Newer Insulins under pressure from QIPP

A government programme aimed at cutting costs (Quality Innovation Prevention and Productivity, or QIPP) means that many PCTs and commissioners are scrutinising the use of insulin analogues.

In particular, the use of Lantus in type 2 diabetes is under the microscope- the suggestion is that professionals should use older, cheaper long-acting insulin and then only switch to the more expensive choice if/when people get hypoglycaemia.

This could have knock on effects for people with type 1 diabetes- we know not all 1e care teams think differently in type 1 vs type 2!

I've observed published safe DAFNE target levels coming down over the years, I believe because modern analog insulins are more 'predictable' [some may say as predictable as a teenager, rather than old NPH being as predictable as a toddler ].

My questions are:

1. is there research evidence of an improved safety record for analogues compared with old NPH/soluble insulins, from the DAFNE database? [one for DAFNE top brass!]
2. do people with type 1 diabetes generally believe/feel they get extra benefits with modern analogues, compared to older human and/or animal insulins? What is your experience?
3. If someone tried to take away your 'Daz' and give you 2 packets of another soap powder, how would you react? How important is choice of insulin to you?

Each PCT has a QIPP programme- attacking analog insulins may not feature in them all, but if you have had your choice of insulin questioned, it would be interesting to hear about it.

Ta

Are PCT QIPP plans publically available documents or would you need a freedom of information request to get hold of them and check what's going on?

I guess they should be public. As it is a gov agenda such plans could be said to be 'only following orders'.
Which PCT do you come under?

On my patch (west of Brum) I have heard rumblings that restrictions may be coming, but have seen no documents to that effect. I have taken the view it is better not to ask, in case this moves into the cross-hairs!

I haven't a clue for the first question lol.

Brum_Taffy said:
2. do people with type 1 diabetes generally believe/feel they get extra benefits with modern analogues, compared to older human and/or animal insulins? What is your experience?

3. If someone tried to take away your 'Daz' and give you 2 packets of another soap powder, how would you react? How important is choice of insulin to you?

Found this on Wikipedia re Analogue Insulins......

'A meta-analysis of numerous randomized controlled trials by the international Cochrane Collaboration found "only a minor clinical benefit of treatment with long-acting insulin analogues (including two studies of insulin detemir) for patients with diabetes mellitus type 2"[6] while others have examined the same issue in type 1 diabetes. Subsequent meta-analyses undertaken in a number of countries and continents have confirmed Cochrane's findings.

In July 2007, Germany's Institute for Quality and Cost Effectiveness in the Health Care Sector (IQWiG) reached a strikingly similar conclusion. In its report, IQWiG concluded that there is currently "no evidence" available of the superiority of rapid-acting insulin analogs over synthetic human insulins in the treatment of adult patients with type 1 diabetes. Many of the studies reviewed by IQWiG were either too small to be considered statistically reliable and, perhaps most significantly, none of the studies included in their widespread review were blinded, the gold-standard methodology for conducting clinical research. However, IQWiG's terms of reference explicitly disregard any issues which cannot be tested in double-blind studies, for example a comparison of radically different treatment regimes. IQWiG is regarded with skepticism by some doctors in Germany, being seen merely as a mechanism to reduce costs. But the lack of study blinding does increase the risk of bias in these studies. The reason this is important is because patients, if they know they are using a different type of insulin, might behave differently (such as testing blood glucose levels more frequently, for example), which leads to bias in the study results, rendering the results inapplicable to the diabetes population at large. Numerous studies have concluded that any increase in testing of blood glucose levels is likely to yield improvements in glycemic control, which raises questions as to whether any improvements observed in the clinical trials for insulin analogues were the result of more frequent testing or due the drug undergoing trials.

More recently, the Canadian Agency for Drugs and Technology in Health (CADTH) found in its 2008 comparison of the effects of insulin analogues and biosynthetic human insulin that insulin analogues failed to show any clinically relevant differences, both in terms of glycemic control and adverse reaction profile'

But on the other hand, Lantus IS apparently better for you....

International clinical studies have confirmed the advantages of insulin glargine in the treatment of heavy hypoglycaemia compared to standard NPH insulin. Insulin glargine reduces the risk of severe nocturnal hypoglycaemia. Extensive clinical studies (ACCORD) have confirmed the higher risk of mortality with higher incidence of severe hypoglycaemia.[3][4] A comparison trial of insulin detemir and glargine proved that subjects randomized to detemir used slightly higher daily insulin doses, but gained less weight on average than glargine-treated subjects.[5] Other systematic reviews corroborate the results of benefit of insulin glargine regarding lower incidence of severe hypoglycaemia.[6]

On June 13, 2009, Diabetologia, the journal of European Association for the Study of Diabetes (EASD), published the results of a 5 year long-term observational, retrospective analysis. During the study no other safety issues, such as unexpected adverse events for either insulin emerged. However, insulin glargine was associated with a lower incidence of severe hypoglycaemia compared with NPH insulin.

I guess there's two sides to every argument and you can make it fit your own standpoint. Personally, I think that analogues were developed as a result of a progression in Diabetic research, and I for one would prefer the latest available drugs that treat my disease.

Thanks for those last 2 posts- I'm aware there is scant 'hard' evidence in this area.
Personal experiences and anecdote/stories are what I am keen to hear.

It's an area where cost:benefit is not easy to calculate. I suspect the traditional way of calculating this (quality adjusted life years) does not do justice to issues like fear of hypoglycaemia and confidence in your medicines/treatment plan.
DAFNE originally had higher target ranges, especially overnight, because of greater worry about hypos with older insulins. I'm hoping DAFNE data will tell us if there is any difference in the experiences of people on analogs vs. human insulin.

Please keep the stories and experiences coming!

Welshmapleleaf said:
But on the other hand, Lantus IS apparently better for you....

International clinical studies have confirmed the advantages of insulin glargine in the treatment of heavy hypoglycaemia compared to standard NPH insulin. Insulin glargine reduces the risk of severe nocturnal hypoglycaemia.

I think it's useful to remember that a lot of the clinical information and other info online might originally come from the companies that make insulin, so they might be putting their 'spin' on the findings they publish, and just because a large trial shows lower risk of hypo with insulin A rather than insulin B, it doesn't mean that it's the same for everyone. I think it's just safe to say that different peope react differently to different types of insulin, and we should all be allowed to decide which one we want to use, with support and advice from GPs and other diabetes specialists.

Brum-taffy, i'm in South Birm PCT, which one are you in? QIPP stands for Quality, Innovation, Productivity and Prevention...so any QIPP plan from a PCT would need to consider all of these areas and they're not just about saving money in the short-term. So if there is evidence that newer analogue insulins reduce hypos and complications, improve control and reduce weight gain (for example) that would all support the widespread use of newer insulins - this could make people that prefer older insulins unhappy!

I know that asking your local PCT for their plans isn't going to make them suddenly think about reducing people's access to insulin, that's not how it works (luckily!).

1. is there research evidence of an improved safety record for analogues compared with old NPH/soluble insulins, from the DAFNE database? [one for DAFNE top brass!]

I can tell you that an audit of the DAFNE database around 4yrs ago asked just that question. And the reuslts?.......

Traditional NPH (Humulin I or Insulatard) used twice daily as per DAFNE regimen resulted in better HbA1c than the modern analogue Background Insulins, however ANY type of BI taken twice daily was better than analogue taken just once daily.

There was no difference in terms of severe hypos (needing 3rd party assistance), however analogue BI showed a trend towards slightly lower rates of minor, symptomatic hypos.

The DAFNE stance therefore is still to default to NPH twice daily as it is still a very effective and proven insulin and this has nothing to do with cost! If people have problems with night-time hypos and/or uncontrollable Dawn Phenomenon on NPH, twice daily Levemir or Lantus is an option.

In addition, much of the work done by Dr Ian Gallen's team at Wycombe has shown an increased risks of prolonged hypos during/following exercise with analogue BIs and they recommend switching back to NPH or using a pump if you're a serious exerciser.

Hope this info helps?

Carolin