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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