ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR) today announced the Medicare durable medical
equipment (DME) Medicare Administrative Contractors (MACs) have issued a proposed
local coverage determination (LCD) that
provides coverage of Tumor Treating Fields, or Optune, for newly
diagnosed glioblastoma (GBM). Proposed LCDs are subject to a 45-day
public comment period during which the DME MACs will consider feedback
from patients, advocacy groups, prescribers and the general public prior
to finalizing the LCD.
The coverage policy criteria proposed by the DME MACs is generally
similar to Optune’s commercial coverage criteria for newly diagnosed
glioblastoma (GBM) with the exception of a proposed restriction on
beneficiary site of care.
The proposed coverage policy is now subject to public comment through
June 24, 2019. An open meeting will be held at the Westin Baltimore
Washington International Airport on June 20, 2019 to discuss the
proposed policy. Following the public comment period, a final LCD will
be published that includes a response to public comments received.
“We view the proposed LCD as a positive step forward in a multi-step
process,” said Bill Doyle, Novocure’s Executive Chairman. “We are
committed to ensuring patients have equitable access to Optune and now
will work with our patients and prescribers to help their voices be
heard during the public comment period.”
“On behalf of the Musella Foundation For Brain Tumor Research &
Information, Inc., we applaud the DME MACs for issuing a draft LCD
allowing coverage of Optune for newly diagnosed GBM patients,” noted Al
Musella, DPM, President of the Musella Foundation. “This is a positive
first step towards ensuring equitable access to care for Medicare
beneficiaries. We have concerns, which we will share directly with the
DME MACs, with the proposed limitations on where patients can access
Optune. We believe strongly that all Medicare beneficiaries should have
access to the therapy deemed appropriate by their healthcare providers.”
Approved Indications
Optune is intended as a treatment for adult patients (22 years of age or
older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult
patients with newly diagnosed, supratentorial glioblastoma following
maximal debulking surgery and completion of radiation therapy together
with concomitant standard of care chemotherapy.
For the treatment of recurrent GBM, Optune is indicated following
histologically-or radiologically-confirmed recurrence in the
supratentorial region of the brain after receiving chemotherapy. The
device is intended to be used as a monotherapy, and is intended as an
alternative to standard medical therapy for GBM after surgical and
radiation options have been exhausted.
Patients should only use Optune under the supervision of a physician
properly trained in use of the device. Full prescribing information is
available at www.optune.com/safety
or by calling toll free 1-855-281-9301.
Important Safety Information
Contraindications: Do not use Optune if you have an active
implanted medical device, a skull defect (such as, missing bone with no
replacement), or bullet fragments. Use of Optune together with implanted
electronic devices has not been tested and may theoretically lead to
malfunctioning of the implanted device. Use of Optune together with
skull defects or bullet fragments has not been tested and may possibly
lead to tissue damage or render Optune ineffective.
Do not use Optune if you are known to be sensitive to conductive
hydrogels. In this case, skin contact with the gel used with Optune may
commonly cause increased redness and itching, and rarely may even lead
to severe allergic reactions such as shock and respiratory failure.
Warnings and Precautions: Use Optune only after receiving
training from qualified personnel, such as your doctor, a nurse, or
other medical personnel who have completed a training course given by
Novocure (the device manufacturer).
Do not use Optune if you are pregnant, you think you might be pregnant
or are trying to get pregnant. It is not known if Optune is safe or
effective in these populations.
The most common (≥10%) adverse events involving Optune in combination
with temozolomide were low blood platelet count, nausea, constipation,
vomiting, fatigue, scalp irritation from device use, headache,
convulsions, and depression.
The most common (≥10%) adverse events seen when using Optune alone were
scalp irritation from device use and headache.
The following adverse reactions were considered related to Optune when
using the device alone: scalp irritation from device use, headache,
malaise, muscle twitching, fall and skin ulcer.
All servicing procedures must be performed by qualified and trained
personnel.
Do not use any parts that do not come with the Optune Treatment Kit, or
that were not sent to you by the device manufacturer or given to you by
your doctor.
Do not wet the device or transducer arrays.
If you have an underlying serious skin condition on the scalp, discuss
with your doctor whether this may prevent or temporarily interfere with
Optune treatment.
Please see http://www.optune.com/safety
to see the Optune Instructions For Use (IFU) for complete information
regarding the device’s indications, contraindications, warnings, and
precautions.
Patients should only use Optune under the supervision of a physician
properly trained in use of the device.
Forward-Looking Statements
In addition to historical facts or statements of current condition, this
press release may contain forward-looking statements. Forward-looking
statements provide Novocure’s current expectations or forecasts of
future events. These may include statements regarding anticipated
scientific progress on its research programs, clinical trial progress,
development of potential products, interpretation of clinical results,
prospects for regulatory submission and approval, manufacturing
development and capabilities, market prospects for its products,
coverage, collections from third-party payers and other statements
regarding matters that are not historical facts. You may identify some
of these forward-looking statements by the use of words in the
statements such as “anticipate,” “estimate,” “expect,” “project,”
“intend,” “plan,” “believe” or other words and terms of similar meaning.
Novocure’s performance and financial results could differ materially
from those reflected in these forward-looking statements due to general
financial, economic, regulatory and political conditions as well as more
specific risks and uncertainties facing Novocure such as those set forth
in its Annual Report on Form 10-K filed on February 28, 2019, with the
U.S. Securities and Exchange Commission. Given these risks and
uncertainties, any or all of these forward-looking statements may prove
to be incorrect. Therefore, you should not rely on any such factors or
forward-looking statements. Furthermore, Novocure does not intend to
update publicly any forward-looking statement, except as required by
law. Any forward-looking statements herein speak only as of the date
hereof. The Private Securities Litigation Reform Act of 1995 permits
this discussion.
Contacts
Ashley Cordova
acordova@novocure.com
212-767-7558