Factsheet: The CATIE Study: Issues for Advocates
Clearly one of the biggest implications of CATIE is the effect on public policy debates about access to medications. Medicaid preferred drug list debates in recent years, the increasing reliance on evidence-based medicine and the trend toward elimination of exemptions for mental health medications demonstrate the high stakes of the interpretation and application of CATIE to reimbursement and access policy. Prescription drug plans are pointing to the phase 1, and perhaps now phase 2 findings, to justify their case to state policy officials as well as CMS, particularly as it affects formulary design for the Medicare prescription drug benefit. MHA continues to communicate with CMS officials about CATIE and to seek public statements from CATIE researchers and NIMH officials about the misinterpretation of CATIE findings.
The issues around access to medications remain the same as before CATIE findings were released: policymakers are looking for concrete, science-centric evidence that decisions to limit access to older, cheaper medications will have little to no impact on patient health outcomes. The following talking points may guide advocates about how to talk about CATIE to local media and especially public policy makers who may be rushing to implement policy change based on false conclusions.
Key talking points for advocates:
- Phase 1, 1B and Phase 2 of CATIE show that there is no "silver bullet" treatment for the complex illness of schizophrenia. The findings confirm what consumers and family members have known for years - there is no "one size fits all" medication.
- The study assumes open choice of medication therapies available to patients and their prescribing physicians.
- The release of data from the first and second phase of CATIE does not tell the complete story. To base public policy changes on this data is premature and risks serious unintended consequences, including poor consumer health as well as increased costs in the form of hospitalization, emergency room utilization, and utilization of other healthcare services due to medication side effects.
- Medications are one part of overall treatment for schizophrenia. Future findings from CATIE hold important information about efficacy, patient choice, and cost-effectiveness that are fundamental to good public policy.
- The findings leave many unanswered questions that are applicable to the public policy decisions facing states and federal agencies, including:
- How do individual factors of gender, race and ethnicity affect response to any individual medication? For example, pharmacogenomic studies in other medication classes clearly show individualized response to medications based on genetic makeup.
- What factors affect a consumer's choice to change or discontinue medication?
- What are the cross-system cost implications of using newer vs. older generation medications?
- How do consumers value the medications in terms of their ability to live in their community, maintain jobs, maintain a housing situation and other quality-of-life indicators?
- Are side effects reversible?
- Does this study reveal that in common clinical practice, many providers are quick to change a medication rather than explore individualized dosage ranges or other factors that may impact discontinuation?
- What are the risks involved in switching medications?
- Discontinuation rates shown in this first phase are not significantly different from rates related to other types of medications. For example:
- In general, two out of every three prescriptions for any illness are not filled.
- The average adherence to a medication for any chronic illness is 30-60 days. Phase 1 of CATIE shows that 25% maintained their medication therapy for 18 months.
Access to Medications, Individualized Treatment
- Both phases of the CATIE study confirm that a complete range of medications is necessary to help consumers and their caregivers find the treatment that works best for them.
The following are excerpts pulled from the CATIE Phase 1B study[1] to support the abovementioned statement:
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In the context of other results from the CATIE study, the effectiveness and acceptability of antipsychotic drugs appears to vary considerably according to clinical circumstances. (Page 415)
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This study provides more evidence to clinicians, patients, and policy makers that response to antipsychotic drug treatment is heterogeneous. (Page 426)
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Consumer preferences and potential side effects, in addition to efficacy, are all critical components of the equation. While one individual may weigh the side effects and benefits of a medication with his or her provider and decide it is an appropriate treatment option, another may view the side effects as too risky given factors such as other health problems or the medication's impact on functioning.
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Until research can better answer questions that matter to consumers-beyond symptom management-individuals need access to the full range of treatments and support in communities. This goes beyond medication to include social, employment and housing support services that maximize and individual's ability to live and work in the community setting.
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Phase 2 did not address the medications' impact on cognition, which is an important factor in improving an individual's functioning. While "time to discontinuation" is a measure of the impact a medication's side effects or ability to treat some of the symptoms of schizophrenia, it does not compare these medications in a key area that influences an individual's ability to hold a job, live in a community setting etc.
Side Effects
- Some side effects, especially those associated with older, conventional antipsychotics, can be life threatening and irreversible. Consumers and health care providers therefore need the flexibility that broad access provides to weigh the risks and benefits, and identify the best treatment options for them.
- Severe side effects may lead people with schizophrenia to discontinue their medication and delay or prevent recovery. In an MHA study conducted in 2002, 72 percent of people with schizophrenia said side effects significantly impact their lives, and 75 percent said side effects caused them to switch medications.
- The same survey also found that while 70 percent of individuals surveyed were satisfied with the efficacy of current medications, only 62 percent were satisfied with the availability of effective medications that do not cause significant side effects.
More Research Needed
- While Phase 2 demonstrated that study participants stayed on clozapine the longest, the authors acknowledged that this finding may have been influenced by the closer clinical attention paid to these patients (due to frequent monitoring required by this medication to avoid serious side effects). CATIE did not investigate the extent to which successful adherence to medication therapies is influenced by changes in frequency or type of clinical interaction. This is an area of research that needs further attention because we know from the real world that medications alone are not sufficient to promote and maintain recovery for an individual with mental illness.
- While the CATIE phase 2 research sheds light on the efficacy of antipsychotics in treating symptoms of schizophrenia, much more research is needed to identify which medications best benefit which individuals and to develop better treatments with fewer life-threatening or irreversible side effects.
[1] Stroup, S. et al., Effectiveness of Olzapine, Quetiapine, and Risperiodone in Patients with Chronic Schizophrenia After Discounting Perphenazine: A CATIE Study. American Journal of Psychiatry 164:3, March 2007.
For More Information:
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