Some time ago (September!!!!) I wrote to Concordia a long mail with lots of points and research articles in it but ultimately I asked the following very specific questions:
1) When will the “significant reduction” in cost of Liothyronine put into action? Are we talking weeks, months or years or a specific date?
2) What specifically in the manufacturing method makes your UK price of T3 5000% more expensive than most non-UK suppliers?
.... Today after months of me chasing them down they finally responded with the below! Thought you all would be interested to read it ........ thoughts welcomed in comments!
“Dear Pamela,
Thank you for your email.
First of all let me apologise for the delay in responding to the remaining parts of your enquiry.
We have checked and have received confirmation that NHS England has never banned or black listed liothyronine. Whilst the recently issued guidelines from NHS England stated that “prescribers in primary care should not initiate liothyronine for any new patient” it went onto clarify that “prescribing of liothyronine for any new patient can be initiated by a consultant endocrinologist in the NHS”. We were also pleased that, following its recent consultation in the Autumn, NHS England issued its view on the de-prescribing of liothyronine in existing patients stating in the guidelines that “de-prescribing in all patients was not appropriate”. This latest NHS England recommendation is consistent with the existing clinical guidelines issued by NICE which states “Combination therapy with LT4 and LT3 may be considered by endocrinology specialists as an experimental approach in people who have persistent symptoms despite compliance with LT4 treatment and a TSH value in the normal range”.
Therefore, in terms of your key concerns about ongoing supply, please be assured that liothyronine tablets are still available as a reimbursed prescription medicine in the UK market. Your doctor and/or specialist would be best suited to advise your treatment options, and to explain the prescription and reimbursement system, and we strongly recommend for you to speak to them directly.
In terms of the questions that you have raised about the complexity and cost of Liothyronine:
· Liothyronine 20mcg is a very old and complex product and due to its potency, requires only a very small quantity of active ingredient in each tablet. This makes manufacturing the medicine, and in particular achieving consistency between tablets, complex and difficult. The MHRA have been particularly interested in these issues in recent years and in 2012 the MHRA declared special interest in both levothyroxine and liothyronine, following the suspension by the MHRA of a levothyroxine marketing authorisation of a major supplier in the UK. Since that date, we have been working closely with the MHRA on the manufacturing process. In addition, all our batches of liothyronine produced have only been released after individual batch approval by the MHRA with a Batch Specific Variation (BSV). This requires compilation of analytical results and preparation of quality and medical expert statements which are submitted to the MHRA to justify the release of every batch. These have meant significant additional time and financial investment.
· As part of this work, the MHRA requested that we modernise the manufacturing process and update the analytical tests in accordance with their new standards. This remains an expensive, complex and time-consuming process. It has involved us revisiting the manufacturing process in detail and working with our contract manufacturer which has arranged a 5-year project to build a completely new facility in order to meet these modern quality and manufacturing standards. Liothyronine will be among the first wave of products transferred to this new facility once it is complete. All this has had a significant effect on our prices, which are now at a level broadly similar to the price of branded Liothyronine (Cytomel®) in North America.
· We have therefore been investing significantly in recent years in keeping liothyronine (and levothyroxine) available for UK patients. As a responsible manufacturer we have worked closely with the UK’s MHRA and have invested heavily in seeking to manufacture in the way that they want us to do. As far as we are aware, the special focus on Liothyronine specifications and manufacturing that has been required by the MHRA in the UK is above and beyond the regulatory requirements elsewhere in Europe and the rest of the world.
· In terms of prices in the UK, the UK’s Department of Health have created one of the most effective generics markets where competition drives down selling prices and where generic medicines are estimated to save the NHS over £13billion each year. Indeed, NHS spending on medicines from generic manufacturers, such as Concordia, represents only 1% of the NHS’ total annual expenditure (£122.6billion in 2016/17). In terms of our Concordia medicines, the average price in the UK is only £6. There are now three suppliers of liothyronine tablets in the UK and in the few months since their introduction we have seen our selling prices fall. We assume that this will flow through to a reduction in the reimbursement price for liothyronine (which is the price paid by the NHS). However, as the Department of Health controls reimbursement prices through the Drug Tariff system, we are not able to speculate on exactly how or when the price paid by the NHS will change.
With regards to your comment on the cost of liothyronine in the rest of Europe, and as mentioned above, as far as we are aware, the special focus on Liothyronine specifications and manufacturing that has been required by the MHRA in the UK is above and beyond the position elsewhere in Europe and the rest of the world. We understand that it is for that reason that the MHRA has not permitted those medicines to be licensed and sold here.
Lastly, we confirm that the DoH have never approached Concordia with any concerns about Liothyronine prices. The increase in liothyronine prices have occurred openly and transparently over the past ten years as the costs of keeping this medicine available for UK patients have increased. Each price application has been submitted in advance to the DoH and prices were not increased until we had received acceptance back. As you can imagine, this remains one of the points of strong discussion with the Competition and Markets Authority (CMA).
I hope this answers your questions. Please feel free to contact me for further information.
Thank you.
Regards,
Medical Affairs Team”
Written by
Pamela0106
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Well - that says it all. Don't care if liothyronine can be sourced elsewhere at a far cheaper cost. That liothyronine was only removed due to cost - nothing else.
No thought given to patients for whom levothyroxine is not suitable (not 'suitable' meaning that the patient doesn't improve on levothyroxine at all) and who also develops far more clinical symptoms. Unable to be free of clinical symptoms as it has been proven by researchers that most patients benefit from T4/T3 or T3 only.
They also withdrew NDT a few years ago from being prescribed, due to False Statements being made about it
Despite three yearly reminders (of the above link) before Dr Lowe's untimely death - they ignored it because they had no scientific answers to oppose it.
Never mind that many patients recovered on NDT and now source their own as many on T3 have had to do out of desperation- suddenly withdrawn without one iota of consideration of the patients. It is well seen that males seem to be the majority in the Endocrinology and none seem to have hypothyroidism who cannot recover on levo.
How much has Big Pharma contributed towards Associations? I hope none at all as that could be deemed 'persuasion'.
We have read many times of members pinning their hopes on a Consultation with an Endocrinologists only to leave deflated by the arrogance of many, which is a shame as we do want a good relationship with our doctors but when they cannot and do not listen to whom do we turn. Help Groups and slowly learn that 'YES' we can get well - we don't have to lose our jobs or homes our relationshipis- but we don't have doctors willing to champion the 'CAUSE' like Dr Skinner who lost his life trying to open the closed minds of those who should have a readiness to 'learn and listen'. Listening is a good trait as closed ears learn nothing and therefore no progress.
I’m really concerned that the CMA are going to have a job on their hands of proving that “provisionally guilty” ruling on anything to do with Liothyronine IF what Concordia say is true that the MHRA and DOH were fully consulted throughout the entire process.
If the DOH approved the prices individually each time then Concordia are surely in the clear and the blame needs to be sought elsewhere.
What’s the DOH agenda here? To allow the price hike so they have an excuse to get rid of Liothyronine because closed minds don’t believe it’s of any use?
The DOH are not paying the money from their personal bank so it seems to be immaterial to them to source the best possible medications at reasonable prices. I don't think the UK T3 is 'a Brand Name' but generic and generics cheaper than brands.
I don't suppose you are surprised at the self-serving Bullsh*t! If what they said about MHRA requirements was true prescribing of European Liothyronine would never have been approved when there was a shortage of Mercury Pharma Liothyronine a few years ago.
1. The price of liothyronine has been hiked since Tertroxin was debranded, long before any claimed improvements were introducted.
2. Concordia do not make liothyronine tablets. This is done by Custom Pharmaceuticals, a manufacturer of low cost drugs.
3. UK liothyronine is inferior to European liothyronine. It's not even bubble packed. The tablets are unstable, decrease in potency after opened and tablets crumble.
4. I did an FOI request, there have been 17 'type 2' (severe) Batch Specified Variations over the past five years. This essentially the batch was allowed through. They need these batch variations because the tablets do not meet specification.
5. On 29/04/2014 the shelf life was reduced from 36 to 24 months and on 31/03/2016 reduced from 24 to 12 months. There was no notice to patients that shelf lifes were reduced, no recall of issued tablets.
6. Concordia have also hiked the prices of other medications such as hydrocortisone. Alleged changes in liothyronine have nothing to do with these price hikes.
7. The DoH do not autorise prices, it's misleading to imply they are getting approval from the DoH.
I will be away for a while, when I have time I will be submitting a complaint to the CMA about the three companies operating a cartel. It's no coincidence they are all charging the same price. I would urge everyone to contact the CMA and keep the pressure up. The CMA needs this patient involvement to strengthen their case.
I would say that the shelf life of Liothyronine has been reduced even further... My last prescription, which I picked up last week, expires on 04/04/2018... That's less than 3 months!!! How do they excuse that, especially when the Unipharma and Cynomel I've received from both Greece and Mexico have a two year expiry date? This response from Concordia is the biggest load of b*llocks I have heard for a long time. They manufacture nothing and they're just releasing old stock they have sitting on their shelves as and when needed... They're no more than a bunch of liars and I'm sure that they're very happy at the outcome of the NHS consultation on Liothyronine...
I suspect some wholesalers who were aware of the progression of the price increases stocked up whilst it was cheaper and are now selling at a greater margin. The shelf life is one year but old batches may be around because so many patients have been taken off it.
That reply from Concordia makes me want to march like the women in USA. They are marching for all types of women's issues, altogether. This whole T3 issue is becoming so massive, ---- I have mentioned Emmeline Pankhurst previously, something drastic would have to be done to change this
Their spin doctors have been working overtime. Surely Concordia has abused its monopoly by raising prices so much, whether or not the DOH is good at negotiating.
I keep hearing about pharmaceutical companies lobbying parliament. Maybe we could do the same- a mass lobby? If we all arrange to visit our MPs on the same day?
Liothyronine 20mcg is a very old and complex product and due to its potency, requires only a very small quantity of active ingredient in each tablet.
very old - in many areas of activity, something that is very old is also very well known. All the issues can have been identified, addressed and resolved.
requires only a very small quantity of active ingredient in each tablet - a liothyronine tablet contains 20 micrograms. The smallest levothyroxine tablet from Concordia is 25 micrograms. Is that such a hugely different amount that it qualifies as an excuse?
That response seems to me to accept that they have been unable to manufacture their liothyronine tablets to an acceptable standard for many years. Quite possibly, forever. Yet it has, it seems, taken specific MHRA interest to get things moving towards an acceptable product. And they have been happily accepting NHS money for that substandard product.
We cannot at this point know for sure, but I suspect that the Yellow Card reports filed by quite a number here could well have had more impact than we were aware of. I know that many have criticised the MHRA, and possibly they deserve some of that, but I think we also have to accept that sometimes they have to move quietly and we don't always get to know.
Please everyone:
Keep filing Yellow Card reports when you consider it appropriate.
I am checking up on the T3 here in France that I buy every four weeks over the counter. I will try to find out more about the process.
The point is this why should the NHS have to pay grossly overrated prices when it should be made clear that the makers of this product should have modernised their process plant for the future as a matter of course the same as any other business would do.
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Competition and Markets Authority issue Supplementary Statement of Objections into alleged excessive and unfair pricing of liothyronine.
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