ICER To Parents: “That’s Why You Don’t Have A Vote”

August 9, 2019 11:04 am

As this blog has noted in the past, patients groups are frequent critics of the Arnold-funded Institute for Clinical and Economic Review (ICER). An article posted last week at STAT News showed why.


Reporter Kate Sheridan attended a meeting where ICER staff reviewed three drugs that treat Duchenne muscular dystrophy, “a rare and fatal disease that causes affected people’s muscles to deteriorate over time.” Individuals with Duchenne, and family members of patients, attended the meeting. (Sheridan said the audience mostly was made up of parents who have children suffering from the disease.)


Here is what ICER President Stephen Pearson told one mother when she asked how she is supposed to quantify the value of her son’s life:


“[T]hat’s why we don’t have you vote. We don’t think that’s fair, certainly.”


It is a jarring statement and implies ICER believes parents – and patients – should have no say in determining the value of a treatment.


Which begs the question: why does ICER have a say?


As we have noted before, ICER is not a federal, or even state, government entity. By our own accounting, it receives nearly 80 percent of its funding from private foundations, including the Laura and John Arnold Foundation. It also has received funding from health insurance companies.


As the STAT News article explains, ICER is simply a group that has “task[ed] itself with determining what a drug is worth.” (Emphasis added.) Is it fair that a self-appointed group, funded by an organization with a clear political agenda, carries such weight when determining the value of a drug?


Sheridan explains ICER’s determinations “hinge on one metric — the quality-adjusted life year, or QALY.” To determine that metric, ICER reviews published clinical trial results, hears testimony from experts about a treatment’s efficacy and reviews information from the drug’s manufacturer. (For the Duchenne drugs, one piece of data reviewed was a measurement of how far a person could walk in six minutes after using a treatment. As one patient advocate explained to STAT News, parents of children with this disease are not concerned primarily with whether their child can speed walk.)


After this review, an ICER panel then votes on what a treatment is worth. (The article does not mention how many individuals sit on the panel.)


There is another important step in the process, however. Sheridan notes insurance companies play an important part in determining the value of a treatment.


Insurance companies also are the end user of ICER’s reports. As Sheridan explains, “ICER has no real power as a regulator. … But insurance companies can still use its reports as a guidepost for decisions about what drugs to cover.” CVS Caremark is one group that has used ICER’s analyses to “allow its clients … to exclude some drugs from their formularies.”


Patient advocate – and mother of a child with Duchenne – Jennifer McNary concluded, “It is unfathomable that after all we have gone through, a private, non-governmental group can take away access to the only treatments that exist to help my children.”


And that is the point.


Determination about the value and cost of drugs must be made.


But that determination should not be left up to a single organization that is funded by insurance companies and a foundation with a clear political agenda; that has acknowledged its inability to effectively quantify the benefits of cutting-edge treatments; and that has told patients and parents it would not be “fair” if they had a say in this debate.