We’ve all likely seen at least one of the countless movies sharing this plot. You know the script: Large rock hurtles through space on a collision course with earth, leading to what will result in a mass extinction level event. That is, of course, unless divine intervention or the planet’s greatest minds hatch a plan to divert path of said rock.
Forgive our sense of the dramatic (and love of clever word play), but this scenario recently came to mind as we awaited what we thought was the imminent market introduction of gene therapy Roctavian. If you follow these sorts of things, you would know that Roctavian just received a rejection from the FDA. (more…)
Responding to client needs within its rapidly expanding drug benefits management practice, the Chelko Consulting Group recently welcomed Lucia Vescera, PharmD, RPh.
Before joining Chelko, Vescera was instrumental in the opening and URAC accreditation of the Cleveland Clinic Specialty Pharmacy where her clinical focus was hepatology, infectious disease, and preventative cardiology. Her role also involved clinical consulting for solid organ transplant patients. (more…)
If recent events have taught us anything, it is to be prepared for the unexpected. While none of us could have fully predicted the dramatic impact of COVID-19 on our families, organizations, and the world economy, hindsight reveals safeguards we might have put in place to lessen the damage.
Ironically, this is a subject I had been wrestling with well before the coronavirus was receiving any attention from the international media. Those of you who follow our firm’s work know we have long been concerned about the growing economic threat posed by rising specialty drug costs to employer-funded health plans and their members. It actually dates back to 2005, when I first learned about a $125,000 oncology drug that didn’t save lives. On average, it only extended life by less than two months of sub-optimal living. (more…)
“The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices.” It’s right there in their job description.
But with the release of new policies meant to promote innovation for patients with unmet clinical needs, the FDA is asking the American people to “accept some level of uncertainty” when it comes to a handful of gene therapies that have been fast-tracked through the approval process. (more…)
The prescription drug market is officially upside down. We were recently looking at a large coalition’s new initiative to “remove unnecessary drugs” from its formulary. The plan, believe it or not, is to charge coalition members over $3 million in fees to exclude these expensive, unnecessary drugs.
Our response: Really? We have to pay them extra for that? Why were those drugs covered in the first place? Weren’t we already paying them to help us avoid spending money on expensive, unnecessary drugs? (more…)
The prescription drug space is making headlines everyday with stories ranging from novel drug approvals to political and legislative proposals that have PBMs and drug manufacturers on edge. Here are three current issues that should be on every plan sponsor’s radar. (more…)