BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical
company utilizing artificial intelligence to develop transformative
medicines in neuroscience, today announced that the Centers for
Medicare & Medicaid Services (CMS) has issued a permanent and
product-specific J-Code for IGALMI™ (dexmedetomidine) sublingual
film, which is approved for the acute treatment of agitation
associated with schizophrenia or bipolar I or II disorder in
adults1,2. Under the Healthcare Common Procedure Coding System
(HCPCS) process, the IGALMI J-Code J1105 will become effective
January 1, 2024.
J-codes are permanent codes used by healthcare providers,
commercial insurance plans, and government payers to help
standardize the reimbursement process. Compared to a miscellaneous
or unlisted product code, a J-code simplifies claims submission,
which in turn streamlines the billing and reimbursement
process.
“Beginning next year, IGALMI will be separately reimbursed under
a direct and predictable J-Code for the hospital outpatient
setting, which we expect will help remove economic barriers that
may have impacted formulary approval decisions and product
utilization to date,” said Vimal Mehta, Ph.D., CEO of BioXcel
Therapeutics. “Ultimately, we believe this commercial milestone
will facilitate additional patient access to this important
therapeutic option for the treatment of bipolar disorder- or
schizophrenia-associated agitation.”
The J-code for IGALMI has been published online in the CMS HCPCS
Application Summaries and Coding Recommendations, Third Quarter,
2023 HCPCS Coding Cycle.
About Agitation Associated with Bipolar Disorder and
SchizophreniaAgitation is a relatively common and
difficult-to-manage symptom associated with bipolar I or II or
schizophrenia in adults.3,4 Prompt identification of agitation
related to schizophrenia and bipolar disorders can help de-escalate
the situation before aggressive or violent behaviors emerge.5,6
Expert consensus best-practice guidelines have recommended that
agitation should be treated by a combination of behavioral calming
techniques, verbal de-escalation, and medications that are
voluntarily accepted by patients without coercion.4 Medication used
in this manner to treat agitation is consistent with the goal to
calm the patient enough so they can be assessed, while avoiding
unarousable sedation.5,6 In many settings, physical restraints and
forcible injections of heavily sedating medications are used, which
can create a hostile and adversarial relationship between
clinicians and patients4,7-8
About IGALMI™ (dexmedetomidine) sublingual film
INDICATION
IGALMI™ (dexmedetomidine) sublingual film is a prescription
medicine, administered under the supervision of a health care
provider, that is placed under the tongue or behind the lower lip
and is used for the acute treatment of agitation associated with
schizophrenia and bipolar disorder I or II in adults. The safety
and effectiveness of IGALMI has not been studied beyond 24 hours
from the first dose. It is not known if IGALMI is safe and
effective in children.
IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects, including:
- Decreased blood pressure,
low blood pressure upon standing, and slower than normal heart
rate, which may be more likely in patients with low blood
volume, diabetes, chronic high blood pressure, and older
patients. IGALMI is taken under the supervision of a
healthcare provider who will monitor vital signs (like blood
pressure and heart rate) and alertness after IGALMI is administered
to help prevent falling or fainting. Patients should be adequately
hydrated and sit or lie down after taking IGALMI and instructed to
tell their healthcare provider if they feel dizzy, lightheaded, or
faint.
- Heart rhythm changes (QT
interval prolongation). IGALMI should not be given to
patients with an abnormal heart rhythm, a history of an irregular
heartbeat, slow heart rate, low potassium, low magnesium, or taking
other drugs that could affect heart rhythm. Taking IGALMI with a
history of abnormal heart rhythm can increase the risk of torsades
de pointes and sudden death. Patients should be instructed to tell
their healthcare provider immediately if they feel faint or have
heart palpitations.
-
Sleepiness/drowsiness. Patients should not perform
activities requiring mental alertness, such as driving or operating
hazardous machinery, for at least 8 hours after taking IGALMI.
-
Withdrawal reactions, tolerance, and decreased response/efficacy.
IGALMI was not studied for longer than 24 hours after the first
dose. Physical dependence, withdrawal symptoms (e.g., nausea,
vomiting, agitation), and decreased response to IGALMI may occur if
IGALMI is used longer than 24 hours.
The most common side effects of
IGALMI in clinical studies were sleepiness or drowsiness, a
prickling or tingling sensation or numbness of the mouth,
dizziness, dry mouth, low blood pressure, and low blood pressure
upon standing.
These are not all the possible side effects of IGALMI. Patients
should speak with their healthcare provider for medical advice
about side effects.
Patients should tell their healthcare provider about
their medical history, including if they suffer from any
known heart problems, low potassium, low magnesium, low blood
pressure, low heart rate, diabetes, high blood pressure, history of
fainting, or liver impairment. They should also tell their
healthcare provider if they are pregnant or breastfeeding or take
any medicines, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Patients should
especially tell their healthcare provider if they take any drugs
that lower blood pressure, change heart rate, or take anesthetics,
sedatives, hypnotics, and opioids.
Everyone is encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You
can also contact BioXcel Therapeutics, Inc. at 1-833-201- 1088
or medinfo@bioxceltherapeutics.com.
Please see full Prescribing
Information.
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical
company utilizing artificial intelligence to develop transformative
medicines in neuroscience. The Company’s drug re-innovation
approach leverages existing approved drugs and/or clinically
validated product candidates together with big data and proprietary
machine learning algorithms to identify new therapeutic
indications. For more information, please
visit bioxceltherapeutics.com. Forward-Looking Statements
This press release includes “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995. We
intend such forward-looking statements to be covered by the safe
harbor provisions for forward-looking statements contained in
Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”) and Section 21E of the Securities Exchange Act of
1934, as amended (the “Exchange Act”). All statements contained in
this press release other than statements of historical fact should
be considered forward-looking statements, including, without
limitation, statements regarding: the CMA’s issuance of a permanent
and product-specific J-Code for IGALMI, and the potential benefits,
expectations and impact from the J-Code on formulary wins, patient
access and the commercialization strategy of IGALMI. The words
“anticipate,” “believe,” “can,” “continue,” “could,” “designed,”
“estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,”
“plan,” “possible,” “potential,” “predict,” “project,” “should,”
“target,” “will,” “would” and similar expressions are intended to
identify forward-looking statements, though not all forward-looking
statements use these words or expressions. In addition, any
statements or information that refer to expectations, beliefs,
plans, projections, objectives, performance or other
characterizations of future events or circumstances, including any
underlying assumptions, are forward- looking. All forward-looking
statements are based upon the Company’s current expectations and
various assumptions. The Company believes there is a reasonable
basis for its expectations and beliefs, but they are inherently
uncertain. The Company may not realize its expectations, and its
beliefs may not prove correct. Actual results could differ
materially from those described or implied by such forward-looking
statements as a result of various important factors, including,
without limitation, its limited operating history; risks associated
with the strategic reprioritization; its limited experience in drug
discovery and drug development; its dependence on the success and
commercialization of IGALMI™, BXCL501, BXCL502, BXCL701 and BXCL702
and other product candidates; its lack of experience in marketing
and selling drug products; the risk that IGALMI or the Company’s
product candidates may not be accepted by physicians or the medical
community in general; undesirable side effects caused by the
Company’s product candidates; its exposure to patent infringement
lawsuits; its reliance on third parties; its ability to comply with
the extensive regulations applicable to it; its ability to
commercialize its product candidates; and the other important
factors discussed under the caption “Risk Factors” in its Quarterly
Report on Form 10-Q for the quarterly period ended June 30, 2023,
which are accessible on the SEC’s website
at www.sec.gov. These and other important factors could
cause actual results to differ materially from those indicated by
the forward-looking statements made in this press release. Any such
forward-looking statements represent management’s estimates as of
the date of this press release. While the Company may elect to
update such forward-looking statements at some point in the future,
except as required by law, it disclaims any obligation to do so,
even if subsequent events cause our views to change. These
forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date of this press release.
Contact Information
Corporate
BioXcel TherapeuticsErik
Kopp1.203.494.7062ekopp@bioxceltherapeutics.com
Investor RelationsBioXcel TherapeuticsBrennan
Doyle1.475.355.8462bdoyle@bioxceltherapeutics.com
MediaRusso PartnersDavid
SchullT: 858-717-2310David.schull@russopartnersllc.comScott
StachowiakT: 646-942-5630Scott.stachowiak@russopartnersllc.com
Source: BioXcel Therapeutics, Inc.
IGALMI is a trademark of BioXcel Therapeutics, Inc.BT BIOXCEL
THERAPEUTICS is a registered trademark of BioXcel Therapeutics,
Inc. All other trademarks are the properties of their
respective owners. Copyright © 2023, BioXcel Therapeutics,
Inc. All rights reserved.
References
- IGALMI™ (dexmedetomidine) [package insert]. New Haven, CT:
BioXcel Therapeutics, Inc.; 2022
- Centers for Medicare & Medicaid Services. Accessed October
23, 2023.
https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system/current-prior-years-level-ii-coding-decisions.
- Sacchetti E, Amore M, Di Sciascio G, et al. Psychomotor
agitation in psychiatry: an Italian expert consensus.
Evidence-based Psychiatric Care. 2017;1:1-24.
- Wilson MP, Pepper D, Currier GW, et al. The psychopharmacology
of agitation: consensus statement of the American Association for
Emergency Psychiatry Project Beta Psychopharmacology Workgroup.
West J Emerg Med. 2012;13(1):26-34.
- Richmond JS, Berlin JS, Fishkind AB, et al. Verbal
de-escalation of the agitated patient: consensus statement of the
American Association for Emergency Psychiatry Project BETA
De-escalation Workgroup. West J Emerg
Med. 2012;13(1):17-25.
doi:10.5811/westjem.2011.9.6864
- Martinez-Raga J,
Amore M, Di Sciascio G, et al. 1st international experts’ meeting
on agitation: conclusions regarding the current and ideal
management paradigm of agitation. Front
Psychiatry. 2018;9:54. doi:10.3389/fpsyt.2018.00054
- Zeller SL, Citrome
L. Managing agitation associated with schizophrenia and bipolar
disorder in the emergency setting. West J Emerg Med.
2016;17(2):165-172.
- Holloman GH Jr,
Zeller SL. Overview of Project BETA: Best practices in evaluation
and treatment of agitation.West Emerg Med. 2012;13(1):1-2.
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