Otonomy Announces Assignment of C Code and Pass-Through Payment Status for OTIPRIO™
May 20 2016 - 7:30AM
Otonomy, Inc. (Nasdaq:OTIC), a biopharmaceutical company focused on
the development and commercialization of innovative therapeutics
for diseases and disorders of the ear, today announced that the
Centers for Medicare and Medicaid Services (CMS) has approved
transitional pass-through status and established a new billing code
for OTIPRIO™ (ciprofloxacin otic suspension). The code, C9479,
will become effective July 1, 2016.
“We welcome CMS’s decision to grant pass-through status and
assign a new C code for OTIPRIO which can be used for billing in
the hospital outpatient and ambulatory surgery center (ASC)
settings,” said David A. Weber, Ph.D., president and CEO of
Otonomy. “Furthermore, the timing of this assignment early in the
launch of OTIPRIO will, we believe, be very helpful in our ongoing
efforts to facilitate patient access.”
According to a CMS reference article, “C codes are unique
temporary pricing codes that were initially established by CMS for
the Hospital Outpatient Prospective Payment System (OPPS). The C
codes are used on Medicare OPPS claims but may also be recognized
on claims from other providers or by other payment systems.”
Hospital outpatient departments and ASCs billing for drugs assigned
a C code are eligible for payment by Medicare for the pass-through
drug in addition to the fee received by the facility for the
related procedure. Pass-through payment is typically available for
two to three years and Otonomy believes, based on long-standing CMS
policy, that pass-through payment for OTIPRIO will be effective
through the end of 2018. Coverage and payment by non-Medicare
payors including Medicaid and commercial insurers is determined by
each payor’s policies and individual provider contracts.
About OTIPRIO
OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone
antibacterial indicated for the treatment of pediatric patients
with bilateral otitis media with effusion undergoing tympanostomy
tube placement. OTIPRIO is administered by a physician as a single
0.1 mL (6 mg) intratympanic administration into each affected ear,
following suctioning of the middle ear effusion. The
thermosensitive suspension exists as a liquid at or below room
temperature and gels when warmed. In two Phase 3 trials, a single
intraoperative administration of OTIPRIO demonstrated a
statistically significant reduction in the cumulative proportion of
study treatment failures compared to tubes alone (p-value
<0.001).
Important Safety Information for OTIPRIO
Contraindications: OTIPRIO is contraindicated
in patients with a history of hypersensitivity to ciprofloxacin, to
other quinolones, or to any of the components of OTIPRIO.
Warnings and Precautions - Potential
for Microbial Overgrowth: OTIPRIO may result in overgrowth
of nonsusceptible bacteria and fungi. If such infections occur,
institute alternative therapy.
Adverse Reactions: Adverse reactions (incidence
at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs
sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and
rhinorrhea (3% vs 2%).
Use in Specific Populations - Pediatric Use:
The safety and effectiveness of OTIPRIO in infants below six months
of age have not been established.
Full prescribing information can be found at
www.OTIPRIO.com.
About Otonomy
Otonomy is a biopharmaceutical company focused on the
development and commercialization of innovative therapeutics for
diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic
suspension) is approved in the United States for use
during tympanostomy tube placement surgery in pediatric patients,
and commercial launch commenced in March 2016. OTO-104 is a steroid
in development for the treatment of Ménière's disease and other
severe balance and hearing disorders. Two Phase 3 trials in
Ménière's disease patients are underway, with results expected
during the second half of 2017. OTO-311 is an NMDA receptor
antagonist for the treatment of tinnitus that is in a Phase 1
clinical safety trial. Otonomy’s proprietary formulation technology
utilizes a thermosensitive gel and drug microparticles to enable
single dose treatment by a physician. For additional information
please visit www.otonomy.com.
Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements generally relate to future events
or future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, whether payors will provide reimbursement according
to the C code, the timing of any such reimbursement, how long
pass-through payments and the C code will remain effective, and the
timing of results for the two OTO-104 Phase 3 clinical trials in
Ménière's disease. Otonomy's expectations regarding these matters
may not materialize, and actual results in future periods are
subject to risks and uncertainties. Actual results may differ
materially from those indicated by these forward-looking statements
as a result of these risks and uncertainties, including but not
limited to: Otonomy's limited operating history and its expectation
that it will incur significant losses for the foreseeable future;
Otonomy's ability to obtain additional financing; Otonomy's
dependence on the commercial success of OTIPRIO and the regulatory
success and advancement of additional product candidates, such as
OTO-104 and OTO-311; the uncertainties inherent in the clinical
drug development process, including, without limitation, Otonomy's
ability to adequately demonstrate the safety and efficacy of its
product candidates, the preclinical and clinical results for its
product candidates, which may not support further development, and
challenges related to patient enrollment in clinical trials;
Otonomy's ability to obtain regulatory approval for its product
candidates; side effects or adverse events associated with
Otonomy's product candidates; competition in the biopharmaceutical
industry; Otonomy's dependence on third parties to conduct
preclinical studies and clinical trials; the impact of coverage and
reimbursement decisions by third-party payors on the pricing and
market acceptance of OTIPRIO; Otonomy's dependence on third parties
for the manufacture of OTIPRIO and product candidates; Otonomy's
dependence on a small number of suppliers for raw materials;
Otonomy's ability to protect its intellectual property related to
OTIPRIO and its product candidates in the United States and
throughout the world; expectations regarding potential market size,
opportunity and growth; Otonomy's ability to manage operating
expenses; implementation of Otonomy's business model and strategic
plans for its business, products and technology; and other risks.
Information regarding the foregoing and additional risks may be
found in the section entitled "Risk Factors" in Otonomy's Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (the "SEC") on May 9, 2016, and Otonomy's future reports
to be filed with the SEC. The forward-looking statements in this
press release are based on information available to Otonomy as of
the date hereof. Otonomy disclaims any obligation to update any
forward-looking statements, except as required by law.
Contacts:
Media InquiriesCanale CommunicationsHeidi Chokeir, Ph.D.Senior
Vice President619.849.5377heidi@canalecomm.com
Investor InquiriesWestwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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