GVS assessment of racecadotril (Hidrasec®) for the treatment of acute diarrhoea in infants (over 3 months of age) and children
The National Health Care Institute has completed its assessment whether racecadotril (Hidrasec®) is interchangeable with another product that is included in the Medication Reimbursement System (GVS). The National Health Care Institute has been advised by professional groups regarding the placement of this treatment. These professional groups feel that there is no place for medical management with regard to the registered indication. The manufacturer responded to this by informing the National Health Care Institute that they wish to withdraw the reimbursement application. Therefore the National Health Care Institute will not proceed with the assessment of the medicinal product racecadotril and advises the minister for Medical Care not to include racecadotril 10 mg granules for oral suspension (Hidrasec baby) and 30 mg (Hidrasec junior) in the GVS.
Registered indication
Racecadotril (Hidrasec®) is available as 10 mg granules for oral suspension (Hidrasec baby) and as 30 mg (Hidrasec junior) granules for oral suspension. It is registered as an adjunctive symptomatic treatment for acute diarrhoea in infants (over three months of age) and children, together with oral rehydration and the usual supportive measures, if these alone are not sufficient to control the patient’s clinical disorder and if causal treatment is not possible. If causal treatment is possible, then racecadotril can be administered as an adjunctive treatment.
The National Health Care Institute's advice
The National Health Care Institute has been advised by the Dutch College of General Practitioners and the Dutch Paediatric Society regarding the placement of this treatment. Both of these professional groups are of the opinion that medical management has no place in the treatment of acute diarrhoea in infants and children, other than the prescription of medicinal products for rehydration such as ORS (oral rehydration solution). If the pathogen has been identified then antibiotics might be prescribed. In the case of vomiting, another medicinal product (ondansetron) can be prescribed, if necessary.
The manufacturer informed the National Health Care Institute that they wish to withdraw the reimbursement application. Therefore the National Health Care Institute will not proceed with the assessment of the medicinal product racecadotril and advises the minister for Medical Care not to include racecadotril 10 mg granules for oral suspension (Hidrasec baby) and 30 mg (Hidrasec junior) in the Medicine Reimbursement System.