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.
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.
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.
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%.
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.
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.
Otezla—the generic name is apremilast—also exploited a new mechanism of action as the first inhibitor of phosphodiesterase 4 (PDE4) that results in increased expression of both anti-inflammatory proteins and reduced expression of their pro-inflammatory counterparts.