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U.S. CMS improves reimbursement for Blue Light Cystoscopy with Cysview®

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™) 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 Cysview procedure as this should result in more patients having access to BLC with Cysview and 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.

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