Anyone else approved for Libre 3?

[barrym]

In reply to @Proud to be erratic , I would say a) lobbying anyone can only do good, and b) I don't think Abbott are supplying the local Trust, but the patient directly and billing NHS.

I have written to my endo again explaining that 'yet another lucky soul' has got L3, and explained how it happened and how the process worked, so hopefully she will look at it. She had told me that the route via the Supply Chain was labour intensive and not sustainable by her team. Doesn't sound like it to me.

 

[BadaBing]

I wonder if @BadaBing can throw any light on this anomaly?

Hello, I hope everyone is enjoying the Bank Holiday.

I can tell you as much as I have gleaned from my consultant, my DSN (who appears to be very clued up on the processes) and what I know is happening with the Dexcom versus Abbott glucose monitor wars.

Of course only Abbott and the NHS England diabetes co-leads really know what’s going on for sure.

My DSN told me that in my local health area ultimately it is the integrated care system ("ICS") (the former clinical commissioning group) in primary care that pays for any diabetic who is given a Libre 3 sensor following a recommendation by their consultant in secondary care.

My DSN would have to complete a 12(?) page blue coloured form saying I would benefit from having a Libre 3 and request funding for the sensors from my ICS. That form is then passed to my GP. If my ICS has agreed the Libre 3 can be funded by primary care, My GP will countersign the form. If not, he won't sign the form.

I would be very surprised if in the majority of cases the ultimate payer (in England) of the Libre 3 sensors isn't your local ICSs.

Financially an ICS is no different to a local council. Legally they are required to balance their budgets each year, and HM government will come down on ICSs like the metaphorical ton of bricks if they fail to balance their budgets. Many ICSs have carried over substantial debts from when they ceased being CCGs on 30 June 2022.

There has been lots of speculation about how much the NHS is paying Abbott for each Libre 3 sensor. I have no idea and neither my consultant nor my DSN know (or if they do, they won't tell me). The last speculative figures I saw (on another forum) was that a 12 month supply of Libre 3 sensors cost roughly £1,800. If that figure is correct, it means (I think) the cost of one Libre 3 sensor is broadly the same as a Dexcom G6 sensor.

If the figure above is correct, you can imagine why ICSs in England have been tortoise-like in authorising GPs to countersign that 12 page blue form!

Based on the latest NICE guidelines for continuous glucose monitors, and a pan-London ICS document (agreed and signed off reportedly by all London ICSs last October/November 2022) to implement the latest NICE guidelines, my consultant and DSN believe I may be eligible to have a Libre 3. My DSN is waiting for my local ICS to put the Libre 3 on a "local" list that will then allow her to complete that 12 page blue form and allow my GP to countersign that form so I can get the Libre 3 sensors (directly from Abbott).

Three or four weeks ago, whilst responding to a tweet (not from me) asking when the Libre 3 would be available "normally" on prescription, Professor Partha Kar, one of the NHS England diabetes co-leads, confirmed the Libre 3 was not available on prescription at present. Professor Kar indicated in his tweet that he was working to try to get the Libre 3 on "normal" prescription like the Libre 2, and Professor Kar said, basically, "watch this space."

Professor Kar also responded to a tweet (again not from me) several weeks earlier indicating that Abbott hadn't applied for the Libre 3 to go on the national formulary. He did not explain why Abbott hadn't done so.

If the £1,800 figure for 12 months supply of Libre 3s is right, Abbott will need to lower that price substantially, or very few ICSs will authorise their GPs in primary care to prescribe a Libre 3 sensor to patients.

Newspaper articles and other forums suggest there have been supply issues for the Libre 3 in Germany and the US over recent months. Abbott is building manufacturing facilities in Ireland to ramp up supply of the Libre 3 in Europe. Unfortunately those new manufacturing facilities aren't due to be operational for many months.

Dexcom and Abbott are also suing each other in Germany, the UK and USA for patent infringement concerning the technology in their respective glucose sensor monitoring products. Assuming the parties don't reach a settlement beforehand, a first instance judgement in the UK proceedings should be issued at some stage this year. Of course, if the initial judgement is appealed all the way to the UK Supreme Court it could be 2024/25 before there is a definitive final judgement.

In Germany all Libre 2 users were contacted by Abbott and moved to the Libre 3 sensors because of the patent litigation that is ongoing between Dexcom and Abbott. I also understand that in Italy Abbott is supposed to have rolled out Libre 3 more quickly because of the dispute with Dexcom.

So one wonders what might happen in the UK if Dexcom prevails and the Libre 2 is found to infringe Dexcom's patents.

The ongoing litigation may (only may) have affected the Libre 3 being more widely available via prescription.

 

[BadaBing]

My DSN is waiting for my local ICS to put the Libre 3 on a "local" list that will then allow her to complete that 12 page blue form and allow my GP to countersign that form so I can get the Libre 3 sensors (directly from Abbott).

P.S. where I referred to the Libre 3 being put on a "local" list, I believe it is the NHS's ICS's local "blueteq" list which I understand is the software system the NHS uses to approve and manage "high cost" medicines and medical devices.

 

[MarkGeordie]

Update -

Took delivery today.

My portal has all scheduled delivery dates already there and they are dispatched automatically.

I get 6 at a time.

Funding end date is early 2025.

Not sure what they do after that.

Observations -

The sensor is smaller as I think we already knew.

The boxes they come in are a lot smaller as there isn’t as many things to be used.

Not as many things to be used as you no longer have to open two separate pieces and connect them together before applying.

It’s already all together, you just unscrew and apply.

Hope that makes sense?

Would people like some pictures?

 

[Proud to be erratic]

Update -

Took delivery today.

Great news for you and offers a light at the end of a tunnel for others (precedent established!).

My portal has all scheduled delivery dates already there and they are dispatched automatically.

I get 6 at a time.

Interesting. Still from repeat prescriptions, or auto delivery from Abbott? We're you previously getting just 2 x L2s at a time? Anyway, 6 makes sense; this monthly remit to submit repeat prescriptions is yet one more hassle from living with D and unnecessary. Given the digital controls that are already in place it really isn't so difficult to regulate against excessive use of sensors.

Funding end date is early 2025.

Not sure what they do after that.

Observations -

The sensor is smaller as I think we already knew.

The boxes they come in are a lot smaller as there isn’t as many things to be used.

Not as many things to be used as you no longer have to open two separate pieces and connect them together before applying.

It’s already all together, you just unscrew and apply.

Hope that makes sense?

Would people like some pictures?

What would (or could) become useful is finding out what your L3 sensors are costing your GP's (or the ICS) prescription budget.

That might be possible to find courtesy of your GP Surgery Pharmacy services [even if you have no in-house Pharmacy all Practices have access to a Pharmacy advisory service which advises on availabilities and other prescribing matters and should be able to see the computer listing of what your L3 is costing the GP allocated prescription funds]. Or, if not in house, your local chemist should be able to see the L3 listing on the ICS Formulary and its cost. Knowing what L3 is (on paper) costing one ICS, might provide a lever to get a no-cost or low-cost swop from G6 or G7 into L3.

 

[MarkGeordie]

Just to clarify, they come direct from Abbott and I have an account on their Libre 3 portal.

No repeat prescription needed at this stage.

Previously my GP would prescribe me x4 of Libre 2 each time I ordered.

I will do my best to investigate costing.

 

[everydayupsanddowns]

No repeat prescription needed at this stage.

Previously my GP would prescribe me x4 of Libre 2 each time I ordered.

Libre 3 is not a regular prescription item - it‘s in the same funding pathway as insulin pumps and rtCGM like Dex 6, Dex 7 and Medtronic G4. Your health authority has to enter into a contract with the manufacturer - it isn’t something GPs or non-specialist Drs can prescribe.

Self-funding for Libre 3 may become available at some point (as you an with Dex 6/7 and Medtronic G4), but I wouldn’t like to guess when!

@curlygirl was asking about Libre3 recently, so I‘m sure will be interested in how you find it 🙂

 

[curlygirl]

As @everydayupsanddowns said I am looking at trying to get the libre 3. The nurse said she thinks it would be good but she needs to get the consultant to agree so...
If you could tell me the size of the sensor, the plastic bit not the tape around it I would be interested to know the dimension @MarkGeordie. Also when you have used it for a bit I wonder if it stays on as well with the adhesive area being less? I find the libre 2 stays well stuck and just lifts towards the last few days. The good thing about the 3 is it will not get caught on things as much...
Hope you get started and find it helpful.

 

[Proud to be erratic]

Libre 3 is not a regular prescription item - it‘s in the same funding pathway as insulin pumps and rtCGM like Dex 6, Dex 7 and Medtronic G4. Your health authority has to enter into a contract with the manufacturer - it isn’t something GPs or non-specialist Drs can prescribe.

Self-funding for Libre 3 may become available at some point (as you an with Dex 6/7 and Medtronic G4), but I wouldn’t like to guess when!

@curlygirl was asking about Libre3 recently, so I‘m sure will be interested in how you find it 🙂

Thanks @everydayupsanddowns . Does this mean that each local authority could theoretically negotiate a different price, or are they setting up a delivery arrangement paid by them but against a price already agreed with NHS Contracts Branch. The whole process feels remarkably "opaque" for procurement by a public body - which I would expect to ultimately comply with the Treasury Rules for procurement. Those rules are pretty tedious (and do not always provide the optimum solution) but do reduce the opportunities for fraud and/or corruption where taxpayers money and public accountability is involved.

 

[BadaBing]

Thanks @everydayupsanddowns . Does this mean that each local authority could theoretically negotiate a different price, or are they setting up a delivery arrangement paid by them but against a price already agreed with NHS Contracts Branch. The whole process feels remarkably "opaque" for procurement by a public body - which I would expect to ultimately comply with the Treasury Rules for procurement. Those rules are pretty tedious (and do not always provide the optimum solution) but do reduce the opportunities for fraud and/or corruption where taxpayers money and public accountability is involved.

My understanding is that - unlike drugs - there is no formal mechanism for the pricing and reimbursement of branded medical devices in the UK. In practice, however, - like drugs - price negotiations are done centrally by HM government, through the Department for Health and Social Care (in England through NHS England).

Which is what Professor Kar and his NHS England negotiators have been doing over recent months for hybrid closed loops.

Theoretically each integrated care system could negotiate a price separately for medical devices, but it wouldn't be a good or efficient way of getting best value for taxpayers who are providing the funds centrally from HM government/HM Treasury.

 

[everydayupsanddowns]

Thanks @everydayupsanddowns . Does this mean that each local authority could theoretically negotiate a different price, or are they setting up a delivery arrangement paid by them but against a price already agreed with NHS Contracts Branch. The whole process feels remarkably "opaque" for procurement by a public body - which I would expect to ultimately comply with the Treasury Rules for procurement. Those rules are pretty tedious (and do not always provide the optimum solution) but do reduce the opportunities for fraud and/or corruption where taxpayers money and public accountability is involved.

CGM used to be made available via IFA - Individual Funding Arrangements between your CCG (not called that any more) and the device manufacturer.

Pricing seems more mysterious. I know that NHS England centrally negotiated a cheaper-than-list price for Libre2 as part of getting that available via prescription.

I have also heard rumours over the years of particular local health authorities pretty much only prescribing one variety of insulin pump (or BG meter… or… or…) because they had negotiated a cheaper price - but I don’t actually know if this happens, or is just said to happen!

To have individually negotiated prices for every clinical/prescription item in every different geographical area of the UK seems like a huge amount of duplicated effort!

 

[Proud to be erratic]

To have individually negotiated prices for every clinical/prescription item in every different geographical area of the UK seems like a huge amount of duplicated effort

Thank you. I agree that individual negotiations seems like a huge amount of duplicated effort and I'm really surprised that NHS England is permitted to do this by the Treasury - unless the NHS England Contracts Branch is in that negotiating chain. I have seen an arrangement in the "service industries" where England has been split into 3 or 4 regions - to take account of different labour rates; eg for grounds maintenance contracts. But never saw this for relatively straightforward "supply".

Judging by the lack of hands on involvement by NHS England in the Libre contract I do wonder if somehow the NHS sits outside the Treasury Rules ... but I struggle to believe that Parliament's Public Accounts Committee (PAC) tolerate that.

I also struggle to believe the Treasury formerly allowed CCGs to negotiate their own IFAs, rather than a CCG using a call-off contract and the only difference would be in the IFA detail of who the supplier sends the bill to, with perhaps limitations or constraints on quantities or such-like; then the CCG had an element of control (including forecasting and budget allocation) over its monthly/ quarterly/ annual bill. Inevitably the financial aspect dominated, never the quality or suitability of the end product; its why I retired with very little hair left!!

It had been my experience that whenever there was a supplier dealing directly with an individual recipient somehow individuals found mechanisms for taking advantage of this to 'cheat' or stretch the rules (perhaps at first with the best of intentions); and cheating meant fraud, with fraud meaning 'theft that would always be prosecuted'. Over 20 years from the 80s to the 00s, I saw periodic tweaking of the Treasury Rules, usually just after yet another defrauding that the media found helpful on a quiet news day.

I can understand CCGs or today's ICSs setting up unique contracts for items such as Radiology equipment - where the core cost is very high, but the installation cost is also high and any one building might have very different needs to make it suitable. Then each item supplied is financially complex as well as probably involving multiple 'stakeholders'.

Anyway, this is a long way from Libre 3. I was just hoping to see some clarity emerging about costs!

 

[BadaBing]

@Proud to be erratic, it sounds like you have extensive experience of how HM Treasury works.

Thank you. I agree that individual negotiations seems like a huge amount of duplicated effort and I'm really surprised that NHS England is permitted to do this by the Treasury - unless the NHS England Contracts Branch is in that negotiating chain. I have seen an arrangement in the "service industries" where England has been split into 3 or 4 regions - to take account of different labour rates; eg for grounds maintenance contracts. But never saw this for relatively straightforward "supply".

I just don't see how HM Treasury could have the necessary scientific/technical expertise to be that closely involved in the nitty gritty of negotiations about the pricing and "value added" of a branded medical device (which the pharma companies will say they have spent upwards of US$1 billion researching and developing, testing and obtaining regulatory approval for and bringing to market).

Surely that "expertise" and proper evaluation of the "value" of medical technology resides squarely under the bailiwick of NHS England, NICE and the MHRA, no?

I have always equated HM Treasury as being akin to the accounts department of any publicly listed company in terms of paying suppliers. However, I assumed every UK government department is allocated a pot of cash each financial year and it is up to each government department to decide how that cash is spent from an accounting standpoint.

Judging by the lack of hands on involvement by NHS England in the Libre contract I do wonder if somehow the NHS sits outside the Treasury Rules ... but I struggle to believe that Parliament's Public Accounts Committee (PAC) tolerate that.

Parliamentary Committee's are creatures of the Blair(?) government from 2008 onwards. In theory they oversee and examine the work of government departments and can make recommendations. However, under our British constitution, (sometimes regrettably) Parliamentary Committees have no power whatsoever to compel new policy, laws nor changes to how government departments function.

The British people elect a government and that government - alone - is entitled constitutionally to proceed with its policy agenda as set out in its election manifesto, to make laws and run government departments how they see fit.