LOVENOX (énoxaparine sodique) - TVP/EP chez les patients atteints d'un cancer actif

Key points

Unfavourable opinion for reimbursement of LOVENOX (enoxaparin) in the extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of their recurrence(s) in patients with active cancer.

Role in the care pathway?

The presence of progressive cancer or cancer under treatment is considered to be a major persistent risk factor for recurrence of a thromboembolic event; patients have a 4 to 7 times greater risk of developing venous thromboembolism (VTE). Thrombosis is the second leading cause of death in cancer patients, after disease progression.

For short-term treatment (up to 10 days), all the injectable antithrombotic agents with a marketing authorisation can be used. In the extended treatment of symptomatic VTE and prevention of recurrences in patients with active cancer and/or on chemotherapy, only dalteparin and tinzaparin are funded. VKAs are also authorised for extended treatment in active cancer patients, following heparin therapy.

For the first 6 months, it is recommended that DVT or PE be treated using low molecular weight heparin (LMWH), without subsequent VKA therapy. The decision to continue treatment beyond 6 months is taken on a case-by-case basis depending, in particular, on the cancer location, the concomitant treatment (presence or otherwise of chemotherapy), the presence or otherwise of a recurrence in the first 6 months and tolerance to the treatment.

The risk/benefit ratio of continuing anticoagulant therapy will be reassessed regularly for any treatment lasting more than 6 months.

Role of the medicinal product in the care pathway

Considering:

• available clinical data, based primarily on the RIETECAT retrospective observational study, for which the low level of evidence does not enable any robust conclusion to be reached with respect to the efficacy and bleeding risk of enoxaparin at the dosage validated by the MA, in comparison with the available alternatives in particular (see section 07.4 Summary and Discussion),
• the available alternatives (dalteparin and tinzaparin), for which the efficacy and safety have been documented with a better level of evidence, particularly for dalteparin in the randomised CLOT study,

the Committee considers that LOVENOX (enoxaparin) has no role in the extended treatment of DVT/PE, and prevention of their recurrence in patients with active cancer.