Photocure ASA

Earnings Release • Nov 5, 2019

Photocure: Cysview® reimbursement further improved from January 2020

Photocure: Cysview® reimbursement further improved from January 2020

CMS final rule expands complexity adjustment for Hospital Outpatient from two to

three procedure codes and increases the reimbursement due to the complexity

adjustment for these procedures by $92 compared to 2019.

Oslo, Norway, November 6,[ ]2019 Photocure ASA., (OSE: PHO), The United States

Centers for Medicare and Medicaid Services (CMS) has released its Final Rule

maintaining the reimbursement code (A Code) for Cysview when used in hospital

outpatient and other sites of care and improved the complexity adjustment

codes.  This will result in additional reimbursement of $92 for certain Blue

Light Cystoscopy (BLCT) procedures when used in hospital outpatient departments

effective January 1st, 2020.

Link for access to the Rule: https://s3.amazonaws.com/public

-inspection.federalregister.gov/2019-24138.pdf

In addition, CMS confirmed that the complexity adjustment will be available for

procedures billed under 52204, 52214, and 52224 (52214 being new for 2020), if

also billed with the A9589 code for the drug and the C9738 code for the

complexity adjustment.  The increased reimbursement due to the complexity

adjustment will be $1,247 ($1,187 in 2019).   This will result in an increase in

reimbursement of payment for Blue Light Cystoscopy procedures when used in

hospital outpatient department under the complexity adjustment conditions

applicable to the three procedures in 2020 from standard white light at $1,771

(for APC 5373) to $3,018 with Cysview (for APC 5374).

"The effectiveness and benefits of using Blue Light Cystoscopy (BLCT) with

Cysview for improved detection and management of bladder cancer are widely

recognized. We are pleased that CMS has implemented an additional complexity

adjustment code for Cysview and improved reimbursement compared to 2019.  We,

along with many stakeholders in the Bladder Cancer Community, (including the

Large Urology Group Practice Association (LUGPA), American Urological

Association (AUA), the patient advocacy group Bladder Cancer Advocacy Network

(BCAN), and individual Urologists and Patients), will continue to work to

further increase access for all patients regardless of the site of care to this

leading-edge technology for the management of bladder cancer," commented Dan

Schneider, President and Chief Executive Officer of Photocure ASA.

About Bladder Cancer

Bladder cancer ranks as the ninth most common cancer worldwide with 430 000 new

cases and more than 165 000 deaths annually. Approx. 75% of all bladder cancer

cases occur in men[1]. It has a high recurrence rate with an average of 61% in

year one and 78% over five years[2]. Bladder cancer has the highest lifetime

treatment costs per patient of all cancers[3].

Bladder cancer is a costly, potentially progressive disease for which patients

have to undergo multiple cystoscopies due to the high risk of recurrence. There

is an urgent need to improve both the diagnosis and the management of bladder

cancer for the benefit of patients and healthcare systems alike.

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. NMIBC remains in the inner layer of cells lining

the bladder. These cancers are the most common (75%) 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[4].

About Hexvix[®]/Cysview[®] (hexaminolevulinate HCl)

Hexvix[®]/Cysview[®] is a drug that is selectively taken up by tumor cells in

the bladder making them glow bright pink during Blue Light Cystoscopy (BLC[TM]).

BLCT with Hexvix[®] /Cysview[®] improves the detection of tumors and leads to

more complete resection, fewer 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 Cysview[®] / Hexvix[®] 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://bit.ly/2wzqSQQ for further information on our

commercial partners.

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

trademarks of Photocure ASA

This press release may contain product details and information which are not

valid, or a product is not accessible, in your country. Please be aware that

Photocure does not take any responsibility for accessing such information which

may not comply with any legal process, regulation, registration or usage in the

country of your origin.

References

1. Globocan. Incidence/mortality by population.  Available

at: http://globocan.iarc.fr/Default.aspx

2. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al.

EAU Guidelines on

non-muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol. 2016

Guidelines Edition:1-40.

3. Sievert KD et al. World J Urol 2009;27:295-300

4. Bladder Cancer. American Cancer Society.

https://www.cancer.org/cancer/bladder-cancer.html

For more information, please contact:

Dan Schneider

President and CEO

Photocure ASA

Tel: + 1-609 759-6515

Email: ds@photocure.com

Erik Dahl

CFO

Photocure ASA

Tel: +4745055000

Email: ed@photocure.com

About Photocure ASA

Photocure: The Bladder Cancer Company delivers transformative solutions to

improve the lives of bladder cancer patients. Our unique technology, which makes

cancer cells glow bright pink, has led to better health outcomes for patients

worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo

Stock Exchange (OSE: PHO).  For more information, please visit us at

www.photocure.com, www.hexvix.com or www.cysview.com