Glycopyrronium bromide (Sialanar®) for the symptomatic treatment of severe sialorrhoea
The National Health Care Institute carried out an assessment whether the product glycopyrronium bromide (Sialanar®) is interchangeable with any product included in the insured package. The National Health Care Institute was advised by the Scientific Advisory Committee (WAR).
Registration
The symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and infants aged 3 years and older with chronic neurological disorders.
Sialorrhoea is described as the involuntary loss of saliva from the mouth. This is normal in growing children from 18 months. After the age of 4 years, continued drooling is regarded as pathological. Patients with severe sialorrhoea are currently treated, if medicinal therapy is being considered, with glycopyrronium bromide in the form of a pharmacy preparation. These are children with chronic neurological disorders (mainly cerebral palsy). Based on national and international literature and the manual of the Dutch Association of Paediatrics, glycopyrronium bromide is the preferred choice for patients with severe sialorrhoea, if medicinal therapy is being considered.
Glycopyrronium bromide (Sialanar®) is registered based on well-established use. When well-established use is being assessed, the applicant does not have to submit new clinical research to the registration authority (EMA). Where new clinical research is lacking, the registration authority uses available scientific literature and current European treatment guidelines for the assessment. The registration of Sialanar® is based mainly on two randomised, placebo-controlled studies in which Sialanar® itself was not studied.
Therapeutic value
Despite the limited data, the National Health Care Institute concludes that the use of the substance glycopyrronium bromide on patients with severe sialorrhoea can be considered as well-established use of a known substance. In comparison with placebo, the use of glycopyrronium bromide reduced sialorrhea. Unfavourable effects – mainly related to its anticholinergic mechanism of action – were also more prevalent, though generally not severe. An optimal balance should be obtained, by means of dose titration, between favourable and unfavourable effects.
National Health Care Institute's advice
Based on the criteria for interchangeability, glycopyrronium bromide (Sialanar®) is not eligible for inclusion on List 1A. Glycopyrronium bromide (Sialanar®) is registered on the basis of well-established use. In principle, based on the above-mentioned consideration, glycopyrronium bromide (Sialanar®) is eligible for inclusion on List 1B. Inclusion on List 1B will be accompanied by additional costs.
This report is a summary of recommendations by National Health Care Institute. The original text of this excerpt is in Dutch.