Omeros Provides Update on Separate Payment for OMIDRIA® in the ASCs
October 01 2020 - 8:00AM
Business Wire
—OMIDRIA meets all objective criteria
established by CMS—
Omeros Corporation (Nasdaq: OMER) today provided an update on
the status of reimbursement for its cataract surgery drug OMIDRIA®
(phenylephrine and ketorolac intraocular solution) 1%/0.3%. The
two-year extension of pass-through status provided by Congress
through the Consolidated Appropriations Act of 2018 for OMIDRIA
expired today. Omeros is actively engaged in requesting from the
Centers for Medicare and Medicaid Services (CMS) and the Department
of Health and Human Services (HHS) confirmation of separate payment
status for OMIDRIA in the ambulatory surgery center (ASC) setting
for 4Q 2020.
Omeros has also submitted to CMS both a comment letter on the
proposed Outpatient Prospective Payment System/ASC Rule for
Calendar Year (CY) 2021 and a legal opinion from the law firm Foley
Hoag LLP, reiterating that CMS regulations require non-opioid drugs
that meet the objective regulatory criteria specified by CMS,
including OMIDRIA, to be paid separately when used in the ASC
setting. Omeros and its advisors are confident that (1) CMS is
required by law to apply its separate payment policy for non-opioid
pain management surgical drugs to OMIDRIA for 4Q 2020 and for CY
2021 and (2) CMS will address this issue soon and no later than its
CY 2021 Final Rule, which is expected to be released on or shortly
after November 1.
CMS’ policy for separate payment applies to non-opioid pain
management surgical drugs that are used in the ASC setting and that
are policy-packaged under CMS’ Outpatient Prospective Payment
System. Now that its pass-through status has expired, OMIDRIA meets
each of the objective regulatory criteria established by CMS for
separate payment in the ASC payment system both for the remainder
of 2020 and for CY 2021 – CMS has confirmed in previous annual
rules that OMIDRIA is a non-opioid pain management drug used in the
ASC setting that is policy packaged as a drug that functions as a
supply in a surgical procedure. For further details, please see the
comment letters referenced above, which can be found on the
investor relations section of Omeros’ website at
www.investor.omeros.com under “featured reports” or, once posted by
the government, at
https://www.regulations.gov/docket?D=CMS-2020-0090.
CMS is the primary insurer for 40-45 percent of cataract surgery
patients. The large majority of cataract surgery procedures are
performed in ASCs. In addition to Omeros’ current request with CMS
and HHS for confirmation of separate payment in the ASCs, the
Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act (H.R.5172
and S. 3067) is continuing to make progress through both chambers
of Congress. The bill has strong and growing bipartisan support,
currently with over 50 sponsors and co-sponsors in the House of
Representatives and more than 20 in the Senate. If enacted, the
bill would provide separate Medicare reimbursement for non-opioid
treatments to manage pain, like OMIDRIA, in both ASCs and hospital
outpatient departments, renewable every five years. In any event,
Omeros will remain committed to physicians’ ability to select the
best medical care for their patients and to providing access to
OMIDRIA for all cataract surgery patients.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting inflammation, complement-mediated diseases, disorders of
the central nervous system and immune-related diseases, including
cancers. In addition to its commercial product OMIDRIA
(phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros
has multiple late-stage clinical development programs focused on
complement-mediated disorders, including COVID-19, and substance
abuse. A rolling biologics license application for narsoplimab, the
company’s lead MASP-2 inhibitor, in hematopoietic stem cell
transplant-associated thrombotic microangiopathy is being completed
for submission to the U.S. FDA. Omeros also has a diverse group of
preclinical programs including GPR174, a novel target in
immuno-oncology that modulates a new cancer immunity axis recently
discovered by Omeros. Small-molecule inhibitors of GPR174 are part
of Omeros’ proprietary G protein-coupled receptor (GPCR) platform
through which it controls 54 new GPCR drug targets and their
corresponding compounds. The company also exclusively possesses a
novel antibody-generating platform.
About OMIDRIA®
Omeros’ OMIDRIA® (phenylephrine and ketorolac intraocular
solution) 1% / 0.3% is the first and only FDA-approved product of
its kind and is marketed in the U.S. for use during cataract
surgery or intraocular lens replacement to maintain pupil size by
preventing intraoperative miosis (pupil constriction) and to reduce
postoperative ocular pain. OMIDRIA also is the only
NSAID-containing product FDA-approved for intraocular use. In
post-launch studies across conventional and femtosecond
laser-assisted cataract surgery, OMIDRIA has been shown to (1)
prevent intraoperative floppy iris syndrome (IFIS) and iris
prolapse, (2) significantly reduce complication rates (including
sight-threatening cystoid macular edema and breakthrough iritis),
use of pupil-expansion devices, and surgical times, (3)
significantly reduce intraoperative use of the opioid fentanyl and
postoperative prescription opioids, and (4) significantly improve
uncorrected visual acuity on the first day following cataract
surgery. While OMIDRIA is broadly indicated for use in cataract
surgery, the post-launch outcomes cited above are not in its
currently approved labeling.
Important Safety Information for OMIDRIA®
Systemic exposure of phenylephrine may cause elevations in blood
pressure. In clinical trials, the most common reported ocular
adverse reactions at two percent or greater are eye irritation,
posterior capsule opacification, increased intraocular pressure,
and anterior chamber inflammation; incidence of adverse events was
similar between placebo-treated and OMIDRIA-treated patients.
OMIDRIA must be added to irrigation solution prior to intraocular
use.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, which are
subject to the “safe harbor” created by those sections for such
statements. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“goal,” “intend,” “likely”, “look forward to,” “may,” “on track,”
“plan,” “potential,” “predict,” “project,” “prospects,”
“scheduled,” “should,” “slated,” “targeting,” “will,” “would” and
similar expressions and variations thereof. Forward-looking
statements, including statements regarding payment and
reimbursement status, expectations for continued separate payment
for OMIDRIA and expected qualification for an exception from
packaged payment, are based on management’s beliefs and assumptions
and on information available to management only as of the date of
this press release. Omeros’ actual results could differ materially
from those anticipated in these forward-looking statements for many
reasons, including, without limitation, availability and timing of
data from ongoing clinical trials and the results of such trials,
changes in regulatory policy, political factors, competitive
developments, litigation, and the risks, uncertainties and other
factors described under the heading “Risk Factors” in the company’s
Annual Report on Form 10-K filed with the Securities and Exchange
Commission on March 2, 2020, as supplemented by its subsequently
filed Quarterly Reports on Form 10-Q. Given these risks,
uncertainties and other factors, you should not place undue
reliance on these forward-looking statements, and the company
assumes no obligation to update these forward-looking statements,
even if new information becomes available in the future.
Source: Omeros Corporation
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version on businesswire.com: https://www.businesswire.com/news/home/20201001005683/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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