Regulatory Filings • Jan 3, 2023
Regulatory Filings
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New study publication reinforces the clinical benefits of Blue Light Cystoscopy in the ASC setting; supports ongoing initiatives to further improve reimbursement
Press release - Oslo, Norway, January 3, 2023: Photocure ASA, The Bladder Cancer
Company, announces the publication of the study "Clinical and Economic Impact of
Blue Light Cystoscopy in the Management of NMIBC* at U.S. Ambulatory Surgical
Centers: What is the Site-of-Service Disparity?" in Urologic Oncology this week.
The research objective was to quantify the clinical and economic impact of the
incorporation of BLC in the management of NMIBC in ambulatory surgical centers
(ASCs) considering 2022 Center for Medicare Services (CMS) patient-physician
coverage and reimbursement.
The study authors Neal Shore**, MD, FACS and Meghan B. Gavaghan, MPH, built a
budget impact model to assess projected ASC costs for a cohort of newly
diagnosed bladder cancer patients over a 2-year follow-up comparing white light
cystoscopy (WLC) alone versus WLC + blue light cystoscopy (BLC[®]). Treatment
and surveillance intervals were based on AUA/SUO clinical guidelines. Clinical
and cost metrics for staging and biopsy rates were assessed, with cost inputs
based on Medicare reimbursement rates. Photocure supported this research with an
unrestricted grant.
In the U.S., BLC for NMIBC surveillance in the ASC setting involves a flexible
cystoscopy, an outpatient procedure without need of general anesthesia, allowing
additional OR time for other hospital procedures. In the published clinical and
health economic model, use of BLC resulted in the identification of 5 additional
NMIBC recurrences compared to white light cystoscopy alone. There was an
associated increased cost of performing BLC in an ASC setting, with a net
increase in the total cost of care for NMIBC of $110 per cystoscopy over a two
-year period. If recurrences missed using WLC alone were to progress prior to
detection, the model projects an increase in treatment costs borne by Medicare
of $9,097-$34,538 due to more intensive treatments required for more advanced
disease.
The authors conclude that due to the modeled results, "the Medicare program will
incur increased costs. . The current discrepancy in reimbursement
disincentivizing community-based ASCs from adopting BLC, resulting in suboptimal
patient care while increasing downstream treatment costs to Medicare,
necessitated when missed disease progresses to higher stage/grade disease. The
findings have important clinical implications for the optimal management of
NMIBC and should inform healthcare policies that promote cost-effectiveness and
enhanced patient outcomes."
"The findings of this paper highlight the benefits of BLC when patients receive
this option for bladder cancer care in ambulatory surgery centers," said Dan
Schneider, President and Chief Executive Officer of Photocure ASA. "The paper
also reinforces the need for fair and equitable reimbursement in all sites of
care, with Medicare payment rates increasing in January 2023, but favoring use
of blue light in hospital outpatient departments (HOPDs) over ASCs. While we are
pleased with the historic step by CMS to provide higher payment rates in both
settings, feedback from ASC accounts is that payment would need to be increased
further before patients treated in this site of care will be offered broad
access to BLC. As a result, Photocure will continue to partner with the medical
community to advocate for improved Medicare coverage in the ASC setting."
Read the full article here:
https://authors.elsevier.com/a/1gI7K3r93nVECK (https://nam11.safelinks.protection
.outlook.com/?url=https%3A%2F%2Fauthors.elsevier.com%2Fa%2F1gI7K3r93nVECK&data=05
%7C01%7Cnshore%40auclinics.com%7C2a1b7f370ab0456f67b908dae3dff903%7Ca885f43f85834
92598d934669fbf0f77%7C0%7C0%7C638072848351177176%7CUnknown%7CTWFpbGZsb3d8eyJWIjoi
MC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=
cydEsyCu8Z6U50uV7TTCYZhlBkan6xi0oXXtrSW9C%2Fo%3D&reserved=0)
*NMIBC: Non-muscle invasive bladder cancer
**Dr. Shore is Medical Director for the Carolina Urologic Research Center and is
a Fellow of the American College of Surgeons. He joined Photocure's Board of
Directors in May 2022.
Note to editors
Hexvix[®]/Cysview[®] and BLC[®] are registered trademarks of Photocure ASA.
This press release may contain product details and information which are not
valid, or a product that 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.
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 annually 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 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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