The National Institute for Health and Clinical Excellence ( NICE ) has conducted an appraisal of inhaled Insulin for the treatment of diabetes ( types 1 and 2 ) and provide guidance on its use to the NHS in England and Wales.
The Committee has developed preliminary recommendations on the use of inhaled Insulin for the treatment of diabetes ( type 1 and 2 ).

The Appraisal Committee reviewed the data available on the clinical and cost effectiveness of inhaled Insulin for the treatment of diabetes ( types 1 and 2 ), having considered evidence on the nature of the condition and the value placed on the benefits of inhaled insulin by people with diabetes mellitus, those who represent them, and clinical experts. It was also mindful of the need to take account of the effective use of NHS resources.

The Committee sought the opinion of the clinical and patient experts about the likely level of need for inhaled Insulin in clinical practice.
The experts advised the Committee that using injected Insulin is not usually a concern for the majority of people with diabetes, given the availability of patient support and education, modern small needle types and insulin pens.
The experts also pointed out that the availability of inhaled insulin would not completely replace the need for injections of insulin for most people with diabetes, and that inhaled insulin might not fully alleviate any problems relating to true needle phobia, because individuals would still need to use needles for glucose testing.

However, the Committee understood that there were reasons why some individuals, who need to improve their glycaemic control, were reluctant either to start Insulin therapy or to intensify injection regimens.
For example, some people with type 2 diabetes are concerned about hypoglycaemic attacks, or believe that the move to Insulin injections represents a failure on their part with oral therapy, or think that the change in therapy indicates that their diabetes has become much worse.
Some people with diabetes may also be concerned about the impact of using insulin on their driving licence status and employment, but these concerns would be equally relevant with inhaled Insulin. The Committee also heard from the clinical and patient experts that a small group of people with diabetes are so averse to injections for psychological or cultural reasons that they would rather face the prospect of diabetic complications than use subcutaneous Insulin.

The Committee discussed the use of inhaled Insulin in people with type 1 diabetes, many of whom need to adjust their dosage on a day-to-day basis in order to achieve optimal control. It was pointed out by the patient experts that the inhaled Insulin device does not allow patients to adjust their Insulin dose sufficiently. This limitation may lead to difficulties in glucose control compared with injections.

The Committee considered the evidence on clinical effectiveness and was persuaded that inhaled Insulin can be regarded as effective in controlling HBA1c levels as short-acting subcutaneous insulin ( as used in the randomized clinical trials, RCTs ). However, concerns were raised regarding the methods of the reported RCTs, none of which compared inhaled Insulin with current standard care in the UK, which uses a range of alternative injection therapies including Insulin pens, Insulin analogues and Insulin glargine. The methods used limit the assessment of the generalisability of the results to routine clinical practice. In addition, none of the RCTs examined the effectiveness of inhaled Insulin exclusively in people whose blood glucose levels are uncontrolled on their current regimen.

The Committee also discussed the uncertainties regarding the long-term safety of inhaled Insulin in terms of potential pulmonary effects and the reported higher levels of insulin antibodies in people with type 1 diabetes.

The Committee concluded that the evidence for the effect of inhaled insulin on patient satisfaction and preference was crucial to the cost-effectiveness analysis. The Committee agreed that the effects on patient preference would only be relevant to this appraisal if they translated into proven utility gain and changes in health-related quality of life.

The Committee expressed concerns about the methods and generalisability of the manufacturer’s studies used to show patient preferences and, in particular, the hypothetical nature of the data and the lack of strength of preferences expressed.
The Committee considered that, outside the RCT setting, patients may state an initial preference for inhaled Insulin, but some may reconsider when they become aware of the size of the device, the time taken to set it up, and the fact that its use is less discreet and may be less flexible than other methods of blood glucose control.

Given the evidence on clinical effectiveness and cost effectiveness, the Committee concluded that inhaled Insulin should not be recommended for the diabetic ( type 1 or type 2 ) population as a whole.
Furthermore, inhaled insulin should not be recommended for patients whose blood glucose levels remained uncontrolled because of a very strong aversion to insulin injections.

The Appraisal Committee concluded that further research is needed to assess the clinical and cost effectiveness of inhaled Insulin compared with injected Insulin in people with diabetes whose blood sugar levels are uncontrolled with their current diabetes regimen. Studies with relevant outcome measures to evaluate effects on quality of life are particularly needed. The Committee therefore recommended that treatment with inhaled Insulin should be offered only as part of appropriately designed clinical trials.

Source: NICE, 2006


XagenaMedicine2006