Bosentan Enters Market With Risk Management Program
To decrease the risk of liver injury and prevent fetal damage from bosentan exposure, Actelion Pharmaceuticals US Inc. has set up the Tracleer Access Program for the company's recently approved oral treatment for pulmonary arterial hypertension. The risk management program, which requires participating dispensers to track but not monitor patients, is coordinated by a business unit of AmerisourceBergen Corp. and involves a network of specialty pharmaceutical companies.
Bosentan is indicated to improve patients' exercise ability and delay their clinical decline. The drug blocks endothelin-1, a blood vessel constrictor, from binding to receptors in endothelia and vascular smooth muscles.
Warnings about bosentan's potential to injure the liver11% of patients in the premarketing studies had at least a threefold increase in the serum concentration of one or both liver transaminasesand almost-certain likelihood to cause serious birth defects appear in a black box in the product's labeling.
FDA, in approving the marketing of bosentan, required that the company set up a restricted distribution system to track every patient taking the drug. The patient and the prescriber must complete the enrollment form, which collects information about insurance coverage and the diagnosis and also serves as the prescription. FDA does not require the specialty pharmaceutical companies to evaluate a patient's test results before shipping each 30-day supply of the drug. Actelion must submit an annual report to FDA regarding the program's success in minimizing fetal exposure and liver toxicity.
Responsibilities of Bosentan Dispensers
The specialty pharmaceutical companies participating in the Tracleer Access Program must
An Actelion spokesman said that the companies are also supposed to check patients' medication profiles for concomitant drugs (glyburide and cyclosporine are contraindicated) and send the Lash Group a daily record of bosentan-related activities, including refills that should have been obtained but were not requested.
To obtain the initial supply of bosentan, a patient or prescriber contacts the Lash Group, an AmerisourceBergen firm that describes itself as primarily a reimbursement consultant. The Lash Group uses the insurance information on the enrollment form to select which of the participating specialty pharmaceutical companiesCaremark Inc., Gentiva Health Services Inc., Nova Factor Inc., or CVS ProCarewill dispense bosentan to the patient.
For patients with primary pulmonary hypertension, bosentan may be an alternative to epoprostenol, or Flolan, a prostacyclin that must be administered by continuous i.v. infusion. Manufacturer GlaxoSmithKline makes the drug available through two specialty pharmaceutical companies: Gentiva Health and AdvancePCS's TheraCom.
Treprostinil sodium, or Remodulin, another prostacyclin, is in the final stage of the approval process to carry an indication for the treatment of pulmonary arterial hypertension, according to manufacturer United Therapeutics Corp. The drug is be delivered by continuous subcutaneous infusion and distributed by Gentiva Health and Priority Healthcare Corp.