Quote this publication Share Print

MANTADIX (amantadine)

Opinions on drugs - Posted on Aug 05 2021

Reason for request

Reevaluation

Key points

Favourable opinion for reimbursement in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease. The clinical benefit is moderate in these patients. Unfavourable opinion for reimbursement in other clinical situations in the disease.

The clinical benefit was previously low in the “Parkinson’s disease” indication.

What therapeutic improvement?

No clinical added value in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.

Role in the care pathway?

There are few specific therapeutic interventions for levodopa-induced dyskinesia. In clinical practice, strategies consist in optimising the anti-Parkinson’s treatment. In advanced Parkinson’s disease, deep brain stimulation is effective for reducing dyskinesia. The combination of levodopa-carbidopa administered by the enteral route can reduce the duration of “off” periods and increase the duration of dyskinesia-free “on” periods.

Non-dopaminergic targets to reduce dyskinesia have been the subject of research for a number of years.

Role of the medicinal product in the care pathway

Immediate-release amantadine, an N-methyl-D-aspartate glutamate receptor antagonist, remains a useful treatment option in the management of levodopa-induced dyskinesia in patients with Parkinson’s disease. Extended-release preparations have been developed, but are not currently authorised in France.

In other clinical situations in Parkinson’s disease, particularly at the start of the disease, immediate-release amantadine has no role in the care pathway in view of the medicinal alternatives.

 


Clinical Benefit

Moderate

The Committee deems that the clinical benefit of MANTADIX is moderate in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.

Insufficient

The Committee deems that the clinical benefit of MANTADIX is insufficient to justify its public funding cover in all other clinical situations in the disease.


Clinical Added Value

no clinical added value

Considering:

  • efficacy data versus placebo for immediate-release amantadine in the short-term treatment of levodopa-induced dyskinesia,

but in view of

  • the low level of evidence of this efficacy data and
  • the partially met medical need,

the Committee considers that MANTADIX (amantadine) provides no clinical added value (CAV V) in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.

 

 


Contact Us

Évaluation des médicaments