Press Release - Oslo, Norway, November 19, 2025: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces the publication of the study
"Hexaminolevulinate-enhanced photodynamic diagnosis in the management of non
-muscle-invasive bladder cancer (NMIBC): The influence of differing European
health care payment systems on the potential financial impact of adoption." in
the Journal of Medical Economics this week. The research objective was to
compare the economic implications of blue light cystoscopy (BLC[®]) adoption in
line with national guideline recommendations in four European markets. The
analysis further explores the impact of the different health care payment
systems on the budgetary impact of BLC adoption by a hospital.

Methods: A previously published budget impact
model (https://www.photocure.com/news/new-health-economic-analysis-in-france
-concludes-there-is-insignificant-cost-difference-between-white-light-and-blue
-light-cystoscopy-use-when-applying-ccafu-guidelines-4644457) was adapted to
allow for the exploration of costs across four different payment environments:
Denmark, France, Italy and Finland. Using the same set of clinical assumptions
around disease risk profiles, recurrence rates and usage of PDD, but applying
local treatment guidelines and country-specific costs per country, the net
budget impact per patient with NMIBC was estimated for each over a 3-year time
horizon. The analysis was carried out from the perspective of a hospital with a
protocol-driven strategy for BLC adoption.

Results: In Denmark, with a differential tariff system between BLC and white
light cystoscopy (WLC), the additional cost of the technology was fully offset
by the tariff, with a net surplus of  Euro 170 per patient. In France and Italy,
both
of which have a flat-rate tariff for BLC and WLC, there was a net cost of  Euro
108
and  Euro 120 per patient respectively. In Finland, with a block contract
system, the
net cost per patient was  Euro 206.

Conclusions: Diagnostic technologies like BLC often present unique challenges
for economic evaluation, requiring linkage between improved detection and
downstream clinical and economic outcomes. In this study, incorporating
predicted clinical outcomes and subsequently modelling the costs based on risk
stratification, guideline recommendations and funding mechanisms, provides a
useful tool to predicting overall cost for patient populations per country.
Future studies for such technologies should integrate economic endpoints at the
trial design stage, enabling better-informed decisions and faster time-to
-adoption for patients.

The authors conclude that BLC offers a clinically meaningful and economically
rational approach to NMIBC management across diverse European healthcare
environments. Through flexible, locally tailored BIMs, stakeholders are better
equipped to assess where and how BLC can be integrated into care pathways -
supporting both improved patient outcomes and sustainable healthcare resource
allocation.

"This multi-country budget impact analyses of blue light cystoscopy using
hexaminolevulinate, otherwise known as Photodynamic Diagnosis, in the management
of non-muscle-invasive bladder cancer, demonstrates the consistent clinical and
economic value of enhanced diagnostic accuracy in reducing recurrence risk.
Despite important structural differences across European healthcare
systems-ranging from various tariff-based reimbursement models in Denmark,
France and Italy to block contract systems in Finland-the reduction in the
requirement for early repeat TURBT is an important clinical benefit. This
clinical benefit inevitably carries both capacity and cost offset implications
for hospitals, regardless of whether this gain is reflected in the local
healthcare payment system," said Dr. Jonathan Belsey, Health Economics expert
and one of the study authors.

"The growing number of approved treatment options and advances in technology and
AI are accelerating the growth of precision diagnostics in bladder cancer. The
pharmaceutical advancements, with emerging immune and gene therapies, are
transforming care. This requires a more precise diagnosis to better select
patients, predict and monitor treatment response and thus ensure the right
treatment for the individual patient. Photocure's expertise in bladder cancer
diagnostics, extensive data and knowledge, strong relationships with key
stakeholders and deep understanding of their needs make us uniquely positioned
to driving progress in uro-oncology precision diagnostics," said Anders Neijber,
Photocure's Chief Medical Officer.

Read the full publication here: https://doi.org/10.1080/13696998.2025.2588728


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About Bladder Cancer
Bladder cancer ranks as the 8[th] most common cancer worldwide - the 5[th] most
common in men - with 1 949 000 prevalent cases (5-year prevalence rate)[1a],
614 000 new cases and more than 220 000 deaths in 2022.[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 [February 2024].
[2 ]Babjuk M, et al. Eur Urol. 2019