NICE Consults on Draft Guidance Recommending New Drug for Type 2 Diabetes

NICE, the health and social care guidance body, is currently appraising canagliflozin (Invokana, Janssen-Cilag) when used in combination with other anti-diabetic drugs, including insulin, for the treatment of type 2 diabetes. In draft guidance issued today for consultation NICE has recommended canagliflozin as a treatment option for some people with the conditioni.

Type 2 diabetes is a long-term condition that causes a person’s blood sugar level to become too high. It occurs when the body does not produce enough insulin – the hormone that controls blood sugar levels and fat metabolism in the body – for it to function properly, or when the body’s cells do not use insulin properly. If diabetes is poorly controlled over a prolonged period it can, among other things, increase the likelihood ofthe arteries becoming clogged up by fatty substances, such as cholesterol (a process calledatherosclerosis). This in turn can lead to poor blood supply to the heart, causing angina (a dull, heavy or tight pain in the chest). It also increases the risk that a blood vessel in the heart or brain will become blocked, leading to a heart attack or stroke.

Complications of type 2 diabetes can also lead to problems with the eyes (retinopathy), nerves (neuropathy), and kidneys (nephropathy).

Canagliflozin is an oral, once-daily medication belonging to a new class of drug called sodium glucose co-transporter (SGLT-2) inhibitors. It works by blocking the reabsorption of glucose in the kidneys which is instead passed out of the body in the urine.

Professor Carole Longson, Director, Centre for Health Technology Evaluation at NICE said: “Type 2 diabetes can be difficult to treat and most people will eventually require a number of drugs, often used simultaneously. Canagliflozin represents a useful addition to the armoury of anti-diabetic drugs available to clinicians. NICE is therefore pleased to be able to recommend its use for some people with type 2 diabetes. The draft guidance is now out for consultation and I would urge all those with an interest in type 2 diabetes to comment via the NICE website.”

Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation until 17 March. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.

Until final guidance is issued to the NHS, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

ENDS

For further information, please contact the NICE press office on 0845 003 7782 / pressoffice@nice.org.uk or out of hours on 07775 583 813.

Notes to editors

References

i The draft guidance states that:

  • Canagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if:

    – the person is at significant risk of hypoglycaemia or its consequences or

    – a sulfonylurea is contraindicated or not tolerated.

  • Canagliflozin in a triple therapy regimen in combination with metformin and a sulfonylurea is recommended as an option for treating type 2 diabetes.
  • Canagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes.

About the draft guidance

1. The draft guidance will be available on the NICE website from Monday 24 February 2014. Embargoed copies of the draft guidance are available from the NICE press office on request.

2. Canagliflozin has a European marketing authorisation for treating type 2 diabetes in adults aged 18 years and older to improve glycaemic control as:

  • monotherapy ‘when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications’.
  • add-on therapy ‘with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control’.

3. The recommended starting dosage of canagliflozin is 100 mg once daily. In patients tolerating canagliflozin 100 mg once daily who have an estimated glomerular filtration rate (eGFR) of at least 60 ml/min/1.73 m2 or creatinine clearance (CrCl) of at least 60 ml/min and need tighter glycaemic control, the dosage can be increased to 300 mg once daily.

4. According to the manufacturer’s submission, the drug’s price is £39.20 for canagliflozin 100 mg (30 tablets) and £49.99 for canagliflozin 300 mg (30 tablets). The expected annual cost of canagliflozin is £477.26 for the 100 mg daily dosage and £608.83 for the 300 mg daily dosage. Costs may vary in different settings because of negotiated procurement discounts.

5. NICE has produced guidance recommending SGLT-2 inhibitor dapagliflozin.

About type 2 diabetes

6. There were approximately 2.6 million people in the UK aged 17 or over with type 2 diabetes in 2011. However, there are many people with undiagnosed type 2 diabetes so the true number could be considerably higher.

7. The UK prevalence of type 2 diabetes is rising 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.

8. Life expectancy is reduced by up to 10 years in people with diabetes.

9. NICE clinical guideline 87 ‘Type 2 diabetes- newer agents’ recommends diet modifications to initially manage type 2 diabetes. If the disease progresses, one or more oral anti-diabetic drugs, such as metformin or a sulfonylurea, may be needed. If one of these drugs is not suitable, a thiazolidinedione (pioglitazone) or a dipeptidyl peptidase-4 (DPP-4) inhibitor (incretin enhancer) such as sitagliptin or vildagliptin can be used as an add-on therapy to metformin or a sulfonylurea as appropriate.

10. The glucagon-like peptide-1 (GLP-1) analogues (liraglutide and exenatide) are recommended in NICE technology appraisal guidance 203 and 248 as options for dual therapy where metformin or a sulfonylurea is not tolerated or contraindicated and a thiazolidinedione and a DPP-4 inhibitor is contraindicated or not tolerated. NICE technology appraisal guidance 288 recommends dapagliflozin in combination with metformin in a dual-therapy regimen, if it is used as described for DPP-4 inhibitors in NICE clinical guideline 87.

11. For people whose disease is not controlled on dual therapy, triple therapy may be considered. NICE clinical guideline 87 recommends either sitagliptin or pioglitazone as options for adding onto metformin and sulfonylurea. Other add-on treatments may include the twice-daily or the prolonged-release regimens of exenatide (an incretin mimetic) in accordance with clinical guideline 87 and technology appraisal guidance 248. Liraglutide is recommended in NICE technology appraisal guidance 203 as a triple therapy if it is used as described for exenatide in clinical guideline 87.

12. Insulin therapy is recommended when the control of blood glucose remains or becomes inadequate with all other measures. Dapagliflozin in combination with insulin with or without other antidiabetic drugs is recommended in technology appraisal guidance 288.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website: www.nice.org.uk and follow us on Twitter:@NICEComms.

Leave a Reply