Question to the Department of Health and Social Care:

To ask His Majesty's Government, further to the Written Answer by Lord Markham on 26 March (HL3163), in each year since 2014, how many prescriptions for vortioxetine were issued; what was the annual cost to the National Health Service of those prescriptions; how many Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA received for vortioxetine; and what consideration has NHS England given to adding sexual dysfunction as a side effect on the patient information leaflets for vortioxetine.

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:

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.

Note: items have been dispensed, but not necessarily prescribed, in England.

"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 The Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, or the International Classification of Diseases 11th Revision. A search of the database would therefore rely on manual assessment of individual cases.

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:

Source: data provided by the MHRA.

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.

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.