BREAKING NEWS

New Collaboration Will Evaluate Combination of Opdivo and NKTR-214
Regimen will target five tumor types and have seven indications
Experts Recommend Continuous Glucose Monitors for Adults with Type-1 Diabetes
Endocrine Society publishes guideline evaluating technologies for treating diabetes
Kyprolis Combo Fails to Meet Endpoint in Phase 3 Multiple Myeloma Trial
Combination did not improve progression-free survival for newly diagnosed patients
Do Gut Microbiomes of Hispanics/Latinos Influence Their Diabetes Risk?
NIH-funded study seeks to explain the group’s disproportionate risk of the disease
Workplace Depression Across Eight Countries Said to Cost $246 Billion
Study includes nations that differ in economic development, income, and culture
FDA Approves Amjevita, the First Humira Biosimilar
Medication is indicated for the treatment of seven inflammatory diseases
Stelara Receives FDA Approval for the Treatment of Crohn's Disease
It is the first biologic that targets interleukin-12 and interleukin-23 cytokines active in the disease
Dupilumab Application Accepted for FDA Priority Review
The potential blockbuster was granted breakthrough therapy status in 2014
FDA Expands Indications for Ilaris for Three Rare Diseases
Drug previously approved for cryopyrin-associated periodic syndromes and active systemic juvenile idiopathic arthritis
NIH Funds Research Network Focused on HIV-Infected Youth
Studies also will address HIV prevention among at-risk groups

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