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 wall2.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 treat2.
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/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.
6 Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.
7 Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.