NICE recommends MSD’s Steglatro®▼ (ertugliflozin) be made routinely available within the NHS for the treatment of adults with type 2 diabetes as monotherapy or in combination with Metformin.
MSD has announced that the National Institute of Care and Health Excellence (NICE) has issued a final appraisal determination (FAD) that recommends Steglatro®▼ (ertugliflozin), a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, as monotherapy in adults with type 2 diabetes for whom metformin is contraindicated or not tolerated, or as part of a dual therapy regimen in combination with metformin. Ertugliflozin demonstrated effective glycaemic control and reductions in blood pressure and weight that are comparable to other SGLT-2 inhibitors offering an additional treatment choice for people with type 2 diabetes mellitus (T2DM).
The effects of ertugliflozin on cardiovascular (CV) outcomes are being studied in the VERTIS CV study, a CV outcome trial including 8,237 patients that is scheduled to be completed in late 2019.
Ertugliflozin is a once daily dosing SGLT-2 inhibitor, which is priced at £29.40 for 28 days treatment – the lowest acquisition cost versus other SGLT-2 inhibitors. As such, NICE has recommended ertugliflozin in line with previously approved SGLT-2 inhibitors.
Currently almost 3.7 million people in the UK live with a diagnosis of diabetes, approximately 7% of the population – a number that has more than doubled in the last 20 years. In addition to those currently diagnosed, there are an estimated 12.3 million people at increased risk of T2DM. The impact of rising rates of diabetes in the UK is a strain on medical infrastructure. In 2017, one in six hospital beds (18%) were occupied by a person with diabetes and in 2016/17, over 52 million items were prescribed for diabetes, costing almost £1 billion or every £1 in £9 spent on prescribing was for a drug used in diabetes. With the predicted rise in the size of the diabetic population and increasing treatment costs, cost-effective treatment solutions are vital to the future of diabetes care.
NICE guidance states that ertugliflozin is recommended as monotherapy only if:
- metformin is contraindicated or not tolerated
- a dipeptidyl peptidase 4 (DPP 4) inhibitor would otherwise be prescribed and
- a sulfonylurea or pioglitazone is not appropriate
and in a dual therapy regimen only if:
- a sulfonylurea is contraindicated or not tolerated or
- the person is at significant risk of hypoglycaemia or its consequences.
NICE based its recommendation for monotherapy on results from the VERTIS-MONO trial, which compared ertugliflozin monotherapy against placebo in 461 people aged 18 years or older with inadequate glycaemic control. The primary outcome was change in HbA1c from baseline to week 26. Both doses of ertugliflozin showed a statistically significant improvement compared with placebo.
NICE’s recommendation for ertugliflozin as dual therapy was based on results from two trials; the VERTIS-MET trial, which compared ertugliflozin 5 mg and 15 mg with placebo in 621 people aged 18 years older with inadequate glycaemic control, and the VERTIS-FACTORIAL trial, which had 2 arms with ertugliflozin in dual therapy. The primary outcome for both studies was change in HbA1c from baseline to week 26 and both doses of ertugliflozin showed a statistically significant improvement compared with placebo for all outcomes in VERTIS-MET. The results for VERTIS-FACTORIAL showed that patients having ertugliflozin had lower mean HbA1c from baseline to week 26 and the committee concluded that ertugliflozin with metformin is a clinically effective treatment compared with placebo.