Biologics in Development
Katherine T. Adams

Sorrento Therapeutics/MabTech have completed late-stage trials in China for STI-001, a cetuximab (Erbitux) biosimilar for the treatment of EGFR-expressing metastatic colorectal cancer, and STI-002, an infliximab (Remicade) biosimilar to treat rheumatoid arthritis. Tenofovir alafenamide is being tested for treating hepatitis B.

Ed Silverman

Coverage restrictions, such as notably treating the sickest patients while denying medication to others who also are infected, are prompting a growing backlash that is predicted to continue unless payers alter their guidelines. A Harvard Law School group is among those that have taken action.

Thomas Reinke

Michael Sherman, MD
CMO at Harvard Pilgrim

Risk-sharing agreements between insurers and drug companies have been used on a limited basis up until now. That’s changing as manufacturers start to offer significant rebates in exchange for preferred status on an insurer’s formulary. For their part, payers want to see quality outcomes and value.

News & Commentary

A study in the New England Journal of Medicine rebuts the contention that hospitals will use observation stays to try and avoid penalties for readmitting Medicare patients within 30 days for certain conditions. Good news for patients, who face costs for observation stays that they don’t have with inpatient stays.

Richard G. Stefanacci, DO
Scott Guerin, PhD

Direct costs related to
people not taking their medications have been estimated at over
$100 billion dollars annually. Lack of adherence is associated with a 30% to 50% increase in treatment failures. Health plans that want to address this problem must be nimble and work on many fronts.

Jan Greene

People don’t adhere to treatment regimens for any number of reasons. IBM’s Watson Health thinks it can put its big-brain cognitive thinking cap on and figure us out, as revealed in the data fingerprints we leave behind when we enter the health care labyrinth.

Legislation & Regulation
Richard Mark Kirkner

Katie Holcomb

The FDA’s foot-dragging on drafting regulations on biosimilars, as spelled out in the Biologics Price Competition and Innovation Act (BPCIA) of 2009, has frustrated and confounded not only the biopharma industry, but also the public, health plans, and pharmacy benefit managers because potential lower-cost competitors to expensive biological agents are stalled in the regulatory pipeline.

Joseph Burns

A flood of tests have insurers ramping up prior authorization and utilization review. Information overload is a problem. As doctors struggle to keep up, health plans need to get ahead of the development of the technology in order to successfully manage genetic testing appropriately.