XEOMIN (toxine botulinique type A) - Sialorrhée chronique

Opinions on drugs - Posted on Apr 29 2022

Reason for request

New indication

Key points

Favourable opinion for reimbursement in the symptomatic treatment in adults of chronic sialorrhea due to neurological disorders associated with Parkinson's disease, traumatic brain injury or stroke only, in the event of intolerance to or failure of anticholinergic agents.

Unfavourable opinion for reimbursement in the other clinical situations of the MA.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

The management of chronic sialorrhea in patients with neurological disorders should be initiated in accordance with a multidisciplinary approach, including behavioural therapies and oral motor physiotherapy as first-line treatments.

If these treatments fail, pharmacological options exist. However, there is little robust data enabling recommendations to be established and to date, all the medicinal products are used off-label.

According to expert opinion, anticholinergic agents (atropine as sublingual drops, scopolamine patches) are used as first-line treatments (off-label). However, this class of medicinal products requires monitoring in the elderly, in particular patients with Parkinson’s disease, due to the risk of cognitive deterioration.

Surgery for chronic sialorrhea (ablation of submaxillary and sublingual glands) and radiotherapy of the salivary glands are last-resort options.

Role of XEOMIN (botulinum toxin type A) in the care pathway:

The proprietary medicinal product XEOMIN is a second-line medicinal treatment for chronic sialorrhea in patients with neurological disorders associated with Parkinson's disease, traumatic brain injury or stroke, in the event of intolerance to or failure of anticholinergic agents.

The Committee highlights the fact that, in accordance with the SPC, XEOMIN should only be administered by an appropriately qualified healthcare practitioner with expertise in the use of botulinum toxin type A.

In the absence of data, XEOMIN has no role in the treatment of chronic sialorrhea associated with other neurological disorders, in particular, in patients with progressive neurodegenerative diseases, such as ALS, who are liable to present swallowing difficulties in the context of bulbar or pseudobulbar dysfunction as the condition worsens.

Special recommendations

The Committee highlights the fact that, in accordance with the SPC, the recommended dose per treatment session is 100 units and this maximum dose should not be exceeded (with treatment intervals of more than 16 weeks).

Therefore the vial of XEOMIN (botulinum toxin type A) 200 units powder for solution for injection is not suitable for the prescribing conditions in this indication.

Clinical Benefit

Moderate	The Committee deems that the clinical benefit of XEOMIN is moderate in the indication for the symptomatic treatment in adults of chronic sialorrhea due to neurological disorders associated with Parkinson's disease, traumatic brain injury or stroke only, in the event of intolerance to or failure of anticholinergic agents.
Insufficient	The Committee deems that the clinical benefit of XEOMIN is insufficient in the other clinical situations of the MA.

Clinical Added Value

no clinical added value

considering:

demonstration of the superiority of botulinum toxin type A versus placebo in a randomised, double-blind study, in the symptomatic treatment of chronic sialorrhea in patients with neurological disorders due to Parkinson's disease, traumatic brain injury or stroke, in terms of change in unstimulated salivary flow rate and improvement in the global impression of change scale (co-primary endpoints), with a moderate effect size,
the debatable clinical relevance of the co-primary endpoints, for which the reproducibility of measurement has not been verified,
the absence of long-term safety data, in particular in patients liable to present dysphagia or swallowing difficulties as their condition worsens,
and despite the need for authorised medicinal products having demonstrated their efficacy, in view of the current strategy based on anticholinergic drugs prescribed off-label as first-line treatment in adults,

the Committee considers that XEOMIN provides no clinical added value (CAV V) in the care pathway for the treatment of adult patients with chronic sialorrhea.

Not applicable