P-06-1550 Place the drug Xonvea on to the formulary for the management of nausea and vomiting in pregnancy – Correspondence from the Petitioner to the Committee, 02 February 2026
Dear Petitions Committee,
Thank you for the opportunity to respond to the information sent by the All Wales Medicines Strategy Group dated the 21st January.
I am pleased to hear that the All Wales Medicines Strategy Group are having continue correspondence with the manufacturers of Xonvea and a re-appraisal is planned in the next 12 months. Thank you also for acknowledging the impact of hyperemesis gravidarum on pregnant people and their families.
I would like to seek clarification and raise several concerns regarding how cost effectiveness is currently being interpreted. I would also like to clarify what specifically would be required for Xonvea to be approved as on formulary in Wales.
In the letter from the AWMSG it is emphasized that cost alone is not the determining factor, but rather cost effectiveness. My concern is that the assessment appears to be based on the acquisition cost of Xonvea rather than a consideration of the financial ramifications of pregnancy sickness not being managed appropriately, including the cost to the NHS of treating patients presenting with physical and mental health complications from hyperemesis gravidarum, the cost of babies being born prematurely or at a low birth weight, and the economic cost of women being unable to work due to severe sickness. In 2016 the estimated cost to the NHS across the UK of nausea and vomiting in pregnancy was £64 million (Gadsby et al, 2019). Xonvea will only ever be used short term, in the worst-case scenario for a maximum of 8 months.
I recognise that an individual patient funding request (IPFR) process is possible and that Xonvea may be prescribed in exceptional circumstances. However, without clearer guidance on this GPs may be reluctant to prescribe. I would like to once again point out that in both the Royal College of Obstetrics and Gynaecology guidelines, and NICE guidelines, Xonvea is recommended as a first line antiemetic and there is no mention of cases needing to be ‘exceptional’ to prescribe. It is the only medication to be licensed for use in pregnancy and has a well-known safety profile. Is there the possibility of an interim measure allowing clearer guidance on when GPs would be able to prescribe this medication? E.g if other first line antiemetics are unsuccessful, if recommended by an obstetrician etc. Although it is also worth pointing out that in both of those cases the cost of delaying prescribing Xonvea will likely outweigh the cost of prescribing it first line. The value of Xonvea (£28) is the value of approximately half of a GP appointment (£56) (Royal College of General Practitioners, 2024) so if three GP appointments were required to try out three other first line antiemetics first (cyclizine, promethazine, prochlorperazine) you would be looking at a total cost of £175.14 before the patient were able to have treatment that is more likely to be effective (Pregnancy Sickness Support, 2025).
In summary I would like to ask the following points:
· How is the AWMSG assessing cost-effectiveness in its appraisal?
· Would data such as audits be taken into consideration alongside manufacturer submissions?
· What steps are being taken to ensure the right women are receiving the right treatment?
· Are there any interim measures that can be taken to ensure that other women are not suffering unnecessarily, including potentially having to terminate their wanted pregnancies, over the next 12 months?
The recent discussion at the Senedd Petitions Committee demonstrated strong cross-party concern that financial concern should not prevent women from accessing licensed and recommend treatment. I hope that further engagement between the AWMSG, the manufacturer, clinicians and patient groups can lead to progress and a more transparent pathway towards approval.
Thank
you for your continued engagement on this issue.
Yours sincerely,
Sarah Spooner (Butterworth) BSc(hons) PGDip Prof Cert Glauc / Med Ret
Reference:
Gadsby, R. et al. 2019. Nausea and Vomiting of Pregnancy And Resource Implications: the NVP impact study. British Journal of General Practice 69 (680) e217-e223
Pregnancy Sickness Support. 2025. Establishing the Cost and Impact of Xonvea for NVP. A summary of findings by Pregnancy Sickness Support [online] available at: https://pregnancysicknesssupport.org.uk/wp-content/uploads/2025/07/Xonvea-Survey-results-and-data-analysis_Pregnancy-Sickness-Support-2025-8.7.25.pdf[Accessed: 02/02/2025]
Royal College of General Practitioners. 2024. Royal College of General Practitioners (RCGP) submission to the Autumn Budget 2024 / Spending Review [online] Available at: https://www.rcgp.org.uk/getmedia/3a1bb4e5-8def-4afb-bdc0-75d4d344f024/Royal-College-General-Practitioners-Budget-submission-Autumn-2024.pdf[accessed: 02/02/2026]