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NICE set to approve dapagliflozin (Forxiga) in the treatment of type 1 diabetes

Forxiga, for Type 1 diabetes from AstraZeneca

The National Institute for Health and Care Excellence (NICE) have published a final appraisal document recommending use of AstraZeneca's dapagliflozin, brand name Forxiga, as an option in treating type 1 diabetes.

Dapagliflozin with insulin is recommended as an option for treating type 1 diabetes in adults with a body mass index (BMI), of at least 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, only if:
  • they are on insulin doses of more than 0.5 units/kg of body weight/day and
  • they have completed a structured education programme that includes information about:
    − the risk of diabetic ketoacidosis
    − how to recognise risk factors for diabetic ketoacidosis, and its signs and symptoms
    − how and when to monitor blood ketone levels
    − what actions to take for elevated blood ketones, and
  • treatment is started and supervised in a hospital diabetes clinic.
NICE recommend that the patients haemoglobin A1c (HbA1c) level is assessed after 6 months and regularly after
this. Stop dapagliflozin if there has not been a sustained improvement in glycaemic control (that is, a fall in HbA1c level of at least 0.3%).


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Why NICE made these recommendations
Evidence from the clinical trials shows small improvements in blood glucose (haemoglobin A1c [HbA1c] levels) and weight loss, and very small improvements in quality of life, when dapagliflozin plus insulin is compared with placebo plus insulin in adults with type 1 diabetes and inadequate blood glucose control despite optimised insulin therapy. The company extrapolates the effects of the small improvement in HbA1c level with dapagliflozin seen at 1 year in the trials to a lower risk of long-term complications over a patient’s lifetime.

In the company’s scenario that assumes no benefit from improved HbA1c levels beyond the trial period (1 year), the cost-effectiveness estimate for dapagliflozin plus insulin compared with insulin alone is within the range that NICE normally considers an acceptable use of NHS resources. Dapagliflozin with insulin is therefore recommended as an option for type 1 diabetes in adults. Because of the increased risk of diabetic ketoacidosis, dapagliflozin should be stopped if blood glucose control does not improve.

About Forxiga (source EMA)
Forxiga is a diabetes medicine used for adults whose condition is not controlled well enough.

In type 2 diabetes, it is used with appropriate diet and exercise to improve blood sugar control. It can be used on its own in patients who cannot take metformin (another diabetes medicine). It can also be used as ‘add-on’ treatment to other diabetes medicines.

In type 1 diabetes, Forxiga is used with insulin in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control blood sugar well enough.

Diabetes can occur when the body does not make enough insulin to control the amount of glucose (sugar) in the blood or when the body cannot use insulin effectively. This leads to high levels of glucose in the blood.

The active substance in Forxiga, dapagliflozin, blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine. By blocking the action of SGLT2, dapagliflozin causes the kidney to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.

Forxiga was first made available in the EU in 2012. It is manufactured by AstraZeneca.

Sources
European Medicines Agency website page for Forxiga
Accessed 16/07/19
Links available in full article

© NICE [2019] %NICE_TITLE% Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

The information provided by NICE was accurate at the time this article was issued.


NICE information on Forxiga

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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