NICE diabetes guidelines still don’t add up, say doctors and pharma company

NICE has re-drafted new guidelines for type 2 diabetes treatments after a major backlash from doctors – but critics say the second attempt is still badly flawed.

The UK's National Institute for Health and Care Excellence (NICE) first issued new guidelines for type 2 diabetes in January, but these were heavily criticised for being out of step with international opinion on the best treatment options.

Diabetologists say the recommendations remain often inconsistent with evidence, illogical, and don't even reflect NICE's own recommendations of newer drugs.

The first draft of the guideline recommended the infrequently used repaglinide as a first line therapy for patients who cannot tolerate metformin. This decision was widely attacked as lacking an evidence base, the drug having a difficult three-times-a-day dosing and carrying a known risk of hypoglycaemia.

The strength of opposition has led NICE to re-draft the guidelines – a very rare occurrence - but stakeholders say major problems remain in the updated version.

The amended draft restores some choice for doctors prescribing drug treatments – but doctors still say repaglinide should not play a prominent role, and that newer drugs have been sidelined without good reason.

Over the last few years, NICE has recommended drugs in the new SGLT2 inhibitor class: AstraZeneca's (AZ) Forxiga (dapagliflozin), Janssen-Cilag's Invokana (canagliflozin) and Boehringer Ingelheim's Jardiance (empagliflozin).

Despite this, the new guidelines only make a passing reference to the drugs, in a footnote at the end of the document.

This has been attacked by clinicians and AZ, which markets Forxiga and a number of other diabetes treatments.

The Association of British Clinical Diabetologists (ABCD) says not including the SGLT2 class is a 'significant omission' to the guidelines, which had been scoped to include them.

The ABCD has welcomed a number of changes included in the revised draft. But the response to the latest consultation made the clinicians' frustration clear:

"The brief reference in footnote 3 exhorting clinicians to read another document and place the class separately from the body of the main algorithm is illogical, and will discredit the update as a resource for busy clinicians."

AZ's UK and Ireland country president Lisa Anson has also voiced her frustration at the guideline.

She welcomed NICE's response to the "groundswell of opinion" against the first draft, and said the revised version had been "improved in many ways" – but said it still fell short.

"One major concern is that the guideline is out of sync with other NICE guidance – for example, the NICE single technology appraisals for SGLT2 inhibitors recommend their use at multiple stages of a patient's treatment for type 2 diabetes, but in this draft they are only included as a footnote in the treatment algorithm."

Anson said the guidance around the use of GLP-1 receptor agonists (which include AZ's Bydureon) remained "unclear and incomplete".

Diabetes is a key area for AZ as it seeks to rebuild its global sales, but the struggle over the NICE guideline is part of a broader picture of slow uptake of newer diabetes drugs in the UK.

Anson concluded: "We urge NICE to again listen closely to concerns from the UK diabetes community and to ensure that the final guidance provides clear, consistent direction that will support health care professionals to deliver the highest standards of patient care."

Overall, the firm says the revised guidelines still don't allow an individualised approach to patient care in type 2 diabetes, because they restrict choice within the treatment algorithim.

AZ and doctors say the joint guideline issued by the European Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA) represents best practice, and that NICE's recommendations still fall short of these standards.

Why is NICE out of step?

Despite all the controversy surrounding the guidelines, there has been little explanation from NICE on why it has recommended repaglinide, a drug not widely used since the 1990s.

However, one leading diabetologist, Anthony H Barnett, of the Heart of England NHS Foundation Trust, Birmingham seems sure that cost-cutting is the main motivation.

Writing in The Lancet in June, Barnett attacked another of its controversial recommendations: to use older, cheaper human insulin, switching to newer insulin analogues 'only after recurrent hypoglycaemia'. He said the recommendations amounted to short-sighted cost control, based on 'drug acquisition costs with little consideration of the value of therapies under consideration'.

It is yet to be seen if NICE will issue a third draft, but this would be unprecedented. The guidelines in the current form will be unpopular with general practitioners and specialists, who may choose to ignore the advice; unlike technology assessments of individual drugs, NICE clinical guidelines do not have a mandatory status in the health service.