OCA gets a green light from FDA : ... - PBC Foundation

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OCA gets a green light from FDA

Betonarme profile image
8 Replies

fiercebiotech.com/intercept...

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Betonarme profile image
Betonarme
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8 Replies

Just read the ink Betonarme.

I have read about this OCA previously when it was bring trialled. I am sceptical as I did read that itching can worsen on using this. (But if needs be I would not write it off with regards to myself in future.)

What I wanted to respond here with is that I checked out UK websites as the link is the US. The link I think appears the same here in the UK website but I wanted to know when it might be available in the UK. The final paragraph states that it is likely to be available in Europe 2017. So things might just get that bit more interesting with regards to this PBC in the near future. I will definitely keep looking regarding this new med.

wessexlifescience.co.uk/ind...

Betonarme profile image
Betonarme in reply to

Hi Peridot,

They suggest to start with small doses to probably avoid the adverse effects (increased itch) if at all in the beginning and go to higher doses if necessary.

But anyway this is a good news and now the PBC patients have an alternative treatment finally. Hopefully there will be more soon.

Now we can start guessing what will be the price for this OCA :(

Coincidentally, there was a Table discussion last night on a German TV where they talked about the extremely high prices for some new revolutionary drugs. As I heard the price for a Opdivo (Nivolumab) I was shocked.

They also referred the Gilead's Hepatitis C treatment which was way beyond the paying capabilities of millions of people around the planet who desperately needs the treatment. Just one single sovaldi pill costs over 600 Euro!

Gilead's sales for Hepatitis C treatment(Sovaldi...) in 2016 was $1 billion in Germany alone and about $17 billion globally!

in reply to Betonarme

Hello again Betonarme.

I was going from what I was reading about this OCA being found in some volunteers in trial that itching was reported and some with increased severity. I suppose though one wouldn't know how they were going to be unless this new medication was administered.

With me being in the UK once it is marketed here then it would be a case of those who are on state benefits receive it for free on prescription and the ones who have to pay (I always have) have to contribute due to the UK having the NHS.

But like everything in life it seems that it is all about money and depending on costings eventually for this OCA it would be a case of which patients are to be given it due to fitting a certain criteria. I know eventually if it is a successful medication then it will more than likely start being produced generically thus cutting costings.

I was informed in the early days of starting the urso that it was costing '£90' according to the GP but I have to say I didn't care as I said to him that I was not taking any other medications, hadn't for over a decade until I was struck by this PBC and my argument was that if I was contributing towards the NHS each time I got a prescription then surely I could have more than a month's supply of them. Managed to argue my case though I did have to argue once more a couple years later when I saw a different GP.

I think it depends too on certain health conditions. I expect there is no way of knowing how a patient will get along if they were not offered and took the urso which again would apparently cost the NHS more to treat a patient if other symptons appeared.

Some things in life are certain very odd.

dollydaydreams profile image
dollydaydreams in reply to

I think it's up to Nice if we can have it on prescription or not, like the product for treating hair loss, it is not available on prescription in Wales only on a private prescription and the last lot I go cost me £79. Some drugs available in England for cancer are not even available in Wales, so I don't hold out much hope for getting it in Wales, I have seen some terrible prices quoted in the US for this new drug

in reply to dollydaydreams

Yes I think you are right dollydaydreams re NICE. I found out some time ago that there is a traffic light system in the UK regarding prescriptions. Some are known as 'off label' for instance and also certain medications can only be prescribed by a hospital consultant.

I know a few years ago I was reading about generic medications and certain ones were not being advised to be replaced from a brand to a generic. I know one is a medication used after patient transplant in the UK.

On the whole it seems a very complex system but it still all comes down to the one word doesn't it, money.

Pea1234 profile image
Pea1234 in reply to Betonarme

I just got prescribed to Ocaliva. I am in the US. My cost through my insurance is $33 for a 30 day supply. Without insurance the cost is $5800. That is so crazy. I was shocked when I saw the cost in an article. I had to ask the pharmacy if this was true and yes that is the truth. This drug is very expensive.

Puddles profile image
Puddles

Very promising news, hopefully Australia (and the rest of the world) will not be long in following suit.

cazer profile image
cazer

Very intetestimg...cazer

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