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.
|
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
RS8XLAGxbUNXVZxq