The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to conditionally admit teduglutide (Revestive®) to the basic health care package. This medicinal product can be used in certain patients with short bowel syndrome. If the Minister adopts our advice, teduglutide will be temporarily and conditionally included in the Medicine Reimbursement System (GVS). Only then will this medicinal product be reimbursed from the health care insurer's basic health care package.
Follow-up to previous advice
On 21 September 2023, the National Health Care Institute advised the Minister of Health, Welfare and Sport to consider teduglutide as a potential candidate for the conditional inclusion of orphan drugs, conditionals and exceptionals. This advice follows on from that advice.
Teduglutide is intended for certain people with short bowel syndrome
Teduglutide is the active substance. The brand name is Revestive®. The medicinal product is an injection administered subcutaneously every day. Subcutaneous means under the skin.
The medicinal product can be used in people from 4 months of age with short bowel syndrome. In short bowel syndrome, the small intestine is usually largely absent or does not function properly. This reduces the absorption of nutrients. This can cause diarrhoea, weight loss, and fatigue. People with short bowel syndrome often receive parenteral nutrition. That is nutrition fed through an IV line directly into the blood. Teduglutide helps the intestines to absorb nutrients and fluids.
Advice from the National Health Care Institute on the reimbursement of teduglutide
The National Health Care Institute advises the Minister of Health, Welfare and Sport to conditionally admit teduglutide to the basic health care package for a period of five years. During these five years, additional studies of the effectiveness of teduglutide will be conducted. When all study results are available, the National Health Care Institute will reassess teduglutide and advise the Minister again on its reimbursement. The advice is to include the medicinal product conditionally in List 1B of the GVS. Certain additional conditions, the so-called List 2 conditions, apply for teduglutide.
For more information on the GVS and the Lists 1A, 1B and 2, see page ‘Reimbursement of outpatient medicines’.
The request for conditional inclusion relates to certain patients with short bowel syndrome. Firstly, these are patients aged 18 years and older who, following surgery, must be stable after a period of intestinal adjustment (according to the starting criteria as formulated in the position statement issued by the professional group). In addition, the following should apply:
- Inflammatory Bowel Disease (IBD) as a cause of intestinal resection and being dependent, at least 3 times a week, on total parenteral nutrition for at least 12 months, or,
- A parenteral nutrition volume greater than 14 litres/week for at least 12 months.
Secondly, conditional inclusion is requested for children aged 6 months to 18 years with short bowel syndrome. For them, the selection criterion is that they are dependent on parenteral support for at least 30 percent of their calorific and/or fluid and electrolyte needs with no or minimal increase in enteral nutrition in the past 3 months or more.
More information or questions?
If you have any questions about this advice, please send your question to the National Health Care Institute via warcg@zinl.nl. If you have questions about the reimbursement of a medicinal product, the personal expenses or whether you should pay a contribution, please ask your health insurance provider.
How did the advice come about?
The Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP) advise the National Health Care Institute about this assessment. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic health care package.
Explanation about the reimbursement of medicinal products
Teduglutide is an extramural drug. Extramural means: medicines for home use that can be obtained at the pharmacy with the prescription from a physician. They are only reimbursed from the basic health care package if they are listed in the GVS.