2006 Pipeline: What can you expect?

December 12, 2005

Though blockbusters that wreak havoc on budgets are not anticipated, some new agents still bear watching.

At a glance

Unlike most people who spend this time of year deciding what gifts to buy, hospital pharmacy directors are carefully planning their departmental budget for the next 12 months. They are trying to determine the expected use for some agents that haven't even received approval. It's often a guessing game.

Just approved

Forecasting experts warn that drugs recently approved by the FDA may also have an impact on next year's spending, as it takes three to six months for diffusion of new products into the market. Here are a few:

Deferasirox (Exjade, Novartis) was approved in November and touts itself as the first and only once-daily oral iron chelator. The drug is approved for the treatment of chronic iron overload due to blood transfusions in adults and children age two and older. According to Novartis, deferasirox tablets should be dispersed into orange juice, apple juice, or water, and administered as a drink. Previously available iron chelator therapy often required a subcutaneous infusion lasting eight to 12 hours per night.

Clinical trials for deferasirox included more than 1,000 adults and children and showed that doses of 20-30 mg/kg/day led to reductions in liver iron concentration, an indication for body iron content in patients receiving blood transfusions. The new drug will cost about 20% more than desferrioxamine (Desferal, Novartis). The list price is $89.49/gm, which at an average dosage, comes to more than $32,000 annually for treatments other than sickle cell disease. Costs for sickle cell treatment are about a third lower. [For more on deferasirox]

Nelarabine (Arranon, GlaxoSmithKline), approved in October, is a new agent for the treatment of adults and children with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma, whose disease has not responded to or has relapsed following at least two chemotherapy regimens. The drug was approved under the FDA's orphan-drug and accelerated-approval programs and is the first drug to treat this limited population of patients. [For more on nelarabine.]

Tramadol ER (Biovail), a once-daily formulation of tramadol HCl, was approved in September for the treatment of moderate to moderately severe chronic pain. According to the company, the once-daily product is expected to launch in early 2006 and will include 100-, 200-, and 300-mg strengths. The trade name for the product is being finalized.