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Photocure ASA

Environmental & Social Information Oct 6, 2023

3714_rns_2023-10-06_86f6e7da-e506-42a6-9d2a-38b49a6cbe44.html

Environmental & Social Information

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New Health Economic analysis in France concludes there is insignificant cost difference between White Light and Blue Light Cystoscopy use when applying ccAFU guidelines

New Health Economic analysis in France concludes there is insignificant cost difference between White Light and Blue Light Cystoscopy use when applying ccAFU guidelines

Press release - Oslo, Norway, October 6, 2023: Photocure ASA, The Bladder Cancer

Company, announces the publication of "A cost-consequences and budget impact

analysis of blue light-guided cystoscopy with Hexvix[®] in patients diagnosed

with non-muscle-invasive bladder cancer in France" in the peer-reviewed

international Journal of Medical Economics this week. This health economic

analysis aims to assess the financial impact of widely adopting Blue Light

Cystoscopy (BLC[®]) as recommended in the French ccAFU guidelines. A budget

impact model (BIM) was developed, that simulates the overall costs of

implementing a range of strategies involving the use of BLC, with analyses then

undertaken to determine the cost consequences for individual hospitals if

implementing the recommended management approach.

The analysis, led by Dr. Jonathan Belsey, [Health Economist & Managing Director

of JB Medical Ltd), details that clinical evidence, such as published in the

recent Cochrane review, supports the benefits of BLC over White Light

Cystoscopies (WLC) alone on the detection of bladder tumors and time to first

recurrence as well as an extended time to disease progression in patients

managed with BLC-assisted TURBT*.

The most recent ccAFU (Comité de cancérologie de l'Association française

d'urologie) guidelines recommend the use of BLC in a number of different

positions in the care pathway for NMIBC. The study authors explain: "The health

economic impact of this strategy has been evaluated using a cost-utility

analysis, from the perspective of the French healthcare system, and was found to

be dominant over WLC - meaning that its use results in better outcomes and lower

costs overall. Despite the existence of a clear clinical and economic evidence

base, however, concerns around the potential budgetary impact of the widespread

adoption of BLC have led to a degree of reluctance to adopt the technology."

ccAFU guidelines are detailed as follows: ".the French guidelines make strong

recommendations that BLC should be used: for the initial diagnostic TURBT in all

but the smallest unifocal tumors; for the second look cystoscopy when cytology

and the absence of papillary lesions with WLC suggest the presence of CIS; for

treating recurrent NMIBC** in all low-risk patients, Small Ta low grade tumors

in intermediate-risk patients, Suspicion of CIS in high-risk patients."

The budget impact model was developed as an interactive tool to provide

organisation-specific results. For illustrative purposes, results have been

analysed for 2 different theoretical scenarios: 1.) a large public hospital

implementing the specific BLC recommendations within the ccAFU guidelines for

300 new patients per year and 2.) a small private hospital, using BLC in a more

high-risk targeted subgroup from a cohort of 100 new patients per year.

The study publication presents the model results estimating the financial

consequences of implementing this strategy for an individual hospital within the

French healthcare system. Although BLC incurs an additional cost of Euro 360 per

case for the Hexvix instillation, this cost is partially offset by a reduced

requirement for subsequent TURBT, attributable to the anticipated reduction in

disease recurrence rates. Based on the two scenarios explored in this paper,

full implementation of the ccAFU guideline recommendations would be expected to

yield a net cost increase of around Euro 269 per procedure, while a more targeted

strategy based on a higher risk subgroup treated in the private sector was shown

to yield a net cost differential of Euro 133 per patient. Given that in France the

mean overall cost of care for these patients ranges from Euro 1,991 in the private

sector to Euro 3,376 in the public sector, it can be seen that the use of BLC is

likely to be associated with an incremental cost of around 5-10% of the index

procedural cost.

The BIM focused on direct medical costs incurred in the French healthcare

system. Recurrence rates for BLC-assisted patients were estimated by applying a

single overall hazard ratio estimate to all patient groups. All the published

data for this outcome, however, relate to the time to the first episode of

recurrence. Any residual benefit of BLC in reducing the risk of second or

subsequent recurrences will therefore not have been captured in this analysis,

potentially underestimating the total cost savings relating to reduced future

event rates. In addition, impact of BLC on disease progression was also excluded

from the calculation. The authors conclude: "Given the high costs of managing

progression to MIBC***, this will have potentially had a significant negative

impact on the cost offset calculated by the model.Using a model of patient care

that reflects the current recommendations of the ccAFU in France, we have shown

that the additional expenditure required to implement BLC-assisted TURBT within

individual hospitals is modest and not disproportionate to the overall cost of

care for these patients. More nuanced targeting of BLC use has the potential to

further improve the budget impact, while future research relating to subsequent

event rates and progression risk offer the potential to move towards cost

neutrality.""

Read the full publication here: https://doi.org/10.1080/13696998.2023.2267929

*TURBT: Transurethral resection of bladder tumor

**NMIBC: Non-muscle invasive bladder cancer

***MIBC: Muscle invasive bladder cancer

Note to editors:

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

trademarks of Photocure ASA

About Bladder Cancer

Bladder cancer ranks as the 8[th] most common cancer worldwide - the 5[th] most

common in men - with 1 720 000 prevalent cases (5-year prevalence rate)[1a], 573

000 new cases and more than 200 000 deaths in 2020.[1b]

Approx. 75% of all bladder cancer cases occur in men.[1] It has a high

recurrence rate with up to 61% in year one and up to 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. In MIBC 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]

1 Globocan. a) 5-year prevalence / b) incidence/mortality by population.

Available at: https://gco.iarc.fr/today, accessed [January 2022].

2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657

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

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

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the

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

with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves

the detection of tumors and leads to more complete resection, fewer residual

tumors, and better management decisions.

Cysview[ ]is the tradename in the U.S. and Canada, Hexvix[ ]is the tradename in

all other markets. Photocure is commercializing Cysview/Hexvix directly in the

U.S. and Europe and has strategic partnerships for the commercialization of

Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer

to https://photocure.com/partners/our-partners for further information on our

commercial partners.

About Photocure ASA

Photocure: The Bladder Cancer Company delivers transformative solutions to

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

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, www.cysview.com

For further information, please contact:

Dan Schneider

President and CEO

Photocure ASA

Email: [email protected]

Erik Dahl

CFO

Photocure ASA

Tel: +4745055000

Email: [email protected]

David Moskowitz

Vice President, Investor Relations

Photocure ASA

Tel: +1 202 280 0888

Email: [email protected]

Media and IR enquiries:

Geir Bjørlo

Corporate Communications (Norway)

Tel: +47 91540000

Email: [email protected]

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