In a preliminary appraisal last August, NICE called for the company to provide more evidence to demonstrate that empagliflozin is a good use of NHS resources when compared with other treatments that are already available. Boehringer Ingelheim responded and submitted a new cost-effectiveness model which showed that empagliflozin combination therapy is a cost effective treatment option for some people with type 2 diabetes¹.

Commenting on the draft guidance Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “We are pleased that Boehringer Ingelheim responded to our consultation and provided new evidence to allow us to recommend empagliflozin as a treatment option for some people with type 2 diabetes.

“Millions of people in England are affected by type 2 diabetes. There are already several NICE recommended treatments specifically for managing blood sugar levels, however each has its advantages and disadvantages that affect how suitable they are for each individual.

“With the addition of empagliflozin to our varied arsenal of treatments for type 2 diabetes, people will now have even more choice to ensure they get the treatment that is right for them.”

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.

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.

Ends

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

About the draft guidance

1. Empagliflozin is recommended as an option for treating type 2 diabetes:

• In a dual therapy regimen in combination with metformin, only if:
  • a sulfonylurea is contraindicated or not tolerated, or
  • the person is at significant risk of hypoglycaemia or its consequences.
  • In a triple therapy regimen in combination with:
    • metformin and a sulfonylurea or
    • metformin and a thiazolidinedione.
  • In combination with insulin with or without other antidiabetic drugs.

1. The draft guidance is available at nice.org.uk/guidance/indevelopment/GID-TAG441.
2. The Committee concluded that the very small differences in costs and QALYs between empagliflozin (10 mg and 25 mg) and its key comparators showed that empagliflozin was a cost-effective use of NHS resources as dual therapy in combination with metformin, triple therapy in combination with metformin and either a sulfonylurea or a thiazolidinedione, and as an add-on treatment to insulin.
3. 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.
4. The cost of empagliflozin is £36.59 (excluding VAT) per pack of 28 tablets for both 10 mg and 25 mg doses (BNF January 2015). The annual cost of empagliflozin is estimated to be £477.30. Costs may vary in different settings because of negotiated procurement discounts.
5. The committee concluded that treatment with empagliflozin did not fulfil the criterion for short life expectancy of the end of life considerations
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.
7. The Scottish Medicines Consortium has published guidance accepting empagliflozin for restricted use within NHS Scotland: https://www.scottishmedicines.org.uk/SMC_Advice/Advice/993_14_empagliflozin_Jardiance/empagliflozin_Jardiance.

Diabetes key facts

• 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.
• 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. March 2014).
• However, there are many people with undiagnosed type 2 diabetes so the true number could be considerably higher.
• 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.