Novartis Pharmaceuticals Canada Inc., a division of Basel, Switzerland-based healthcare solutions provider Novartis AG (NVS), said Wednesday that a decision by the Common Drug Review or CDR on June 25, which counseled provincial drug plans not to reimburse osteoporosis treatment Aclasta, is a major setback in terms of access to a new and effective treatment for the condition. However, each provincial authority takes a final decision based on its own priorities and resources.
Aclasta is indicated in women with postmenopausal osteoporosis or PMO and is administered once in a year as a 15-minute intravenous infusion that can be done at a hospital or at home. Aclasta is indicated as an alternative to oral bisphosphonates taken daily or weekly.
According to the company, there is significant data to show that Aclasta provides therapeutic and economic advantages over raloxifene, a selected estrogen receptor modulator that is the therapeutic option currently reimbursed for PMO patients
who are unable to take or do not respond to an oral bisphosphonate. Novartis said the committee reviewing the file, however, felt there was insufficient evidence to recommend listing in this group of patients.
Novartis had proposed that Aclasta be listed for the treatment of postmenopausal women with evidence of intolerance, inability to take, or inadequate response to oral
bisphosphonates.
The company noted that compliance is a real issue when it comes to osteoporosis drugs, as many patients stop the treatment within a year or have difficulty taking them, thus exposing them to risk of fractures.
Novartis said raloxifene is listed at a higher price than Aclasta and has shown poor compliance among PMO patients, as demonstrated by a one-year probability of discontinuation of 52% in one study and persistence rates reported at only 16.2% in another study.
Efficacy and safety data from a three-year fracture trial published in The New England Journal of Medicine, showed that an annual infusion of Aclasta increases bone strength and reduces fracture risk in areas of the body typically affected by osteoporosis. The drug was also shown to reduce spine fractures by 70% and hip fractures by 41% compared to placebo.
Another important trial, also published in The New England Journal of Medicine, showed that an annual infusion of Aclasta administered within 90 days after repair of a low-trauma hip fracture was associated with a reduction in the rate of new clinical fractures and improved survival compared to placebo.
The CDR is mandated to provide objective, rigorous reviews, and evidence-based recommendations to help support and inform drug plan decisions. The final say, however, rests with provincial authorities who make a final benefit-listing and coverage decisions based on its own priorities and resources.
Quebec's Conseil du médicament, which conducts a separate review process from the CDR, is expected to make a recommendation on the listing of Aclasta in the fall. Ontario will be reviewing the file later in 2008, with decision expected later in the year.
NVS is currently trading at $56.81, up $1.86 or 3.38%, on 1.50 million shares.
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