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!
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.
Medical Affairs Team”