Reason for request

Inclusion

-


Clinical Benefit

Low

- low in the management of severe, chronic cancer pain in adults that can be adequately managed only with opioid analgesics, except for intractable cancer pain.

Insufficient

- insufficient in the management of severe, chronic, non-cancer pain that can be adequately managed only with opioid analgesics.


Clinical Added Value

no clinical added value

Severe, chronic cancer pain
In light of the comparison between PALEXIA LP proprietary medicinal products and placebo or low-dose oxycodone LP, the Transparency Committee considers that the PALEXIA LP proprietary medicinal products do not provide any improvement in actual benefit (level V, non-existent) in the management of severe, chronic cancer pain in adults, when comparedwith other available opioid analgesics.
Owing to its noradrenergic activity, tapentadol LP could be associated with a risk of ideation and suicidal behaviour, although no causal link has been established according to the EMA.

Not applicable

Severe, chronic non-cancer pain
Not applicable.