Sage Therapeutics & Collaborators Announce Publication Highlighting Epidemiology & Burden of Illness for Super-Refractory Sta...
August 30 2016 - 7:00AM
Business Wire
Largest epidemiology-focused SRSE study to date
and first study to examine economic impact of related
hospitalization
Study suggests SRSE is associated with high
mortality and morbidity, and significant healthcare cost
Projections based on study findings suggest
estimated U.S. annual incidence of approximately 25k to 41k cases
of SRSE
Sage Therapeutics (NASDAQ: SAGE), a clinical-stage
biopharmaceutical company developing novel medicines to treat
life-altering central nervous system (CNS) disorders, today
announced the publication of a study conducted with collaborators
from Massachusetts General Hospital (MGH) on the epidemiology of
super-refractory status epilepticus (SRSE). The paper, titled
“Burden of illness for super-refractory status epilepticus,” was
recently published in the Journal of Medical Economics (doi:
10.1080/13696998.2016.1223680).
“While SRSE has been known to be a devastating, life-threatening
condition associated with high cost of care, few studies have
examined the incidence rate or quantified the healthcare resource
utilization of this condition,” said Lidia Moura, MD, MPH, a
neurologist and health services researcher in the Department of
Neurology at MGH and Harvard Medical School and co-author of the
paper. “In addition, most of the existing studies focused on
smaller patient populations outside of the U.S. The findings from
this study help to provide a new understanding of the high
mortality and morbidity, and significant use of healthcare
resources associated with SRSE.”
“This research, undertaken by Sage and our collaborators, helps
to provide a new data-driven understanding of the clinical and
economic costs of SRSE,” said Tom Anderson, Chief Commercial
Strategy Officer of Sage. “By estimating the potential patient
population and related medical expenses associated with SRSE, the
data highlight the tremendous need for development of treatment
options for this disorder and the importance of conducting
additional studies in SRSE.”
Study Summary and Key Findings:
- The Premiere Hospital Database was
utilized to estimate the annual number of SRSE cases in the U.S.
and to evaluate utilization of hospital resources by SRSE patients
based on hospital discharges during 2012. The Premiere Hospital
Database included 5.3 million hospital discharges in 2012,
accounting for approximately 20% of U.S. annual hospital
discharges.
- SRSE does not currently have a specific
ICD-9 (International Classification of Diseases, 9th Revision) code
and status epilepticus codes are used inconsistently. Discharges
were classified as SRSE cases in the study based on an algorithm
using seizure-related International Classification of Diseases-9
(ICD-9) codes, Intensive Care Unit (ICU) length of stay (LOS) and
treatment protocols (e.g., benzodiazepines, antiepileptic drugs and
ventilator use). Secondary analyses were conducted using more
restrictive algorithms for SRSE.
- A total of 6,325 hospital discharges
were classified as SRSE cases using the primary algorithm from the
total 5.3 million hospital discharges in 2012 in the Premiere
Hospital Database. This projects to an estimated 41,156 cases of
SRSE in the U.S. during 2012, or an estimated annual incidence rate
of approximately 13/100,000, when applying a weighted projection
based on hospital characteristics and 2012 U.S. demographics.
Secondary analyses using stricter algorithms to classify SRSE
resulted in an estimated 35,150 annual SRSE cases (or an incidence
rate of approximately 11/100,000) and 25,915 annual SRSE cases (or
an incidence of 8/100,000), respectively. Given the limitations of
the methodology, the authors noted that more in-depth studies are
needed.
- The mean LOS for SRSE hospitalizations
was 16.5 days and the mean LOS in the ICU was 9.3 days. The most
common LOS was 10-19 days. Twenty-four percent of SRSE patients
spent 20 or more days in the hospital. The mean cost of an SRSE
hospitalization was $51,247, increasing with LOS to a mean cost of
$156,500 for patients with LOS of 30 or more days (11% of SRSE
cases identified).
About Super-Refractory Status EpilepticusStatus
epilepticus (SE) is an acute medical emergency of persistent,
unremitting seizure lasting greater than five minutes. An SE
patient is first treated with benzodiazepines, and if no response,
is then treated with other, second-line, anti-seizure drugs. If the
SE persists after the second-line therapy, the patient is diagnosed
as having refractory SE (RSE), admitted to the ICU and placed into
a medically induced coma. Physicians typically use anesthetic
agents to induce the coma, along with antiepileptic drugs in an
attempt to stop the SE, in RSE patients. After a period of 24
hours, an attempt is made to wean the patient from the anesthetic
agents to evaluate whether or not the SE has resolved.
Unfortunately, not all patients respond to weaning attempts, in
which case the patient must be maintained in the medically induced
coma. At this point, the patient is diagnosed as having SRSE.
Currently, there are no therapies specifically approved for
SRSE.
About the STATUS TrialSage is currently enrolling the
Phase 3 STATUS Trial to evaluate the efficacy and safety of
SAGE-547 in approximately 126 evaluable patients with SRSE, ages
two years or older, in the U.S., Canada and Europe.
In the double-blind trial, patients are randomized 1:1 to receive
either SAGE-547 or placebo in addition to standard-of-care
third-line anti-seizure agents for six days. The primary endpoint
is successful resolution of status epilepticus (SE) after weaning
the patient off all third-line agents, and SAGE-547 or placebo,
without resumption of SE within 24 hours after completion of
blinded SAGE-547 or placebo administration. The STATUS Trial is
being conducted under a Special Protocol Assessment (SPA) agreement
with the U.S. Food and Drug Administration (FDA).
About SAGE-547SAGE-547 is an allosteric modulator of both
synaptic and extrasynaptic GABAA receptors. SAGE-547 is an
intravenous agent in Phase 3 clinical development as an adjunctive
therapy for the treatment of super-refractory status epilepticus
(SRSE) and is being developed for severe postpartum depression.
SAGE-547 has been granted both Fast Track and orphan drug
designations by the U.S. Food and Drug Administration (FDA)
for the treatment of SRSE. For more information about the STATUS
Trial, please visit www.statustrial.com.
About Sage TherapeuticsSage Therapeutics is a
clinical-stage biopharmaceutical company committed to developing
novel medicines to transform the lives of patients with
life-altering central nervous system (CNS) disorders. Sage has a
portfolio of novel product candidates targeting critical CNS
receptor systems, GABA and NMDA. Sage's lead program, SAGE-547, is
in Phase 3 clinical development for super-refractory status
epilepticus, a rare and severe seizure disorder, and is being
developed for severe postpartum depression. Sage is developing its
next generation modulators, including SAGE-217, SAGE-689 and
SAGE-718, with a focus on acute and chronic CNS disorders. For more
information, please visit www.sagerx.com.
Forward-Looking StatementVarious statements in this
release concern Sage's future expectations, including our estimates
and projections as to the potential number of patients with SRSE
and the burden and costs associated with SRSE. These
forward-looking statements are neither promises nor guarantees of
future performance, and are subject to a variety of risks and
uncertainties, many of which are beyond our control, which could
cause actual results to differ materially from those contemplated
in these forward-looking statements. There are limitations in the
methodology we and our collaborators used to estimate SRSE patient
numbers and disease burden and costs. As a result, our estimates
and projections may prove not to be accurate. The actual number of
patients with SRSE and the burden and costs associated with SRSE
may be significantly lower than our estimates. These risks and
additional risks are more fully discussed in the section entitled
"Risk Factors" in our most recent Quarterly Report on Form 10-Q, as
well as in discussions of potential risks, uncertainties, and other
important factors in our subsequent filings with
the Securities and Exchange Commission. In addition, any
forward-looking statements represent our views only as of today,
and should not be relied upon as representing our views as of any
subsequent date. We explicitly disclaim any obligation to update
any forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20160830005263/en/
Investor Contact:Sage TherapeuticsPaul Cox,
617-299-8377paul.cox@sagerx.comorMedia Contact:Suda
Communications LLCMaureen L. Suda,
585-387-9248maureen.suda@sagerx.com
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