More information needed on type 2 diabetes drug empagliflozin
NICE has called for more evidence from Boehringer Ingelheim on its drug empagliflozin for treating type 2 diabetes in new draft guidance.
Type 2 diabetes is a long-term, progressive condition that causes blood sugar levels to become too high. It occurs when the body is not able to use or produce enough insulin – the hormone that controls blood sugar levels and fat metabolism in the body. Many people with diabetes eventually need help to manage their blood sugar levels.
Empagliflozin (marketed as Jardiance) works by blocking the reabsorption of glucose in the kidneys which is instead passed out of the body in the urine. It is an oral, once-daily medication belonging to a class of drugs called sodium glucose co-transporter (SGLT-2) inhibitors.
Commenting on the draft guidance Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: "Type 2 diabetes is a major problem facing the NHS, affecting almost 2.5 million people in England, so it's important to have a varied arsenal to tackle it.
"NICE already recommends several treatments, alongside lifestyle and dietary advice, specifically for managing blood sugar levels in people with type 2 diabetes. Each has its advantages and disadvantages that affect how suitable they are. New treatments, like empagliflozin, will help clinicians give people with type 2 diabetes the right treatment.
"There is good evidence which shows that empagliflozin is clinically effective. But we need more information to demonstrate that it is cost effective when compared with other treatments the NHS already provides. The Committee has requested more information to help it decide whether empagliflozin is a cost-effective use of NHS resources."
Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations via the NICE website. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.
This is draft guidance; NICE has not yet issued final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
About the guidance
1.The draft guidance is now available
2. The draft guidance states that:
• The Committee is minded not to recommend empagliflozin in combination with oral antidiabetic agents with or without insulin for treating type 2 diabetes.
• The Committee recommends that NICE requests further analyses from the company, which should be made available for the second Appraisal Committee meeting, and should include:
i. revised estimation of the incremental cost-effectiveness ratios of empagliflozin using a validated economic model, informed by the corrected results of network meta-analyses and compared with relevant comparators (sodium glucose cotransporter-2 inhibitors and dipeptidyl peptidase-4 inhibitors)
ii. sensitivity analyses which should also include probabilistic exploration of parameter uncertainty.
3. Empagliflozin has a European marketing authorisation for the treatment of type 2 diabetes to improve glycaemic control in adults as:
• Monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
• Add-on combination therapy with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control'.
4. The recommended starting dosage is 10 mg once daily for both monotherapy and as an add-on combination therapy with other glucose lowering medicinal products including insulin. According to the summary of product characteristics, the dosage can be increased to a maximum of 25 mg daily for people who tolerate empagliflozin well and need tighter glycaemic control, if they have an estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73 m2 or more.
5. According to the company's submission, the price of empagliflozin (excluding VAT) is £36.59 per pack of 28 tablets for both 10 mg and 25 mg doses. The annual cost of empagliflozin is estimated to be £470.30. Costs may vary in different settings because of negotiated procurement discounts.
6. NICE recommends the following blood glucose-lowering therapies for type 2 diabetes: biguanides (metformin), sulfonylureas (for example gliclazide or tolbutamide), dipeptidylpeptidase-4 inhibitors (sitagliptin, vildagliptin), thiazoladindiones (pioglitazone), sodium-glucose co-transporter 2 inhibitors (canagliflozin, dapagliflozin) glucagon-like peptide-1agonists (liraglutide, exenatide), rapid-acting insulin secretagogues (nateglinide, repaglinide) and insulin.
All guidance can be viewed on the managing type 2 diabetes pathway.
Diabetes key fact
7. There were approximately 2.7 million people in England with diabetes in 2013. Diabetes UK estimates that 90% of people with diabetes have type 2 diabetes.
Diabetes UK. Diabetes: facts and stats. Version 3 March 2014.
8. However, there are many people with undiagnosed type 2 diabetes so the true number could be considerably higher.
9. The UK prevalence of type 2 diabetes is increasing because of rising levels of obesity, decreased physical activity and increased life expectancy after diagnosis because of better cardiovascular risk protection. Type 2 diabetes is particularly prevalent in people of African, South Asian and Caribbean family origin.
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