Semulaparin: Effective Maybe, Cost Effective?

It’s difficult to assess the cost effectiveness of a new intervention when price data is unavailable.  That’s the case with semulaparin, a new anticoagulant that is not FDA approved.

The NEJM this week reports that using semulaparin decreases the incidence of blood clots in cancer patients.

Venous thromboembolism occurred in 20 of 1608 patients (1.2%) receiving semuloparin, as compared with 55 of 1604 (3.4%) receiving placebo (hazard ratio, 0.36; 95% confidence interval [CI], 0.21 to 0.60; P<0.001), with consistent efficacy among subgroups defined according to the origin and stage of cancer and the baseline risk of venous thromboembolism.

There was a slight increase in bleeding complications in the semulaparin group 2.8% vs 2% in the placebo group.

The authors conclude that the drug reduces the incidence of thromboembolism in patient on chemotherapy.

Sanofi’s press release touted the results as well:

Sanofi (EURONEXT: SAN and NYSE: SNY) announced today results of the pivotal SAVE-ONCO study which demonstrated that, in cancer patients initiating a chemotherapy regimen, investigational semuloparin significantly  reduced the risk of the composite of symptomatic-deep vein thromboembolism (DVT), non-fatal pulmonary embolism (PE) or venous thromboembolism (VTE)-related death by 64%[]i], meeting the study primary endpoint (respectively 1.2% and 3.4% for semuloparin and placebo HR 0.36 95% CI (0.21-0.60)), p< 0.0001).

Medicynical Note:  The daily costs of the currently available low molecular weight heparins are between $35 and $80 dollars/day.  Assuming self-injection and negligible cost for other materials. 

The mean duration of the treatment regimens in the NEJM study was 3.5 months (approximately 100 days).  $35/day for 100 days and 80/day for 100 days gives a treatment cost for patient of between $3500 and $8000/patient.

1608 patients were treated in the study.  Using this number and the estimated cost/day, providing a low weight molecular heparin to these patients would be between $5,628,000 million dollars if the drug costs $35/day and $12,864,000 at $80/day.

The benefit noted in the article was a difference of 35 occurrences of venous thrombo-embolism between the placebo and treated group.  This gives a cost range of between $160,000 and $367,542 per thrombo-embolus prevented.

Cost effective?  Probably not.