- Date 07 June 2017
- Documents : 4
- Economic analysis
- History
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OCALIVA (obeticholic acid), bile acid
HEPATOLOGY - New medicinal product
Opinions on drugs -
Posted on
Oct 04 2017
Reason for request
Inclusion
No clinical benefit demonstrated in the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with insufficient response to UDCA, or as monotherapy in adults who do not tolerate UDCA.
- OCALIVA has marketing authorisation in the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with insufficient response to UDCA, or as monotherapy in adults who do not tolerate UDCA.
- Its efficacy has been demonstrated versus placebo only on an interim composite biochemistry endpoint but with no impact on morbidity and mortality.
- This is a second-line treatment.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
-
Economic analysis
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