JERSEY CITY, N.J., July 25, 2017 /PRNewswire/ -- MT Pharma America,
Inc. today announced that healthcare providers (HCPs) now can begin
the insurance benefits investigation process for their patients in
preparation for availability of RADICAVA™ (edaravone), an
intravenous infusion treatment approved in May by the U.S. Food and
Drug Administration (FDA). RADICAVA is indicated for all adult
patients diagnosed with amyotrophic lateral sclerosis (ALS), also
known as Lou Gehrig's disease, and
is on schedule to be available to patients in the U.S. in
mid-August 2017.
"We have initiated the benefits investigation process now to
allow people diagnosed with ALS access to RADICAVA as soon as it
becomes available," said Atsushi
Fujimoto, President, MT Pharma America. "We are committed to
making the process of accessing RADICAVA as seamless as possible
and encourage healthcare providers to begin the process now for
their patients."
The benefits investigation and product access process is
initiated by the HCP and facilitated through the Searchlight
Support™ hub, which provides assistance for people who are
prescribed RADICAVA. Key steps in the process include:
1) TREATMENT DECISION: Patient visits HCP, who
determines whether RADICAVA is an appropriate treatment for
him/her.
2) BENEFITS VERIFICATION: Before beginning
treatment the patient's insurance coverage must be confirmed:
- HCP submits Benefits Investigation and Enrollment Form to
connect patient to Searchlight Support. Forms (available at
www.RADICAVA.com/HCP) can be submitted by the HCP online through a
secure HCP portal, faxed or mailed.
- Searchlight Support conducts rapid benefits investigation to
confirm patient insurance coverage and assigns a patient ID.
- A Care Coordinator from Searchlight Support can help the HCP's
office identify a location for infusion service based on individual
patient's insurance benefits and geographical proximity (ALS
center, home infusion, physician's office, free-standing infusion
center or hospital outpatient department).
- Case manager contacts patient to explain benefits and discuss
co-pay support options.
3) SCHEDULING INFUSIONS: Patient or HCP office
contacts infusion site or home infusion provider to schedule the
first cycle of treatment.
4) RADICAVA ORDERED: Site of care submits order
form with patient ID to Searchlight Support to obtain RADICAVA for
scheduled treatment. Searchlight Support facilitates RADICAVA
shipment from distributor to infusion site once available in
mid-August.
For more information on the benefits investigation process call
1-844-SRCHLGT (1-844-772-4548).
About RADICAVA™ (Edaravone)
The U.S. Food and
Drug Administration (FDA) approved RADICAVA™ (edaravone) on
May 5, 2017 as a new treatment option
indicated for all adult patients diagnosed with amyotrophic lateral
sclerosis (ALS).1 In clinical trials, people given
RADICAVA experienced a 33 percent lower rate of decline in loss of
physical function, compared to placebo as measured by the ALS
Functional Rating Scale-Revised (ALSFRS-R), a validated rating
instrument for monitoring the progression of disability in people
with ALS.1,2,3
RADICAVA is administered in 28-day cycles by intravenous
infusion. It takes 60 minutes to receive each 60 mg dose. For the
initial cycle, the treatment is infused daily for 14 consecutive
days, followed by a two-week drug-free period. All cycles
thereafter are infused daily for 10 days (e.g., Monday through
Friday and the following Monday through Friday) within a 14-day
period, followed by a two-week drug-free
period.1
Edaravone was discovered and developed for ALS by Mitsubishi
Tanabe Pharma Corporation (MTPC) and will be commercialized in the
U.S. by MT Pharma America. MTPC group companies began researching
ALS in 2001 through a comprehensive clinical platform over a
13-year period. In 2015, edaravone was approved for use as a
treatment for all patients diagnosed with ALS in Japan and South
Korea.
IMPORTANT SAFETY INFORMATION
Before you receive RADICAVA, tell your healthcare provider about
all of your medical conditions, including if you:
- have asthma.
- are allergic to other medicines.
- are pregnant or plan to become pregnant. It is not known if
RADICAVA will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
RADICAVA passes into your breast milk. You and your healthcare
provider should decide if you will receive RADICAVA or
breastfeed.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
What are the possible side effects of RADICAVA?
- RADICAVA may cause serious side effects including
hypersensitivity (allergic) reactions and sulfite allergic
reactions.
- Hypersensitivity reactions have happened in people receiving
RADICAVA and can happen after your infusion is finished.
- RADICAVA contains sodium bisulfite, a sulfite that may cause a
type of allergic reaction that can be serious and life-threatening.
Sodium bisulfite can also cause less severe asthma episodes in
certain people. Sulfite sensitivity can happen more often in people
who have asthma than in people who do not have asthma.
- Tell your healthcare provider right away or go to the nearest
emergency room if you have any of the following symptoms: hives;
swelling of the lips, tongue, or face; fainting; breathing
problems; wheezing; trouble swallowing; dizziness; itching; or an
asthma attack (in people with asthma).
- Your healthcare provider will monitor you during treatment to
watch for signs and symptoms of all the serious side effects.
The most common side effects of RADICAVA include bruising
(contusion), problems walking (gait disturbance), and headache.
These are not all the possible side effects of RADICAVA. Call
your healthcare provider for medical advice about side effects. You
may report side effects to MT Pharma America, Inc. at
1-888-292-0058 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
For more information, including full Prescribing Information and
Patient Information, click here www.RADICAVA.com.
About MT Pharma America, Inc.
Based in Jersey City, N.J., MT Pharma America (MTPA) is
a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation's
(MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe
Pharma Holdings America, Inc. MTPA is dedicated to delivering
innovative products that address the unmet medical needs of
patients in the U.S. It was established by MTPC to commercialize
approved pharmaceutical products in the U.S. with plans to expand
its product line through collaborations with partners. For more
information, please visit www.mt-pharma-america.com or follow us on
Twitter at https://twitter.com/MTPharmaUS.
Overview of Mitsubishi Tanabe Pharma
Corporation
Mitsubishi Tanabe Pharma, which was founded in
1678, has its headquarters in Doshomachi, Osaka, which is the birthplace of Japan's pharmaceutical industry. With business
centered on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is a
well-established company and has the longest history of any listed
company in Japan.4 In
accordance with the corporate philosophy of "contributing to the
healthier lives of people around the world through the creation of
pharmaceuticals," the Company formulated the key concept of Open Up
the Future under the Medium-Term Management Plan 16-20. Through the
discovery of drugs that address unmet medical needs, centered on
its priority disease areas — autoimmune diseases, diabetes and
kidney diseases, central nervous system diseases, and vaccines —
Mitsubishi Tanabe Pharma will strive to contribute to the health of
patients around the world. MTPC is the parent company of MTPA and
the license holder of RADICAVA. For more information, go to
http://www.mt-pharma.co.jp/.
Media inquiries:
Sara
Baker
212-849-9474
Sara.Baker@inventivhealth.com
Debbie Etchison
908-340-8578
Media_MTPA@mt-pharma-us.com
1 RADICAVA™ U.S. Prescribing Information.
May 2017.
2 Simon, N. G., Turner, M. R., Vucic, S., Al-Chalabi,
A., Shefner, J., Lomen-Hoerth, C., & Kiernan, M. C. (2014).
Quantifying Disease Progression in Amyotrophic Lateral Sclerosis.
Annals of Neurology, 76(5), 643–657.
3 Abe K, Aoki M, Tsuji S, et al. (2017). Safety and
efficacy of edaravone in well-defined patients with amyotrophic
lateral sclerosis: a randomised, double-blind, placebo-controlled
trial. Lancet Neurology. DOI:
http://dx.doi.org/10.1016/S1474-4422(17)30115-1.
4 Research by TOKYO
SHOKO RESEARCH, LTD.
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SOURCE MT Pharma America, Inc.