The National Institute for Health and Care Excellence has re-opened a second consultation on its diabetes guidelines following a barrage of criticism from all sides on previous draft proposals.

The Institute faced accusations of placing too great an emphasis on cutting costs in its updated draft guidance on blood-lowering medicines, largely because of its stance on the use of Novo Nordisk’s NovoNorm/Prandin (repaglinide) and pioglitazone, “with concerns including patient safety and confusion in primary care”.

NICE was calling for the use of repaglinide as an alternative monotherapy when metformin can’t be used instead of a sulfonylurea, sparking widespread condemnation because of a perceived lack of supporting evidence. 

Noting that the drug is used “very, very little” in diabetes care, diabetes consultant Greg Jones told PharmaTimes Digital earlier this year that it has “no sound CV outcome data and whilst causing less hypoglycaemia and weight gain than sulphonyurea treatments it still does cause these side effects”.

In its latest guideline, the Institute is still recommending that all type II diabetics should be offered standard-release metformin as the initial treatment, but in those who cannot take the drug, treatment with a dipeptidyl peptidase-4 (DPP-4) inhibitor, pioglitazone, repaglinide or a sulfonylurea should be considered. Patients should be aiming for an HbA1c level of 53 mmol/mol.

Changes welcomed but concerns remain

Lisa Anson, country president, AstraZeneca UK & Ireland, has welcomed the revisions. “AstraZeneca is very pleased to see NICE responding to the groundswell of opinion that the previous draft needed substantial revision and that, as a result, there should be a second consultation phase. This is a stark turnaround in NICE’s position and a very unusual, but welcome, step for them to take,” she told PharmaTimes Digital.

“The latest draft has changed substantially and, upon initial review, we are pleased to see that it allows for a more flexible, patient focused approach to treating people with type II diabetes compared to the linear first draft”. 

However, Anson also highlighted a number of remaining concerns, “including the prominence of pioglitazone without clear information regarding its benefit:risk profile; unclear positioning of GLP-1s in the treatment pathway; and no clear considerations given to individual patient characteristics including weight, risk of hypoglycaemia, age and occupation, when considering the most effective treatment option for an individual”. 

According to new figures by Diabetes UK, the number of people with diabetes in the UK has now reached an all-time high of 3.9 million, costing the NHS around £10 billion a year. Around 80% of these costs are spent on managing avoidable complications, highlighting the urgent need to get blood-glucose lowering therapy right.