Biotech Values

[DewDiligence]

Re: MNTA / alleged competition from Arixtra

The following study presented at the CHEST 2008
conference in October shows why it’s a pipedream
to think that Arixtra (branded or generic) will have
a meaningful impact on MNTA’s potential sales of
generic Lovenox. As previously noted, Arixtra is a
fine drug in terms of efficacy, but it has little chance
of becoming more than a niche player. Its current
market share among all heparin-related drugs in
all indications is 3% (#msg-26739674).

The numeric details of this study should be taken
with a grain of salt because the study was funded
by SNY. However, the main point of the study—that
Arixtra offers no cost advantage to Lovenox that
would offset Arixtra’s perceived safety issues—is
completely valid, IMO.

http://www.docguide.com/news/content.nsf/news/852571020057CCF6852574F4007E2120

›Enoxaparin More Cost-Effective Than
Fondaparinux for Preventing VTE

›By Em Brown

PHILADELPHIA -- November 1, 2008 -- Venous thromboembolism (VTE) prophylaxis is much more cost-effective with the low-molecular-weight heparin enoxaparin compared with the newer Factor Xa inhibitor fondaparinux, investigators reported here at CHEST 2008, the annual meeting of the American College of Chest Physicians.

The savings per patient with enoxaparin VTE prophylaxis is approximately $3,000 per patient, noted principal investigator Geno J. Merli, MD, Thomas Jefferson University, Philadelphia Pennsylvania, speaking here on October 28. "The annual cost of VTE prophylaxis is around $1.5 billion."

Dr. Merli's team retrospectively reviewed 364,000 patient discharges from their institution of individuals aged 40 years or older who had been hospitalised between 2002 and 2006 with an International Statistical Classification of Diseases and Related Health Problems (ICD-9) code indicating VTE risk, such as cancer, heart failure, lung disease, orthopaedic or abdominal surgery, or serious infection.

The investigators compared total direct medical costs of enoxaparin prophylaxis (administered in 96.8% of patients) with fondaparinux prophylaxis (administered in 3.2% of cases).

Patients treated with enoxaparin had, on average, more severe disease than those treated with fondaparinux -- 65.5% and 52.1%, respectively. [Badly worded; they meant to say that a higher proportion of the Lovenox patients had severe disease.]

Enoxaparin discharges had a mean total direct medical cost of $9,755 compared with $12,683 for fondaparinux discharges, for a difference of $2,928 per patient, Dr. Merli reported. After adjusting for patient and hospital characteristics, the costs associated with enoxaparin were $6,479 compared with $6,658 with fondaparinux, for a difference of $179 [this is essentially no difference inasmuch as $179 is below the realistic level of quantitation in this kind of study].

The cost of anticoagulant therapy was also lower for enoxaparin discharges than for fondaparinux discharges, at $130 and $163, respectively.

"The total adjusted medical cost savings per patient was $442 with enoxaparin compared with fondaparinux," Dr. Merli stated. "This is a significant savings, considering the number of patients treated each year for VTE prophylaxis."

"Both drugs are efficacious," Dr. Merli pointed out. "Enoxaparin has been on the market a lot longer. It has a better safety profile and a shorter half-life of 4.5 to 6.5 hours, compared with 17 to 20 hours with fondaparinux. The longer half-life increases the potential risk of bleeding complications."

"For fondaparinux, there is no reversing agent, if there are complications. With enoxaparin, we have protamine," he pointed out. Fewer, more manageable complications increase the savings with enoxaparin, Dr. Merli noted.

Funding for this study was provided by Sanofi-aventis. The study title is, “Total Hospital-Based Costs of Enoxaparin or Fondaparinux Prophylaxis in Patients at Risk of Venous Thromboembolism.” The abstract number is AP2296.‹