Tysabri subcut uncut

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Jodi: Welcome, everyone, to the MS Boost. Today, I am talking to Louise Rath, who has been an MS nurse as part of probably the largest MS clinic in the Southern Hemisphere. We are going to have a chat about a new medication that is arriving as part of the repertoire for the different treatments available for people with MS. We wanted to get the inside scoop about what this medication is all about and what it means for people with MS. So, thanks for giving us your time, Louise.

Louise: It's a pleasure.

Jodi: And we're just going to fire off some rapid questions that we think people will be asking about this new medication.

Louise: So, I guess I'd want to stop you there, Jodi, because when you say "new medication," we know that Natalizumab or Tysabri has been around for quite some time. So, this is just a new formulation of it. It's not a new medication; it's just a different way of giving it.

Jodi: So what we're talking about, Louise, is Natalizumab, or commonly called Tysabri. Tysabri is usually given intravenously. It's been a part of MS treatment for a long time now, since 2007 or 2008. And now we're looking at a new formulation. What does a new formulation mean? And what are the changes?

Louise: So, what's been developed through a couple of studies is whether we can give it subcutaneously. Normally, you give Tysabri into a needle into the arm, what's called an infusion. And what we're doing now, a lot of people would know about subcutaneous injections for heparin or if you've had IVF. So, something that is into the subcutaneous fat, normally in your tummy, and that's the new mode of delivery that we're looking at. So, same drug, same dosage, 300 milligrams, but instead of it being in a bag of fluid at the infusion centre, it'll be given one millilitre, two injections into both sides of your tummy, if that's what you elect to do.

Jodi: Okay, and I know some people who have been on MS treatments for a long time remember the dark old days when it was routine to give MS medications into your subcutaneous or fatty tissue. But you could also use the back of your arms and your thighs. Is that the same with Tysabri or is it just for your tummy?

Louise: So technically, of course, you could give it anywhere where you've got subcutaneous fat. There's no reason, but, you know, the trials have just been done. Because it's only monthly and it's only two small injections, it's easier if the nurses use your tummy on either side. So, one of the key things with this medication is that it's not something that you'll be able to do yourself at home. We still want you to go to a healthcare provider. That might be the infusion centre, it might be a small clinic at the hospital. It could be with your GP, or it could be where the nurses are working with the GP in another area. But you know, it's very clear from the brochure and Biogen that it needs to be done under the supervision of a healthcare provider.

Jodi: Okay, that's pretty big, really. It's a significant change in the way that Tysabri was given because previously it had to be at an infusion center. So, what does that look like if I'm a person who lives out in Cape Paterson and I don't want to come to the hospital anymore? What will that mean? And I want to switch to this Tysabri. My first question is going to be to you. Does it work the same? And my next question then is how am I going to get it? How am I going to access it?

Louise: Well, I think what you would do is you would come to your clinic appointment with some questions written down for your neurologist and you would be saying, you know the studies that have been done to approve this mode of administration really do look like it's the same efficacy.

Some people will say they were short studies, we know that it seems equal. But it's always good to question your neurologist just to make sure that you're both very happy with that. We also hope that most studies now are really quite short and that's why it's important to be part of an MS-base registry or real-world studies continuing on so that we get lots of knowledge about this drug as we move forward.

Then what you're going to ask your doctor is, well, I would really like it in the community. So hopefully you're going to think about your GP and whether your GP is happy to do that. So, you might get an appointment with your GP as well to say, is this something that you can help me with? Do you have a nurse in your clinic that could help me inject this? Do I have to make an appointment every time? Will you bulk bill me or will I be out of pocket? So I think, coming in and asking your GP for assistance as to where you can do it is really important and what your costs will be.

Jodi: Okay, what about other people who might be involved? Can I just get the script and take it to any old pharmacist?

Louise: Yeah, so you can get the script from your neurologist, and then you're going to take it to your local pharmacy and they will order it in. You will then pick it up from your pharmacist. Now, the drug is stored at 2 to 8 degrees, the little syringes that are in a box. And you've got 24 hours when it's out of the fridge to get that injected into you.

So, you might pick it up on the way to your GP, you know, go to the pharmacist on the way, pick up the drug and then head straight to the GP or the nurse or the local infusion centre or the local injecting room at the local hospital. Anywhere where you can get it done and then just have your two injections.

Jodi: Okay. I understand that pharmacists won't keep this on their shelves. It'll be something that pharmacists will order. Is that right?

Louise: That is right, but that's exactly the same as some of our oral medications. The pharmacists are incredibly good once you've got a local pharmacist and they will order it in they know that it's monthly, so they will have it on the shelf there for you.

Jess: And Louise, is it something that a GP has to apply for a special permit to be able to prescribe, or can it only come from the neurologist?

Louise: So the GP can't prescribe it. The script will still need to be coming from your neurologist. And they will have a script of one and five repeats. You take that to the pharmacist, and then you've got six months of injections, one a month. And then you will need to, touch base again with your neurologist for a consultation. And remembering that you'll still have to have your JCV test done every six months. So you still need that done, you still need your MRI, you still need your neurology consult. It's just a new way of delivering it.

So I think it's really important to think. Have you got a fabulous GP? Have you got a pharmacist who's willing to help? Is it quicker for you to go this method than coming into an infusion centre? And then I think people really need to consider the cost that will happen. So most people in an infusion center have no charge. But, if you're getting this from your chemist, you will have a dispensing fee, which will either be 30 dollars or 7 dollars with a healthcare card. And then you need to make sure that you know how much at a cost your GP will be for giving this injection. So, before you jump straight in, it's really good to explore, what does this mean for me?

Jodi: One thing that when you were talking I thought about was is there any side effects or are the risks the same with Tysabri when you were talking about JCV testing? And are there any side effects that are different or new or are they much the same?

Louise: So when you look at the two studies, the refined and the defined studies that approved subcutaneous, of course if you do a little injection into your tummy, it's always going to hurt a little bit, but no different to if you're getting a cannula in your arm or a needle. Some people would say it's a, well, it's a 27 gauge, it's a tiny little needle, so for some people it will be a lot less painful, but for others it won't make a difference. And remember, it's one injection on one side, one injection, you know, straight away on the other side. So, it is two injections that you're having on that day, one after the other.

Some people will prefer to have the first injection. If they've never had Tysabri before, you're going to be asking your neurologist, should I have the first two doses? In a bigger place like an infusion centre, just because with any drug, you can always have a reaction to it. And you know, dose two is always a bit more trickier. But for most people, this drug is the same profile as intravenous. It's just another way that some people might find it easier and more comfortable to be closer to home.

Other people will prefer to come into what they're doing and if they're having the shorter rapid infusions, they might really like that time out with the infusion nurses and might like to not have to worry about the logistics. This isn't swapping one for the other. This is just giving another choice to patients to try and make their MS care work for them and their family and how they're living their lives. So don't feel that you have to swap. It's just, collect the information, and work out what's best for you.

Jodi: And what about the risk of PML? Is that the same? For people who don't know what it is, I'll just quickly say progressive multifocal leukoencephalopathy (PML) is a very rare risk with Tysabri treatment, but one that is taken under careful consideration and risk managed through lots of different ways within MS clinics and out in the community.

One of those ways is getting a six-monthly blood test called called a JCV test. So if you want to learn more about that, feel free to give one of our nurses a call, just because it takes a long time to explain all of that. But, but is the risk the same with subcutaneous Tysabri?

Louise: The risk is exactly the same. So you still have to, you know, to continue Tysabri, even if you're in the country and doing it with a GP, we still need you to have that JCV test to get the next script. So, you know, we're really hoping that people will be just as engaged with their healthcare, whether they're in the infusion centre or getting it at home. It's really important that you know you need that test every six months.

Jodi: Thanks. And my understanding is that the reason why people need to have this medication supervised in GP clinics is because they can still have an allergic reaction to it. And that allergic reaction can look like lots of different things, but essentially, you know, no? ok.

Louise: mmm-mm. So, the reason that we know that when Tysabri first got popped on the market that we knew that it had this potential side effect of PML in certain people who are JCV positive. So, to keep people safe, they do the pre-infusion questionnaire that's been adapted now for subcut and to maintain the JCV surveillance, and to have an updated copy of the CMI, which is the medical information and, you know, all the latest data, and the wallet card. And so, for our safety profile, that's the reason why it has to be continued with a healthcare provider.

Jodi: Right, for the risk management of PML.

Louise: Yeah.

Jodi: Okay. If I was thinking about switching, what other tests would be required?

Louise: There would be no other tests required. So you've been on IV intravenous for, you know, the last 12 months and you want to go to subcut and you've worked out for you this is going to be okay and financially it's okay and logistically, then you would talk to your neurologist about, should I do the first subcut in an infusion centre where there's a little bit more medical backup? Maybe the first two, and then I'll go to the community.

In the guideline for subcut Tysabri, when you're swapping from intravenous to subcut, they recommend that you stay one hour after the infusion, and then it's up to you after that 15 minutes or so. When you are naive and you've never had Tysabri, then the recommendation is for the first six infusions you stay one hour. So there's a little bit of logistics and rules and of the observation time, whether you're naive to Tysabri or whether you're switching.

Jess: And Louise, one thing I'm hearing is, what would happen, with the infusion, if you miss your infusion date, people are going to know, you know, like your appointment or that sort of thing. If you're going to subcut, is it up to you to make sure that you've got that appointment set wherever you're going to get your injection done? Like, how would that process work if, if you were to miss that dose?

Louise: Yeah, so one of the things that Biogen has set up, and it's not a patient support group, but it's a logistic opt-in for GPs and patients and the site that's prescribing the drug, to basically have a flow chart of where patients are at. It's not mandatory, but it may be helpful for some GPs to say, you know, the patient didn't turn up today and they can feed that back to our site. So, in the background, Biogen set up a really helpful flow chart for managing these types of things.

But what we are hoping that, you know, if you had COVID and you couldn't attend the GP that day, that the GP is now familiar with Tysabri, and would go, come in when you're ready. It might be five or, you know, six weeks, same as at the hospital, and then we'll get you back to your four-weekly cycle.

So, of course, we're really hoping, we've learned from previous subcut injections that patients have done themselves at home, that it can get a little, you know, blurry. We're not as good as we used to be, so we're really hoping that this is a team effort. The patients take the subcut every four weeks like they would in a hospital.

Jodi: And how long, if I was going to go to the GP, I mean you explained that there are differences like within those first six infusions, whether I have or haven't started Tysabri yet long term. Once I'm sort of past the six injections all going well six months down the track, how long would it take? What can you expect for the time that it would take?

Louise: So I think you would walk into, you would pick up your box of your two syringes from the chemist. You would then go to your, just say it's the nurse at the GP clinic. They will need to do the pre-infusion questionnaire with you, so they will ask you some questions about how you've been. They may ask, where's your JCV result? So that might take five to ten minutes to have a conversation. Then you'd lay down on the couch in there. Two injections, I reckon I could do them in five minutes. You might hang around talking to the nurse about something local you know, because they're also part of your team now. So, I think you could be out within 15-20 minutes.

Jodi: Ok, they need to waiver, you need to sign an agreement about leaving earlier than they recommended time?

Louise: For the first six months you would definitely need to, then after that it's 10- 15 minutes. And by the time you pull down your shirt, you know, look at things, say hello, thank you, all those things, probably is 10 to 15 minutes.

Jodi: It's still pretty quick. Yeah.

Louise: It's still pretty quick. But really, really consider the logistics of your GP service and whether they have access to the nurse and how smooth it is, how long you're waiting in the waiting room if they're busy with little kids so that you've got something slick that's easy.

Jodi: Yeah, good tip, good tip. And if by chance it didn't work out, could you go back to intravenous Tysabri?

Louise: Absolutely. It'll just be at your next four weekly ones. So I think, you know, there's no problems with this. This is great that there's another option for patients to try and make their MS care, as easy as for them with the least amount of impact on their family life and on their work life. So, it's great that there's another option.

Jodi: It sure is and thank you for giving us all the details on all of that Louise , and making sure that people can think about all the things that you'll need to think about when you are planning a switch, if that's what you want to do. And really importantly, to have a conversation with your neurologist where you can make sure that you note down your questions first and say, you know, what are my concerns? What do I need to think about? And is there any final tips that you've got, Louise?

Louise: Yeah, I know some people really struggle getting access to GPs. So Biogen's being incredibly helpful, but in their program that they've, not a patient support, but more a doctor, nurse, clinic support, that they'll be able to, if you're having trouble finding a GP who will do this, you'll ring your MS nurse at the clinic and say, can you help me find a GP who's got this system down pat now?

So it might be someone just maybe 10 minutes further away, but that might be an ease. So don't, if your GP can't do it, give your MS nurse a call and we can try and work out another way for you to get this closer to home and better for you.

Jodi: Perfect. Thank you. Great tip. And if you don't have an MS nurse, then you can also contact the MS nurses at MS Plus, who will also be able to help you with that information about where you might be able to access this medication.

Well, that's it. Really exciting. Thank you, Louise, for answering those questions and stepping us through that. And if you have any questions, please don't hesitate to reach out to MS Plus and our nurses will certainly be able to help you as well.

Thanks for listening to the MS Boost. Let us know, are you considering switching medications? Make sure to subscribe to hear our next episode on medical gaslighting.