GVS advice doxylamine succinate/pyridoxine hydrochloride (Xonvea®) for the treatment of nausea and vomiting during pregnancy

Indication for which reimbursement is requested

Doxylamine succinate/pyridoxine hydrochloride is indicated for the treatment of nausea and vomiting during pregnancy in women who do not respond to conservative management.

The recommended starting dose is 2 tablets before bedtime. If this dose adequately controls the symptoms the next day, the patient may continue to take 2 tablets before bedtime. Guided by the symptoms, the dose can be increased to 4 tablets per day.

Outcome of the substantive assessment

For the assessment, the National Health Care Institute made an indirect comparison between doxylamine succinate/pyridoxine hydrochloride and meclozine/pyridoxine. Currently, meclozine/pyridoxine is the only medicinal product included in the GVS for pregnancy nausea and vomiting and that is reimbursed for this indication. Meclozine monotherapy is only available as an over-the-counter medicinal product. The assessment has shown that there is no proof of a clinically relevant effect on relevant outcome parameters for meclozine/pyridoxine. 

National Health Care Institute's advice

The National Health Care Institute advises the Minister to not include doxylamine succinate/pyridoxine hydrochloride in the GVS. In addition, the National Health Care Institute recommends that meclozine/pyridoxine should no longer be designated as an insured benefit for the treatment of nausea and vomiting during pregnancy, and that meclozine/pyridoxine should no longer be included in the GVS for this indication. The National Health Care Institute therefore recommends to apply the medicinal product only for an insured person when the medicinal product is used to treat nausea and vomiting after surgery or after radiotherapy.

This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.