Rationale and impact

Rationale and impact

These sections briefly explain why the committee made the 2021 recommendations and how they might affect practice.

Long-acting insulin

Recommendations 1.7.3 to 1.7.9

Why the committee made the recommendations

Evidence showed that there were fewer severe and nocturnal hypoglycaemic events with insulin detemir twice daily compared with neutral protamine Hagedorn (NPH). Insulin detemir twice daily was also found to be the most cost-effective treatment strategy in the economic analysis. Based on this evidence and their clinical experience, the committee recommended twice-daily insulin detemir as a basal insulin therapy for adults with type 1 diabetes.

The committee agreed there were situations in which an insulin other than twice-daily insulin detemir might be preferred, and set out specific clinical scenarios where alternative long-acting insulins could be used. This includes if the person is already using an insulin regimen that is working well for them and helping them meet their treatment goals.

Some people may not be able to tolerate insulin detemir, or for some, a once-daily regimen may be necessary (either because the person has a strong preference for once-daily injections or there are circumstances that make twice daily not practical). Glargine (100 units/ml) was found to be the most cost-effective once-daily insulin (particularly when the costs of glargine biosimilars were considered) so it was recommended as the appropriate alternative in these cases.

People on insulin therapies can still have hypoglycaemic episodes. This can be a cause of concern, particularly if they have nocturnal hypoglycaemic events. Evidence showed a lower proportion of nocturnal hypoglycaemic events with degludec (100 units/ml), when compared with other once-daily insulins. Degludec (100 units/ml) is an ultra-long-acting insulin, which means it has a longer duration of action compared with long-acting insulins. The committee agreed that once-daily degludec could therefore be considered as an alternative basal insulin therapy if there is a particular concern about nocturnal hypoglycaemia.

The committee agreed that once-daily ultra-long-acting insulin regimens, such as insulin degludec (100 units/ml), may also be needed by people who need support from a carer or healthcare professional to administer injections, for example, because they are frail or have a physical or mental health condition, or learning disability. Insulins that offer flexibility in dosing time, such as insulin degludec (100 units/ml), have a long duration of action and may be particularly useful because they give more flexibility in when the dose can be given. Insulin glargine (300 units/ml) is another example of an ultra-long-acting insulin. Healthcare professionals should also refer to NHS England's patient safety alert, which highlights that there is a risk of severe harm and death from inappropriately withdrawing insulin from pen devices.

Biosimilars have the potential to offer the NHS considerable cost savings. To gain approval for use, biosimilar medicines have to be shown to be safe and as effective as the original reference medicine, and have the same quality. Based on this understanding, the committee noted it was appropriate when starting a new prescription of an insulin where a biosimilar is available, to use the one with the lowest cost.

Additionally, people may be using an insulin for which a lower cost biosimilar is available. In such cases, the committee recommended discussing with people the possibility of switching to the biosimilar. This could happen at the person's routine review. They also agreed that switching to the biosimilar should be carefully planned, taking into consideration the dose-switching protocols, monitoring and the person's concerns about switching from their existing regimen, and a shared decision reached. Healthcare professionals should also refer to the summary of product characteristics for further information when considering switching to biosimilars.

The committee retained the recommendation from the 2015 version of the guideline on considering the use of other basal insulin regimens not covered by other recommendations. Based on their clinical understanding, they added comorbidities (such as renal function), risks of hypoglycaemia and diabetic ketoacidosis and concerns about adherence to the factors to take into account when considering alternative regimens. To support pharmacovigilance and patient safety, the committee also recommended that insulins should be prescribed by brand name.

How the recommendations might affect practice

Use of long-acting insulins varies across the country, with some centres offering twice-daily insulin detemir to people who are newly diagnosed, whereas other centres start with once-daily regimens. A major shift in practice is unlikely but the recommendations do set out scenarios where other insulins such as ultra-long-acting insulins and biosimilars may be useful and cost effective.

Return to recommendations

  • National Institute for Health and Care Excellence (NICE)