“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…)
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…)