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NICE provisionally backs new drug for depression

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Draft guidance from the National Institute for Health and Care Excellence has recommended vortioxetine (Brintellix) for treating major depressive episodes.

In final draft guidance published today NICE has recommended vortioxetine for some adults with major depressive disorder – defined as clinical depression, major depression, unipolar depression, and depression.

NICE has provisionally ruled that the drug is a cost-effective option for treating major depressive episodes in adults whose condition has responded inadequately to two antidepressants within the current episode.

“Vortioxetine’s effectiveness was comparable with that of other third-line antidepressants”

Carole Longson

The positive recommendation follows the submission of further evidence from the drug’s manufacturer Lundbeck that NICE requested in its previous draft guidance.

Vortioxetine, which is administered orally, is a multimodal antidepressant that is thought to exhibit its clinical effect through direct modulation of receptor activity and inhibition of the serotonin transporter.

The recommended starting dosage is 10mg once daily in adults younger than 65 years of age, and 5mg 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 20mg once daily or decreased to a minimum of 5mg once daily. Treatment for at least six months is recommended after the depressive symptoms resolve.

The price of a pack (28 tablets) of 5mg, 10mg or 20mg tablets is £27.72 (excluding VAT).

Professor Carole Longson, director of NICE’s Centre for Health Technology Evaluation Centre, said: “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“Following publication of the previous draft guidance on vortioxetine the company submitted further evidence on its use for adults who had not tolerated, or whose major depressive episode had not responded to two previous antidepressants,” she said.

“The [NICE] 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,” she added.

Professor Carole Longson

Professor Carole Longson

The draft guidance is now out for consultation until 30 October and, therefore, subject to appeal.

Once NICE issues its final guidance on the drug, it will replace local recommendations across the country.

Major depressive disorder affects 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 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.

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.


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