Competition and Markets Authority issue Supplementary Statement of Objections into alleged excessive and unfair pricing of liothyronine.

[holyshedballs]

From londonstockexchange.com/exc...

Supplementary Statement of Objections issued

The CMA today issued a supplementary statement of objections ('SSO') to all parties to its investigation into alleged excessive and unfair pricing of liothyronine tablets in the UK.

An initial statement of objections in this case was issued on 21 November 2017. Today's SSO follows the judgment of the Competition Appeal Tribunal in Flynn/Pfizer in June 2018.

The CMA has slightly altered its investigation period, provisionally finding that Advanz Pharma (formerly Concordia) breached UK and EU competition law from at least 1 January 2009 to at least 31 July 2017 by charging excessive and unfair prices for Liothyronine tablets in the UK.

The SSO is also addressed to HgCapital and Cinven, private equity firms and previous owners of the relevant business in the investigation, which is now owned by Advanz Pharma.

Liothyronine tablets are a medicine used in the treatment of hypothyroidism. Between January 2009 and July 2017, the price paid by the NHS for liothyronine tablets rose from £15.15 to £258.19, a rise of 1,605%, while production costs remained broadly stable. During that period, Concordia was the only supplier of liothyronine tablets in the UK.

Further information relating to the investigation is available on the investigation case page.

No conclusion should be drawn at this stage that there has been an infringement of competition law. The parties have the opportunity to make written and oral representations in response to the SSO. The CMA will carefully consider such representations, and the evidence as a whole, before any final decision is taken as to whether competition law has in fact been infringed.

[diogenes Remembering]

You really wonder at the drastic drop in IQs. The UK's T3 is uniquely expensive. Either this is monopoly or we have some rotten chemists. Rocket science?

[holyshedballs in reply to diogenes]

From the brief conversation I had with the chap at the CMA, the case needs to circumvent a decision on another similar but different case involving Flynn/Pfizer. Flynn/Pfizer won that case and it has taken the CMA 6 months to overcome those appeal decisions in the current liothyronine case. It is encouraging in that they have not abandoned the original case but have added other companies to the case. To me, that infers that they believe the case is strong, so strong that they can go further than Concordia.

The unfortunate thing is that it takes so long to bring the case, allow for the companies to have their reply and then issue a declaration. Plus there is also the prospect of an appeal to drag out the case further.

May be efforts should be made to direct the NHS to cheaper suppliers during course of this case. It seems unfair that the company can still charge astronomical prices during an investigation, but they can still charge the prices until they have been found "guilty".

[m7-cola in reply to holyshedballs]

Absolutely! And what’s wrong with the NHS purchasers?

[MaisieGray in reply to m7-cola]

m7-cola Can you clarify to which NHS purchasers are you referring? In terms of the High Street pharmacists ie not hospital dispensing, there is no NHS involvement until the pharmacy submits its request to the NHS to be reimbursed for the med it has bought and dispensed against a prescription. To that point, its a purely commercial trail from manufacturer, to importer and/or wholesaler as appropriate, to pharmacy.

[MissGrace in reply to MaisieGray]

I think m7-cola may be referring to details the initial post:

‘Between January 2009 and July 2017, the price paid by the NHS for liothyronine tablets rose from £15.15 to £258.19, a rise of 1,605%, while production costs remained broadly stable. During that period, Concordia was the only supplier of liothyronine tablets in the UK.’

This makes it sound like the NHS pays for the medication. Can pharmacies buy it from anywhere then? So if they bought Thybon from Germany, would that mean they would cost the NHS less when they were reimbursed? Does that mean it’s the purchasers at the pharmacy that lack imagination in this one? Not sure how it works. (I know it feels wrong though!) 🤸🏿‍♀️

[MaisieGray in reply to MissGrace]

MissGrace "So if they bought Thybon from Germany, would that mean they would cost the NHS less when they were reimbursed? Does that mean it’s the purchasers at the pharmacy that lack imagination in this one? Not sure how it works".

If a pharmacist chooses to source say, Thybon Henning in order to fulfill a specific prescription, he is dependent on his wholesaler to access it on his behalf, in exactly the same way as any other drug. However, how a drug is ultimately reimbursed for, depends entirely on how it is categorised within the NHS Drug Tariff framework. If for example, it is classified with drugs with the same active ingredient, or for the same purpose, in the same category/tariff, it will be reimbursed in the same way as the others. So certain categories/tariffs of drugs will be reimbursed at a certain rate, irrespective of how much has been paid for it, at its wholesale price. Therefore it's in the pharmacist's interest to enter into purchasing arrangements with their wholesaler, to get the best price, and then their return is greater, or may even make the difference between profit or loss, depending on market rates. Other drugs may be reimbursed differently; and in addition, the NHS might for instance, deduct an automatic discount from the reimbursed amount, in anticipation that the pharmacist will also have secured a discounted price, even if he hasn't. Conversely, if a pharmacist has to buy a larger amount of the drug, in order to dispense the smaller amount prescribed, he will be paid in full, in anticipation that the rest may be dispensed at a later date, and so he couldn't then submit a further request for reimbursement. It is a very complex set of rules. It's nothing to do with the pharmacist lacking imagination, but that they are running a business which at it's simplest, is like any other retailer, they buy stock in and sell it on, the only difference being that instead of the customer paying the full price of the goods, they pay part of it (the prescription charge, unless they are exempt) and the NHs later pays the remainder.

[holyshedballs in reply to MaisieGray]

This document details NHS procurement of drugs in 2017

sps.nhs.uk/wp-content/uploa...

[MissGrace in reply to holyshedballs]

So it is NHS led then. Thanks. 🤸🏿‍♀️

[MaisieGray in reply to MissGrace]

No, people are getting confused. That paper refers to the procurement of drugs for acute care, which is what I indirectly referred to in my previous post viz "ie not hospital dispensing". In primary care, the NHS does not source routine meds such as thyroid hormones etc. The drugs are manufactured, they are purchased by wholesalers who may or may not also be international importers, and the pharmacies then buy from the wholesalers to maintain their stock of drugs for dispensing against NHS prescriptions, to individual patients. When a prescription is dispensed, the pharmacist, or dispensing contractor in NHS-speak, may then submit a request to the NHS for reimbursement of the money he has expended in purchasing the drug himself, and the costs of providing the service ie in effect, his professional and business overheads. He does this within the national Drug Tariff Framework. There is no NHS purchasing in that process; only reimbursement of the pharmacists at the end point. Separately, and to what that paper refers, secondary and acute treatment will require servicing with drugs &etc, which will be resourced from within the NHS; but not routine dispensing in primary care, of such as our meds.

[Hidden in reply to diogenes]

Follow the money

Liothyronine Sales, Price Analysis, & Sales Forecast – 2017

researchandmarkets.com/repo...

Liothyronine Market - Global Trends, Market Share, Industry Size, Growth, Opportunities and Market

researchcorridor.com/liothy...

Thyroid Gland Disorders Treatment Market (Disorders - Hypothyroidism (Levothyroxine and Liothyronine) and Hyperthyroidism (Imidazole and Propacil)) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2017 - 2025

[crimple]

it just beggars belief that we can buy from Germany or France from legitimate pharmacies for £30 equivalent that costs NHS£1000. I really feel like shaking someone very hard in the hope it might knock some sense into the situation. The worst thing about this is that those of us who can negotiate the European websites and have the necessary funds to pay our own way are enjoying better health than others on this site who cannot afford to buy abroad. So much for equality of health.

[Hashihouseman]

So the NHS accountants were happy to allow prescribing of T3 until the price went up then they conveniently cobbled together 'lack of evidence' of clinical need - what they should have done is hammered the supply chain back into shape. A sign that it is accountants and managers telling ignorant medics to bend to their will, instead of the other way around.

[MaisieGray in reply to Hashihouseman]

I don't think that's an accurate representation of the situation. UK Drs have been anti or confused about the necessity/benefit of medicating with T3 for many years, even before any price increase wasconceived. My GP was being advised 12/13 years ago by the local hospital's Consultant Pharmacologist (not just an Endo) that liothyronine should only ever be prescribed, was only ever needed, in critical cases of myoedema coma or crisis, and only within ITUs; and never for routine management of hypothyrioidism in primary care - at a time when there had been NO price hikes of any description. I forget the actual figure, but at the time a friend showed me the respective price of Levo and liothyronine within MIMS (she is a qualified Nurse but more latterly an award-winning pharmaceutical agent) and I remember her pointing out that T3 cost a little more than T4 at the time, but it wasn't astronomical as it is now. It is only in the past few years that Concordia's dramatic inflation of the price of its liothyronine sodium has taken place, and it has happened independently of, and subsequent to, years during which Drs were being indoctrinated by poor training, coupled with a dearth of research to prove otherwise, and Drs have generally continued to be misinformed ever since, not least because of their professional advisors reinforcing erroneous beliefs. At one point, when there was no stock due to alleged manufacturing difficulties, and our T3 was sourced by pharmacists on an emergency basis from France, Concordia made a case for certain of its price rises being acceptable due to the creation of a new manufacturing facility to address its problems, this was accepted and endorsed; which would seem to be evidence of the intention to continue prescribing it. Whilst Finance Directors might advise on the general need to make budgetary adjustments, they would not have the authority to make unilateral clinical decisions. However it is not the function nor remit of the NHS to involve itself in the pharmaceutical "supply chain", that is vested in other agencies such as NICE for assessing value for money of new drugs, and the Pharmaceutical Pricing Regulation Scheme (PPRS) which also plays a role in controlling the price of branded drugs, for instance.

[Hashihouseman in reply to MaisieGray]

And yet the latest RMOC statement which firms up the negative stance does coincide with the price increases doesn’t it? And finance managers I know in the NHS do ‘influence’ reviews and policy under the supposed VFM arguments. Cost is of course a consideration but it should never be used as the motive for expediency in assessing evidence or selective presentation of research findings. Bias is rife! Where oh where does any clinician find actual direct evidence that replacing failed thyroidal output with physiologically normal levels of T3 isn’t appropriate?