BREAKING NEWS

Congress Finally Approves Funding to Fight Zika Virus
More than 3,000 cases reported in continental U.S.
FDA Expands Orkambi Label to Include Cystic Fibrosis Patients Ages 6 Through 11
Lumacaftor/ivacaftor combination previously approved for patients 12 years of age and older
FDA Approves First Automated Insulin Delivery Device for Type-1 Diabetes
“Artificial pancreas” adjusts insulin levels
Migraine Drug Erenumab Succeeds in Phase 3 Trial
Treatment reduces monthly migraine days
Expert Demoted After Questioning CDC’s Zika Test
Singleplex trumps Trioplex, lab chief says
FDA Approves Diabetes Sensing System
Arm patch provides continuous glucose monitoring
Researchers Discover How Resveratrol Reduces Airway Inflammation
Compound could be used in new anti-inflammatory agents
FDA Accepts Application for Osteoporosis Drug Romosozumab
Approval decision scheduled for July
CDC Teams Up With Dialysis Groups to Reduce Infections
First stakeholder meeting to be held this month

P&T September 2016
Table of Contents

Features

Value Purchasing Programs Make Plodding Progress
Escalating drug prices have seeded interest in value-based purchasing, but confusion and controversy have slowed the Centers for Medicare and Medicaid Services, state agencies, and private insurers from pursuing the potential savings.
Covering the Cost of the Cure
As researchers devise ever-more-costly therapies and P&T committees try to balance innovation and affordability, managed care experts warn that the struggle to pay the bills could threaten the sustainability of the nation’s inefficient health care system.
Health Care & Law
Telehealth: Applications From a Legal and Regulatory Perspective
Telehealth is becoming mainstream in the U.S., as more consumers, employers, hospital systems, and even insurers adopt the technology. The authors explore the challenges of regulation, reimbursement, and licensing as the modality evolves.
Meeting Highlights
ESMO World Congress on Gastrointestinal Cancer And European Post-Chicago Melanoma/Skin Cancer Meeting
We present sessions on the latest trials and treatments for colorectal cancer from the ESMO World Congress and report on new developments in diagnostics and therapy presented at the European Post-Chicago Melanoma/Skin Cancer Meeting.

Departments

Medication Errors
Developing Productive Partnerships With Technology and Device Vendors To Improve the Training of Staff
Improve staff training with vendor partnerships
Prescription: Washington
Congress Enters Contentious Debate on Biosimilar Naming
Congress set to tackle biosimilar naming debate
New Drugs/Drug News
Drug and Device News
Approvals, new indications, regulatory activities, and more
Pharmaceutical Approval Update
Cabozantinib (Cabometyx) for advanced renal cell carcinoma; glycopyrrolate/formoterol fumarate (Bevespi Aerosphere) for chronic obstructive pulmonary disease; and ephedrine sulfate (Akovaz) for hypotension during anesthesia
Drug Forecast
Aripiprazole Lauroxil (Aristada)
Aripiprazole lauroxil (Aristada) for the treatment of schizophrenia
Research Briefs
Supplements for Chronic Fatigue Syndrome?

P&T TV

Regorafenib Safe for Older Colorectal Cancer Patients

Eric Van Cutsem, MD, discusses a subgroup analysis involving patients 75 years of age and older in the Consign study of regorafenib for treatment-refractory metastatic colorectal cancer. The analysis found no major differences in safety compared with younger patients as long as the patients were fit enough to be eligible for treatment—so age itself is no reason to withhold regorafenib.

ESMO World Congress on Gastrointestinal Cancer, June 29–July 2, 2016