NY State Quality Improvement Effort Increases Clozapine Use

The proportion of new clozapine trials for Medicaid patients with schizophrenia, among all new outpatient antipsychotic trials, increased 40 percent between 2009 and 2013 in New York state, following a multifaceted state initiative aimed at educating clinicians, patients, and their families about the benefits of clozapine and providing support to clinicians in its use.

The largest gains occurred in state-operated clinics, according to a report by representatives from the New York State Office of Mental Health (NYSOMH) published in Psychiatric Services in Advance (January 4).

“Clozapine has always challenged the mental health system, but for some individuals it can be an absolutely critical component of their recovery plan,” said lead author Jay Carruthers, M.D., the medical director of the Bureau of Psychiatric Services and director of the Suicide Prevention Office at NYSOMH. “I think the initiative in New York demonstrated that with a strong commitment to putting the right supports in place—for prescribers, patients, and family members—and by leveraging the principles of quality improvement, clozapine can be made more accessible to those who stand to gain the most,” he told Psychiatric News.

Clozapine has been shown to be the most effective antipsychotic for treatment-resistant schizophrenia, yet clinicians have been reluctant to use it for a host of reasons. In 2010, NYSOMH introduced the “Best Practices Initiative—Clozapine” to promote the evidence-based use of clozapine in state-operated facilities. The initiative engaged academic partners at the New York State Psychiatric Institute (NYSPI) research institutions and clinical leaders from state-operated psychiatric centers. NYSOMH also partnered with the Center for Practice Innovation at NYSPI to create interactive, Internet-based educational programs to provide information about clozapine to consumers, family members, and prescribers.

To evaluate the initiative, Carruthers and colleagues conducted a retrospective, longitudinal study of patterns of new antipsychotic starts for individuals identified by Medicaid data as having schizophrenia. This analysis revealed 115,320 “new starts” of antipsychotics between 2009 and 2013. The percentage of clozapine new starts among all new antipsychotic trials increased from 1.5 percent in 2009 to 2.1 percent in 2013, according to the report.

The initiative also led to “a doubling in the estimated rate of new clozapine prescriptions at state-operated facilities (an increase of 36 to 71 per 1,000 new starts),” according to the report.

Carruthers credited these changes to the multifaceted nature of the program including clinician and patient education, a telephone consultation service in which clinicians can call psychiatrist experts with questions, and regular monitoring and performance improvement at state facilities, among other activities. But he especially highlighted the importance of a quality improvement effort that included feedback from NYSOMH about clozapine utilization allowing NYSOMH systems to compare themselves with statewide patterns of use.

There is room for continued improvement, but Carruthers also noted that it is difficult to know the “right number” of individuals with psychosis who might benefit from clozapine: just 2 percent of all new antipsychotic starts are clozapine starts, yet roughly one-third of all persons with psychosis do not respond to antipsychotic treatment, suggesting that more patients could be prescribed clozapine.

He noted that the drug has had a circuitous history since it was first synthesized in the late 1950s, and deaths associated with use of clozapine chilled efforts to bring the drug to market in the 1970s. Carruthers said clozapine was held to “an unprecedented” standard for FDA approval in the late 1980s, calling for regular blood monitoring of patients to assess for the risk of agranulocytosis.

(In September the FDA announced changes to the requirements for monitoring, prescribing, and dispensing clozapine. While implementation of the new rules has not been without some technical challenges, the modifications are part of an effort to give prescribers more flexibility in prescribing clozapine to individuals who would otherwise be excluded from a trial because they have baseline neutrophil counts below the prior standard [Psychiatric News, December 4, 2015].)

Because of this history, clozapine use has been and continues to be a challenge for public systems. Barriers to further improvements in clozapine utilization include lack of training in residency programs that have not traditionally had leaders skilled in use of the drug; Carruthers said future efforts at the state level include engaging training programs in the quality improvement initiative.

“Building on the success is going to require a sustained effort at removing supply- and demand-side barriers, including development of a workforce skilled in its use,” he said.

Lloyd Sederer, M.D., chief medical director of NYSOMH and a coauthor of the study, said he believes the New York initiative can be successful in other areas of the country. “But it’s not a one-shot deal,” Sederer told Psychiatric News. “It’s a matter of leadership taking this on and sustaining a clinical performance improvement campaign.” ■