Hello, everyone, and welcome to this week’s edition of Excelsior Solutions’ ICER Weekly Update.
Here is this week’s ICER recap:
- ICER has posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value of treatments for Duchenne muscular dystrophy (DMD). ICER’s assessment will focus on eteplirsen (Exondys 51™, Sarepta Therapeutics), golodirsen (Sarepta Therapeutics), and deflazacort (Emflaza®, PTC Therapeutics). Eteplirsen was approved by the FDA in September of 2016, deflazacort was approved in February of 2017, and golodirsen has an anticipated FDA approval decision expected in the middle of 2019. ICER’s report on DMD therapies will be the subject of a July 2019 meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC), one of ICER’s three independent evidence appraisal committees.
EXCELSIOR ACTION POINT: While we always encourage you to read ICER’s Draft and Final Evidence Reports for yourselves and to avail yourselves of the open public comment opportunities, this category is particularly noteworthy for your attention considering the costs and the clinical outcomes associated with these treatments for a disease that impacts young people. If you have any utilization of these products in your plan, I’m certain that you will want to take a look at this work.
- ICER posted a draft protocol describing a new annual analysis — an ICER “Unsupported Price Increase” (UPI) report — that will analyze significant prescription drug increases and determine whether or not new clinical evidence exists that could be used to support those increases. Public comment is being sought to inform a final version of the analytic protocol. Once finalized, the protocol will guide the development of the first of these annual reports, currently scheduled for October 2019.
EXCELSIOR ACTION POINT: Having spoken to all of you, I know that you all have opinions on this topic. This is your opportunity to weigh and let your thoughts guide what will undoubtedly become a high-profile annual report. See the link above to learn how to let your plan’s voice be heard!
If you would like to discuss these ICER activities, or any other aspects of your Pharmacy Benefit Plan, simply reach out to your Excelsior Solutions account team and we will be happy to quickly set up a call.
Until next week!
Bob has more than 30 years of diverse experience in the pharmacy industry. Over the course of his career, Bob has led clinical and PBM operations teams in successfully managing more than $4 billion in annual drug spend. This was also while limiting per-member-per-year spending growth to levels that have simultaneously drawn industry acclaim and consistently high levels of member and payer satisfaction.