Hello, everyone, and welcome to a very full edition of Excelsior Solutions’ ICER Update. Here is this week’s ICER recap:
- ICER posted a Draft Scoping Document outlining a planned review of the comparative
clinical effectiveness and value treatments for ulcerative colitis (“UC”). All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. Comments can be submitted by email to email@example.com and must be received by 5 PM ET on October 18, 2019. All comments submitted must meet ICER’s formatting specifications.
EXCELSIOR ACTION POINT: Since biologic treatments are increasingly part of the standard of care for the treatment of UC, plans ought to review this document and send feedback to ICER to assist in focusing their analysis.
- ICER also posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value treatments for cystic fibrosis (“CF”). ICER’s report will focus on elexacaftor/tezacaftor/ivacaftor (Vertex Pharmaceuticals). ICER also will examine any new data that has become available since its May 2018 review of three other CF treatments already approved by the FDA: tezacaftor/ivacaftor (Symdeko®, Vertex), lumacaftor/ivacaftor (Orkambi®, Vertex), and ivacaftor (Kalydeco®, Vertex).
EXCELSIOR ACTION POINT: Even more than with UC, since biologic treatments now constitute the core of the standard of care for the treatment of CF, plans ought to review this document and send feedback to ICER to assist in focusing their analysis.
- ICER posted a revised scope for its sickle cell disease assessment. The next deliverable will be the research protocol, which will be available on November 5th.
EXCELSIOR ACTION POINT: This revision was created in response to, and based on, public comments received on the recent initial scope document, proving how much public comments do matter in the ICER review process.
- ICER’s Note on Last Week’s Rheumatoid Arthritis Draft Evidence Report
Many of you noticed that between the time last week’s ICER Update was published and the time you received it, the Rheumatoid Arthritis Draft Evidence Report disappeared from the ICER website. Many of you reached out to ask what happened, and here is what ICER had to say, in addition to what they said on October 2nd at the link above:
“Regarding our ongoing assessment of treatments for rheumatoid arthritis, we’ve decided to reevaluate the modeling inputs used in our Draft Evidence Report published on September 26. In lieu of waiting to make this adjustment until our Revised Evidence Report, we now plan to issue an updated Draft Evidence Report at some point over the next several days. We still will have a full Public Comment period on the forthcoming draft report, and we anticipate that the comments we receive will be more productive if they’re based on our latest thinking around the most accurate way of modeling the JAK inhibitors. We appreciate the patience of all the key stakeholders involved in this assessment.”
It was a busy week at ICER! If you would like to discuss these, or any prior, ICER reports, 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 time!
Bob Kordella, RPh, MBA