Xiapex to be discontinued

Well the news is official. Endo has already discontinued Xiapex in Australia and Asia, and plans to do the same to Europe by the end of 2019. The reason? They won't say. We suspect the higher prices in the US and the pending license for cellulite play a role. Even if they proclaim to be an ethical company, they want more return for their shareholders and bonusses for their CEO's. At the cost of depriving patients, and denying them a treatment that may help keep their hands mobile, straighten their penis, keep their life normal.
This is the letter Endo and Sobi published, but keep in mind Sobi wanted to keep supplying and Endo made the decision one sided.

Healthcare Professional Information regarding de-registration of XIAPEX® 

Dear Healthcare Professional

This letter is to inform you that Sobi will discontinue the commercialisation of XIAPEX by the end of 2019.

XIAPEX is a product owned by Endo Ventures Limited (‘Endo’). Currently, XIAPEX is commercialised in the EU and other European and Middle Eastern countries by Sobi. Endo and Sobi have agreed to terminate the cooperation agreement for Xiapex effective December 31, 2019. The decision to withdraw is not based on safety or efficacy concerns.

Endo and Sobi are committed to managing the de-registration of Xiapex from the Sobi territories in an ethical and transparent manner and Sobi will process the withdrawal of the EU Marketing Authorisation, which will be effective from 1 March, 2020.

Please be assured that the wellbeing of patients during the discontinuation process is of paramount importance to Sobi and we are committed to the safety and comfort of all patients during the process of transition to other therapies. We want to emphasize that, subject to product availability from our supplier, Sobi is committed to providing XIAPEX up until the end of 2019.

We would like to thank you for your interest in XIAPEX over the years and deeply regret any inconvenience this may cause you.

If you have any questions or concerns, please do not hesitate to contact us at your convenience. 

After de-registration, all enquiries, questions or requests for Named Patient Use of Xiapex must be referred directly to Endo. Contact www.endo.com/contact

Yours Sincerely,

Carolyne Dyson
Business Unit Director

Sobi

 

And this is the letter I send to Endo:

It has come to my attention that Endo Pharmaceuticals is planning to withdraw Collagenase Clostridium Histolyticum (CCH) injection from the whole of the European market. I sincerely hope I have been misinformed, but would like to express our Societies view on this to make you aware of how we feel about this possible development.

CCH is an important addition to the limited treatment options for Dupuytren's Contracture. The only alternative treatment would be a type of surgical procedure, and not every patient, not every hand or finger is suitable for that. For some patients CCH is their main or indeed only hope of regaining and keeping hand function. Similarly for Peyronie's patients CCH is an important additional treatment option, one that allows non surgical treatment and regaining normal function and appearance of their penis.

We as a charity have spent a lot of time and effort fighting to get CCH accepted by NICE as a treatment for Dupuytren's Contracture, so it is now used by the NHS under the right circumstances. It has been an enormous joint effort of Sobi UK, Auxilium, The British Dupuytren's Society for the patients, the British Society for Surgery of the Hand and the British Association of Hand Therapists for the health care providers to reach an acceptance by NICE.

By withdrawing CCH from the UK (and indeed EU) market you are making a mockery of all the arguments we used to explain why the drug is needed and is a revolutionary treatment for patients.

There are several trials ongoing or about to start, at least two in the UK, to evaluate the effects directly and long term of CCH compared to some of the surgical options available. These trials have a lot of money and manpower put into them already, and if they can not proceed that will be wasted, careers of the researchers may be damaged and awarding bodies may be reluctant to back similar trials in the future. Important questions will not be answered about the effects of CCH compared to more traditional surgical treatments.

Withdrawing CCH would leave patients in limbo; there will be Peyronie's patients who are somewhere in the cycle of injections where the treatment can't be finished, and both Dupuytren and Peyronie's patients who have agreed with their physicians that CCH is the best option for them, who will be denied that treatment.

Withdrawing CCH for what may well be profit reasons is reinforcing "Big Pharma's" bad name. Endo Pharmaceuticals has a code of conduct for their employees, that states "Endo is committed to conducting business in an ethical and compliant manner". How can it be ethical to withhold treatment from a large population group, and the group that statistically tends to be the worst affected with the disease the treatment was developed for? You would be turning your back on exactly those patients your treatment is supposed to help.

Endo is supposed to have a commitment to patients and communities, to "provide better access to care for patients". This decision would achieve the opposite of what you aim to achieve according to your Code of Conduct.

Your president Mr Patrick Berry said in his speech in 2017 : "Endo is committed to delivering quality medicines to patients in need". If Endo is withdrawing CCH from the European market in order to have more of the drugs accessible for cellulite treatment (at a higher price), you would be doing the exact opposite of what your president wants. Cellulite is not a disabling condition and does not impact on basic daily activities, whereas Dupuytren's and Peyronie's are disfiguring and impede normal functioning of the affected body part, leaving the patient disabled. Surely patients needs should come before profits in a health care company that professes to have an ethical stance.

Yours

A S Schurer, for the British Dupuytren's Society

What more can we do? I emailed Endo (ok, to all 10 different email addresses I found online), emailed all news papers that published articles on Xiapex in the last few years that I could find.
I think patients should let Endo know what they think. Email them!! The more comments they get the better. We need to show them that Dupuytren's and Peyronie's patients stand united in the fight for better treatments and eventually hopefully a cure.
 

 

 

Last Thursday was the NICE meeting on radiotherapy. Ian Ireland very kindly volunteered to go as I could not, and Gemma Matthews went as well.

The meeting could only be observed, but they did mention the statement I had made on behalf of the BDS, statements from other patients and did they really have to assess safety as radiotherapy has been evaluated for so many other conditions already.

The committee members did not seem to have any special knowledge of Dupuytren's, we came across that at the Xiapex appraisal as well but there we had the chance to spend a few hours informing them of what the condition does and means for patients. That was a different group of people, and apparently they had not communicated. I discussed the condition with someone before the questionnaire was made, but that person was not in this committee either. Shame a decision is taken about a treatment for a condition that those who take the decision don't really know much about.

So now we have to wait for the decision.

 

On another note NICE has decided to hold the next Xiapex meeting, a week short of a year after the appeal meeting! Can't accuse them of rushing things.

 

I am still trying to get more scientists on our research page, found a mention of stem cell research in Wellington New Zealand which the researchers think might help us! I hope they are next on my research page. If they reply to my email.

 

Seeing many patients would like to discuss radiotherapy but most doctors tend to dismiss it, I have started making a list of doctors willing to discuss it as potential treatment and even refer for it. If anyone knows of such a doctor please let me know! anna@dupuytrens-society.org.uk

July 2016

We had a trustee meeting last week, everyone agreed the Peyronie's campaign had been a success and the message went further than we had expected. Now to decide whether to do the same thing for Dupuytren's and Ledderhose. Dupuytren's has had quite a bit of attention in the media with first Pfizer, then Sobi doing awareness campaigns. Ledderhose is the forgotten condition that gets hidden away in shoes and nobody notices it.

 

The BSSH together with the JLA (James Lind Alliance) have a survey they would like patients in Britain with hand or wrist conditions to take (or those that care for a patient with hand or wrist problems) Check this page for more information and links to the survey. http://www.bssh.ac.uk/patients/bssh_james_lind_alliance_partnership.aspx  

 

We have started writing to researchers hoping to put together a webpage on research being done at the moment. Ideally every team would write a few lines for us explaining their research and what they are hoping to achieve. After 2 days I had 3 replies already, so far so good. Only 15 more replies to come I hope!

 

We are still waiting for NICE to make their final decision on Xiapex after it went back to the appraisal committee, and for a different group from NICE to make a decision about radiotherapy. Let's hope both decisions are patient friendly and allow access to the treatments the patients want!

Keep well and look after yourself folks!

Radiotherapy for Dupuytren's experience wanted, and video interviews for general awareness

Even though NICE has not decided on Xiapex use yet, they have now decided to review the guidance for radiotherapy in early Dupuytren's. So far it was limited guidance with any NHS treatment needing to be done in a centre where the results were special arrangements for clinical government, consent, and audit or research are in place. This has limited the number of centra willing to perform the treatment.

NICE now decided on a consultation where they want patient to fill in a questionaire, to help them decide if the procedure is safe and effective enough and if special consent is needed.

So we are looking for any patients who have had radiotherapy treatment and are willing to help, to start by filling in a questionaire, maybe at some stage one or two will be asked to come to London or Manchester for the appraisal if NICE wants to ask more questions (that is what happened with the Xiapex appraisal, but you can just say no if you can't come).

So please, anyone who had radiotherapy and wants to help try and make it available for more patients, contact me on anna@dupuytrens-society.org.uk , or via our Facebook page or group.

We are also still looking for people to do a video interview with SayCommunications on how Dupuytren's has affected their life, everyday tasks, work and / or hobbies, for an awareness campaign.

This will be to explain to doctors and the rest of the community that even if Dupuytren's is not dangerous it does need  treatment before a patients hands get really bad.

And of course we are still working on a campaign for Peyronie's, Dupuytren's little brother disease that nobody likes to talk about. But we will change that!

So if you want to help us with any of these causes, use my email, go via the website on the contact us page, go to our Facebook page.. get in touch!!

Summertime

Time for an update, it has been a while.

Groningen: the conference was good, a lot of very clever people all discussing what they can offer patients and what research needs doing to improve the treatments. There are still distinct fractions, such as radiotherapists versus surgeons, but there was good conversation also between the groups so I hope the differences in opinion are getting less. After all we all want what is best to slow or halt the disease, never mind how it is done. Abstracts of the presented papers can be found online: http://dupuytrensymposium.com/program_2015.php  (scroll to the bottom) and the talks will be put on YouTube.

The Dupuytren's Foundation is hoping to set up a databank with samples from as many ppatients as they can get, to aid in identifying the cause of the disease. PLEASE HELP!! Go to this website http://dupuytrens.org/get-the-newsletter/  and register for the newsletter, they will let you know as soon as the study starts . It would mean having a bloodsample taken, that's all. Anyone with Dup's or Ledderhose in any country, please join.

Since then the website is being transferred, we found a good server but it means I can't update any pages untill the transfer is complete.

I have met up with Lorraine and Louise from Say Communications, Sobi has kindly agreed to fund a secretariat function for 2 days per month for the next 6 months, and Louise will look into funding, membership, a new logo, newsletters to GP's.. all these things we wanted for the BDS but did not have time to do. So all in all the BDS is moving forward. We have 350 followers on our Facebook page, and the Dup Ld and related conditions group is oding even better with 406 members.

All we need now is a cure!

Anna

Appraisal meeting July 2014

The next step in the NICE appraisal is over. We had the meeting on Tuesday, A big thank you to Mr Henk Giele and Mr Chris Bainbridge who took the time to come from their busy practises to attend and answer a lot of questions from the committee. I would have ben in trouble without them. The comittee still did not quite understand Dupuytren's I felt (who does? It does not follow any set pattern, just does what it feels like), and the two clinical experts did a brilliant job explaining that you can never know which patient will respond well to treatment and which won't, that any treatment you give works better if the contracture is not too far advanced, that patients seek medical help when the condition becomes a problem for them, which can be in an early or a late stage depending on their lifestyle.

And now we have to wait for a decision, and that will be a while, as the committee already scheduled another discussion between them in a few months. Unless they have more questions for patients I won't need to attend that one, and I don't think I can say more than I already said and put in my statements and comments. It has been a lot of work, I hope it will have been worth it when the decision comes.

That means now we can start planning for the website training, so someone can explain to me what they mean when asking what 'platform' I use for the website (I thought platforms were for catching the right train!)

The weather does not know what it's doing today, rain and sunshine both in the last half hour. I will stay indoors a bit longer till I decide what to do with my last day off.

Meetings

Two days ago I met up with Mark Bell, a representative of Sobi who will be marketing Xiapex in Europe and Asia. He seemed nice, keen and had good knowledge of Dupuytren's and the other conditions Xiapex is being trialled or considered for. I am happy to say we have a Peyronie's patient on our side now, as Mark asked if we support patients with PD and for some reason I feel better letting men discuss that amongst themselves.

Sobi is a smaller company than Pfizer but no less committed, and the have some good ideas. They will keep us informed of trial results and published articles and can help finding surgeons who use Collagenase injections if a patient send us a query where to fine one.

 

Then yesterday was the next meeting with Nice, to discuss the finalised scope for Xiapex and the forthcoming multi-technology appraisal, what they want from us in the way of information and help, how they are going about searching for articles and calculating the improved QALY of patients, that kind of thing. I was impressed with the way everyone at Nice now understood the disease, and the meeting was fruitful.

 

We also send a letter to Bapras  http://www.bapras.org.uk/ last week asking them to review and update the information on their website about Dupuytren's. At the moment it states 'Surgery is the only treatment available for Dupuytren’s Contracture' and we would like that adjusting to mention the  different treatments that are available. We shall see what happens.

 

It's been a busy week, but it was constructive. Anna

Language is a difficult thing. I spend some time working on the website again yesterday, and the designer and I speak a very different language, even if it's both based on English. Web language and medical language don't have much in common. But  think we started to find a compromise, and have worked out how to refer to each webpage if I want him to change anything.  I don't say 'the page on Dupuytren's surgery' but just send him the internet link, that way we should both be talking about the same thing.

A big thank you to John who allowed me to use some of his post-surgery pictures on our site. It is always better to know what kind of wound or scar to expect, so it's not too big a shock when the bandage comes off.

Auxilium seems to have found a new European partner, a Swedish firm this time.  I had never heard about them, Swedish Orphan Biovitrum AB or Sobi for short, but being Swedish they may be familiar with the condition? We'll wait and see what changes they make to the advertising and marketing of Xiapex.