Mississauga, ON, November 15, 2019, – Bayer Inc. is disappointed with the recent recommendation by INESSS to not reimburse VITRAKVI^® (larotrectinib) in Quebec. VITRAKVI® is the first tumour-agnostic cancer treatment approved by Health Canada and evaluated by INESSS. If the recommendation to the Health Minister to not reimburse VITRAKVI® in Quebec is endorsed by the Health Minister, patient access to VITRAKVI^® will be restricted.

The clinical benefit of VITRAKVI^® is supported by the NAVIGATE (TRK fusion cancer in adolescents and adults) and SCOUT (TRK fusion cancer in children from one-month to age 21 years) clinical studies, which are on-going. The interim results of these studies resulted in accelerated and conditional regulatory approvals in major global regulatory jurisdictions. Health Canada granted a Notice of Compliance with conditions (NOC/c) on July 10, 20191 . VITRAKVI^® has the largest and longest-term data for any TRK fusion cancer inhibitor, including the broadest range of tumour types and ages studied. INESSS’s rationale for its decision can be found here: https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Novembre_2019/Vitrakvi_2019_10.pdf

Bayer understands there is a need for treatment for TRK fusion cancers 

“NTRK fusion proteins have unequivocally been shown to be oncogenic drivers, as defined by their clear ability to transform normal cells into cancerous cells, both in the petri plate and in animal models of NTRK-driven tumours. There is no question that drugging this alteration, i.e. targeting the root cause or genomic driver of cancer rather than the traditional modality of broadly treating a cancer based on its presumptive tissue type of origin, represents a major step forward in cancer therapeutics. To deny patients, including very young pediatric cancer patients, access to this highly effective drug is puzzling, and demonstrates a disconnect of the invigilators with the science behind the original discovery of NTRK fusions” explains Dr. Poul Sorensen, Professor of Pathology and Laboratory Medicine at University of British Columbia, who first discovered the most commonly-diagnosed NTRK gene fusion (ETV6-NTRK3), leading to the eventual commercialization of VITRAKVI® nearly two decades later. For his research, Dr. Sorensen was awarded the 2019 Bloom Burton Award. 

“Because of innovations in individualized medicine, patients of all types can be treated better based on their individual characteristics and, as a coalition representing people of all types and ages affected by cancer, we see the advent of tumor-agnostic medicines as a very positive step forward in cancer therapy. Treatment based on genetic mutations, biomarkers or tumor characteristics instead of simply tumour site represents a paradigm shift. Science has progressed but attitudes are slow to change. Past approaches are no longer in line with reality. These promising treatments give hope to patients with several types of cancer, especially rarer and pediatric cancers, that no longer respond to available treatments and for which there are no other treatment options. However, policy makers and governments have a long way to go to demonstrate more openness towards this new targeted and individualized approach. We very much hope that the INESSS and the Ministry of Health and Social Services will recognize the innovative and promising nature of this approach and modernize their evaluation process to account for the distinctive features of studies on rare diseases (since any precision medicine is by definition rarer)”, said Eva Villalba, Executive Director, Coalition Priorité Cancer au Québec.

“Generally speaking, studies show that the response is rapid and sustained in the vast majority of patients treated with larotrectinib. The response rate is especially impressive given the fact that in most patients, there were no other treatment options. Three patients are currently being followed and treated in our institution. Two patients demonstrate complete response and in the other, response is almost complete. The medication is very well tolerated, with no significant side effects, and patients enjoy excellent quality of life. Without larotrectinib, these three patients would have undergone surgeries and received treatments that would most certainly have been associated with significant morbidity and side effects. Larotrectinib charts a new course in targeted therapy and gives hope to hundreds of patients and families”, said Dr. Sébastien Perreault, Clinical Assistant Professor, Department of Neurosciences, Faculty of Medicine, University of Montreal, and Clinical Researcher, CHU Sainte-Justine.

Bayer’s commitment to collaboration with INESSS and the Health Minister and support for Canadian TRK fusion cancer patients 

In line with the Health Minister’s objective, Bayer is committed to ongoing collaboration with INESSS to ensure a tailored and adaptive evaluation framework is implemented for the evaluation of emerging and complex treatments such as VITRAKVI^®. Despite this recommendation, Bayer will continue to work with Quebec stakeholders, including the Health Minister, to find a solution to allow access to VITRAKVI^® for adult and pediatric TRK fusion cancer patients. Bayer will also continue to collect data, including real-world evidence, on the effectiveness and safety of VITRAKVI^®.

In the interim, Bayer will continue to provide its TRAKTION Patient Support Program to help eligible patients, and will continue to fund FastTRK, the NTRK fusion testing program. However, these are not long-term, sustainable solutions for adult and pediatric patients with TRK fusion cancer who rely on public coverage. 

- 30 - 

About VITRAKVI^® 

VITRAKVI^® has received approval under the Notice of Compliance with conditions policy for the treatment of adult and pediatric patients with solid tumours that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory treatment options. Treatment with VITRAKVI^® should be initiated following confirmation of an NTRK gene fusion in a tumour specimen using a validated test. This policy facilitates earlier access to promising new medicines that treat, prevent or diagnose serious, life-threatening and/or severely debilitating diseases for which there is no alternative medicine available in Canada, or where the new medicine offers a significant improvement through its risk/benefit profile over existing medicines, and creates a mechanism for the appropriate completion of confirmatory trials to verify the clinical benefit of a drug authorized under the policy while ensuring transparency. The complete product monograph can be found at https://www.bayer.ca/omr/online/vitrakvi-pm-en.pdf. 

About TRK Fusion Cancer 

TRK fusion cancer is rare and occurs when an NTRK gene fuses with another unrelated gene, producing a TRK fusion protein that becomes constitutively active or overexpressed, triggering a signaling cascade. These TRK fusion proteins act as oncogenic drivers promoting cell growth and survival, leading to TRK fusion cancer, regardless where it originates in the body. TRK fusion cancer is not limited to certain types of tissues and can occur in any part of the body. TRK fusion cancer occurs in various adult and pediatric solid tumours with varying frequency, including lung, thyroid, gastrointestinal cancers (colon, cholangiocarcinoma, pancreatic and appendiceal), sarcoma, CNS cancers (glioma and glioblastoma), salivary gland cancers (mammary analogue secretory carcinoma) and pediatric cancers (infantile fibrosarcoma and soft tissue sarcoma). TRK fusion proteins are rare in common cancers and common in rare cancers. 

TRAKTION Patient Support Program

Bayer’s VITRAKVI^® TRAKTION Program offers a single point of contact nurse for patients and the health care community. Services include investigation of reimbursement options, including support with reimbursement applications as well as personalized delivery services for VITRAKVI^®.   

The TRAKTION Program also currently offers a bridging program, which provides VITRAKVI^® at no cost to patients who meet the program criteria until such time as public or private coverage is available and secured.

FastTRK: the NTRK fusion testing program   

The recently launched, Bayer-funded FastTRK program is a clinical testing program for the diagnosis of NTRK gene fusions. Sponsored by Bayer, this is a complimentary service for clinicians to determine whether their patients’ cancer has an NTRK gene fusion. Solid tumour samples from eligible patients (in the form of a solid tumour block or prepared slides) will be tested by immunohistochemistry (IHC) and/or next generation sequencing (NGS). The FastTRK program will be supported at least until the end of 2021. For more information on this program, please email fasttrk@bayer.com. 

Bayer: Science For A Better Life

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to www.bayer.ca.

Contact: 

Bayer Inc. 

Communications Department 

(905) 282-5541 

mediacanada@bayer.com 

• 1VITRAKVI has been issued marketing authorization in Canada with conditions, pending the results of trials to verify its clinical benefit.