Advice on a possible candidate for the conditional inclusion of teduglutide (Revestive®)
The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to designate teduglutide (Revestive®) as a potential candidate for conditional inclusion (CI) in orphan drugs, conditionals and exceptional. Teduglutide can be used in certain patients with short bowel syndrome.
Recommendations from the National Health Care Institute
On 14 July 2023, the parties submitted an application for the conditional inclusion of teduglutide (Revestive®). Teduglutide is a medicinal product that is similar to the natural hormone glucagon-like peptide 2 (GLP-2). This hormone helps the intestines to absorb nutrients and fluids. It is registered for the treatment of patients aged 4 months and older with Short Bowel Syndrome (SBS).
In short bowel syndrome, the small intestine is usually largely absent or does not function (intestinal failure). In particular, reduced nutrient uptake can cause problems such as diarrhoea, weight loss and fatigue. This reduced uptake of important nutrients is also called malabsorption. This is why patients with short bowel syndrome often receive parenteral nutrition. That is nutrition fed through an intravenous line directly into the bloodstream.
In its advice in 2018, the National Health Care Institute concluded that teduglutide does not meet the established medical science and medical practice for patients with short bowel syndrome. At the time, it was unclear whether the effect of teduglutide was relevant to the patient, since teduglutide did reduce the amount of parenteral nutrition these patients needed, but it could not be completely stopped. Nor did their quality of life improve. Several parties, including the professional group, indicated that they would like teduglutide to be available for a carefully selected group of patients with short bowel syndrome. It is estimated that this group consists of approximately 60 to 95 patients. The drop-down menu shows exactly which patients fall into this group.
Based on the data in the dossier and the advice of the Scientific Advisory Board (WAR), the National Health Care Institute has concluded that treatment with teduglutide for a selection of patients aged 6 months and older with short bowel syndrome meets the criteria for conditional inclusion. Those criteria are as follows:
- Teduglutide has been granted marketing authorisation by the European Medicines Agency (EMA) and has orphan drug status;
- there is an unmet medical need;
- the marketing authorisation holder is the dossier’s lead applicant. The co-applicants are the treating physicians, an independent research centre and the patient association;
- the package question can be answered on the basis of the data collected by the registry study;
- the National Health Care Institute can answer the package question within 5 years.
Based on these conclusions, the National Health Care Institute recommends that teduglutide be designated as a potential candidate for conditional inclusion. If the Minister adopts the advice of the National Health Care Institute, phase 2 of the procedure will begin. In this phase, the parties must develop their plans further and draw up a covenant setting out the agreements needed to ensure a careful and successful CI process.
Temporary admission to the basic health care package
Since 1 January 2012, healthcare that does not meet 'the established medical science and medical practice', i.e. healthcare that is not proven to be effective, can still be temporarily admitted to the basic health care package. We call this "conditional inclusion." The condition is that the study group collects data on the effectiveness and cost-effectiveness of a medical intervention or medicinal product during the period of conditional inclusion. These data will help to determine, at the end of the conditional inclusion period, whether a medical intervention or medicinal product can be a permanent part of the basic health care package.