UPDATE: The following piece was originally posted to Linked In by Rick Chelko on June 28, 2018. Shortly thereafter, Rick met with a senior Health & Human Services (HHS) official working on drug pricing reform to discuss this and related issues. Ironically, the official expressed concern that the marketplace might view the removal of safe harbor protection for rebates to be “a windfall for Big Pharma.”
Nonetheless, we were pleased to see the Office of Inspector General (OIG) and HHS submit a proposed rule change on July 18 to the Office of Management and Budget (OMB). This proposed rule appears to remove the safe harbor protection for prescription drug rebates under the Federal Anti-Kickback Statute. If and when the rule will be finalized is unclear, as is the effective date. Here’s hoping that it will be soon.
A bill allowing patients with serious illnesses to try unproven experimental treatments has been approved by Congress and is now on its way for signature by a supportive President.
For the sake of this discussion, let’s put aside some of the safety and ethical concerns. On the surface, everything may seem palatable from a plan sponsor perspective. But that’s until you start pondering some of the potential issues lurking beneath the surface. (more…)
Preparing to pay for a new era of effective gene therapy
Could you imagine seeing stars in the night sky for the first time or even the site of your own parents’ faces after ten or even twenty years of significant visual impairment? The Food and Drug Advisory Committee heard personal testaments like these from patients explaining their miraculous results as part of two experimental gene therapy trials.
More than 25 years in the making, the FDA approved Luxturna® (voretigene neparvovec-rzyl), the first gene therapy for an inherited disorder involving a progressive form of blindness, typically starting in early childhood. Currently, no pharmaceutical alternative is available for these patients. (more…)
Responding to client needs within its rapidly expanding specialty drug management practice, the Chelko Consulting Group recently welcomed Kelly Prymicz, PharmD, RPh. (more…)
Specialty drug costs continue to vex most health plan sponsors. This article from NEJM Catalyst brings to light some of the key issues and opportunities for employers. It highlights the Cleveland Clinic’s recent effort to eliminate $8.5 million of annual waste associated with two commonly used cardiovascular drugs. Employers have got to like that result! (more…)
While the rapid evolution of modern medicine offers innovations in patient care, the resulting advancements are placing a fair amount of stress on our existing service delivery and payment models.
A prime example is orphan drugs — defined by the FDA as drugs and biologics for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug. (more…)