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Long-awaited treatment for a movement disorder known as tardive dyskinesia could remain out of reach – unless an upcoming cost-effectiveness analysis acknowledges its value to patients.

Known as “TD,” the disease is characterized by grimacing, lip smacking and other involuntary facial movements. It stems from the use of antipsychotic medications that treat mental illnesses such as bipolar disorder and schizophrenia.

Without treatment, these serious and chronic mental illnesses can lead to sleep disruptions, delusions and even suicide. But treatment with antipsychotics can bring complications of its own. Patients who develop TD from taking antipsychotics may face immense social stigma, compounding that already associated with their mental illness.

Treatment Cost & Value to Patients

That’s why a new therapy that minimizes or controls TD symptoms holds enormous value for patients. Known as valbenazine, it’s the first drug approved by the Food and Drug Administration to treat TD. Another TD treatment, deutetrabenazine, is currently under FDA review.

Treating TD can help to restore patients’ day-to- day lives, allowing them to approach public settings and social activities with more confidence. But the drug’s price has prompted a cost-effectiveness analysis from the Institute for Clinical and Economic Review (ICER). Unless this review take patients’ values into consideration, it could embolden health plans to block patients from accessing the drug.

The National Alliance on Mental Illness outlined such concerns in a recent letter to ICER.

“By limiting the focus to clinical effectiveness and economic impact,” the alliance’s Mary Giliberti, JD, explains, “the ICER review fails to consider the social impacts of TD….” Giliberti points out that the social isolation resulting from TD stigma can increase feelings of worthlessness, exacerbating symptoms of bipolar disorder, and cause patients to withdraw further from society.

Past ICER reports have been likewise criticized for failing to incorporate patient factors and experiences. While these measures are difficult to quantify, patient groups continue to point out their importance for analyses that may ultimately impact access.

Options & Access for Movement Disorders Patients

ICER analyses can shape health plan coverage, allowing insurers to justify slowing or blocking patients’ access to certain drugs. For patients with TD – as well as other movement disorders – such barriers can be devastating. Lack of approved therapies is a common challenge for patients with movement disorders, who often find few viable options to treat their debilitating and chronic conditions.

Just this year, for example, the FDA approved a first-of- its-kind drug to treat hallucinations and delusions associated with psychosis in Parkinson’s disease patients. The agency also approved a therapy for Huntington’s chorea, the twisting and writhing associated with Huntington’s disease, this year. It is only the second FDA-approved drug for the condition.

Innovative treatments are a welcome advance for conditions with scant treatment options. Now, patients and health care providers remain hopeful that these – and other movement disorders treatments to come – can overcome a final hurdle: accessibility.

ICER’s draft evidence report on TD treatments is scheduled for release October 2.

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