Lilly Canada remains steadfast in commitment to access options for patients amidst controversial CDA-AMC recommendation for Ebglyss™ (lebrikizumab)

TORONTO, Nov. 19, 2024 /CNW/ - Eli Lilly Canada Inc. (Lilly Canada) is disappointed and strongly disagrees with Canada's Drug Agency (CDA-AMC)'s Final Recommendation for Ebglyss™ (lebrikizumab), published on Friday, November 15, 2024. The CDA-AMC recommended that Ebglyss not be reimbursed by public drug plans, excluding Quebec, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults and adolescents 12 years of age and older.¹

Lilly Canada stands behind Ebglyss as a first-line biological therapy for the treatment of atopic dermatitis and we remain committed to patients. Access to Ebglyss for new and existing patients with moderate-to-severe AD via LillyPlus^® will not change as we tenaciously pursue options for private and public reimbursement in Canada. We have shared our concerns with the CDA-AMC leadership and believe that the CDA-AMC are applying differential standards to biologic therapies for the treatment of AD that are not founded upon their own requirements. Lilly Canada continues to explore all options to overcome this recommendation.

"CDA-AMC's recommendation is inconsistent with all other HTA bodies that have reviewed Ebglyss, including L'Institut national d'excellence en santé et services sociaux (INESSS) in Quebec, the National Institute for Health and Care Excellence (NICE) in the United Kingdom, the Haute Autorité de santé (HAS) in France, and the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, which have all issued positive recommendations for Ebglyss in atopic dermatitis. Repeat misalignment with other domestic and international HTA agencies does not establish Canada as a predictable or competitive market for innovative medicines." said Kenneth Custer, General Manager Lilly Canada. "CDA-AMC's decision is not consistent with their own requirements and the evidence supporting the safe and efficacious use of Ebglyss but also seemingly ignored patient and physician input. Limiting therapeutic options not only restricts access to care, but it also raises many unintended consequences ranging from supply chain resilience to patient choice."  

Ebglyss (lebrikizumab) was approved by Health Canada on June 24, 2024. On August 1, 2024, L'Institut national d'excellence en santé et services sociaux (INESSS) issued a positive reimbursement recommendation with conditions for Ebglyss as a first line biological therapy in Quebec, recognizing the clinical benefit that Ebglyss could bring to patients living in Quebec.   

"The CDA-AMC recommendation seems oblivious to the need for different approaches in the management of complex patients with life-altering skin disease. Many of the points put forward by CDA-AMC are completely at odds with the clinical opinions of the physicians who are on the front lines of managing these patients," said Dr. David Adam, Medical Director of Baywood Dermatology and President of the Dermatology Association of Ontario." There is no question in my mind, or the minds of my colleagues with whom I consulted, that the long-term safety and efficacy of lebrikizumab is well established from the robust clinical data collected in the studies."

"There is a need for Canadian health care providers, and ultimately patients, to have options for reimbursed treatments for atopic dermatitis (commonly known as eczema). Atopic dermatitis is a complex and heterogeneous condition, and patients need access to a variety of therapies," said Amanda Cresswell-Melville, Executive Director of the Eczema Society of Canada. "Atopic dermatitis and the accompanying itch and pain can be a serious condition that can have a significant impact on quality of life, including sleep, self-esteem, and mental health. As an organization, we remain committed to working with decision-makers to better understand the treatment and care needs of patients."

To ensure that Canada does not become a global outlier in the treatment of atopic dermatitis and for the benefit of patients, Lilly Canada will be persistent in our work to obtain public and private coverage of Ebglyss for atopic dermatitis patients across Canada.

About Atopic Dermatitis

Atopic Dermatitis (AD), a form of eczema, is a chronic inflammatory skin condition characterized by areas of dry skin that are red and intensely itchy. Rigorous moisturizing and skin care treatment regimens, constant monitoring of the condition, lifestyle changes to avoid triggers, and sleepless nights can greatly impact the quality of life for all members of the family.² Documented implications of AD on daily life include depression and anxiety, increased risk of suicide, attention deficit/hyperactivity disorder, poor sleep quantity and/or quality and decreased productivity at work. Given both the prevalence and chronic nature of AD, the impacts of AD can be very difficult and long-lasting for a large number of Canadians. ³

About Lilly Canada

Lilly is a medicine company turning science into healing to make life better for people around the world. Lilly has been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Lilly's Canadian Affiliate, Eli Lilly Canada Inc. was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin.

Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.

To learn more about Lilly Canada, visit Lilly.com/en-CA, or follow us on LinkedIn. 

Ebglyss™ and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Endnotes and References:

1.	*with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
2.	Eczema Society of Canada. What is Eczema. Retrieved Friday, October 21, 2024 from: https://eczemahelp.ca/about-eczema/
3.	The Skin I'm In: A National Report of the Patient and Caregiver Experience with Atopic Dermatits. November 2022. Canadian Skin Patient Alliance and Eczéma Québec. https://canadianskin.ca/media/attachments/2022/11/22/ad-report-2022_full_en.pdf

SOURCE Eli Lilly Canada Inc.

Media Contact: Jason Haug, Eli Lilly Canada Inc., [email protected], [phone]