The NICE clinical guideline on the management of type 2 diabetes (which is currently being updated; publication date to be confirmed) recommends that, when insulin therapy is necessary, human NPH (isophane) insulin is the preferred option. Examples of NPH (isophane) insulin include Insulatard, Humulin I or Insuman Basal. The guideline recommends that the long-acting insulin analogues, insulin glargine and insulin detemir, can be considered as an alternative in some people. This includes people who need assistance from a carer or healthcare professional to inject their insulin, people whose lifestyle is restricted by recurrent symptomatic hypoglycaemia, people who would otherwise need twice-daily NPH insulin injections in combination with oral glucose-lowering drugs, or those who cannot use the device to inject NPH insulin.
Based on the results of the studies by Garber et al. (2012) and Zinman et al. (2012), insulin degludec is likely to be marketed as a basal insulin for type 2 diabetes with potential benefits in reducing hypoglycaemia, particularly nocturnal hypoglycaemia (Ratner et al. 2013). However, the limitations of the study (discussed in the section on evidence strengths and limitations) need to be considered. The absolute differences in hypoglycaemic rates between insulin degludec and insulin glargine were statistically significant but small in absolute terms. There is also no comparison with NPH (isophane) insulin, no patient oriented efficacy outcome data and no information on the efficacy or safety of insulin degludec over longer than the one year data currently available.
The concerns over a possible risk of medication errors with the double-strength 200 units/ml formulation also need to be considered. The Medicines and Healthcare Products Regulatory Agency has issued advice to minimise the risk of medication errors associated with this higher strength formulation, a 200 units/ml prefilled pen device (see the section on safety for more information; Drug Safety Update April 2013).
The evidence review conducted for the NICE clinical guideline on type 2 diabetes: newer agents (NICE clinical guideline 87) found that there was no difference in terms of HbA1c lowering between the long-acting insulin analogues available at that time (insulin glargine and insulin detemir) and NPH (isophane) insulin in type 2 diabetes. Compared with NPH (isophane) insulin, both these long-acting insulin analogues were associated with statistically significant reductions in the rates of any hypoglycaemia and of nocturnal hypoglycaemia, but not severe hypoglycaemia. The cost-effectiveness analysis conducted for the NICE clinical guideline on type 2 diabetes found that the long-acting insulin analogues, insulin glargine and insulin detemir, did not appear to be cost-effective options when compared with NPH (isophane) insulin in type 2 diabetes. All the incremental cost-effectiveness ratios (ICERs) were outside the conventional limits of cost effectiveness, with ICERs ranging from about £100,000 to £400,000 per quality-adjusted life year (QALY) gained depending on the scenario in which they are used. These are substantially greater than the £20,000 to £30,000 per QALY gained threshold usually considered in NICE's cost-effectiveness evaluations. Therefore, long-acting insulin analogues are only recommended for certain people with type 2 diabetes (see above).
Insulin degludec will be included in the update of the NICE clinical guideline on the management of type 2 diabetes. The publication date for this guideline is to be confirmed.
The Health and Social Care Information Centre report, Prescribing for diabetes in England - 2005-2006 to 2011-2012 stated that the net ingredient cost of insulin therapy in primary care in 2011/12 was £314.7 million: a growth of 42.5% from 2005/6 to 2011/12. In the year to September 2012, 1.3 million items of insulin glargine were prescribed at a cost of nearly £78 million, and just over 650,000 items of insulin detemir at a cost of £41 million. This compared with 370,000 items of NPH (isophane) insulin at a cost of just over £13 million (NHS Business Services Authority: personal communication July 2013).
The cost of insulin degludec 100 units/ml is £72.00 for 5×3 ml cartridges or pre-filled pens. This is more expensive than similar formulations of insulin glargine and insulin detemir, which are £41.50 and £42.00 respectively. NPH (isophane) insulin formulations are about half the cost of insulin glargine or detemir, at between £17.50 and £22.90.
The manufacturer has estimated an uptake of 5%, 10% and 15% of the eligible population in years 1, 2 and 3 respectively. It has have defined the eligible population as adults (18 years or over) with type 2 diabetes currently on a basal long-acting insulin analogue (not basal NPH [isophane] insulin). Based on these estimates, for basal dosing in combination with oral antidiabetic drugs and for a population of 100,000 patients, this translates to the use of insulin degludec in 4 patients in year 1, 8 patients in year 2 and 12 patients in year 3. For use within a basal-bolus regimen, this translates to the use of insulin degludec in 7 patients in year 1, 14 patients in year 2 and 20 patients in year 3. This gives a total estimated uptake of 11 patients in year 1, 22 patients in year 2 and 32 patients in year 3 per 100,000 population (Novo Nordisk: personal communication August 2012).
Estimated usage in type 1 diabetes is given in the accompanying evidence summary on insulin degludec in type 1 diabetes.