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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. NMHA 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:
- 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 ommunity, 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.
- 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.
- 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.
- 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 NMHA 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.
For additional information or to speak with an expert or individual
with mental illness, please call (703) 797-2588 or email mediainfo@nmha.org.
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