Poor adherence to prescription drug regimens has long been seen as a substantial roadblock to achieving better outcomes for patients. Data show that as many as half of all patients do not adhere faithfully to their prescriptions, and the result is more than $290 billion spent each year on avoidable medical treatment.
Breakthrough therapy designation: FDA’s newest mechanism for accelerating approval for promising pipeline therapies
In July of 2012, a provision in the newly ratified Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA), paved the way for the FDA to further assist drug manufacturers in expediting the development and introduction of new drugs demonstrating early signs of advancement in the treatment of key conditions. Known as the “breakthrough therapy” designation, this new tool is seen by many as yet another positive sign that the FDA is committed to ensuring that innovative drug products are brought to market even more quickly for the millions of patients with serious medical conditions, desperately in need of new therapeutic options.
Medicinal cannabis, despite its emerging popularity, presents unique issues to managed care and hospital decision makers. Exactly how does a quasi-legal substance, which has existed outside the sphere of mainstream medicine, become integrated into a traditional hospital and managed care setting?
"I have made an appointment for you with an oncologist."
States with restrictive Medicaid policies need to alter those policies because of delayed medical care, according to a recent New England Journal of Medicine letter to the editor.
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released new regulations about the reporting of fees, meals, travel expenses, and other transfers of value for the implementation of the Physician Payment Sunshine Act (PPSA). These new regulations require that data on the payments and gifts that drug and medical device companies make to physicians will become available publicly in a searchable database beginning in September 2014.1
The Medicare Part D prescription drug program has emerged as the poster child for how private plans can control costs while providing quality care. Even critics of health insurers acknowledge that the drug benefit has been a success.
The passage of the FDA Safety and Innovation Act will support innovation, answer the current shortages, and even regulate mobile applications.
While scientists and biomedical researchers at the recent meeting of the American Society of Clinical Oncology (ASCO) applauded encouraging data on dozens of breakthrough cancer therapies, analysts pondered strategies for convincing payers to cover the new life-saving drugs.
The drive for personalized medicine and greater patient involvement in treatment decisions demands more informative data on the effects and risks associated with drugs and medical products.