Photocure ASA

Legal Proceedings Report • Jul 17, 2017

Photocure ASA : UPDATE ON MEDICARE REIMBURSEMENT FOR BLUE LIGHT CYSTOSCOPY WITH CYSVIEW®

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.