WESTLAKE VILLAGE, Calif.,
June 28, 2021 /PRNewswire/
-- MannKind Corporation (Nasdaq:
MNKD) appreciates the recent efforts of the Centers for
Medicare and Medicaid Services (CMS) in conjunction with the
Medicare Administration Contractors (MACs) to implement a policy
change to the Local Coverage Determination (LCD) L33822, allowing
the approval to Medicare patients living with diabetes to select
both Afrezza® and Continuous Glucose Monitors (CGMs).
Effective July 18, the criteria
change lifts the restriction on patients of having to choose
between the two diabetes tools.
"Prior to this change, Medicare denials were occurring for
patients using CGMs and inhaled insulin as an alternative to
injected mealtime insulin," explained Michael Castagna, PharmD, Chief Executive
Officer of MannKind Corporation. "MannKind is committed to
providing convenience for patients, and believes that patients
should have the choice to use any of today's tools to help manage
their diabetes."
MannKind requested that the Durable Medical Equipment (DME) MACs
reconsider the existing language in the LCD: Glucose Monitors
(L33822) to include use of inhaled insulin. Previously, the
criteria defined patients as taking insulin either with multiple
daily injections or an insulin pump. The amended definition
now includes a patient that takes insulin with inhalation as an
alternative.
"This is a win-win for Medicare patients and providers that
serve those patients," said Stella
Ilyayeva, MD, FACE, an Endocrinology, Diabetes and
Metabolism specialist. "In 2020, almost 2/3 of T1D Afrezza
patients were utilizing a CGM concomitantly. I anticipate this
change will open up more doors for the population of Afrezza
users."
About Afrezza®
Available by prescription,
Afrezza® (insulin human) Inhalation Powder is an ultra
rapid-acting inhaled insulin indicated to improve glycemic control
in adult patients with diabetes mellitus. Afrezza consists of a dry
powder formulation of human insulin delivered from a small and
portable inhaler. Administered at the beginning of a meal, Afrezza
dissolves rapidly upon inhalation to the lung and passes quickly
into the bloodstream (in less than one minute). This rapid
absorption allows Afrezza to begin reducing blood sugar levels
within minutes of administration. Afrezza is available in 4-unit,
8-unit and 12-unit single-dose cartridges of insulin powder that
can be used, as prescribed by a health care professional, in
combination with other diabetes medications to achieve target blood
sugar levels. For Afrezza doses exceeding 12 units, patients may
use a combination of existing cartridge strengths. For more
information about Afrezza, please visit afrezza.com.
About MannKind Corporation
MannKind Corporation
(Nasdaq: MNKD) focuses on the development and commercialization of
inhaled therapeutic products for patients with endocrine and orphan
lung diseases. MannKind is currently commercializing
Afrezza® (insulin human) Inhalation Powder, the
Company's first FDA-approved product and the only inhaled
ultra-rapid-acting mealtime insulin in the United States, where it is available by
prescription from pharmacies nationwide. Afrezza is also available
by prescription in Brazil, where
it is commercialized by the Company's partner, Biomm SA. MannKind
was established in 1991, and is headquartered in Westlake Village, Calif., with a manufacturing
and R&D facility based in Danbury,
Conn. The Company also employs field sales and medical
representatives across the U.S. Please visit mannkindcorp.com
to learn more.
Forward-looking Statements
Statements in this report
that are not statements of historical fact are forward-looking
statements. Words such as "plans," "anticipates," "expects,"
"intend," "will," "targeted," "potential" and similar expressions
are intended to identify forward-looking statements.
Forward-looking statements include statements regarding: providing
convenience to patients and opening more doors for Afrezza users.
These forward-looking statements are based upon MannKind's current
expectations. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include, without limitation: risks that Afrezza may not become
widely accepted by physicians, patients, third-party payers and the
healthcare community, and risks that third-party payers may not
cover Afrezza. These and other risks are detailed in MannKind's
filings with the Securities and Exchange Commission ("SEC"),
including under the heading "Risk Factors" in MannKind's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on
May 12, 2021. You are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date of this report. All forward-looking
statements are qualified in their entirety by this cautionary
statement, and MannKind undertakes no obligation to revise or
update any forward-looking statements to reflect events or
circumstances after the date of this report.
AFREZZA is a registered trademark of MannKind Corporation.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/policy-change-allows-approval-for-medicare-patients-living-with-diabetes-to-use-both-afrezza-and-continuous-glucose-monitoring-devices-beginning-july-18-301320512.html
SOURCE MannKind Corporation