Photocure ASA:U.S. CMS improves reimbursement for Blue Light Cystoscopy with Cysview®
November 02 2017 - 3:07AM
Oslo, Norway, November
2,2017: Photocure ASA (OSE: PHO), announced today that the
United States Centers for Medicare & Medicaid Services (CMS)
has issued a Final Rule stating that it will reimburse hospital
outpatient departments for certain Blue Light Cystoscopy
(BLC(TM)) with
Cysview® procedures
from January 1, 2018.
"The effectiveness and benefits of using Blue
Light Cystoscopy (BLC) with Cysview for improved detection and
management of bladder cancer are widely recognized. It is
very positive that the CMS have created a separate payment code and
additional payment for Blue Light Cystoscopy with Cysviewprocedure
as this should result in more patients having access to BLC with
Cysviewand should increase equality of care in the management of
bladder cancer patients," said Cheryl Lee, M.D., FACS Chair,
Department of Urology, Dorothy M. Davis Chair in Cancer
Research at The Ohio State University.
To ensure appropriate reimbursement for BLC with
Cysview, CMS has created new and unique codes to describe Blue
Light Cystoscopy with the fluorescent imaging agent, Cysview. The
CMS final rule for Medicare patients is outlined in the New 2018
CMS hospital outpatient prospective payment system (OPPS) final
rule and can be accessed at: http://bit.ly/CMS-Final-Rule
"We are pleased that CMS has implemented new
improved coverage and coding for Blue Light Cystoscopy with Cysview
procedures. We, along with many stakeholders, including the
American Urological Association (AUA), Society of Urological
Oncology (SUO), the patient advocacy group Bladder Cancer Advocacy
Network, Hospitals and Urologists, have worked hard to secure a
reimbursement path for Cysview, in order to ensure better access
for Medicare patients to this leading-edge technology for the
management of bladder cancer. We estimate the new rule will
positively impact approximately 50% of Medicare bladder cancer
resection procedures (TURBTs), so this is an important step forward
both for patients and our mission to improve the management of
bladder cancer," commented Kjetil Hestdal, President and CEO of
Photocure ASA.
The effectiveness and benefits of Blue Light
Cystoscopy (BLC) with Cysview for improved detection and management
of bladder cancer have been recognized by the AUA/SUO. In 2016, BLC
with Cysview was adopted into the AUA/SUO Non-Muscle Invasive
Bladder Cancer NMIBC Guidelines.
About Bladder
Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the
US and is the fourth most common cancer found in men in the
US.1,2,3 In
2016, it is estimated that 76,960 new cases of bladder cancer will
occur along with 16,390 deaths due to bladder cancer.
Bladder cancer is one of the most expensive
cancers to manage, accounting for approximately $3.7 billion in
direct costs each year.4,5
Bladder cancer is classified into two types,
non-muscle invasive bladder cancer (NMIBC) and muscle-invasive
bladder cancer (MIBC), depending on the depth of invasion in the
bladder wall. 2 NMIBC
remains in the inner layer of cells lining the bladder. These
cancers are the most common (70%) of all BC cases and include the
subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when
the cancer has grown into deeper layers of the bladder wall. These
cancers, including subtypes T2, T3 and T4, are more likely to
spread and are harder to treat. 2
About Hexvix®/Cysview®
Hexvix®/Cysview® is a
drug that is selectively taken up by cancer cells in the bladder
making them glow bright pink during Blue Light Cystoscopy
(BLCTM).
BLCTM with
Hexvix®
/Cysview® improves the
detection of tumors and leads to more complete resection, less
residual tumors and better management decisions.
Cysview® is the tradename in the US and Canada,
Hexvix® is the tradename in all other markets. Photocure is
commercializing Hexvix®/Cysview® directly in the US and the Nordic
region, and has strategic partnerships for the commercialization of
Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand.
Please refer to
https://www.photocure.com/Partnering-with-Photocure/Our-partners
for further information on our commercial partners.
About Photocure
Photocure, headquartered in Oslo Norway, is a specialty
pharmaceutical company focusing on urology. Based on its unique
proprietary Photocure Technology® platform, Photocure is committed
to developing and commercializing highly selective and minimally
invasive solutions to improve health outcomes for patients
worldwide. The company is listed on the Oslo Stock Exchange (OSE:
PHO). More information about Photocure is available at
www.photocure.com, www.hexvix.com, www.cysview.com
Company contacts:
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no
Erik Dahl, Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no
References:
1. SEER Cancer Statistics Factsheets: Bladder
Cancer. National Cancer Institute. Bethesda, MD.
http://seer.cancer.gov/statfacts/html/urinb.html. Accessed April
2016.
2. Bladder Cancer. American Cancer
Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf.
Accessed April 2016.
3. Hall M, Chang S, Dalbagni G et al. Guideline for the Management
of Nonmuscle Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007
Update. J Urol. 2007;178(6):2314-2330.
4. Avritscher EB et al., Clinical model of lifetime cost of
treating bladder cancer and associated complications. Urology.
2006; 68:549-553.
5. Botteman et al. Clinical model of lifetime costs of
treating bladder cancer: a comprehensive review of the published
literature. Pharmacoeconomics. 2003; 21:315-1330.
This information is subject to the disclosure
requirements pursuant to section 5-12 of the Norwegian Securities
Trading Act.
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Photocure ASA via Globenewswire
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