A premature review of a new medication’s cost-effectiveness could complicate access for people with schizophrenia.
In its final assessment, the Institute for Clinical and Economic Review labeled the new drug, KarXT, “inconclusive.” The Institute for Clinical and Economic Review, or ICER, is a national health economics organization that uses a population health approach to gauging new medications’ cost-effectiveness.
ICER’s conclusion is unsurprising given the organization’s hasty rush to judgment. KarXT won’t even undergo its safety and efficacy scrutiny by FDA until later this year.
But the assessment may still lead to access barriers for patients.
“Not enough data” — So why did ICER rule?
By prematurely giving KarXT an “inconclusive” label, ICER provides insurers an easy excuse to avoid paying the costs associated with offering this treatment to patients. This short-sighted approach may limit access for patients who could benefit from the therapy, which stands to offer significant reductions in both symptoms of cognitive impairment and side effects.
The “inconclusive” label indicates that ICER lacked sufficient information to make a final assessment but issued one anyway. The drug has a promising track record of success in randomized, double-blind, placebo-controlled trials, but long-term data from clinical trials are still being collected.
Yet ICER chose not to wait on the full data required for an accurate analysis.
Premature Ruling Threatens Patient Access
ICER’s rush to judgment is problematic because the organization’s assessments are often used in coverage decisions made by payers.
More than 75% of private insurers, PBMs and multiple-employer coalitions use ICER’s assessments to inform formulary decisions, coverage criteria and price negotiations. If ICER’s findings obscure the benefits of treatment to patients, many marginal cases also will be denied coverage, leaving patients to face cognitive decline and difficult side effects.
Patients should not be denied breakthrough medications simply because they are new. This is especially true for progressive diseases like schizophrenia, the burden of which weighs heavily on patients who wait eagerly for innovative and accessible treatment options.
