This week we launched Evidex Alerts, a new feature that provides our clients with real-time updates on the latest impactful drug safety news. This is a project that our development and analyst teams have worked on diligently for the last three months, and I am excited to announce that it became a reality this week.
In the Q3 2014 FDA Adverse Event Reporting System (FAERS) data file, FDA quietly added a new field that links a patient and case report to a literature reference. Or in other words, there is additional information on the adverse event (AE) report that previously was not available. These literature references can provide beneficial context to the patient case report, validate or refute a causal relationship to an adverse event, and often times bring to the surface data that is otherwise undiscoverable.
For the last few years, we have been working continuously to turn post-market patient data from the FDA’s Adverse Reporting system (FAERS) into insight that can be used by healthcare providers to quantify the costs and risks associated with the drugs that their patients are prescribed. Along the way, we have had a number of “naysayers” tell us it cannot be done.
We are proud to announce after months of hard work and dedication from everyone on the Advera Health development team that we have launched the newest version of RxSignal. RxSignal is our proprietary tool which identifies serious adverse events which are most likely to be added to a drug’s label in the future. This latest version produces more accurate signals that lead to label changes involving more important medical events while producing a lower number of signals that do not lead to label changes or actions by the FDA.
A few weeks ago, I was on a call with one of our Business Development Managers, explaining the details of our proprietary analytics to a Pharmacy Director at a health plan that we were trying to turn into a client. We were walking through our RxSignal technology for a particular drug and the executive said to us, “This looks great but you can’t possibly predict what the FDA is going to do in the future”.
I’m pleased to share the news that this week we launched RxOutcome.
RxOutcome is a powerful new dashboard on the AdverseEvents Explorer platform that allows our clients to compare drugs across an indication, class, or mechanism of action.
With RxOutcome, subscribers can now compare actual incidence rates and patient outcome rates of a group of medications to see which drug is the safest option or which drug causes particular safety issues versus others in its peer group.
Tomorrow, there will be an FDA panel meeting where a committee of drug safety and pharmacology experts will decide whether Chantix’s black box warning for neuropsychiatric events should be removed from its label. This warning has been on the label since 2008, when the FDA found in its Adverse Event Reporting System (FAERS) a number of suicide-related, mood-related and aggression related events that were large enough in scope to cause the FDA to require this change. In my opinion, this black box warning should not be removed at this time.
It’s that time of year again. It’s August, the summer is winding down and people are taking their last vacations before the kids go back to school. Football players are in training camp and baseball pennant races are coming down to the wire. And most importantly to all of us at AdverseEvents, Prescription Benefit Managers (PBMs) are telling the world which drugs they are excluding from their preferred drug formulary coverage in 2015.
Last week, we found out that Express Scripts and CVS Caremark will be excluding two drugs from their respective formularies, Vimovo (naproxen/esomeprazole) and Duexis (ibuprofen/famotidine). The news was not so good for the maker of those drugs, Horizon Pharma, whose stock is down more than 30% since the announcement was made. Horizon stated in their 8-K that these formulary deletions could cost them 30% of their revenue and the market reacted accordingly. These drugs both combine an anti-inflammatory agent with an anti-ulcer agent, seemingly a very logical and safer combination since heavy anti-inflammatory use can sometimes cause ulcers. However, each individual component of these drugs is available much cheaper if they were prescribed separately. Based on this, Express Scripts and CVS decided the combination drug was a waste of money (namely theirs) and they weren’t going to tolerate it anymore. Now, everybody is speculating whether other combination drugs that combine cheap generic individual components are next on the PBMs’ chopping block.
Sometimes, great opportunities arise out of some of the worst events in your life. One day during the fall of 2009, my family experienced one of those terrible yet transformative events. I was at my office in San Diego that afternoon when I got a call from my wife Lisa. I picked up the phone and she simply said to me “Come home now”. When I heard those words, my keys were in my hands instantly and I was headed out the door.
When I got home, I found my wife lying in bed, face and neck swollen, struggling to breathe and panic-stricken. She had just taken a commonly provided medicine the day before and now was experiencing an “adverse event” because of it. I took her to the doctor and she was given steroids, which reduced the severity of her symptoms but seemed to make her more jittery and anxious. Despite the short term improvement after this initial treatment, the majority of her symptoms persisted for almost two more months, including vision problems, headaches, and throat swelling. After 15 visits to various doctors over that time including neurologists and ophthalmologists, nobody had any solutions for her. They just promised her that her problems would eventually go away with time. Fortunately, those problems did go away.