Government Programs & Pharma Drug Presentations

Last week and this week I'm spending my time within Government Programs--Medicare Part D clinical formulary management. As my first task, I was given a binder and was told to read "chapter 6." This chapter includes drugs not covered by Medicare Part D and policies and procedures regarding formulary management such as negative changes and ANOC (annual notice of change).

The project assigned to me dealt with HRM's (high risk medications). As the title implies, HRM's are medications that should not be used in the elderly or be used with caution. I was responsible for comparing utilization PMPM (per member per month) between 2009 and 2010 of HRM's. The control group are HRM's not removed from formulary, and variable group are HRM's removed from formulary. Ideally we'd like to see utilization to decrease from 09 to 10.

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Pharma Drug Presentations
So far, I've attended 3 drug presentations presented by drug companies for Cayston (aztreonam inhalation solution), Zyclara (imiquimod 3.75% cream) and Vimovo (esomeprazole and naproxen). Each presentation was an experience in and of themselves. It's like a formal ritual-- introductions are made, business cards exchanged left and right...I'm forming quite a collection of business cards. I've noticed that the drug companies send teams of 3: medical science liasion (PharmD), expert of therapeutic topic (MD and/or PhD) and national account manager (business person concerned with money). The expert gives a presentation on the pathophysiology of disease being treated and the drug product being promoted. My preceptors and I will interject with questions, and the whole time the national account manager is writing away notes of our comments/requests in a diary-like notebook. So the flow of the presentations are pretty smooth...until we come upon the clinical studies section. Here is often where my preceptors drill and nit pick the expert and MSL (medical science liaison). I realize at that time how MSL's really really need to be on top of their game of knowing the literature AND keep their composure at the same time. I give them credit for the heat they have to take.

Today a presentation was given on Vimovo. I am fairly familiar with this drug product since I created its drug monograph. So I already had some questions prepared beforehand since some details were not exactly complete when I was doing research. There were 2 studies mentioned in the package insert (PI) saying that some result was "statistically significant." However, no p-value was referenced. I searched ClinicalTrials.gov, Medline, and Vimovo's dossier but could not find the p-value! So I asked the presenter what the p-value was, thinking that my question isn't even that complicated, and she couldn't even answer my question. She even went on to tell me the studies weren't mentioned in the PI, so then I pointed it out to her...but yea, she said she would send me some data that would contain more details on the study.

Please note: I am not dissing the pharmaceutical companies...next week I am actually going to be working alongside a medical outcomes specialist from Pfizer as part of my internship. My internship is sponsored by AMCP and Pfizer, so I get to experience managed care pharmacy and industry. I am looking forward to next week because I want to hear the perspective of a pharmacist in industry and place it within the scope of my experiences thus far. I will also be going to various sites with my Pfizer guy so looking forward to the new experience!