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NICE draft guidance recommends vortioxetine (Brintellix) for treating major depressive episodes

London, UK (October 16, 2015) – In final draft guidance issued today NICE has recommended vortioxetine (Brintellix, Lundbeck) for some adults with major depressive disorder. The positive recommendation follows the submission of further evidence from the company that NICE requested in its previous draft guidance.

Major depressive disorder is relatively common, affecting an estimated 5% to 10% of people seen in primary care, 10% to 14% of medical inpatients and up to 15% of older people.

It often has a remitting and relapsing course and is characterised by a low mood and loss of interest usually accompanied by symptoms including low energy, change in appetite, weight or sleep pattern, poor concentration, feelings of guilt or worthlessness and suicidal ideas. In severe disease, psychotic symptoms such as hallucination or delusion may be present. Major depressive disorder can impair a person’s social life and ability to work, as well as have a negative impact on the lives of their families and carers.

Commenting on the draft guidance, Professor Carole Longson, Director of the Centre for Health Technology Evaluation Centre at NICE, said: “The Committee acknowledged that having access to a range of treatments is important for people with major depressive disorder.”

“Following publication of the previous draft guidance on vortioxetine the company submitted further evidence on its use for adults who had not tolerated, or whose major depressive episode had not responded to 2 previous antidepressants. The Committee concluded from this evidence that vortioxetine’s effectiveness was comparable with that of other third-line antidepressants and that vortioxetine could be recommended as a cost effective option for treating major depressive episodes in adults whose condition has responded inadequately to 2 antidepressants within the current episode.” 

The draft guidance is now with consultees, who have the opportunity to appeal against it.

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

Notes to Editors

About the guidance

• The draft guidance is available from the NICE website at http://www.nice.org.uk/guidance/indevelopment/gid-tag351
• Vortioxetine (Brintellix, Lundbeck) is a multimodal antidepressant that is thought to exhibit its clinical effect through direct modulation of receptor activity and inhibition of the serotonin transporter. Vortioxetine has a marketing authorisation in the UK ‘for the treatment of major depressive episodes in adults’.

• Vortioxetine is administered orally. The recommended starting dosage is 10 mg once daily in adults younger than 65 years of age, and 5 mg once daily in adults 65 years of age and older. Depending on how the symptoms respond, the dose may be increased to a maximum of 20 mg once daily or decreased to a minimum of 5 mg once daily. Treatment for at least 6 months is recommended after the depressive symptoms resolve.
• The price of a pack (28 tablets) of 5 mg, 10 mg or 20 mg tablets is £27.72 (excluding VAT; company’s submission). Costs may vary in different settings because of negotiated procurement discounts.

About major depressive disorder 

1. Major depressive disorder is also referred to as clinical depression, major depression, unipolar depression, and depression.
2. In the UK it is estimated between 5% and 10% of people seen in primary care, 10% to 14% of medical inpatients and up to 15% of older people have major depressive disorder. The risk of relapse is 50%, 70%, and 90% after the first, second, and third episodes of major depressive disorder respectively. The rate of major depressive disorder in women is twice as high as in men.
3. The treatment and management of depression in adults is outlined in NICE’s 2009 clinical guideline.

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.

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.

The National Institute for Health and Care Excellence (NICE), 16.10.2015 (tB).