot of trouble since then ... both regarding widespread public condemnation, and even legal investigations of him and his company.

If the problem gets too bad, even politicians will have to do something about it. So they hand out a few freebies to placate the masses

Hi Valentijn,

Genentec does have a program for their expensive drugs for those who can't afford them. The problem is that it has to be for an approved indication. Presently CFS/ME is not one of them. Having objective evidence of an autoimmune disease may qualify, but generally require a review by the companies medical director. There is little incentive for the company to approve Retuximab when there is no FDA approved indication. I suspect there might even be some liability on their part unless they can support it's use for a non approved indication

Best,
Gary

 

[Gingergrrl]

Having objective evidence of an autoimmune disease may qualify, but generally require a review by the companies medical director.

@Butydoc Do you know historically if someone has rock solid evidence of autoimmune disease, BUT it was not RA or one of the FDA approved conditions for Rituximab, if Genentech can approve on a case by case basis or would this be unheard of? It sounds like you are saying it is possible with approval from their medical director? But I assume it is still very rare?

 

[debc]

Hello all. I have an auto immune diagnosis (neuro myelitis optica) for which Rituximab is not FDA approved, but is the standard of care. I provided Genentech with a statement of medical necessity from my neurologist, and proof that the drug cost is great than five percent of my gross adjusted income for the year. I was approved to receive the medication for free. I am now struggling to find an infusion center willing to infuse it for free, as most hospital clinics want the giant profit that comes from administering such a drug and can't see their way through the red tape to bill anyone zero for anything. BUT I did get the approval from Genentech. Please let me know if anyone needs help with this process - it required a lot of tenacity! @Butydoc @Gingergrrl

 

[debc]

It is the Genentech Access to Care Foundation that handles all this stuff. There are a lot of very dumb people working there. And an occasional helpful one.