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17/07-2017 08:03:56: (PHO) Photocure ASA : UPDATE ON MEDICARE REIMBURSEMENT FOR BLUE LIGHT CYSTOSCOPY WITH CYSVIEW®

Oslo, Norway, July 17, 2017: Photocure ASA (OSE: PHO), 
announced today that the United States Centers for Medicare 
& Medicaid Services (CMS) has released the Proposed Rule 
outlining its 2018 plan to reimburse hospital outpatient 
departments using Blue Light Cystoscopy (BLCTM) with 
Cysview®. To ensure appropriate reimbursement for BLCTM with 
Cysview, CMS has proposed to create a new set of codes 
specific to Blue Light Cystoscopy allowing for improved 
reimbursement for those procedures. 

The CMS draft rule for Medicare patients can be accessed at: 
http://bit.ly/CMS-DRAFT-Rule

"We are grateful that CMS has heard the concerns from 
stakeholders that the current Medicare reimbursement for 
Blue Light Cystoscopy procedures involving Cysview® is 
creating a barrier to patient access to reasonable and 
necessary care," stated Kjetil Hestdal, President and CEO of 
Photocure ASA. "We are pleased that CMS has proposed to 
improve the reimbursement to hospitals for Blue Light 
Cystoscopy, and we will submit comments in support of the 
proposal in the coming weeks," he noted. 

The effectiveness and benefits of Blue Light Cystoscopy 
(BLCTM) with Cysview® for improved detection and management 
of bladder cancer have been recognized by leading urology 
associations including the AUA (American Urological 
Association), and SUO (Society of Urological Oncology) and 
patient groups have recognized the potential of using 
Cysview® as well. In 2016, BLCTM with Cysview® was adopted 
into the AUA/SUO Non-Muscle Invasive Bladder Cancer (NMIBC) 
guidelines.

The comment period for the Proposed Rule closes in early 
September, and CMS is expected to issue a Final Rule in the 
fourth quarter of 2017 effective on January 1, 2018.

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 
and www.cysview.com.

For more information, please contact:
Kjetil Hestdal
President and CEO, Photocure ASA
Tel: +47 913 19 535
Email: kh@photocure.com

Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no

[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/003
085-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. 
[6] Bladder Cancer. American Cancer Society. 
http://www.cancer.org/acs/groups/cid/documents/webcontent/003
085-pdf.pdf. Accessed April 2016.
[7] Bladder Cancer. American Cancer Society. 
http://www.cancer.org/acs/groups/cid/documents/webcontent/003
085-pdf.pdf. Accessed April 2016.

Ekstern link: http://www.newsweb.no/index.jsp?messageId=431445

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