Promising Schizophrenia Drug, Cobenfy, May Face Challenges
Cobenfy (xanomeline/trospium chloride; formerly KarXT) was approved for schizophrenia in adults by the Food and Drug Administration in late September. This drug has a new mechanism of action, which is the first for schizophrenia in several decades. Cobenfy targets cholinergic receptors instead of balancing dopamine and serotonin levels, which is what common antipsychotics do, such as Abilify (aripiprazole) and Zyprexa (olanzapine). But insurance access challenges may lie ahead for Cobenfy due to its much higher cost than existing standards of care.
Schizophrenia is a chronic and disabling mental illness that affects the way a person thinks, feels and behaves. About 2.8 million people in the United States suffer from this disease.
About a third of patients have treatment-resistant schizophrenia, which means there is an unmet need in this area of treatment. Cobenfy can fill a small gap, especially in patients who do not respond well to atypical antipsychotics because they have limited options for managing their symptoms. New data presented last week at the 2024 Psych Congress suggest continued improvement in schizophrenia symptoms with long-term treatment. In addition, unlike conventional antipsychotics, Cobenfy does not have a boxed warning of increased mortality in elderly patients with dementia-related psychosis or suicidal ideation with use. similar to antidepressants.
In addition, Cobenfy’s new mode of action appears to be associated with fewer metabolic side effects such as weight gain and drowsiness. And in clinical trials there have been no reports of tardive dyskinesia, or involuntary body movements caused by blocking dopamine receptors. Tardive dyskinesia is a common side effect in patients taking Zyprexa and Risperdal (risperidone).
Adverse events associated with older medications may lead to reduced patient adherence. However, Cobenfy requires oral administration twice a day, a more frequent dosing regimen than the existing set of atypical antipsychotics. Therefore, it is unclear what the effects on patient compliance and tolerance will be.
Cobenfy is expected to face access challenges related to its cost and cost-effectiveness evidence base. The estimated annual cost of Cobenfy is $22,500, compared to $540 for a common antipsychotic like Abilify. This may present a problem with coverage and access given that in its review of the evidence, the Institute for Clinical and Economic Review panel voted 10-2 that the current evidence is sufficient to show a health benefit good compared to Abilify.
ICER analyzes can inform payer decisions about the use of prescription drugs. It’s possible that insurers or pharmacy benefit managers will require Abilify to fail before Cobenfy is reimbursed, a plan called a first-failure plan.
That said, the ICER analysis has mixed results. A majority of ICER panelists (7-5) reviewing the evidence found it sufficient to show a health benefit compared to Zyprexa or Risperdal. And ICER added a price between $16,000 and $20,000 per year that would align with expected clinical benefit. This is close to the list price of $22,500. With discounts and rebates, Cobenfy’s price can fall within the acceptable ICER price range.
However, the ICER technology review panel’s choices leave some doubt about Cobenfy’s effectiveness over current treatment options.
At least two-thirds of patients with schizophrenia are on Medicaid, a federal government program that helps cover medical expenses for people with limited income and resources. Under the Medicaid rebate program, manufacturers who want their drugs covered must drop at least 23.1% of the manufacturer’s total cost to the government. In turn, Medicaid must cover FDA-approved drugs made by those manufacturers.
However, plans that regulate the pharmacy benefit may still impose safety restrictions, including use control tools, such as prior authorization, prior plan requirements and treatment time limits. Therefore, for many patients, Cobenfy will probably not be the first choice of treatment. Instead, it is expected to be an option for patients who have a poor or partial response to atypical antipsychotics or who cannot tolerate the side effects of weight gain, swimming , and movement disorders associated with atypical antipsychotics.
Competitive forces in the schizophrenia space will likely bring changes that provide opportunities and create challenges for Cobenfy’s sponsor, Bristol Myers Squibb. The company is looking to expand the product’s reach while researching new indications, including the use of Cobenfy as an adjunctive treatment for schizophrenia patients who do not respond adequately to their antipsychotics. the background and diagnosis of dementia and dementia that often accompany Alzheimer’s. death. At the same time, Cobenfy could eventually face competition, including the once-daily novel treatment emraclidine that is being investigated in phase 2 for schizophrenia and Alzheimer’s psychosis.
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