GSK's ZEJULA is recommended for reimbursement by CADTH and INESSS for advanced ovarian cancer following response to first-line platinum-based chemotherapy

MISSISSAUGA, ON, May 4, 2021 /CNW/ - ZEJULA (niraparib) has received conditional positive recommendations for reimbursement from the Canadian Agency of Drugs and Technology in Health (CADTH) and L'Institut national d'excellence en santé et en services sociaux (INESSS), both Canadian Health Technology Assessment (HTA) bodies.

The organizations recommend reimbursement for ZEJULA for monotherapy maintenance treatment of female adult patients with newly diagnosed epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. ZEJULA received Notice of Compliance (NOC) from Health Canada for first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer in October, 2020.

"These recommendations are a positive and significant step forward in ensuring that all women who could potentially benefit from ZEJULA are able to do so," said Alex Romanovschi, MD, Country Medical Director at GSK. "We continue to work towards broad reimbursement in collaboration with Canadian public payers. In the interim, ZEJULA remains accessible for appropriate patients via the GSK Patient Support Program."

Ovarian cancer is most frequently diagnosed in women aged 55 to 64 years (median age 63 years), is the 5th most common cancer for women and is the most serious women's cancer.^1,2

"Every year ovarian cancer claims 1,950 lives, and it's estimated 3,100 Canadian women will be newly diagnosed with this disease this year" said Elisabeth Baugh, CEO of Ovarian Cancer Canada. '' But the arrival of new drugs such as Zejula is starting to change outcomes of the disease and will help ensure women with ovarian cancer can thrive.''

Full details on the recommendations, including recommended criteria for reimbursement, are available on the CADTH website (https://cadth.ca/niraparib-zejula-first-line-ovarian-cancer-details) and INESSS website (https://www.inesss.qc.ca/en/themes/medicaments/drug-products-undergoing-evaluation-and-evaluated/extract-notice-to-the-minister/zejula-projet-aligne-inesss-acmts-sante-canada-5624.html?DemandePluginController%5Bonglet%5D=0&cHash=00ffdd9fa17d8655f8ba588589587dc1).

GSK will be working in collaboration with the pan-Canadian Pharmaceutical Alliance (pCPA) and public and private payers to ensure that they have the data and information required to make timely reimbursement decisions for ZEJULA. GSK is committed to ensuring that patients can access ZEJULA through public funding as soon as possible.

About ZEJULA (niraparib)
ZEJULA is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor. The approval of ZEJULA in the first-line setting was based on the results of the phase III PRIMA study (ENGOT-OV26/GOG-3012)³, which enrolled patients with newly diagnosed advanced ovarian cancer following a complete or partial response to platinum-based chemotherapy regardless of biomarker status.

Please consult the Product Monograph at www.gsk.ca for complete safety information.⁴  The Product Monograph is also available by calling 1-800-387-7374.

About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information, please visit www.ca.gsk.com

Beyond ZEJULA, GSK has an extensive and diverse oncology pipeline, enriched by the 2019 acquisition of TESARO and the global alliance with MERCK KGaA, providing access to new scientific capabilities and expertise that will increase the pace and scale at which we can help patients living with cancer.

References
1.	Ovarian Cancer Research Alliance. Available from: https://ocrahope.org/patients/about-ovarian-cancer/statistics  Accessed April 2021.
2.	Ovarian Cancer Canada. About Ovarian Cancer. Available from: https://ovariancanada.org/About-Ovarian-Cancer.  Accessed April 2021
3.	González-Martín A. et al, N Engl J Med 2019; 381(25):2391-2402.
4.	Zejula (niraparib) Canadian Product Monograph, October 2, 2020

SOURCE GlaxoSmithKline Inc.

Corporate Communications, [phone] (Mississauga), [phone] (Laval)

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