Download opinion
Add to my selection
Quote this publication Print

ESKESIA (esketamine) - Anaesthesia

Opinions on drugs - Posted on Apr 25 2023

Reason for request

Reassessment

Reassessment.

 

Key points

Favourable opinion on reimbursement as an adjuvant to regional or local anaesthesia solely as an analgesic supplement in adult patients.

Unfavourable opinion on reimbursement in paediatric patients and in the other clinical situations where an adjuvant to local and regional anaesthesia is used in adult patients.

 

What therapeutic improvement ?

No therapeutic improvement in the management strategy.

 

Role in the care pathway?

Locoregional anaesthesia (LRA) is based on the use of local anaesthetics in the amino amide family administered locally close to peripheral nerves, via the epidural or intrathecal route.

According to the expert opinion, during regional anaesthesia, an adjuvant can be used to:

  • reinforce the action of local anaesthetics,
  • improve the clinical conditions for the performance of a surgical procedure under locoregional anaesthesia intraoperatively (sedation) and postoperatively (analgesia).

The adjuvants that can be used in clinical practice are:

  • clonidine, racemic ketamine and dexamethasone used to reinforce the action of local anaesthetics used off-label;
  • midazolam and propofol used to improve the clinical conditions for the performance of a surgical procedure under locoregional anaesthesia intraoperatively (sedation);
  • opioids (with an MA) used to improve the clinical conditions for the performance of a surgical procedure under locoregional anaesthesia post-operatively  (analgesia). Clonidine, racemic ketamine and dexamethasone can be also used in this context off-label.

In children, clonidine is also used off-label as well as opioids (morphine, fentanyl and sufentanil) to obtain analgesia.

 

Role of ESKESIA (esketamine) in the therapeutic strategy:

Taking into account the available data and the wording of the doses of the SmPC, in local or regional anaesthesia, ESKESIA (esketamine) is an adjuvant treatment that can be used solely as an analgesic supplement in adult patients.

Due to lack of data, ESKESIA (esketamine) has no role in the treatment of paediatric patients and in other clinical situations where an adjuvant to local or regional anaesthesia is used in adult patients.


Clinical Benefit
Low

The clinical added value provided by ESKESIA (esketamine) is low in the indication “adjuvant to local or regional anaesthesia” solely as an analgesic supplement and in adult patients.
Insufficient

The clinical added value provided by ESKESIA (esketamine) is insufficient to be covered by national insurance schemes in paediatric patients and in other clinical situations where an adjuvant to local or regional anaesthesia is used in adult patients.

Clinical Added Value
no clinical added value

In view:

  • of the absence of robust data demonstrating the benefit of esketamine in terms of efficacy or tolerance compared to the available alternatives; these data being derived from single centre studies, with low numbers of subjects, with no distinction of the primary endpoint for the studies by Suppa et al. et Mendola et al. and with no method to manage inflation of the α risk, the results are purely exploratory;
  • of the fact that the medical need is met by these alternatives;

the Committee considers that ESKESIA (esketamine) 5 and 25 mg/ml, solution for injection/ infusion, provides no clinical added value (CAV V) in the current therapeutic strategy as an adjuvant to local or regional anaesthesia or as an analgesic supplement in adult patients.
Not applicable

In the other situations of the MA indication: Not applicable.

Documents

English version

Contact Us

Évaluation des médicaments
All our publications