Reason for request
No clinical benefit demonstrated in the extended treatment of symptomatic venous thromboembolism and prevention of its recurrence in patients who have active cancer and/or are undergoing chemotherapy when compared with other anticoagulants.
INNOHEP has Marketing Authorisation in the extended treatment of symptomatic venous thromboembolism and in the prevention of its recurrence in patients who have progressive cancer and/or who are undergoing chemotherapy.
It has not been evaluated in this specific clinical situation. The studies of tinzaparin have a low level of evidence.
The efficacy of prolonged treatment with tinzaparin has not been established after 3 to 6 months of treatment, but only after 12 months of treatment. This efficacy was demonstrated by comparison with treatment with unfractionated heparin (UFH) or low molecular weight heparin (LMWH) followed by an early switch to a vitamin K antagonist (VKA). No difference between the two treatments in major bleeding or mortality was demonstrated.
No comparison with FRAGMINE is available. Demonstration of the therapeutic benefit of INNOHEP with respect to VKAs has not been solidly established
Substantial in this extension of indication.
Improvement in actual benefit
INNOHEP does not provide any improvement in actual benefit (level V, non-existent) in the therapeutic strategy for extended treatment of symptomatic venous thromboembolism and prevention of its recurrence in patients who have progressive cancer and/or are undergoing chemotherapy. There are no direct comparisons between LMWHs in this indication, in particular not between tinzaparin (INNOHEP) and dalteparin (FRAGMINE), and the therapeutic benefit of INNOHEP versus oral vitamin K antagonist anticoagulants has not been solidly established.