Photocure ASA

Regulatory Filings • Nov 2, 2017

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

Photocure ASA: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((TM))) 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 Cysviewprocedure as

this should result in more patients having access to BLC with Cysviewand 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

(BLC(TM)).  BLC(TM) 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

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.

This information is subject to the disclosure requirements pursuant to section

5-12 of the Norwegian Securities Trading Act.