Brintellix (vortioxetine) has been recommended by the National Institute for Health and Care Excellence (NICE) as a clinically and cost-effective treatment option for patients with major depressive episodes (MDE) who have not adequately responded to two other antidepressants within the current episode.
This is the first positive Technology Appraisal that NICE has completed for an antidepressant, providing a new treatment option for patients with MDE for whom previous treatments are sub-optimal or cause intolerable side-effects.
Current treatments for MDE have only a 50% success rate due to the diversity of the condition and individual patient profiles. Studies show that a third of all patients with depression will not have achieved remission of their episode after two antidepressant treatments.
Professor Allan Young, chair of mood disorders at King's College London, said: “As a condition, depression is recurrent, complex and challenging to treat effectively. Providing physicians with a choice of effective and well-tolerated treatments with a range of mechanisms of action is essential to allow patients the best chance of recovery from depression.”
Vortioxetine is a multimodal antidepressant that has shown efficacy in a broad range of patients, including those with severe depression, depression with high concomitant anxiety, as well as elderly patients with depression. It has also been shown to improve the symptoms of cognitive dysfunction associated with depression in a range of patient types.
Clinical data also showed that for patients who had a sub-optimal response to a previous antidepressant (SSRI or SNRI), vortioxetine significantly improved depressive symptoms as well as levels of response and remission (as assessed by MADRS) at 8 weeks of treatment, compared to agomelatine, a licensed antidepressant used in current clinical practice.
Vortioxetine is the first licensed antidepressant which, in addition to improving symptoms of mood, has been shown to consistently improve some aspects of cognitive function in depression. Cognitive functions are everyday brain-based skills that are responsible for how we learn, remember, problem-solve and make decisions. Cognitive dysfunction is a key feature of depression, affecting the majority of patients during their depressive episodes; it is present for up to 94% of time during an episode of depression, and up to 44% of time between episodes of depression.
In its final guidance, NICE acknowledged that vortioxetine may be a valuable treatment option for people with a major depressive disorder experiencing cognitive dysfunction.
Emer O’Neill, chief executive of Depression Alliance, said: “People with depression will now have access to a wider choice of effective treatments to help manage their depression particularly those who, as it often happens, find they do not respond optimally to the first or even second antidepressant given. This option may also help people who experience problems with cognition in addition to their mood symptoms. Many people, including some healthcare professionals, don’t realise that cognitive dysfunction is a common and hugely frustrating feature of depression.”
News of the decision by NICE was welcomed by Lundbeck Ltd, which manufactures the medicine. Doctor Andrew Jones, medical director UK and Ireland at Lundbeck, said: “We believe that its efficacy data and multimodal mechanism of action will offer an alternative treatment option for healthcare professionals seeking new, effective and well-tolerated choices for some of their patients, allowing the best chance of an effective recovery.”
Vortioxetine is generally well-tolerated, with low discontinuation rates due to adverse events. In clinical trials, the most common adverse event was nausea, which was generally mild to moderate, transient, and did not generally lead to cessation of therapy. Based on the available evidence, NICE concluded that vortioxetine was equally effective as other antidepressants but that it may have a better overall safety profile.