Main Category: Diabetes
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Today, as part of its Single Technology Appraisal (STA) the National Institute for Health and Clinical Excellence (NICE) published its final guidance on the use of Victoza® (liraglutide) for patients with type 2 diabetes in England, Wales and Northern Ireland.
This new guidance is an instruction from NICE to the National Health Service (NHS) to provide mandatory funding for liraglutide. Primary care trusts (PCTs) must find funding for the drug within three months for the appropriate patients as indicated by the guidance.*
The guidance recommends once-daily liraglutide 1.2 mg as a clinically and cost effective therapy in combination with two oral anti-diabetic tablets for the control of specific subgroups of people with type 2 diabetes detailed in the guidance.
The exact recommendation by NICE can be found in the boxed area below. Importantly NICE also recommends, irrespective of BMI, that liraglutide 1.2 mg can be used in combination with just one oral anti-diabetic tablet if other tablets are unsuitable in combination with current treatments or cannot be taken due to intolerances.
Dr Marc Evans, Consultant Diabetologist, Llandough Hospital Cardiff, commented, "Liraglutide represents a valuable option for patients with type 2 diabetes and their healthcare professionals. This is a significant step towards achieving health equality for people in England, Wales and Northern Ireland who qualify for treatment with liraglutide, which now requires mandatory funding from each PCT."
People currently receiving liraglutide who do not meet the criteria specified in the guidance or who are receiving liraglutide 1.8 mg, should have the option to continue their current treatment until they and their clinicians consider it appropriate to stop.
"We are delighted that NICE has recommended liraglutide as a valuable treatment option for people living with type 2 diabetes. We are committed to ensuring that people with diabetes receive the highest quality of care and we believe liraglutide in combination with either one or two anti-diabetic tablets can have significant benefits for people living with type 2 diabetes," said Viggo Birch, Managing Director, Novo Nordisk Limited.
Liraglutide is a once-daily injectable human GLP-1 analogue licensed in Europe, the US, Japan and India. It has been available in the UK since July 2009 for the treatment of people with type 2 diabetes in the following therapeutic indication: Liraglutide is indicated for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control:
In combination with:
- Metformin or a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea.
In combination with:- Metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.1 Liraglutide lowers blood glucose levels by stimulating the release of insulin only when glucose levels become too high. In addition, it also inhibits appetite.1
NICE guidance on liraglutide 1.2 mg:
Liraglutide 1.2 mg daily in dual therapy regimens (in combination with metformin or a sulphonylurea) is recommended as an option for the treatment of people with type 2 diabetes, only if:
- the person is intolerant of either metformin or a sulphonylurea, or treatment with metformin or a sulphonylurea is contraindicated, and
- the person is intolerant of thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors, or treatment with thiazolidinediones and DPP-4 inhibitors is contraindicated.
Liraglutide 1.2 mg daily in triple therapy regimens (in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedione) is recommended as an option for the treatment of people with type 2 diabetes, when control of blood glucose remains or becomes inadequate (HbA1c ≥ 7.5%, or other higher level agreed with the individual), and the person has:
- a body mass index (BMI) ≥ 35 kg/m2 in those of European descent (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight, or
- a BMI < 35 kg/m2, and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.
Treatment with liraglutide 1.2 mg daily in a dual therapy regimen should only be continued if a beneficial metabolic response has been shown (defined as a reduction of at least 1.0 percentage point in HbA1c at 6 months). Treatment with liraglutide 1.2 mg daily in a triple therapy regimen should only be continued if a beneficial metabolic response has been shown (defined as a reduction of at least 1.0 percentage point in HbA1c and a weight loss of at least 3% of initial body weight at 6 months).
Notes:
1. NICE is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health. NICE has considered guidance for healthcare professionals on the use of liraglutide, following approval of liraglutide to be used in the UK.
2. *About NICE guidance and funding:
Statutory Direction issued by Secretary of State for Health in 2003 states:
a Primary Care Trust shall, unless directed otherwise by the Secretary of State...apply such amounts of the sums paid to it...as may be required to ensure that a health care intervention that is recommended by NICE in a Technology Appraisal Guidance is, from a date not later than three months from the date of that Technology Appraisal Guidance, normally available: (a) to be prescribed for any patient on a prescription form for the purpose of his NHS treatment; or (b) to be supplied or administered to any patient for the purpose of his NHS treatment
i.e. Unless the direction has been amended or waived for a specific treatment, PCTs are required to make funding available for treatments recommended by NICE within three months of publication of final Technology Appraisal Guidance (TAG). Statutory funding direction does not apply to NICE clinical guidelines, but only to technology appraisals.
3. The STA final guidance (dated 27 October 2010) states:
On dual therapy
Liraglutide 1.2 mg daily in dual therapy regimens (in combination with metformin or a sulphonylurea) is recommended as an option for the treatment of people with type 2 diabetes, only if:
- the person is intolerant of either metformin or a sulphonylurea, or treatment with metformin or a sulphonylurea is contraindicated, and
- the person is intolerant of thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors, or treatment with thiazolidinediones and DPP-4 inhibitors is contraindicated.
Treatment with liraglutide 1.2 mg daily in a dual therapy regimen should only be continued if a beneficial metabolic response has been shown (defined as a reduction of at least 1 percentage point in HbA1c at 6 months). The potential benefits and risks of treatment with liraglutide should be discussed with the person to enable them to make an informed decision.
On triple therapy
Liraglutide 1.2 mg daily in triple therapy regimens (in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedione) is recommended as an option for the treatment of people with type 2 diabetes, when control of blood glucose remains or becomes inadequate (HbA1c ≥ 7.5%, or other higher level agreed with the individual), and the person has:
- a body mass index (BMI) ≥ 35 kg/m2 in those of European descent (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight, or
- a BMI < 35 kg/m2, and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.
Treatment with liraglutide 1.2 mg daily in a triple therapy regimen should only be continued if a beneficial metabolic response has been shown (defined as a reduction of at least 1.0 percentage point in HbA1c and a weight loss of at least 3% of initial body weight at 6 months).
On 1.8 mg dose
In the recommendation from NICE, liraglutide 1.8 mg daily is not currently recommended for the treatment of people with type 2 diabetes.
People with type 2 diabetes currently receiving liraglutide who do not meet the criteria specified in the guidance, or who are receiving liraglutide 1.8 mg, should have the option to continue their current treatment until they and their clinicians consider it appropriate to stop.
4. Diabetes is a metabolic condition that leads to high blood sugar levels, which can have serious consequences for short- and long-term health. People with diabetes have raised blood sugar because of either a defect in insulin secretion, insulin action, or both.
Most people with diabetes (90%) have type 2 diabetes,2 where the pancreas produces insufficient quantities of insulin and/or the insulin has a reduced effect on the muscle and liver cells.
References:
1. Liraglutide Summary of Product Characteristics, Novo Nordisk, Jan 2010
2. Diabetes in the UK 2010: Key statistics on diabetes, Diabetes UK .
Source:
Novo Nordisk
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