Canada’s Drug Agency (CDA-AMC) is currently welcoming patients and their caregivers to provide input to patient organizations on the manufacturer’s submission for inebilizumab (Uplizna®) for immunoglobulin G4-related disease.
To help them make their recommendations, CDA-AMC accepts input from patient organizations and groups, like Arthritis Consumer Experts (ACE). Because patient input is vitally important to government decision-making about medications, we would like to gather your views and share them with CDA-AMC.
These are the questions they are asking:
- Description of patients and/or caregivers: Are you a patient living with immunoglobulin G4-related disease or a caregiver to someone living with immunoglobulin G4-related disease? Which city and province or territory do you live in? Do you have experience with inebililzumab (Uplizna®) for immunoglobulin G4-related disease?
- Equity and diversity: Does immunoglobulin G4-related disease affect systemically marginalized people (e.g. Indigenous, Black, or other racialized people; people with low incomes; people from 2SLGBTQ+ communities or those living in rural or remote locations) more than others, or in different ways? If so, describe how.
- Clinical value: Does immunoglobulin G4-related disease affect what people can do in their daily lives and how they feel physically or emotionally (for example, difficulties with moving around, taking care of themselves, or doing their usual daily activities, and feelings of pain, discomfort, anxiety, or depression)?
- Which symptoms have the biggest impact on day-to-day life or well-being?
- Which treatment outcomes are most important to you (for example, symptom relief, slowing disease progression, living longer, improving health-related quality of life such as mobility, daily functioning, mental health, energy and sleep)? If possible, rank these from most important to least important.
- If you had experience with the medication under review, how, if at all, did it affect your life? What effects (good or bad) have you or your caregivers observed?
- Unmet clinical need: How well are you managing your condition with current treatments?
- What treatments are you currently taking to manage your condition?
- What short-term or long-term side effects, if any, do you experience with current treatments? Which are more bothersome or hardest to manage?
- What trade-offs, if any, do patients, families, and caregivers consider when choosing a treatment (for example, trade-offs between how long the treatment will keep the condition from getting worse and risk of serious side effects)?
- Do current treatments fall short? If so, how? Are there clinical needs that are not being met by your current treatment (for example, a need for a treatment that addresses a specific outcome or a treatment with fewer side effects)? If no treatment is available, please state this.
- Are there groups of patients within the indication under review who have a greater need for treatment (for example, those for whom current treatments are not effective)?
- Distinct social and ethical considerations: In what ways might the medication under review help address challenges patients and caregivers face in accessing or receiving current treatments?
- Are there any challenges related to how the current treatments are delivered (for example, how they are taken, where they are given, how long they take, or what support or equipment is needed)?
- Are there any aspects of the way current treatments are delivered that relate to patients’ daily lives; dignity; autonomy; privacy; relationships; and ability to work, study, or participate in social and community life?
- Are there any aspects of the way current treatments are delivered that relate to families’ daily lives; relationships; and ability to work, study, or participate in social and community life?
- Could the medication under review make these challenges easier or harder? If so, how?
- Economic considerations: What are they key kinds of costs people face when managing or treating immunoglobulin G4-related disease?
- What are the most impactful kinds of costs (not dollar amounts) that people face when managing or treating this condition (for example, out-of-pocket costs for treatments, time off work, transport costs to and from treatment centres, need for paid caregivers, childcare, devices, or equipment)?
- Impacts on health systems: From the perspective of patients and caregivers, how does living with this condition affect how often people need to interact with the health system, and how, if at all, might the medication under review change that?
- What parts of the health system do patients rely on most right now (for example, clinic visits, tests, IV care, hospital care, or specialist services)?
- How, if at all, would the medication under review affect interaction with the health system?
- If applicable, what are patients’ and caregivers’ experiences with the testing associated with the medication under review? What challenges, if any, do patients face when accessing the test? Are there any cost-related considerations?
- Additional information: Is there anything else the review teams and expert committee should know about patients’ or caregivers’ experiences with this condition or the medication under review?
If you live with immunoglobulin G4-related disease or care for someone with immunoglobulin G4-related disease, please send us your input by March 19, 2026. Your input will be anonymous.
Please click here to provide your input. You may also provide input by emailing us at feedback@jointhealth.org.