Advocates Push Back on ICER’s Tardive Dyskinesia Report

November 2, 2017

What’s the value of being able to stop involuntary lip smacking, facial grimacing or torso twitching – and the public stigma they cause?

This question is at the heart of debate on a recent report from the Institute for Clinical and Economic Review, or ICER.  The drug price watchdog has deemed new treatments for tardive dyskinesia, a movement disorder associated with the long-term use of antipsychotics to treat mental illness, to be too expensive.  In a 133-page draft report, ICER concludes that valbenazine and deutetrabenazine, known as VMAT2 inhibitors, “far exceeded commonly utilized cost-effectiveness thresholds.”

But does the report put economics above patients’ needs?

In a letter to ICER, the Institute for Patient Access outlined four overarching concerns:

The report doesn’t account for patients’ improved adherence to their antipsychotic medication.

Patients sometimes attempt to stop their tardive dyskinesia symptoms by discontinuing the medication for their underlying mental illness.  The move leads to poor health outcomes.Better controlling tardive dyskinesia could encourage patients to adhere to their antipsychotic medications, which IfPA’s letter characterized as a “fundamental benefit” of treatment.  ICER’s report, however, does not account for this benefit because the treatments being evaluated have not been available long enough to generate sufficient clinical data on the topic.

The cost-effectiveness model is biased against VMAT 2 inhibitors.

Research suggests that the quality-adjusted-life-year metric, which ICER uses, places treatments for mental health and other qualitative conditions at a disadvantage.Moreover, cost-effectiveness calculations may be inherently flawed at evaluating drugs for relatively small patient populations, such as that for tardive dyskinesia.  The fewer the patients, the higher the cost per patient, IfPA’s letter notes.

There is an association between tardive dyskinesia and mental illness severity.

Patients with tardive dyskinesia have been documented as experiencing more severe mental illness than those without, IfPA explains.  Yet “the draft report does not adequately discuss, let alone quantify [better controlling severe mental illness] as a benefit.”

ICER assumes that there is no association between tardive dyskinesia and increased mortality.

ICER states that tardive dyskinesia does “not have a direct effect on mortality.”  Yet two studies have suggested a link between the disease and mortality rates.  While the link is not universally demonstrated, IfPA’s letter suggests that ICER should have at least acknowledged and addressed existing research on the issue.

And these issues are not limited to the tardive dyskinesia report.  IfPA’s letter to ICER also called out several “concerning trends” across the organization’s reports, noting:

…ICER repeatedly attempts to evaluate the cost-effectiveness of a therapy before all the necessary data is available.  Such was the case with ICER’s draft report on therapies for atopic dermatitis, which were not even priced and publicly available when ICER completed its analysis.  Timing is once again a factor in the data available for assessing TD therapies’ cost-effectiveness…

Another recurring concern is whether cost-effectiveness studies and the QALY metric in particular are appropriate and accurate for diseases that are inherently qualitative…  Treatments for some disease states simply do not lend themselves to economic number crunching.

Finally, despite ICER’s laudable efforts to engage patients and advocacy groups, the framework used to evaluate these patients’ therapies has no meaningful way to incorporate their insights. 

IfPA also published a one-pager summarizing its concerns about the report.

[SEE: What ICER’s Analysis of Tardive Dyskinesia Treatments Doesn’t Explain]

Several other organizations also weighed in. In an October 30 letter, the Movement Disorders Policy Coalition noted that it “respects the need for payers to balance limited dollars with treatment value, but it is critical to consider more than just the bottom line. TD patients and caregivers understand the value of reduced stigma and improved quality of life.”  The National Alliance on Mental Illness also commented on the report.

ICER reports can inform health plan coverage, potentially justifying insurers in reducing access to drugs that the organization determines to be too expensive.  The impact on patient access could be significant, especially for diseases with few viable treatments option, like tardive dyskinesia.

ICER’ final report is scheduled for publication on December 21.

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