2023_Tralokinumab (Adtralza)_12 years +_CADTH

CADTH Reimbursement Review – Patient Input Template 

 

Name of the Drug and Indication	Tralokinumab (Adtralza) for the treatment of moderate-to-severe atopic dermatitis (AD) in patients aged 12 years and older
Name of the Patient Group	Eczéma Québec & Canadian Skin Patient Alliance
Author of the Submission	Charlie Bouchard, Eczema Quebec Rachael Manion, Canadian Skin Patient Alliance
Name of the Primary Contact for This Submission	Charlie Bouchard
Email	charlie.bouchard2@affiliate.mcgill.ca
Telephone Number	514-268-3727

Eczéma Québec, a Québec registered not-for-profit incorporated in 2020, is the only organization in Quebec dedicated to raising awareness, providing education, and advocating for patients with eczema. Our focus is on raising awareness, providing education, and advocating for patients affected by this condition. We are committed to partnering with patients, healthcare professionals, and experts living with atopic dermatitis, both adolescents and adults, to enhance the standard of care within the Quebec region. For more information about our work and initiatives, please visit our website at www.eczemaquebec.com.

The Canadian Skin Patient Alliance (CSPA) is a national non-profit organization with a mission to improve the health and wellbeing of people across Canada affected by skin, hair, and nail conditions, through collaboration, advocacy, and education. For more information, please visit www.canadianskin.ca.

Eczéma Québec conducted a comprehensive information gathering process from February to May 2023 to ensure a wide range of perspectives and experiences for this patient input submission.Our approach included an online campaign to invite people to share their stories with Eczéma Québec via our newsletter, social media and website which resulted in six written patient testimonials, ten interviews and two group discussions (one with six participants, another with seven), including feedback from participants in the ECZTRA 2 Tralokinumab Monotherapy trial for moderate to severe. Testimonials were adapted and translated (where necessary) to more effectively convey the patients’ intended messages in written form. Finally, insights for this submission were gleaned from the comprehensive expertise of the McGill University Health Centre (MUHC) Center of Excellence for Atopic Dermatitis (COE-AD), a renowned tertiary care centre dedicated to adult atopic dermatitis research and care. 

We also drew insights from “The Skin I’m In: 2022 Update“, a report jointly published by the CSPA and Eczéma Québec in November 2022. The report highlights the considerable impacts of AD on daily activities, emotional, and mental health, and emphasizes the need for safe and effective treatment options. The survey was open from November 1 to 30, 2021, and was supplemented with data from the Canadian Institute for Health Information (CIHI) on AD-related emergency room (ER) visits and hospitalizations from 2016 to 2020, to gain a fuller understanding of healthcare utilization associated with this condition. The survey team included members from the CSPA and Eczéma Québec, affiliated with the internationally accredited MUHC COE-AD. The report was supported by funding from AbbVie, LEO Pharma, Pfizer, and Sanofi, with survey incentives provided by Galderma (Cetaphil), Beiersdorf (Eucerin), and La Roche Posay.

Atopic dermatitis (AD) is a chronic skin condition that presents a range of symptoms that can significantly interfere with daily life. These include dry, red skin, and intense itching; in some cases, there may be a thickening of the skin or skin infections. The burden of the disease, however, extends beyond the skin, and is often associated with related allergic conditions like asthma, seasonal allergies, and allergies or intolerances to certain foods and environmental factors. AD is also linked to higher incidences of sleep disorders, anxiety, and depression.

Approximately 20% of children and 10% of adults in high-income countries are affected. This suggests that   around 3,194,310 Canadians over the age of 15 suffer from this condition based on 2021 population data. While AD often develops before the age of 5 and was previously thought of as a disease of childhood, it’s worth noting that the condition can also emerge in adulthood, highlighting the disease’s diverse profile.

“From the earliest days I can remember, I have been locked in an unyielding battle against AD. As a child, brief periods of peace were punctuated by the mild eruptions of my symptoms, usually in response to moments of heightened stress. But, as I transitioned into adulthood, my eczema resurfaced with an unheralded intensity, a severe onslaught that infiltrated every facet of my existence. The persistent itch was, by far, the most incapacitating aspect.” – 26-year old female AD patient

For adults and adolescents with moderate to severe AD, the symptoms can be so intense and constant that they become debilitating. For instance, the itching can be so severe that it disrupts sleep, affects concentration, and hinders routine activities.

“The itch is the last thing I feel before sleep and the first thing I notice when I wake up.” – 38-year old female AD patient

“Some nights, it’s like there’s bugs crawling all over me. I know there’s nothing there, but the itching is so intense, I can’t help but check under the sheets.” – 67-year old male AD patient

“I’ve had to stumble out of bed at 2am, desperate for relief, and practically scald myself in a hot shower just to numb the itch.”  – 25-year old female AD patient

Skin rashes can be not only painful but also a source of embarrassment and stigmatization, thus affecting self-esteem and social relationships. The results of the survey conducted for the ‘The Skin I’m In Report: 2022 Update’ show that the physical and emotional toll of AD is significant, with 89% of respondents reporting that AD has a moderate to a lot of impact on their quality of life. Patients navigating the relentless discomfort and visibility of AD often face a profound emotional toll, manifested in heightened anxiety and depression levels. This correlation likely arises from the relentless itch and sleep disturbances associated with AD, which significantly impair quality of life and can induce emotional distress. Comprehensive treatment strategies that address both the physical and mental health aspects of AD management are still urgently needed.

“There are mornings when I wake up to find my eyes sealed shut. It’s terrifying. The process of prying them open is beyond painful. It feels like I’ve been thrust into some gruesome horror film. The ordeal often results in my eyelids bleeding, so before I can even manage a good morning to my husband, I’m rushing off to the bathroom to apply a compress. It just makes everything difficult. And these thing happen way too frequently to call off work or take time off. So I’ve just learnt to push through it. But in bad periods, I cry myself to work most days.” – 26-year old female AD patient

Such symptoms can significantly impact professional life, leading to frequent absences from work. Nearly 38.1% of patients surveyed at the MUHC COE-AD reported missing days of work in the past year due to their eczema. Among them, 18.4% missed work once, 23% twice, 23% 3-4 times, 8% 5-6 times, and 27.6% more than seven times. The reasons for these absences can vary from severe symptoms, frequent doctor visits, or lack of workplace support and accommodations.

“By May 2020, my doctor put me on medical leave. Even without washing my hands, they didn’t improve. Plus, I couldn’t sleep due to the itch and pain. I was suffering round the clock. I even thought about suicide because I felt so hopeless and didn’t see a way out.” ­– 42-year old female AD patient

“I’ve lost count of the number of jobs I’ve lost due to the sick leaves I needed because of my AD. Each job starts out with hope, but eventually, I hit a bad phase where I start coming in late because of the lack of sleep or the unpredictability of the mornings. I have to get excused from shifts to get to appointments. It’s heartbreaking to feel like a failure because of something you have no control over.” – 46-year old female AD patient

“I remember having to call in sick because my flare-up was so bad I couldn’t wear clothes, let alone step outside. But I don’t know how to explain it, it’s like humiliating and hard to explain to someone that your skin feels like it’s burning and that that’s the reason you can’t make it.” – 48-year old male AD patient

Access to healthcare is a significant challenge. With a ratio of 1.62 dermatologists per 100,000 inhabitants in Canada in 2021, access to specialized care can be challenging, especially for those residing in remote areas. Treatments can be costly and require regular follow-ups, creating additional stress for patients.

“I’ve spent months on a waiting list, hoping to see a specialist. The wait is excruciating. And even when I get an appointment, there’s always the anxiety over whether the prescribed treatment will work or if I’ll have to start the process all over again. The treatments can be expensive, adding financial stress to an already challenging situation. The constant waiting – for appointments, for answers, for relief – is emotionally and physically draining. I often wonder if I’ll ever find lasting relief from this condition that so deeply affects my daily life.” – 25-year old female AD patient

Eczéma Québec and the CSPA reviewed data obtained from the Canadian Institute for Health Information (CIHI) and found a considerable burden of disease with significant numbers of emergency room visits and hospitalizations associated with AD.

Number of ER Visits per Age Group and Sex, with AD as main problem

 

Emergency room visits for AD as the main problem were found mostly in the 0-11 and 18-64 age groups, reflecting the prevalence of AD in childhood and adulthood. Hospitalizations for conditions coded as dermatitis and eczema were primarily found among adults, indicating that the burden of these conditions extends beyond childhood. Interestingly, females were hospitalized more than males for eczema and dermatitis.

Hospitalizations by gender and age with dermatitis and eczema as main diagnosis

Another important aspect of the disease is its impact on family life. Relatives of people with moderate to severe AD are faced with a variety of emotional and psychological challenges. They may experience significant emotional distress, including worry, frustration, guilt, and despair, due to their loved one’s illness. These feelings can be exacerbated by a sense of helplessness and a lack of control over the situation. In addition, the cost of treatments and necessary products patients need to buy to care for their condition can pose a financial burden on patients and their families. The sleep of relatives can also be affected, as the symptoms of AD can disrupt the child’s sleep, requiring constant attention and care.

“The Skin I’m In: 2022 Update” report shows that caregivers reported several ways in which caring for a person with AD had a negative impact on various aspects of their lives. The emotional effect is clearly difficult, with the majority of respondents expressing feelings of despair and guilt. Two-thirds of caregivers also reported that their own health had been affected by anxiety and fatigue.

Comprehensive and personalized management of moderate to severe AD creates psychological and socio-economic burdens, including a profound impact on the day-to-day lives of patients, often restricting their engagement in regular activities and their enjoyment of life. Traveling, a joy for many, can turn into a stressful situation for those with AD, because of the unpredictability of the condition, potential exposure to unfamiliar allergens, and the necessity of maintaining a meticulous skincare routine. Sports and physical activitiescan be daunting. Sweat is often a trigger for AD flares, and combined with potential irritants in sporting equipment or clothing, makes participation in these activities a minefield of potential discomfort.

“I used to love the gym, but now sweating is painful. Not being able to exercise messes with my head. It feels like my body is against me.” – 50-year old male AD patient

“I found myself withdrawing from the physical activities that I once reveled in.” – 26-year old female AD patient

Moreover, the daily dietary choices of AD patients can be heavily impacted as certain foods may trigger flare-ups. This dietary restriction can not only limit their nutrition but also create a constant state of alertness about what they consume, adding an additional layer of stress to their everyday lives.

Patients suffering from AD are advised to use large volumes of moisturizing creams to seal the skin barrier. It is important to note that moisturizing creams are not covered for reimbursement and the annual cost can represent a significant sum. In addition to regular moisturizing and applying other topical products, other personal care habits can also help manage AD. Patients suffering from AD are often recommended to eliminate certain elements from their environment, such as perfumes, harsh soaps and detergents, as well as certain fabrics that can irritate the skin, like wool and certain synthetic textiles.

Topical Corticosteroids (TCS): These drugs are often the first line of treatment for AD. They are effective in reducing inflammation and itching. However, their long-term use can lead to undesirable side effects. Common side effects of TCS include thinning of the skin, stretch marks, redness, pimples, and changes in skin color. More serious side effects, although rare, can include hormonal problems, an increase in intraocular pressure, and cataracts.

“I use steroid creams, and sure, they work to an extent, but they have this side effect of thinning out your skin. Over time, I’ve noticed my skin’s become super delicate. I’m not kidding when I say that even the slightest scratch can cause bleeding. And once you have a wound, it takes forever to heal.” – 32-year old female AD patient

Calcineurin inhibitors (TCI): These drugs are usually used when TCS are not effective or cannot be used. They are effective in reducing inflammation and itching, but may take longer to act than TCS. Common side effects of TCI include burning and itching at the application site, redness, and rashes. More serious side effects, although rare, can include skin infection, lymphomas, and skin cancers.

“I stopped using [my TCI] when I saw that it could cause skin cancer” – 40-year old male AD patient

“I use [a TCI]  for maintenance as part of my routine, but it’s not always easy. There are days when it stings so badly on application, feels like it’s just aggravating my skin rather than soothing it. And that’s tough because I rely on it to keep my eczema in check.” – 19-year old female AD patient

Phosphodiesterase 4 inhibitors (TPDE4i): These drugs are used to treat moderate to severe atopic dermatitis. They work by reducing inflammation and itching. Common side effects of TPDE4i include burning and itching at the application site, redness, and rashes.

That being said, TCS, TCI, and TPDE4i can be messy and can stain clothes, glasses, bedding, and block the shower drain due to accumulation of product in the pipes.

“it’s not just about the skin anymore, it’s also the mess that comes with it. My clothes are always catching stains, and the shower can get all blocked up because of the product buildup. Everything I touch seems to get a greasy smudge, from my glasses to my cellphone.” – 38-year old female AD patient

Off-label oral systemic medications are often used in the treatment of AD, especially in cases where conventional treatments have not provided sufficient relief, have side effects or are contraindicated. These medications are not specifically approved for the treatment of AD, but they may help manage symptoms.

These off-label treatments include immunosuppressants like cyclosporine, methotrexate, and azathioprine, which work by suppressing the immune system’s overactive response. However, these medications come with their own set of risks and side effects, including potential impacts on kidney function, liver function, and an increased risk of infections. These treatments are reserved for severe cases and used carefully.

“I tried methotrexate for 18 weeks, but it didn’t help.” – 42-year old female AD patient

Another off-label treatment often used is oral corticosteroids (e.g., prednisone). These can be highly effective in reducing inflammation and controlling symptoms but not for long-term use due to the risk of serious side effects, including osteoporosis, hypertension, and diabetes.

“In times where I experienced severe, full-body flares, it was like my body was on fire, from head to toe. During these periods, the doctors would put me on prednisone. It helped short term, but once the medication was stopped, the intense itch and inflammation would come back.” – 67-year old male AD patient

Dupilumab (Dupixent): Dupilumab has been shown to reduce itching, clear skin, and improve the overall quality of life. Common side effects can include conjunctivitis and injection site reactions. The safety profile of dupilumab is better understood than oral Janus kinase inhibitors (JAKi), and it does not require the same level of monitoring as JAKi.

“I started Dupixent. It changed my life. Within the first few weeks, the itchiness decreased significantly. Gradually, my eczema almost entirely disappeared, and I was able to return to work. Unfortunately, the medication has lost some of its effectiveness, so some eczema has returned, but it’s still manageable without the itch, so for now, I’m sticking with Dupixent. However, I had to change jobs because even with Dupixent, if I wash my hands too much, the eczema flares up on them. So, while Dupixent helps a lot, I still have to follow a routine of using mild soaps, unscented moisturizing creams, cortisone creams, and so on. I had no difficulty getting Dupixent because I was able to prove that I had tried other treatments without success, and I had a DLQI score of 22/30”  – 42-year old female AD patient

Janus kinase inhibitors (JAKi): These drugs are relatively new AD treatments, are taken on a daily basis orally and are generally used when other treatment options are not effective. They are effective in reducing inflammation and itching, but their long-term use is not yet well understood. JAKi are often associated with a higher risk profile and require continuous clinical monitoring.

“Starting [a JAKi] was a game-changer for me, honestly. I was scared at first, had some side effects right out of the gate, but I stuck with it. And let me tell you, I’m so glad I did. My skin has cleared up more than I ever thought possible, and within the first week, I started feeling less and less itchy”. – 46-year old female AD patient

But despite the use of advanced treatments, the burden of disease can remain considerable. The survey results from the ‘the Skin I’m In: 2022 Update’ showed a majority of respondents (59%) rated their disease as moderate to severe even while under treatment and a majority of respondents (70%) reported dissatisfaction with their current treatment. 

Reimbursement criteria imposed by payers can also have adverse impacts on AD patients. Although more tailored treatments are now available in Canada, there are still only a limited number of options, and some of them remain to this day in the evaluation process for reimbursement as the prices of these therapeutic options are considered high, and are very challenging for individuals to afford out of pocket.

“Management wise, I found a promising ally in Dupilumab in 2019. My skin improved, the itching subsided, and my nights were filled with restful sleep. Yet, two years later, I faced a setback. Severe conjunctivitis and eczema on my eyelids began a cycle of unending inflammation. I found myself caught in a disconcerting position – should I trade the known for the unknown, considering the other available options came with more risks and uncertain long-term safety?” – 26-year old female AD patient

“Now my treatment regimen includes Dupixent and an immunosuppressor. But despite this, my AD is still very much present. I can still see the patches of dry, inflamed skin peeking out from under my sleeves. And the itch, it’s always there, a constant reminder. It continues to impact my daily life; from the clothes I choose to wear to the activities I can engage in. It feels like a never-ending challenge.” – 67-year old male AD patient

When evaluating new therapies, patients, caregivers, and families have voiced a range of desired outcomes and improvements not currently met by existing treatments.

Safety: Safety is a paramount concern for patients when considering new treatments. Patients and caregivers want treatments that have minimal side short-term and long-term effects. The fear of potential side effects can often deter patients from trying new treatments, even if they promise better symptom control. The ‘The Skin I’m In: 2022 Update” report describes how the majority of survey respondents (57%) had stopped a treatment because it was not safe for long-term use.

“First and foremost, I’d love a treatment that could control the itching without causing more harm to my skin.” – 35-year old female AD patient

Symptom Management: Patients hope for therapies that can decrease the negative feelings and physical discomfort associated with AD. This includes reducing itch intensity, sleep disturbances, skin bleeding, oozing, cracking, flaking, and dryness. Improvements in these areas would not only alleviate physical discomfort but also enhance overall mood, wellbeing, and daily functionality.

“I’m really hoping for something… something that gives real, long-lasting relief, you know? Not just a band-aid on the problem, but something that truly helps my skin heal. […] . I just want a chance to be in control again, not always feeling like my skin is calling the shots. That’s what I’m really looking forward to in a new treatment.” – 67-year old male AD patient

Reduction in Itch Frequency and Intensity: A decrease in itching would allow patients to better concentrate on their daily tasks and enhance their overall quality of life.

Improved Sleep: The constant itching and discomfort often interrupt sleep, leading to fatigue and diminished quality of life. A more restful night’s sleep would improve their mood and productivity.

“I would love a treatment that would give me more than just temporary relief. Something that could help break the itch-scratch cycle, so I could have a good night’s sleep, or focus on my work without constant discomfort.” – 32-year old female AD patient

“The primary thing I’d hope for is an effective treatment that controls her severe itchiness and soothes her skin. It’s heartbreaking to see her suffering from the constant irritation.” – Caregiver to a 63 year old AD patient

Improved productivity: By effectively managing symptoms, patients would be able to focus better, not having to constantly deal with the itch or take frequent breaks to apply creams or ointments. This could lead to better performance at work or school, and less stress about completing tasks. Moreover, fewer sick days would be needed due to severe flare-ups, leading to better job or academic stability.

“I had to change jobs because even with Dupixent, if I wash my hands too much, the eczema flares up on them. So, while Dupixent helps a lot, I still have to follow a routine of using mild soaps, unscented moisturizing creams, cortisone creams, and so on. I find it challenging that people don’t know much about severe eczema, so they show little empathy.” – 42-year old female AD patient

Life Impact Reduction: By lessening the overall impact of AD on the patient’s life, they would better be able to carry out daily activities, participate in leisurely activities, and manage work or school tasks without constant interruption from the condition.

“My symptoms got worse, so much so it feels like I’m dealing with a whole new disease. I’ve always loved the outdoors, travelling, hiking, camping. But now, with the unpredictability of my skin and the demands of treatment, it’s hard to enjoy these things..[…] Now, it’s just a reminder of how my skin holds me back. I can’t even think about staying in a hotel without worrying about staining their clean white bedsheets with blood from scratching. It’s embarrassing and makes me incredibly self-conscious. I’m hoping things will get better, but for now, it’s tough.” – 56-year old male AD patient

Improved Personal Relationships: By gaining better control over the condition, patients would feel less anxious about physical intimacy, which would increase overall relationship satisfaction.

Enhanced Self-Esteem: Therapies that reduce the visible aspects of AD could lead to increased confidence and social engagement, improving comfort being in public without fear of judgment or stigma.

“Every comment on “how bad” it looked or “how painful” it seemed when referring to my raw patches of skin all over would only draw me back to the itching, stinging, burning, boiling feeling of my skin. Every well-meaning yet misguided advice confronted me with the thought of me failing to manage my condition. Alienation was profound and painful.” – 26-year old female AD patient

Treatment Ease of Use: Treatment for AD should be as seamless as possible. An ideal treatment would be easy to use, have manageable side effects, and be something that patients can adhere to without it feeling like a burden. Improvements in this area would directly increase overall treatment satisfaction.

Flexibility in Treatment: AD patients often have to follow strict treatment schedules, which can be restrictive and interrupt daily routines. Greater flexibility in terms of administration and timing is sought that doesn’t require multiple applications throughout the day, or can be applied at any time without needing to avoid certain activities afterward. A treatment with more flexibility would lessen the burden of managing the condition. The ‘The Skin I’m  In: 2022 Update” report’s survey results highlighted that The majority of respondents (56%) reported that they had stopped a treatment because it was inconvenient to use.

“The time I need to put into my skin routine often feels like a part-time job.” – 19-year old female AD patient

Long-lasting Effects: Many current treatments offer only temporary relief, leading to a cycle of symptom resurfacing and retreatment. A longer-lasting treatment effect would provide longer periods of comfort and relief and lessen the worry about when symptoms might return. A treatment with long-lasting effects could greatly improve patients’ peace of mind and overall satisfaction with their treatment regimen.

Affordability: Treatments need to be affordable. Many patients struggle with the financial strain of current treatment options. An ideal new treatment would balance effectiveness and affordability, providing relief from symptoms without causing financial stress. In the ‘The Skin I’m  In: 2022 Update” report, the majority of respondents (52%) reported having stopped a treatment because it was too expensive.

“I’ve had severe AD since I was around 15. Since moving out of my parents’ home, it has become increasingly difficult to afford everything I need to manage my skin. Between the volumes of creams, the special soaps, cleaning products, unscented laundry detergent, cotton sheets, clothes that I ruin, the costs add up. I currently use dupilumab and it’s helping so much, but it’s another expense and with the current cost of living, it’s hard for me to keep up.” – 22-year old female AD patient

The testimonial shared with Eczema Quebec by participants in the ECZTRA 2 Tralokinumab Monotherapy trial for moderate to severe AD revealed that Tralokinumab addresses critical needs of AD patients. Compared to their previous therapies, which varied from patient to patient but often included TCS, TCI, and systemic immunosuppressants, Tralokinumab offered a substantial reduction in the unbearable itching, which patients consistently ranked as their highest priority.

“Tralokinumab has been a game-changer for me. For the first time in years, I felt like I had control over my skin.” – 35-year old female AD patient

“When I started on the tralokinumab trial, I was desperate for a solution. The change was gradual, but I started to notice improvements in my skin and, most importantly, in my sleep. The constant itching started to decrease, and for the first time in years, I was able to sleep through the night.” – 37-year old male AD patient

The patients also reported improvements in skin healing, with fewer new flare-ups and less severe symptoms when flare-ups did occur. The impact of these benefits on their daily lives was profound. Enhanced ability to focus on work, participate in social activities, and lead a less restricted lifestyle overall were frequently mentioned.

“It was just a matter of weeks before I noticed the itch had improved. And after a couple of months, it felt like I was living in a different skin – it was practically clear. It’s not a cure, but it’s the closest thing to relief I’ve had in a very long time.” – 35-year old female AD patient

Regarding side effects, patients either did not mention experiencing any side effects or found them to be tolerable and manageable. The occasional injection site reaction were significantly less distressing than the side effects of some of the previous treatments they had endured.

“Sometimes the injections can be a bit painful, and I’ve had some bruising and bleeding, but I can manage that. It’s better than the constant itching.”  – 19-year old female AD patient

“The side effects have been minimal and manageable, I had a couple of back-to-back weeks where I felt like I had caught a cold, but otherwise, nothing compared to the distress I was experiencing before. The itching started to fade, and my skin began to clear up. I’ve been able to participate more fully in my life. I’m more present in my relationships, more productive at work, and I’ve even started picking up old hobbies that I had given up because of my AD. It’s like I’m finally living, and not just surviving.” – 37-year old male AD patient.

Patients expressed a preference for Tralokinumab’s injection format compared to the labor-intensive application of topical treatments. They found it better than having to take a pill every day, as they didn’t want to feel like they were constantly relying on medications. Additionally, some patients mentioned that attending multiple phototherapy visits in a week was laborious and inconvenient.

“I still get a bit of itch, but it’s so more manageable and everything including the creams has become less demanding.” – 35-year old female AD patient

From the experiences shared, Tralokinumab appears to be particularly beneficial for patients whose symptoms are not adequately controlled by the current treatments, and for those who are affected by the distressing side effects of existing systemic therapies (e.g., conjunctivitis). The key values that are important to patients and caregivers concerning Tralokinumab are its ability to provide effective relief from symptoms, especially the distressing itch, its manageable side effects, and its relative ease of use. The hope that this drug brings for an improved quality of life cannot be overstated.

There is no companion test.

Despite increased number of AD treatments in Canada, a considerable number of patients still find themselves underserved by the available options. Specifically:

• Patient Burden: AD is far more than a skin condition. It impacts patients’ physical, emotional, and social lives, disrupts sleep, mental health, work and school productivity, and quality of life.
• Existing Treatment Challenges: Current treatment options often come with side effects that can be as distressing as the disease itself, and are not accessible due to logistical and financial constraints.
• Tralokinumab’s Potential: Tralokinumab presents a promising option with meaningful benefits for patients. Its efficacy in improving symptoms and quality of life, with manageable side effects, is an important AD treatment option.
• Diverse Patient Experiences: AD is a heterogeneous disease and some patients remain unserved with available treatments.

 

We extend our gratitude to CADTH for considering this submission. Your decision regarding the review and reimbursement of Tralokinumab can greatly influence the trajectory of many lives, offering hope and much-needed relief to those living with AD. We trust you appreciate the magnitude of your decision and the potential for positively impacting the lives of patients across the country. Thank you for your consideration.

 

Appendix: Patient Group Conflict of Interest Declaration

We have received assistance from entities outside of our patient group to complete this submission and want to transparently outline the support we’ve been given.

Completion of this submission:

We received substantial help from the McGill University Health Centre (MUHC) Center of Excellence for Atopic Dermatitis (COE AD) and the Canadian Skin Patient Alliance (CSPA). The MUHC COE AD provided a wealth of data, insights from scientific literature, medical and clinical expertise, insights from their research, and facilitated contact with patients. A patient committee also reviewed this submission.

Data collection or analysis:

For data collection and analysis, our collaboration with the MUHC COE AD has been invaluable. Their involvement extended to areas such as data gathering, analysis, and interpretation, lending invaluable insight from their research and practical clinical experience. The CSPA offered professional guidance, strategic planning assistance, and performed a review of our submission.

Companies or organizations that have provided Eczéma Québec with financial payment over the past two years AND who may have direct or indirect interest in the drug under review.

Company	Check Appropriate Dollar Range
	$0 to 5,000	$5,001 to 10,000	$10,001 to 50,000	In Excess of $50,000
AbbVie Canada				X
Leo Pharma			X
Sanofi				X
Pfizer			x

 

I hereby certify that I have the authority to disclose all relevant information with respect to any matter involving this patient group with a company, organization, or entity that may place this patient group in a real, potential, or perceived conflict of interest situation.

 

On behalf of Eczéma Québec

Name: Charlie Bouchard

Position: Director

Patient Group: Eczéma Québec

Date: 2023-06-16

 

Companies or organizations that have provided the Canadian Skin Patient Alliance with financial payment over the past two years AND who may have direct or indirect interest in the drug under review.

Company	Check Appropriate Dollar Range
	$0 to 5,000	$5,001 to 10,000	$10,001 to 50,000	In Excess of $50,000
AbbVie Canada				X
Leo Pharma			X
Sanofi			X
Pfizer			x

 

I hereby certify that I have the authority to disclose all relevant information with respect to any matter involving this patient group with a company, organization, or entity that may place this patient group in a real, potential, or perceived conflict of interest situation.

 

 

On behalf of the Canadian Skin Patient Alliance

Name: Rachael Manion

Position: Executive Director

Patient Group: Canadian Skin Patient Alliance

Date: June 21, 2023