A cutting-edge treatment may soon change the lives of people with schizophrenia – unless hasty value judgments from a health economics organization stand in the way.
The new treatment, KarXT, interacts with receptors in the brain to reduce schizophrenia symptoms. KarXT does not seem to have side effects like sleepiness, restlessness and weight gain, which are common among other psychotherapeutic drugs. And a treatment that’s better tolerated by patients increases compliance with medication regimes, improving quality of life for both the patient and those around them.
A Premature ICER Review Could Undercut Patient Access
Before this new treatment can reach those who will benefit most, however, it will undergo review by a group called ICER, or the Institute for Clinical and Economic Review. The health economics organization announced in July that it would review KarXT – even before the Food and Drug Administration has a chance to determine that the medication is safe and effective. Researchers are seeking long-term trials and an FDA approval next year.
ICER’s choice to analyze a drug that doesn’t yet have full clinical trials data is, unfortunately, becoming a more common occurrence. ICER has begun to review medications earlier and earlier, often before FDA approval. This poses challenges in ensuring an accurate, complete analysis. Given the significant social impact of schizophrenia, patients and their families need an accurate analysis – and not just for the sake of accuracy. ICER’s decisions often impact insurance coverage and, in turn, patients’ ability to access the medication.
Without full clinical trials data and real-world evidence, both ICER and insurers could underestimate the drug’s effectiveness over time, leading to more limited access to potentially life-changing treatment.
Promising New Treatment
Schizophrenia doesn’t just impact individuals, but also their families and communities. The disease is often linked to homelessness and incarceration.
Taking time to gather all the necessary background and data should be prerequisite to determining the value of a given treatment – and which patients can access it.