Published: 28 November 2013Medical InformationProduct Announcements

Oslo, Norway, November 28, 2013: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces that the US Centers for Medicare & Medicaid Services (CMS) has released the final rule for the Medicare  Outpatient program, which included provisions addressing payments for drugs and procedures for 2014.

Photocure announced on 22 October 2013, in its third quarter 2013 report, that CMS proposed to create a new package payment category to package Cysview® (hexaminolevulinate) into the overall procedure reimbursement code. In the final ruling, CMS confirmed the creation of this new package category for 2014. The rule, which will be effective starting January 2014, will result in reduced payments to hospitals when using Cysview and may compromise patient access to this revolutionary drug. 

Kjetil Hestdal, President and CEO of Photocure, said: "The effectiveness and benefits of using Cysview for improved detection and management of bladder cancer are unparalleled and widely recognized. The leading urology associations AUA, BCAN, as well as other patient groups, see the potential of using Cysview in the treatment of bladder cancer.  Although this ruling is disappointing, we will continue to work closely with CMS to secure a long-term separate payment code for Cysview. Photocure remains confident in the long-term potential for Cysview. However, we do expect some new potential customers to be impacted by the CMS ruling in the fourth quarter."

The US Medicare reimbursement payments for drugs and procedures are annually reviewed by CMS. The CMS review of the US Medicaid reimbursement program can be accessed at: 

For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email:

CFO Erik Dahl
Tel: +47 450 55 000, Email:

Hume Brophy
Mary Clark, Hollie Vile, Supriya Mathur
Tel: +44 20 3440 5653, Email:

Notes to editors

About Photocure ASA
Photocure ASA, headquartered in Oslo Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology(TM) platform, Photocure develops and commercializes highly selective and effective solutions within disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, colorectal cancer and skin conditions. Our aim is to provide solutions which can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at

About Hexvix®/Cysview®
Hexvix/Cysview is the first approved drug-device combination procedure for improved detection and management of bladder cancer. It is designed to induce fluorescence in the malignant cells in the bladder during a cystoscopic procedure, making it easier for the urologist to detect non muscle invasive bladder cancer, as an adjunct to white light cystoscopy. It is the first product in a new diagnostic class known as Photodynamic Diagnostic agents. Hexvix is an approved product in Europe and the US. Photocure markets and sells Hexvix in the Nordic region, and has initiated the commercialization of Cysview directly in the US. Ipsen is commercializing Hexvix in Europe excluding Nordics.

All trademarks mentioned in this release are protected by law and registered trademarks of Photocure.

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)

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