National Institute for Health and Clinical Excellence (NICE)
NICE asks for more information on vortioxetine (Brintellix) for major depressive disorder
In a draft guidance issued yesterday for consultation, NICE has asked Lundbeck to provide more information about its drug vortioxetine (Brintellix) for treating major depressive episodes in adults.
Major depressive disorder is estimated to affect between 5% and 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.
Commenting on the draft guidance, Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said: “Major depressive disorder is relatively common and can impair a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.
“The Committee acknowledged that having more treatment options was important for patients, and that vortioxetine may be beneficial for some people with a major depressive episode after initial treatment in primary care with a generic selective serotonin reuptake inhibitor (SSRI). However, the Committee concluded that there was no convincing evidence to show that vortioxetine was any more or less effective than other antidepressants. They also felt the company had not sufficiently defined how vortioxetine would be used in the NHS, or reflected its potential position, within its economic model.
“The Committee was therefore minded not to recommend vortioxetine for treating adults with major depressive episodes after SSRI therapy and has requested further clarification and analyses from the company to address the issues identified before it can decide whether vortioxetine is a cost-effective use of NHS resources.”
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. Comments received during this consultation will be fully considered by the Committee at its next meeting, following which the next draft guidance will be issued.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.
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
- The draft guidance is available from the NICE website athttp://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 dosage is 10 mg once daily in adults less than 65 years of age, and 5 mg once daily in adults 65 years of age and older. Depending on individual patient response, the dose may be increased to a maximum of 20 mg once daily or decreased to a minimum of 5 mg once daily. After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response.
- 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
- Major depressive disorder is also referred to as clinical depression, major depression, unipolar depression, and depression.
- 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.
The treatment and management of depression in adults is outlined in NICE’s 2009 clinical guideline.
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.
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