Good news for once …

[LemonZest11]

For those who might remember that I have been on a quest to have my 12 month allocation of TCZ extended, I have good news. After lobbying my State Health Minister (whose jurisdiction it isn’t), and my Federal Health Minister who couldn’t help me because it’s the Therapeutic Goods Administration who approves drugs for the Pharmaceutical Benefits Scheme (subsidised medications) in Australia, I took the advice of the Federal Minister and approached Roche directly, rather than sign up for another public hospital trial (which there was no guarantee of). TCZ has worked for me and the thought of having to start another drug, Methotrexate, with all that comes with that, was my argument. I did beg and plead and eventually got my rheumatologist on board, because Roche doesn’t deal with patients. Today I heard that Roche are going to subsidise my continued use of TCZ, indefinitely, with a few provisos. There is still the need for my rheumatologist to complete more paperwork, and I have to sign wavers because the research isn’t beyond 12 months, but I just feel so relieved that I can continue on my path. It will cost, it won’t be free, but at around AU$40 a jab (I take them 3 weekly), I will go with that. I feel relieved and thankful.

[PMRpro Ambassador]

Hallelujah!! It does need this sort of thing to get it used more. There is enough evidence that using it for long enough MAY result in the underlying autoimmune problem burning out - it does anyway usually but this may be noticeably faster. But no-one in the UK and Aus will authorise its funding without the right numbers presented to them.

What I don't understand is why/how the company got it done for RA but not for GCA.

[LemonZest11 in reply to PMRpro]

They have explained that there is no research on results for treatment longer than 12 months, hence the 12 month allocation. The thing that is really interesting in the correspondence from Roche is that my rheumatologist wrote that I had “systemic vasculitis”, for which it isn’t approved under our PBS system. Then what in bloody hell did she tell them I had to get it approved in the first place? I’m wondering if that might be the reason for her reluctance to cooperate in my attempts. I will ask her, for what was TCX originally approved. Anyway, I have to sign paperwork and it’s still at a cost, more than on our PBS, but far less than without their support. Will keep you posted, and thanks for caring.

[PMRpro Ambassador in reply to LemonZest11]

Yes - that is their line, I was told that by NICE at a meeting last week. There IS a follow-up study but it doesn't appear to conform with NICE's requirements so it appears the company didn't do their side properly and now don't want to go forward spending money. TCZ is out of patent and has turned out to be a cash cow for Covid without them going to the effort for GCA which is a not enormous field of use. Money talks.

[LemonZest11 in reply to PMRpro]

How interesting. Makes sense, it’s always about the $$ and covid made sure that was fulfilled. Anyway, I will talk to my rheumatologist, who I am not completely happy with just quietly, and see what her answer is. You always have your finger on the pulse, thanks for being that person. Will let you know what the cost is and all the details when I know. Just glad I kept going on this because, as I said to rheumatologist, I just don’t want to put another drug (methotrexate), into my body, as she rolled her eyes at me.

[PMRpro Ambassador in reply to LemonZest11]

Especially when there is no guarantee it will work and you know TCZ does. If MTX didn't work there wouldn't have been a going back I assume.

Someone at the meeting did get ruffled feathers when I suggested part of the reason was because the QUALYS (Quality-Adjusted Life Year) didn't add up for older patients as we are perceived to be! RA gets TCZ without limitation ...

[LemonZest11 in reply to PMRpro]

So far. Now I can take it forward and see how this drug works beyond the allocation. I might just be the test pilot, hope it works out for us all. Talk soon.

[Helipad in reply to LemonZest11]

I’ve been on TCZ for 18 months and, fingers crossed, everything is still going well.

[LemonZest11 in reply to Helipad]

And hopefully you will continue to be able to access it because in Australia, 12 months is the limit.

[Rugger]

Brilliant news and all down to your perseverance! Well done you.

Too late for me to try and do something similar, as I've already started on Methotrexate.

[DorsetLady PMRGCAuk volunteer]

Good news indeed

[LemonZest11]

Well Rugger, it might just work out fine for you. I hope so and with your optimism, I reckon it will. We'll talk again.

[LemonZest11]

I'm uncertain now just what my Rheumatologist originally prescribed and got approval of tcz for. Firstly she told Mr GCA, then LVV, but now I see in the Roche approval letter she told then systemic vasculitis, for which tcz is not approved in Australia. I will ask her on Thursday what she actually put in the initial application. I'm glad it's worked out for you, it clearly works differently in Australia, with just 12 months of government subsidised allocation available.

[LemonZest11]

Thanks Dad2Cue. The thing is that Roche says in their letter to me that TCZ isn’t approved for systemic vasculitis and that there has been no study and they can’t guarantee the efficacy or side-effects. For what then, was it approved originally. We have a Therapeutic Drugs Authority that approves drugs to go on our PBS for government subsidy. That is what they are referring to. A question for my doc.

[TheMoaningViolet]

Wow!👍

[PMRCanada]

👍👍👍