FDA approves ADHD drug for adolescents
PHILADELPHIA — The Food and Drug Administration has approved an attention deficit hyperactivity disorder drug for use in adolescents.
British drug maker Shire announced Monday the approval of Vyvanse (lisdexamfetamine dimesylate) capsules for patients aged 13 to 17. The drug was already approved for children ages 6 years to 12 years and adults.
“This adolescent indication for Vyvanse is good news for kids in this age group diagnosed with ADHD and their caregivers as it offers an additional treatment option to help them manage their symptoms,” Shire SVP ADHD business Mike Yasick said in a statement. “The approval of Vyvanse for children and adults — and now for adolescents — underscores Shire’s commitment to helping ADHD patients and their families.”
NACDS, NCPA claim pharmacy victory after withdrawal of Medicaid program provisions
ALEXANDRIA, Va. The National Association of Chain Drug Stores and the National Community Pharmacists Association heralded the withdrawal of two provisions from the Medicaid program that would have had retail pharmacies selling generic drugs at a loss.
The Centers for Medicare and Medicaid Services cut provisions that defined average manufacturer price and determined calculation of federal upper limits. The NACDS and NCPA sued CMS in the U.S. District Court for the District of Columbia in November 2007 to obtain an injunction against the provisions, which the court granted. In response, CMS revised its definition of multiple source drugs in October 2008, though the pharmacy lobby groups amended their lawsuit to block that as well, saying it was still against the law. CMS’ new rule removes that provision as well.
In a joint statement, NACDS president and CEO Steve Anderson and NCPA EVP and CEO Kathleen Jaeger heralded the decision, saying the rule would have reduced patients’ access to pharmacies by cutting reimbursements, thus forcing retail pharmacies to sell generic drugs at a loss.
“We insisted that this policy was not appropriate,” the statement read. “Separately, we also have urged that policy-makers should recognize the ability of pharmacies and pharmacists to help improve health and reduce healthcare costs. We are gratified that this sense is reflected in the pharmacy provisions of the new healthcare-reform law. The new law contains provisions ranging from dramatically reducing the [accelerated manufacturing of pharmaceutical] cuts to advancing medication therapy management, through which pharmacists can help patients take their medications correctly, which is referred to as ‘medication adherence.’”
Roadside announces partnership to further ‘drive’ wellness programs
BOSTON Two companies have formed a partnership to provide services for long-haul truck drivers.
Sleep HealthCenters and Roadside Medical Clinic + Lab announced a partnership Wednesday to provide sleep medicine services as part of Roadside’s driver-wellness programs.
Roadside provides medical services, such as Department of Transportation-compliant physicals, drug testing, driver-wellness programs and sleep services for professional drivers on the highway and at company terminals. Sleep HealthCenters will support Roadside’s programs by providing education, professional diagnosis and treatment support, which will be incorporated into the driver-wellness program.
“You cannot effectively screen, test and treat sleep apnea without addressing and improving drivers’ overall health condition, such as weight, [body-mass index], stress and cardiac strength,” Roadside COO Rob Scheschareg said. “By providing continuous care for drivers for sleep, fitness, health and [Department of Transportation] compliance from the terminal to the highways, Roadside Medical is able to move the needle toward better driver health.”