Had a read of the NICE Guidelines - it's quite revealing...

tim2000s

Expert
Retired Moderator
Messages
8,934
Type of diabetes
Type 1
Treatment type
Other
There is a lot of discussion amongst T1s about a lot of aspects of care, but one of the most interesting for me is the choice between Levemir and Lantus. Having a spare 30 mins< I thought I'd read the NICE guidelines for Diabetic care, and it reveals a great deal with regard to why certain insulins are selected by GPs/Clinics.

The NICE Guidelines name only NPH and Glargine specifically. There is no mention of Detemir (Levemir) anywhere.

The key recommendation for me from the guideline is R50, which states:

R50 Adults with Type 1 diabetes should have access to the types (preparation and species) A of insulin they find allow them optimal well-being.

As far as I am concerned, this is a legitimate argument for being put onto Degludec.

On the topic of Metformin, the basis of the reasoning for very few T1s being put on it is that there is limited evidence of lowered Hba1C when using Metformin. it is therefore not normally prescribed in the UK, wrongly or rightly, due to R65:

Oral glucose-lowering drugs should generally not be used in the management of adults D with Type 1 diabetes.

On the topic of CGMs, the reason for a complete lack of any of the technology in this area being properly identified is that there has not been a study or enough evidence collected that demonstrates that over the long term, CGMs can have a statistically significant effect on long term diabetes management, indeed the statement is:

However, none of these studies address viable outcomes of glycaemic control or long-term use.

It is recognised as having short term benefits, however, I think we as a community now have a way of providing a proper level of research. The current recommendation is:

Continuous glucose monitoring systems have a role in the assessment of glucose B profiles in adults with consistent glucose control problems on insulin therapy, notably:
● repeated hyper- or hypoglycaemia at the same time of day
● hypoglycaemia unawareness, unresponsive to conventional insulin dose adjustment.


There are now avast number of Libre and Dexcom users. If we could pull the data together and show improvements over the course of 12-24 months, it would provide a body of evidence that could be persuasive.

Having read through the guidelines, I can understand the reticence of the healthcare bodies to prescribe anything useful. NICE needs evidence. We as a community are uniquely positioned to provide that evidence, and I, for one, am up for trying to provide it. Is anyone else?
 
  • Like
Reactions: 9 people

AndBreathe

Master
Retired Moderator
Messages
11,320
Type of diabetes
I reversed my Type 2
Treatment type
Diet only
There is a lot of discussion amongst T1s about a lot of aspects of care, but one of the most interesting for me is the choice between Levemir and Lantus. Having a spare 30 mins< I thought I'd read the NICE guidelines for Diabetic care, and it reveals a great deal with regard to why certain insulins are selected by GPs/Clinics.

The NICE Guidelines name only NPH and Glargine specifically. There is no mention of Detemir (Levemir) anywhere.

The key recommendation for me from the guideline is R50, which states:

R50 Adults with Type 1 diabetes should have access to the types (preparation and species) A of insulin they find allow them optimal well-being.

As far as I am concerned, this is a legitimate argument for being put onto Degludec.

On the topic of Metformin, the basis of the reasoning for very few T1s being put on it is that there is limited evidence of lowered Hba1C when using Metformin. it is therefore not normally prescribed in the UK, wrongly or rightly, due to R65:

Oral glucose-lowering drugs should generally not be used in the management of adults D with Type 1 diabetes.

On the topic of CGMs, the reason for a complete lack of any of the technology in this area being properly identified is that there has not been a study or enough evidence collected that demonstrates that over the long term, CGMs can have a statistically significant effect on long term diabetes management, indeed the statement is:

However, none of these studies address viable outcomes of glycaemic control or long-term use.

It is recognised as having short term benefits, however, I think we as a community now have a way of providing a proper level of research. The current recommendation is:

Continuous glucose monitoring systems have a role in the assessment of glucose B profiles in adults with consistent glucose control problems on insulin therapy, notably:
● repeated hyper- or hypoglycaemia at the same time of day
● hypoglycaemia unawareness, unresponsive to conventional insulin dose adjustment.


There are now avast number of Libre and Dexcom users. If we could pull the data together and show improvements over the course of 12-24 months, it would provide a body of evidence that could be persuasive.

Having read through the guidelines, I can understand the reticence of the healthcare bodies to prescribe anything useful. NICE needs evidence. We as a community are uniquely positioned to provide that evidence, and I, for one, am up for trying to provide it. Is anyone else?

Forgive me for not looking them up myself, but are those guidelines you quote the current ones or the proposed new ones that are just our our about to go out for re-comment, due to the number of changes (for T2s)?
 

tim2000s

Expert
Retired Moderator
Messages
8,934
Type of diabetes
Type 1
Treatment type
Other
Forgive me for not looking them up myself, but are those guidelines you quote the current ones or the proposed new ones that are just our our about to go out for re-comment, due to the number of changes (for T2s)?
This is the T1 ones from 2004. The newer ones include Detemir and we should see that cause a significant change in prescribing (for T1s at least). The other aspects show little difference.
 

AndBreathe

Master
Retired Moderator
Messages
11,320
Type of diabetes
I reversed my Type 2
Treatment type
Diet only
This is the T1 ones from 2004. The newer ones include Detemir and we should see that cause a significant change in prescribing (for T1s at least). The other aspects show little difference.

Thanks Tim. Sorry again, but was your last comment, regarding Detemir, from the newly re-issued or the less recent iteration? If it's from the latest iteration, do you have a link at all, I haven't happened upon them yet.
 

tim2000s

Expert
Retired Moderator
Messages
8,934
Type of diabetes
Type 1
Treatment type
Other
The Detemir reference is from the 2015 draft. My original comments are based on the still current 2004 edition.
 

Daibell

Master
Messages
12,642
Type of diabetes
LADA
Treatment type
Insulin
Hi. Yes, do read the 2015 drafts. They include various changes including Detemir being the preferred Basal. They also suggest anyone presenting as slim should be suspected as being a T1 (good news). The bad news is that they suggest plain Metformin is OK rather than needing the SR version. I think this is wrong based on the number of problem posts on this forum.
 

smidge

Well-Known Member
Messages
1,761
Type of diabetes
LADA
Treatment type
Insulin
There are now avast number of Libre and Dexcom users. If we could pull the data together and show improvements over the course of 12-24 months, it would provide a body of evidence that could be persuasive.

Having read through the guidelines, I can understand the reticence of the healthcare bodies to prescribe anything useful. NICE needs evidence. We as a community are uniquely positioned to provide that evidence, and I, for one, am up for trying to provide it. Is anyone else?

I agree Tim. I'd happily share data for this purpose, but we would all have to collect it consistently - same format and content - for it to be of any use. I wouldn't know how to go about this.

Smidge
 

tim2000s

Expert
Retired Moderator
Messages
8,934
Type of diabetes
Type 1
Treatment type
Other
I think this probably requires some thinking about for the NHS public access scheme, but leave it with me.
 
  • Like
Reactions: 3 people

donnellysdogs

Master
Messages
13,233
Type of diabetes
Type 1
Treatment type
Pump
Dislikes
People that can't listen to other people's opinions.
People that can't say sorry.
Hi

I have written to all NICE directors and board members of my CCG ref degludec on Friday and their costings of it making it a double red lined drug.

I had a telephone call from CCG today confirming all letters has been recieved.

This is now logged as a complaint and is going to yhe head of prescribing to investigate and for the CEO of my CCG to confirm the outcome in writing to me.

I should have a written outcome of the investigation within 2-3 weeks.

I have the right to appeal if the outcome is not acceptable.

I suggest that persons that instead of whinging when people can't have good service from their CCG's/NICE that they do the same...
 
  • Like
Reactions: 3 people

donnellysdogs

Master
Messages
13,233
Type of diabetes
Type 1
Treatment type
Pump
Dislikes
People that can't listen to other people's opinions.
People that can't say sorry.
I suggested Libre letters to CCG's previously.... Shame nobody did it. One CCG I know gives CGM's, degludec and Libres without any problems.
 
  • Like
Reactions: 3 people

donnellysdogs

Master
Messages
13,233
Type of diabetes
Type 1
Treatment type
Pump
Dislikes
People that can't listen to other people's opinions.
People that can't say sorry.
What you need to do with degludec is just go to DR Google and type in your CCG name and degludec or your CCG name, degludec and red line...

That will give you pretty much data for all of the drugs that your CCG has redlined or double redlined.

Then all you have to do is google the name of your CCG with "annual report" to get an up to date one - they should be just releasing them now.

Then on the report it has to state details of the board members.. And the address of your CCG.. Just write to them all.

With NICE I have asked for information under FOI 2000 regarding proof of their procedures and CCG's in ensuring that red lined or double redlined products are correctly assessed.

If you really want to change things you all should be standing up and doing something....
 
  • Like
Reactions: 3 people

donnellysdogs

Master
Messages
13,233
Type of diabetes
Type 1
Treatment type
Pump
Dislikes
People that can't listen to other people's opinions.
People that can't say sorry.
The reasoning for degludec being off limits according to consultants is money... If you can prove that the CCG reasoning for costings is flawed then you have to do something.

There is a get out clause though for NICE and CCG's which is that "it has demonstrated non-inferiority to insulin glargine".....however my ccg states "concerns were slso raised about the very high cost of this insulin"

I have asked on tresiba posting somewhere tonight for people on tresiba to give details of how much they use compared to levemir/lantus.
As many users have to have split doses of lantus/levemir etc then true costings of using tresiba is better... Ie if (as you should) change needles with every jab... Then CCG's have not accounted for double the needles for split doses or double the wastage for a prime of the needle each time etc. If you then (as was suggested to me) were using 17 units split daily and advised to start on 12 units of tresiba... Then again this is a 1/3rd less insulin needed for tresiba.

My CCG could save £11.19 a year by prescribing tresiba.... Instead of split dose levemir.
 
  • Like
Reactions: 3 people

AndBreathe

Master
Retired Moderator
Messages
11,320
Type of diabetes
I reversed my Type 2
Treatment type
Diet only
Blimey, DD. You were on a roll, with five consecutive posts!
 

donnellysdogs

Master
Messages
13,233
Type of diabetes
Type 1
Treatment type
Pump
Dislikes
People that can't listen to other people's opinions.
People that can't say sorry.
Blimey, DD. You were on a roll, with five consecutive posts!

I know... Its something I am very passionate about..

Rather than just whinging and moaning I believe that people should take positive steps to doing something....

Great that some people are yhinking about Libres now.. But I did this 9 months ago... I mentioned it.. Gave copies of what I had written etc.. Its no good people just saying the NHS system is unfair and whinging..

Thats why I do my PPG work voluntarily for NHS. I am grateful for them keeping me alive free of charge but I am behind the scences a sort of mini suffragettte trying to get things changed for the benefit of patients.. Doing something positive...
 

tim2000s

Expert
Retired Moderator
Messages
8,934
Type of diabetes
Type 1
Treatment type
Other
Further - the update paper discusses the following questions with regard to CGMs and makes the following recommendations:


56.Do not offer real-time continuous glucose monitoring routinely to adults with type 1 diabetes. [new 2015]

57.Consider real-time continuous glucose monitoring for adults with type 1 diabetes who are willing to commit to using it at least 70% of the time and to calibrate it as needed, and who have any of the following that persist despite optimised use of insulin therapy and conventional blood glucose monitoring: 
  • more than 1 episode a year of severe hypoglycaemia with no obviously preventable precipitating cause 
  • complete loss of awareness of hypoglycaemia 
  • frequent (more than 2 episodes a week) asymptomatic hypoglycaemia that is causing problems with daily activities 
  • extreme fear of hypoglycaemia. [new 2015]

58.For people who are having continuous glucose monitoring, use the principles of flexible insulin therapy with either a multiple daily injection insulin regimen or continuous subcutaneous insulin infusion (CSII or insulin pump) therapy. [new 2015]

59.Continuous glucose monitoring should be provided by a centre with expertise in its use, as part of strategies to optimise a person’s HbA1c levels and reduce the frequency of hypoglycaemic episodes. [new 2015]

The cost basis for CGM is wholly based on existing CGMs and not the Libre cost model, so the average cost of CGM is calculated at £3593 rather than the £1269 of the Libre. This compares to £1059 for fingerpricking when ten tests are done per day.

The studies cited by the document do show an improvement in Hba1C for CGM users, of 0.3%, only when used intensively. This is considered "Just significant", or in other words, if the cost was appropriate, then the use of the CGM technology has enough of an impact to make a difference.

In terms of quality of life measurement, the paper states that use of CGM is equivalent value to fingerpricking ten times daily. What it doesn't take into account is the quality of life impact of fingerpricking ten times daily. A fabulous circular miss in my book!

An original economic analysis compared SMBG with different frequencies to CGM; this analysis showed that CGM is more effective (increases QALYs) compared with SMBG up to 4 times but it is not more effective than SMBG 8 or 10 times a day; CGM is also more costly than any selected frequencies of SMBG (up to 10 times daily). SMBG 8 times daily was the most cost-effective strategy in the probabilistic analysis while SMBG 10 times daily was the most cost effective strategy in the deterministic analysis; in both analyses CGM was more costly and less effective than these strategies. In the base case analysis, the decrease in HbA1c level obtained with CGM in the meta-analysis of studies comparing CGM with SMBG was assumed to have been estimated compared with SMBG 4 times daily. In order to test whether CGM could be cost effective in some circumstances, a series of sensitivity analyses were conducted where the effectiveness of CGM at reducing HbA1c level was assumed to be estimated compared with SMBG 10. In these analyses CGM was not dominated anymore but Type 1 diabetes in adults Blood glucose control 254 Update 2015 its high cost was not offset by its increase in effectiveness. A subgroup analysis on people with hypo unawareness who have a risk of hypoglycaemic events 6 times higher than in the other type 1 diabetes population was conducted; in this analysis, the baseline risk of hypo events was increased and the effectiveness of CGM at reducing hypo events was 100% (no events occurred in the CGM arm of the model) and the cost of CGM was decreased by 30%. The results showed that the ICER of CGM versus SMBG 10 times daily was £30,203 per QALY, which is still above the NICE threshold. This analysis had some important limitations in terms of uncertainty in key parameters (quality of life associated with hypo events) and missing links between model outcomes (achieved HbA1c level and hypo events). Also the clinical effectiveness data on different frequencies of SMBG was obtained from a cross-sectional study; a higher frequency of testing could lead to a decrease in hypoglycaemic events but these data could not be obtained from the available study. The population in this analysis may not be representative of people with type 1 diabetes who have problems at controlling their HbA1c level with SMBG and self-injection only. The cost effectiveness of CGM in combination with insulin pumps was not assessed and it may be that this combination is cost effective in people with glycaemic control issues, , also because the prices of CGM equipment is lower when used in conjuction with insulin pumps.

I'll leave it to the evidence in the paper itself to describe the conclusions about CGM as it shows what is required:

It was clear to the GDG that current data do not support the routine use of CGM. There is some evidence of clinical benefit but this is not compelling, and it is not currently a cost-effective intervention.
 

tim2000s

Expert
Retired Moderator
Messages
8,934
Type of diabetes
Type 1
Treatment type
Other
On the topic of access to Degludec, there are also some interesting points.

The most effective long acting at reducing Hba1C was shown to be, on average, Detemir once or twice daily, Detemir twice daily, Glargine once daily, Detemir once daily, NPH (!) once or twice daily and then Degludec once daily.

When you read through all the results of the insulin studies, Degludec doesn't come out particularly well, as whilst it costs considerably more per person to provide, it didn't show any clinically important benefits over Glargine, where Detemir does.

In terms of ranking of insulin therapies, Insulin Detemir twice daily is ranked as the method with the most clinical benefit, at a slightly higher cost than Glargine, so I would expect to see more recommendations of this approach for therapy.

It is worth noting the final word on the topic of Basal Insulin Therapies:

The GDG were unable to make a full assessment of degludec as there is currently insufficient data regarding its clinical effectiveness in comparison to other insulin regimens.
 

pinewood

Well-Known Member
Messages
788
Type of diabetes
Type 1
Treatment type
Insulin
Does anyone know when Sanofi's Toujeo basal is launching in the UK? I read that in the US it has been priced very similarly to Lantus. I can imagine that when it launches in the UK Novo will have to cut the price of Tresiba to remain competitive, potentially making it better available in more CCGs?

EDIT - actually, Toujeo just looks like a stronger version of Lantus and not something new or different like Tresiba, so maybe scrap my comments above....
 

donnellysdogs

Master
Messages
13,233
Type of diabetes
Type 1
Treatment type
Pump
Dislikes
People that can't listen to other people's opinions.
People that can't say sorry.
Doesn't this just emphasise though that NICE make the gudelines and then it is down to our CCGs (and the head of prescribing) to interpret them how they wish to.., therefore we get the CCGs giving us postcode lotteries unles the Patients stand up and approach the CCG's and their methods of nterpreting them.

Why is it that one particular CCG can have a Head of Prescribing and their staff that are evaluating to allow CGM's, Libres's, Degludec and o enext door that allows nothing!!

NICE are only giving guidelines on drugs and equipment. If your CCG's are not adhering or interpreting costs correctly then uts down to the paients to approach their Head of Prescribing and to lodge a very clear letter asking them to re assess...
 

tim2000s

Expert
Retired Moderator
Messages
8,934
Type of diabetes
Type 1
Treatment type
Other
My take is that CCGs are looking at the NICE data which contains a huge amount of study based evidence covering costs and clinical outcomes and saying "Well, NICE have done all this work for me, I don't need to do anything more as it is all well understood". I suspect there is very little local CCG cost assessment being undertaken at all. More they are looking at the ICER outcomes and simply saying "That's just too expensive".