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First Opinion: The Biden Administration Needs to Look Beyond ICER for Evaluating Drug Therapies

(STAT) Feb 9, 2021 - As breakthrough drugs stream out of biopharmaceutical laboratories, how much they should cost and who will get access to them remain thorny issues.

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William McGivney, PhD (Posted: February 15, 2021)

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It is extremely disconcerting to think that ICER could be thought of as possibly playing a significant role in evaluating and determining what appropriate pricing should be for therapeutic drugs and biologics in Oncology; and even worse playing the lead or only role. Concepts developed by those who generally have sprung from academia without ever having the sole responsibility for making patient care decisions are often flights of fancy that threaten great real-world accomplishments. For example, the FDA record for approvals of therapeutics for cancer has been exemplary under the leadership of Rick Pazdur, MD, an Oncologist who came to the FDA after years of practice and treating patients at MD Anderson. The FDA approval process is now a model for evaluation and efficiency in drug approval. What if the availability of FDA-approved innovative agents to patients in need had to wait a time period for some esoteric “cipherin” (to use Jethro Bodine’s technical term) to grant permission for general availability and access.
Again, one needs to sit in the “Chair” and, actually, carry out and apply the policies that one writes for patients in need. In doing so, one quickly realizes that many of those patients look line one’s mother, brother, daughter, etc. The ICER Policy Paper, Unsupported Prices Increases, seems to communicate an aloof, academic view that the only good evidence is ICER-accepted evidence. In a cited Boston Globe article, ICER was referred to as the “Boston Watchdog”. This reminds me of my book, “On the Road to Kick-Ass Healthcare”. Is that the Road that we want to be on when in need of innovative, effective agents to address the serious healthcare needs of loved ones or even ourselves.
Esoteria are ok in theoretical decision-making, I guess, but I still cannot find the model that applies to the following:
“Dr. McGivney:
My name is Jane Smith and I am the mother of two little boys, one is 23 months old and one is 9 months. About 5 years ago I was diagnosed with a precancerous lesion on my tongue. I had the lesion surgically excised. I have had three subsequent lesions all removed surgically. I am starting to experience some difficulty in my speech. I have just been diagnosed again with such a lesion. My doctor prescribed a well-known drug called Accutane. Two of the medical directors at your insurance company have denied coverage for the drug. I cannot afford it myself. I was referred to you. If I have to have surgery, my speech will only get worse. I beg of you, I plead with you to cover the drug so that I do not need to get surgery again. I need to try the drug because all that I want to be able to do is to teach my two little boys how to talk!!"
I sat there numb!! There is a story as to how I covered that drug but too long for these electronic pages. The story is true and, as such, I ask as one sits alone in a room with eight other cases all marked “urgent”, trying to make that decision for Ms. Smith: How does one model that decision-making process?

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