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New drug approvals, clinical trials, drug management. Three times per week.

Drug management

Drug pricing & markets, value-based pricing, cost control, real-world evidence for safety and effectiveness
In theory, this approach could help untangle some knotty cost and quality concerns about medications as they move from clinical trials and into clinical use. But there’s that credibility issue.
Thomas Morrow, MD
Hemlibra demonstrates how far antibody science has progressed. Genentech’s drug, approved late last year, connects two clotting factors to prevent the devastating bleeds in hemophilia patients with inhibitors. The high price may be offset by avoided costs in patients with factor VIII inhibitors.
Timothy Kelley
Opioid overdoses have killed more than 300,000 since 2000—and the death rate is rising. Buprenorphine could save thousands more lives than it does—if it weren’t for legal barriers, a fear of disruptive patients, and insurance red tape. And it can be prescribed in the primary care physician’s office.
Thomas Reinke
Some say gene editing platforms like CRISPR are a truer version of gene therapy because they are designed to home in on a particular genomic location.
2018 Year in Preview
Robert Calandra
PBM consultant Linda Cahn says that if Amazon gets into the PBM business it could insist that drugmakers simultaneously submit the net discount price for each of their drugs for the subsequent six months. Amazon could then publicize every drug’s actual price, by drug and by therapeutic category.
2018 Year in Preview
Timothy Kelley
For all the sturm und drang, experts foresee neither a hurry-up nor a halt for 2018, just a fairly steady continued rise at roughly last year’s higher-than-inflation pace. The Drug Price Forecast, for example (based on hospital and nonacute settings, but not retail pharmacy), reports that that means a tidy year-over-year increase of 7.61%.
Thomas Reinke

Robert Rifkin, MD,
US Oncology

Seven biosimilars have crossed the FDA-approval finish line. The FDA has largely held to the abbreviated pathway it laid out originally. The big change is that the rest of the world is starting to understand it. Approvals are based upon “the totality of evidence,” “analytic similarity,” and clinical performance with much less emphasis placed on phase 3 trials.
Robert Calandra
PBMs say their deals need to be kept private so they can drive a hard bargain with manufacturers. But employers, consumer groups, and legislators are calling for more PBM transparency. There’s bipartisan support for legislation that would force more openness.