Invega approved as schizophrenia treatment for adolescents
TITUSVILLE, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.
J&J said Monday that the FDA had approved Invega (paliperidone) extended-release tablets for patients ages 12 to 17 years. The drug is marketed by J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals. The drug originally was approved in 2006 for treating schizophrenia in adults.
“Although rare, schizophrenia in adolescents is a very serious and disabling brain condition that affects every aspect of an adolescent’s life and has significant consequences,” J&J Research & Development global therapeutic head of neuroscience Husseini Manji said. “This new indication for Invega provides an additional option for clinicians who treat adolescents with schizophrenia and further demonstrates our commitment to helping people with diseases of the brain.”
Sanofi-Aventis closes Genzyme acquisition
PARIS — Genzyme now officially is a wholly owned subsidiary of Sanofi-Aventis.
The Paris-based drug maker said that the closing followed the completion of the exchange offer for drug maker Genzyme last week. As its subsidiary, Genzyme will become a new platform in Sanofi’s sustainable growth strategy and expand the company’s presence in biotechnology, Sanofi said. Genzyme will continue to operate out of its Cambridge, Mass., headquarters, and will be led by Sanofi CEO Christopher Viehbacher for several months.
Genzyme rejected several buyout offers from Sanofi last year, which included a deal worth $18.5 billion, or $69 per share. The two finally settled on a price of $74 per share.
NCPA: Florida’s Medicaid Managed Care pilot program raises concerns
ALEXANDRIA, Va. — A Georgetown University Health Policy Institute study of Florida’s Medicaid Managed Care pilot program should raise doubts for states considering the use of for-profit managed care companies to reduce Medicaid costs, the National Community Pharmacists Association cautioned on Friday.
The Georgetown study found that some companies hoping to profit from providing Medicaid managed care services have not achieved the success they envisioned and sometimes choose to leave the program with little notice, causing a disruption for patients. For example, health plans accounting for two-thirds of the market share in Broward County in 2008 are no longer participating today. Such disruption can particularly harm those Medicaid beneficiaries who need more coordinated care for serious chronic conditions, such as diabetes.
In terms of managed care costs savings, the Georgetown study found “insufficient data available to draw conclusions,” adding that reductions in expenditures may actually be due, in part, to patients being denied care.
Even so, Florida is pushing legislation that expands the program statewide, and other states might follow suit, NCPA warned. Instead of continuing with the fee-for-service system operated by the state at lower administrative costs, compared to private health insurance plans, the pilot program adds another layer of bureaucracy and fees, the association asserted.
“Independent community pharmacists sympathize with states like Florida that are facing a budgetary crisis and are looking for solutions to rein in the costs of Medicaid,“ stated NCPA EVP and CEO Douglas Hoey. “However, this type of flawed Medicaid managed care approach is not the solution. The recently released Georgetown University study indicates that the envisioned benefits of Medicaid managed care are not materializing, while patient health may be at risk in some instances.”