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Hep C Discussion Forum -> General Discussion -> Cirrhotics in UK, new draft guidelines
Post Info TOPIC: Cirrhotics in UK, new draft guidelines
Gracie


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RE: Cirrhotics in UK, new draft guidelines
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I went to see my hepologist yesterday and asked about my status as my Fibroscan was 15.5 which is considered cirrhotic. I had a scope which showed zero damage and my blood tests are not bad. She said she would have no reason to think that I would ever progress to decompensated "IF" I reach SVR.  If I don't for some reason and never treat again, I'd most likely be very sick in 10 or so years. 

With SVR tuning decompensated to compensated, and preventing the worsening of very sick high cost patients (and there would be a lot of us in 10 years), treating is of the utmost importance. 

I think the insurance companies are trying to draw a line in the sand. That they won't stand for such high priced treatments. The sad thing is...a lot who want to and should be treated have their hands tied. 

Good luck on your 5k run Nirmalee! I started running 5 years ago when I was 47 and love it! Mostly do 5k runs. Keeps me feeling good and breathing better! 



__________________
  1. Gracie

1A. Previously treated non responder Rebetron in 2000 And Incevik in 2014 with a breakthrough at week 12. Fibroscan 15.5. VL 6,000,000. Finished 24 weeks harvoni on Dec. 19, 2015. SVR. Latest Fibroscan 8.8.
dragonfly


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If I can give you any more info I hope this helps.  Gilead have very strict limits on their trials and I was considered twice and rejected because one of my bloods was outside their parameters.  When I was offered my chance my consultant actually said if your bloods are still as rubbish as they were before - you're in.  - if you sign up to one of these programmes you consent to your details being shared with relevant agencies; I have no problem with that if it helps others.  The long term effects of these drugs are yet to be seen as you can see from posts here.  The difference in feeling when you go to decompensated back to compensated is like a different world - my consultant is fighting to get all his cirrhotic patients on this programme and information on how patients progress is important in pushing this point.  This is why I am trying to do a 5k run in the New Year - something I haven't been able to do since 2008 to show that it is a false economy to deny patients this treatment.

Best wishes,

Nirmalee



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Brian1412


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Hi jill all. What is happening there has already happed here. I did my lsbs today and the number of people who got the grant i got is skyroceted. My home state did not open a exhange nor ecpanded medacaire For hep c no. Have no issues to get grant for Harvoni..

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Gracie


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I don't think this will last. These drugs are really causing an uproar everywhere. I heard on the news here in little eastern Canada that our provincial drug plan (which anybody can get no matter what history), will cause many companies to cancel their group plans, as their employees can get covered on their own. They actually mentioned the high cost of hepatitis c treatments as a catalyst for this. Why would a company pay for and give a benefit that their staff can get for free. And insurance prices will for sure increase and become less affordable for businesses to maintain, as we can get the 24 week treatments (I'm on it and grateful for it every day). 

Something has to be done. Because if they get away with it, our future will be full of overpriced, unaffordable medications which won't be good for anybody. Harvoni has put a crack in the dam.....



__________________
  1. Gracie

1A. Previously treated non responder Rebetron in 2000 And Incevik in 2014 with a breakthrough at week 12. Fibroscan 15.5. VL 6,000,000. Finished 24 weeks harvoni on Dec. 19, 2015. SVR. Latest Fibroscan 8.8.
Cinnamon Girl


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Hi Susie,

Yes of course, I can give you some information about this.  The Compassionate Use Programme (CUP) was set up in Europe for those people who are in the most need of the newest `all oral` DAA drugs, and who would not be able to get access to these treatments otherwise.  Each European member state administers the programme separately.  The programme is available for categories of people who are at the highest risk of irreversible liver damage or even death if not treated within 12 months, and who are unable to tolerate interferon based treatment. 

Here`s a link which tells you more about this...

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/02/news_detail_002032.jsp&mid=WC0b01ac058004d5c1

And here`s some information about it from the NHS in England...

http://www.england.nhs.uk/wp-content/uploads/2014/04/sofosbuvir-pol-stat.pdf

Hope that helps, please let us know if you`d like any more information.

Welcome to the forum! smile

 

 

 

 



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
susieg2


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Hi Jill (and SP) -

 

Do you mind me asking, What is this "European `Compassionate Use Programme? I have never heard that mentioned before.

 

Thanks SUsie



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Cinnamon Girl


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Thanks for adding that, Nirmalee, that`s good to know, and very useful information. 

Let`s hope all cirrhotics in the UK who are eligible will continue to be offered the same DAA treatment as you were, through the European `Compassionate Use Programme`.

Cheers, Jill

 



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
dragonfly


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Just to add to my previous post - I was told that if I tested positive in 6 months I would be retreated for 24 weeks.

Nirmalee



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SickPuppy


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That used to be the case until a week ago. Now, as per what I posted below, the official document, and what the previous poster said (taken from the same document) is the fact that if you are cirrhotic, you have to be CPT A, with 75000 platelet, no history of varices or anything like that, and then you get 12 weeks. Otherwise, though luck.

If you are TX-naive, it's not specified, but I doubt that means you'll get anything if you are CPT B.

Meanwhile, Gilead recommends 24 weeks for all TX-experienced cirrhotics, not 24 weeks. So not only it is limiting access very, very finely but also not offering the recommended duration. SVR chances for what they are doing are 86%.

I was lucky to be offered treatment right before this document, but of course, still only 12 weeks, still low chances.

And guess what? I used to be CPT C and I'm now CPT A. Everywhere you read, "decompensation to compensation hasn't been seen". Well, 15 years ago I puked blood 4 times, had varices for 3 years. Since then, I have had portal hypertension and took Propranolol, but I've been healthy for 15 years. The varices have completely gone as per my last endoscopy, and I've had no ascites, jaundice, HE or any other problems, except red palms.

By the latest NHS document, I shouldn't be offered treatment. I'm 25 and feel healthier and more lively than ever. I work full time at one of the Big 4 IT companies and pay a very huge taxes.

Why shouldn't I be offered treatment the proper treatment? And then, according to the last document, why should I, or others in my situation, be left out to die, with no treatment?


This document they put out is outrageous and requires a full-blown revolution. I can't believe anyone is trying to rationalize it. It's black on white right there. If you have not met this arbitrary criteria, you don't get treatment.

75000 platelets is a criteria. Really? In an interferon-free regimen? Ribavirin, nor Harvoni, affects platelets. Interferon is the culprit of marrow suppression and platelet reduction. Thousands of patients began treatment with Harvoni with a low platelet count and saw an immediate RISE in platelet within weeks of treatment.

This is a document made by bankers, not doctors.



__________________

GT1a - TX-naive

Baseline:

16.2 kPa
ALT: 61 iu/L
ALP: 74 iu/L
Albumin: 38g/L
Bilirubin: 27 umol/L 
Platelets: 80
VL: 792,000
History of 4 violent varices bleeding episodes and splenomegaly present. 

21/07/2015 - TX start - Harvoni + Ribavirin 1200mg 12 weeks.
dragonfly


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Hi, I think what is happening in the UK at the moment is that they are prioritising cirrhotics  but because of expense, are concentrating on those with decompensated cirrhosis under what is known as a CUP scheme where the NHS pay 50% and the drug companies pay the rest.  This is what I was given but as far as I am aware this was only offered to 300 candidates. As far as I know only 2 people from that cycle of treatment did not achieve SVR and at one point I became very seriously ill. Refinements to treatment regimes are being made all the time and I believe that Ribavarin is now not deemed necessary.  These were all geno 3 as the standard treatments have been proved to be not only ineffective but can cause further harm.  I'm not a doctor but I would hazard a guess that this relates to the period of time you have had the virus.  When I last spoke to my clinical nurse she said that the demand for these drugs would bring the price down and would make more sense than the expense of transplants.  Please don't give up hope.  I am now compensated.  No consultant wants to see their patient die.

Nirmalee



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SickPuppy


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All DAA regimens require 24 weeks for those that are TX-experienced and cirrhotic (especially CPT B). Otherwise the chances of SVR go down quite a bit.

There are no 24 weeks in the UK, ergo, most TX-expeirneced cirrhotics (who are also the ones most likely to be TX-experienced) will not get treatment. If they will, they will only get it if CPT A, and only for 12 weeks.

If you're CPT B/C, there is no treatment offered. Not even the 12 weeks. Read the document.

This is a complete reversal of the previous (not even a week ago) stance that the ones most likely to die soon or at high risk should be treated first.



__________________

GT1a - TX-naive

Baseline:

16.2 kPa
ALT: 61 iu/L
ALP: 74 iu/L
Albumin: 38g/L
Bilirubin: 27 umol/L 
Platelets: 80
VL: 792,000
History of 4 violent varices bleeding episodes and splenomegaly present. 

21/07/2015 - TX start - Harvoni + Ribavirin 1200mg 12 weeks.
Cinnamon Girl


Guru

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Posts: 5629
Date:
Permalink  
 

Hi SP,

Thanks for posting this, it was pretty much what we expected, given that the cost of the new drugs and the financial constraints of the NHS.

However, your heading to this thread is rather misleading and alarmist considering that many cirrhotic patients will qualify under these suggested guidelines. 

It`s a big step forward for many Hep C patients in the UK who will qualify for these treatments.  Hopefully in time this will be extended but in the meantime I hope that those who aren`t included in the criteria will still be able to have treatment with new DAA regimens through a European Compassionate Access scheme.

Here`s a breakdown of the draft guidelines, note that this is still at a consultation stage..

The National Institute for Clinical Excellence (NICE) has today issued appraisal consultation documents for three new hepatitis C therapies; ledipasvir-sofosbuvir (Harvoni), daclatasvir (Daklinza, and ombitasvir/paritaprevir/ritonavir (with or without dasabuvir).
A summary of the recommendations, which at this stage are preliminary, are below:


Ledipasvir-sofosbuvir (Harvoni)


Genotype 1
Recommended for use on treatment-naïve patients without cirrhosis for 8 weeks.
Recommended for use on treatment-experienced patients without cirrhosis for 12 weeks.
Recommended for use on treatment-naïve patients with compensated cirrhosis for 12 weeks.
Recommended for use on treatment-experienced patients with compensated cirrhosis for 12 weeks if a number of criteria (related to platelet count and previous history) are met.


Genotype 4
Recommended for use on treatment-naïve patients without cirrhosis for 12 weeks.
Recommended for use on treatment-naïve patients with compensated cirrhosis for 12 weeks.
Recommended for use on treatment-experienced patients with compensated cirrhosis for 12 weeks if a number of criteria (related to platelet count and previous history) are met.

Daclatasvir


Recommended for use on genotype 1 and 4 treatment-experienced patients and patients who are interferon-ineligible or intolerant if the patient has significant fibrosis (METAVIR fibrosis stage F3-F4).
Ombitasvir/paritaprevir/ritonavir (with or without dasabuvir)


Genotype 1b
Recommended for use on treatment-naïve patients without cirrhosis for 12 weeks.
Recommended for use on treatment-experienced patients without cirrhosis for 12 weeks.
Recommended for use (with ribavirin) on treatment-naïve patients with compensated cirrhosis for 12 weeks.
Recommended for use (with ribavirin) on treatment-experienced patients with compensated cirrhosis for 12 weeks.
 Genotype 1a


Recommended for use (with ribavirin) on treatment-naïve patients without compensated cirrhosis for 12 weeks.
Recommended for use (with ribavirin) on treatment-experienced patients without compensated cirrhosis for 12 weeks.

 

Ombitasvir/paritaprevir/ritonavir (with or without dasabuvir)

Genotype 1b

Recommended for use on treatment-naïve patients without cirrhosis for 12 weeks.

Recommended for use on treatment-experienced patients without cirrhosis for 12 weeks.

Recommended for use (with ribavirin) on treatment-naïve patients with compensated cirrhosis for 12 weeks.

Recommended for use (with ribavirin) on treatment-experienced patients with compensated cirrhosis for 12 weeks.

 Genotype 1a

Recommended for use (with ribavirin) on treatment-naïve patients without compensated cirrhosis for 12 weeks.

Recommended for use (with ribavirin) on treatment-experienced patients without compensated cirrhosis for 12 weeks.

The full document can be read here.

 



Thanks, Jill.



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
SickPuppy


Member

Status: Offline
Posts: 15
Date:
Permalink  
 

The UK has decided not to offer a 24 weeks course of Harvoni, Viekira or any other expensive DAA under any circumstance. It has also decided that instead, they will offer 12 weeks Harvoni + Ribavirin only to TX-naive cirrhotics.

TX-experienced cirrhotics will not get treatment (not even the 12 weeks one) if they have portal hypertension, have platelets under 75,000 or other retarded reasons. Not economically viable to save they say.

 

Document available here: https://www.nice.org.uk/guidance/GID-TAG484/documents/hepatitis-c-chronic-ledipasvirsofosbuvir-id742-appraisal-consultation-document-22



-- Edited by SickPuppy on Wednesday 29th of July 2015 10:08:55 AM



__________________

GT1a - TX-naive

Baseline:

16.2 kPa
ALT: 61 iu/L
ALP: 74 iu/L
Albumin: 38g/L
Bilirubin: 27 umol/L 
Platelets: 80
VL: 792,000
History of 4 violent varices bleeding episodes and splenomegaly present. 

21/07/2015 - TX start - Harvoni + Ribavirin 1200mg 12 weeks.
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