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<p>The following table shows the number of items issued for vortioxetine and the net
ingredient cost (NIC) from 2014 to 2023, and from January to May of 2024:</p><table><tbody><tr><td><p>Year</p></td><td><p>Items
issued</p></td><td><p>Total NIC</p></td></tr><tr><td><p>2014</p></td><td><p>0</p></td><td><p>£0</p></td></tr><tr><td><p>2015</p></td><td><p>74</p></td><td><p>£2,068.11</p></td></tr><tr><td><p>2016</p></td><td><p>12,736</p></td><td><p>£298,577.07</p></td></tr><tr><td><p>2017</p></td><td><p>43,023</p></td><td><p>£987,197.31</p></td></tr><tr><td><p>2018</p></td><td><p>80,922</p></td><td><p>£1,877,715.10</p></td></tr><tr><td><p>2019</p></td><td><p>134,351</p></td><td><p>£3,127,305.68</p></td></tr><tr><td><p>2020</p></td><td><p>193,682</p></td><td><p>£4,553,134.74</p></td></tr><tr><td><p>2021</p></td><td><p>248,533</p></td><td><p>£5,720,498.19</p></td></tr><tr><td><p>2022</p></td><td><p>290,907</p></td><td><p>£6,859,280.34</p></td></tr><tr><td><p>2023</p></td><td><p>339,017</p></td><td><p>£8,188,709.76</p></td></tr><tr><td><p>2024</p></td><td><p>156,164</p></td><td><p>£3,787,227.18</p></td></tr><tr><td><p>Total</p></td><td><p>1,499,409</p></td><td><p>£35,401,713.48</p></td></tr></tbody></table><p>Source:
data provided by the NHS Business Services Authority, based on information within
the Prescription Cost Analysis published statistics, using British National Formulary
chemical substance vortioxetine.</p><p>Note: items have been dispensed, but not necessarily
prescribed, in England.</p><p>"Persistent sexual dysfunction" does not represent
a specific medical condition, so this term is not a category available for a structured
search of the Medicines and Healthcare products Regulatory Agency’s (MHRA) Adverse
Drug Reaction database. The structured data field search terms are drawn from the
regulatory drugs dictionary, the medical dictionary (MedDRA), or from terms adopted
in clinical coding guidance such as <em>The Diagnostic and Statistical Manual of Mental
Disorders Fifth Edition</em>, or the <em>International Classification of Diseases
11th Revision</em>. A search of the database would therefore rely on manual assessment
of individual cases.</p><p>The MHRA has received a total of 29 Yellow Card reports
of sexual dysfunction related reactions, suspected to be associated with vortioxetine,
between 1 January 2014 and 21 July 2024. This includes reactions grouped under MedDRA
Higher Level Terms, which are more specific than sexual dysfunction and persistent
sexual dysfunction. The following table shows the number of spontaneous suspected
Yellow Card reports of sexual dysfunction related reactions suspected to be associated
with vortioxetine in the United Kingdom, received by the MHRA each year from 2014
to 2024:</p><table><tbody><tr><td><p>Year</p></td><td><p>Reports of sexual dysfunction</p></td></tr><tr><td><p>2014</p></td><td><p>0</p></td></tr><tr><td><p>2015</p></td><td><p>0</p></td></tr><tr><td><p>2016</p></td><td><p>2</p></td></tr><tr><td><p>2017</p></td><td><p>1</p></td></tr><tr><td><p>2018</p></td><td><p>1</p></td></tr><tr><td><p>2019</p></td><td><p>0</p></td></tr><tr><td><p>2020</p></td><td><p>7</p></td></tr><tr><td><p>2021</p></td><td><p>6</p></td></tr><tr><td><p>2022</p></td><td><p>3</p></td></tr><tr><td><p>2023</p></td><td><p>6</p></td></tr><tr><td><p>2024</p></td><td><p>3</p></td></tr></tbody></table><p>Source:
data provided by the MHRA.</p><p>The inclusion of a particular report on the MHRA’s
system does not necessarily mean that the adverse reactions reported have been caused
by the suspect drug. Additionally, the number of reports received should not be used
as a basis for determining the incidence of a reaction, as neither the total number
of reactions occurring, nor the number of patients using the drug, is known.</p><p>Sexual
dysfunction was assessed as part of the clinical studies to support the authorisation
of vortioxetine. The clinical studies indicated that doses between 5 milligrams and
15 milligrams did not show a difference from placebo in relation to the risk of sexual
dysfunction. However, the 20 milligram dose was associated with an increase in sexual
dysfunction. This information was included in the Summary of Product Characteristics
(SmPC) for healthcare professionals for all strengths of vortioxetine since authorisation
in 2021. The SmPC and patient information leaflet were subsequently updated in April
2024 to list sexual dysfunction as a possible side effect for all strengths, following
reports of sexual dysfunction associated with doses below 20 milligrams.</p>
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