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Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH. CADTH is not responsible for any errors, omissions, injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the contents of this document or any of the source materials. This document may contain links to third-party websites. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the third-party website owners’ own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites. CADTH has no responsibility for the collection, use, and disclosure of personal information by third-party sites. Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada’s federal, provincial, or territorial governments or any third party supplier of information. This document is prepared and intended for use in the context of the Canadian health care system. The use of this document outside of Canada is done so at the user’s own risk. This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors. Redactions: Confidential information in this document may be redacted at the request of the sponsor in accordance with the CADTH Drug Reimbursement Review Confidentiality Guidelines. Stakeholder Input: The views expressed in each submission are those of the submitting organization or individual; not necessarily the views of CADTH or of other organizations. As such, they are independent of CADTH and do not necessarily represent or reflect the view of CADTH. No endorsement by CADTH is intended or should be inferred. By filing with CADTH, the submitting organization or individual agrees to the full disclosure of the information. CADTH does not edit the content of the submissions.
A Review of Genomic Data Holdings in the Atlantic Provinces
Genomic datasets exist in Canada; however, many are inaccessible because they are held by individual researchers on institutional servers or by third-party sequencing companies abroad. As a result, the genomic evidence needed to evaluate new therapies is often difficult to find. Genome Canada is working to improve data accessibility through the Canadian Precision Health Initiative and the Pan-Canadian Genome Library. The Atlantic Cancer Consortium and Atlantic PATH have also built federated models with formal access processes.
Copyright (c) 2026 Canadian Journal of Health Technologies
The founder effect occurs when an isolated population inherits the genetic and phenotypic traits of a small group of founders, leading to differences from the larger surrounding population over time. Recessive genes and genetic illness can be more prevalent in these groups due to the smaller gene pools. Atlantic Canada is home to multiple populations shaped by founder effects, such as those in Newfoundland and Labrador and the Acadian populations in Nova Scotia and New Brunswick. However, the availability of genomic datasets and past genetic research has not yet been mapped. This project aimed to identify and summarize the genomic datasets available for populations in Atlantic Canada, with particular attention to the FAIR (findable, accessible, interoperable, and reusable) principles. Searches of the literature and communications with researchers indicate there are rich genomic data collected that have been used for secondary research (reusable), which are not necessarily easily findable, accessible, or interoperable because they are held by individual researchers not a centralized repository.
Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec. This review assesses Pegcetacoplan (Empaveli), 1,080 mg/20 mL (54 mg/mL) solution for subcutaneous infusion. Indication: Proposed: For the treatment of adults and adolescents aged 12 years and older with C3G or primary IC-MPGN.
Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec. This review assesses Caplacizumab (Cablivi), 11 mg, powder for solution, IV or SC injection Indication: For the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange (PE) and immunosuppressive therapy.
Reimbursement reviews of drugs later in the life cycle include a comprehensive assessment of clinical value, unmet clinical need, distinct social and ethical considerations, economic considerations, and impacts on the health systems. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial drug plans and cancer agencies. This review assesses empagliflozin, 10 mg and 25 mg, oral tablets. Indication under consideration for reimbursement: Treatment of CKD in adult patients.
Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec. This review assesses roflumilast (Zoryve) foam, 0.3% w/w for topical use, supplied in a 60 g pressurized aluminum can. Indication: For topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older.
Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec. This review assesses Teprotumumab (Tepezza), 500 mg lyophilized powder in a single-dose vial for reconstitution and IV use. Indication: In adults for the treatment of moderate to severe active Thyroid Eye Disease (TED).
Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec. This review assesses tezepelumab (Tezspire), 210 mg single-use prefilled syringe or pen (110 mg/mL solution) administered by subcutaneous injection. Indication: As an add-on maintenance treatment with INCS in adult patients with severe CRSwNP inadequately controlled by systemic corticosteroids and/or surgery.
Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec. This review assesses obinutuzumab (Gazyva), 25 mg/mL, concentrate for solution for intravenous infusion. Indication: For the treatment of adult patients with active lupus nephritis who are receiving standard therapy.
Reimbursement reviews of drugs later in the life cycle include a comprehensive assessment of clinical value, unmet clinical need, distinct social and ethical considerations, economic considerations, and impacts on the health systems. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial drug plans and cancer agencies. This review assesses Evolocumab, 140 mg in 1.0 mL (140 mg/mL), 420 mg in 3.5 mL (120 mg/mL), solution for injection, subcutaneous injection. Indication under consideration for reimbursement: Evolocumab is indicated as an adjunct to diet and other LDL-C–lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in adult and pediatric patients aged 10 years and older with HoFH who require additional lowering of LDL-C.
Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec. This review assesses lurbinectedin (Zepzelca), 3.2 mg/m2, IV infusion over 1 hour. Indication: Treatment of adult patients with Stage III or metastatic small cell lung cancer (SCLC) who have progressed on or after platinum-containing therapy.
Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec. This review assesses dupilumab (Dupixent), 300 mg single-use syringe or pen (300 mg/2 mL), solution for subcutaneous injection. Indication: Add-on maintenance treatment in adult patients with chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils inadequately controlled by the combination of an inhaled corticosteroid (ICS), a long-acting beta2 agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.
Canada’s Drug Agency (CDA-AMC) recommends that Lunsumio subcutaneous (SC) be reimbursed by public drug plans “as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (Grades 1 – 3a) who have received at least two prior lines of systemic therapy,” if certain conditions are met. The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that it is uncertain whether Lunsumio SC demonstrates acceptable clinical value in “adult patients with relapsed or refractory follicular lymphoma (Grades 1 – 3a) who have received at least two prior lines of systemic therapy.” Given that Lunsumio SC is expected to be an alternative option for third-line and beyond therapy, acceptable clinical value refers to at least comparable value relative to other third-line and beyond therapies relevant in the context in Canada. Direct evidence from 1 clinical trial (GO29781) showed that treatment with Lunsumio SC resulted in response rate benefits considered clinically meaningful and durable by the CDA-AMC consulted experts and suggested potential survival benefits. Evidence from an indirect treatment comparison (ITC) suggested that overall survival (OS) and response outcomes with Lunsumio SC may be broadly comparable to other third-line and beyond therapies, although results were uncertain and mixed across comparisons. Uncertainty remains due to the single-arm study design, limited comparative evidence, and imprecision in indirect estimates. pERC concluded that, although the evidence suggests mosunetuzumab SC monotherapy has uncertain clinical value, given the rarity and severity of the condition the drug may address a significant unmet clinical need to a degree that justifies a positive recommendation despite the uncertainty in the clinical value. pERC discussed the direct and indirect evidence and the clinical experts’ input and noted that the overall evidence suggested that Lunsumio SC may address a significant unmet clinical need, offering a chemotherapy-free, fixed-duration treatment with manageable safety profile that can be given in an outpatient setting, and is readily available, particularly for patients with limited access to existing therapies. pERC noted significant unmet nonclinical needs and health inequities among patients with relapsed or refractory follicular lymphoma (r/r FL). pERC also noted that Lunsumio SC may improve access to care, as it can be provided off the shelf and administered outside specialized centres, potentially reducing travel, clinic visits, and reliance on tertiary care services, particularly for patients in rural or underserved settings. The committee considered the IV and SC formulations of Lunsumio to have comparable efficacy and safety and therefore preferred the SC formulation, while allowing flexibility based on patient preference and for individuals who may require IV administration due to substantial injection site reactions. Based on all of the preceding considerations, pERC recommended that Lunsumio SC be reimbursed. Lunsumio SC should only be covered for adults with histologically confirmed r/r FL (grades 1 to 3a) who have received at least 2 prior lines of systemic therapy, including an anti-CD20 therapy and an alkylating agent, and who have good performance status. Lunsumio SC should not be covered for patients with nonfollicular indolent lymphoma or a disease with central nervous system involvement. Lunsumio SC should be prescribed by clinicians experienced in managing hematologic malignancies and bispecific antibody-related complications, and given in settings with access to tocilizumab and appropriate supportive care. Reimbursement should be for a fixed duration of 8 or 17 cycles as per the drug’s product monograph and should be discontinued upon the occurrence of complete response, unacceptable toxicity, or disease progression. Re-treatment may be considered for patients whose disease relapses after a treatment-free interval of at least 6 months following completion of the initial treatment course. The total cost of Lunsumio should not exceed the total cost of treatment with the least costly relevant chemotherapy comparator for the same indication. Important budget impact considerations and organizational implications must be addressed for health systems to be able to adopt Lunsumio.
Canada’s Drug Agency (CDA-AMC) recommends that Ubrelvy be reimbursed by public drug plans for the acute treatment of migraine, with or without aura, in adults if certain conditions are met. The Canadian Drug Expert Committee (CDEC) determined that Ubrelvy demonstrates acceptable clinical value compared with appropriate comparators (triptans) in adult patients with migraine. This determination was enough for CDEC to recommend that Ubrelvy be reimbursed. Evidence from 2 clinical trials showed that patients who had a migraine attack and took Ubrelvy were more likely to be pain free or have less severe pain, and they were less likely to have symptoms associated with migraine, when compared with patients taking a placebo pill. Evidence from an indirect treatment comparison was associated with limitations and did not consistently demonstrate meaningful differences between Ubrelvy and publicly funded oral triptans that are commonly used to treat migraine attacks. While acknowledging the uncertainty of the indirect treatment comparison, CDEC found it reasonable to consider Ubrelvy and publicly funded oral triptans comparable. Ubrelvy should only be covered for adults with migraine, with or without aura. Ubrelvy should only be reimbursed if initiated in adults with a history of migraine attacks associated with moderate to severe headache pain. Alternatively, public drug plans may choose to align the reimbursement criteria for Ubrelvy with existing formulary criteria for triptans, where such criteria exist. In either case, the cost of Ubrelvy should not exceed the least costly oral triptan used for the same indication. Important budget impact considerations must be addressed for health systems to be able to adopt Ubrelvy.
Canada’s Drug Agency (CDA-AMC) recommends that Nilemdo be reimbursed by public drug plans for primary hyperlipidemia and cardiovascular disease (CVD), if certain conditions are met. The Canadian Drug Expert Committee (CDEC) determined that Nilemdo demonstrated acceptable clinical value versus ezetimibe in patients with primary hyperlipidemia and CVD. However, it was uncertain whether Nilemdo demonstrates acceptable clinical value versus alirocumab, evolocumab, or inclisiran in patients with primary hyperlipidemia and CVD. This determination was enough for CDEC to recommend that Nilemdo be reimbursed. Given that Nilemdo is expected to be an alternative lipid-lowering therapy, acceptable clinical value refers to at least comparable value versus lipid-lowering therapies other than statins. Evidence from 1 clinical trial showed that Nilemdo, compared with placebo, reduced the risk of major cardiovascular events from happening (including death, heart attack that does not result in death, stroke that does not result in death, or surgical procedures that restore blood to parts of the heart) when given for a median follow-up of 3.4 years. This study included adults who had CVD and high levels of lipids in the blood, and who were unable to receive stable, recommended statin therapy. In those who were receiving the highest tolerated dose of statins, evidence from 2 clinical trials showed that 12 weeks of treatment with Nilemdo reduced low-density lipoprotein cholesterol (LDL-C) levels compared with placebo in the presence of CVD and high levels of lipids in the blood. Evidence from an indirect treatment comparison showed that there was no clear difference between Nilemdo and ezetimibe for reducing LDL-C levels after 24 weeks of treatment, but that injectable lipid-lowering therapies (e.g., alirocumab, evolocumab, and inclisiran) were more effective than Nilemdo or ezetimibe at reducing LDL-C levels. The indirect treatment comparison included adults who had high levels of lipids in the blood and who had CVD or were at high risk of CVD, despite receiving stable, recommended statin therapy or being unable to receive recommended statin therapy. Nilemdo may address an unmet need for treatment that reduces the risk of cardiovascular events in patients with high LDL-C levels who are at high risk of CVD, and who are either unable to receive stable, recommended statin therapy, or who are already receiving the highest tolerated dose of statins. Based on all of the preceding considerations, CDEC recommended that Nilemdo be reimbursed. Nilemdo should only be covered for adults with a history of CVD or at high risk of CVD and who have elevated LDL-C levels. Nilemdo should be initially covered for 3 months and may be continued if the patient shows a meaningful reduction in LDL-C of at least 10% from before treatment began with Nilemdo, and the cost of Nilemdo does not exceed the drug program cost of ezetimibe. Important budget impact considerations must be addressed for health systems to be able to adopt Nilemdo.
Canada’s Drug Agency (CDA-AMC) recommends that Kevzara be reimbursed by public drug plans for adult patients with polymyalgia rheumatica (PMR) whose disease has responded inadequately to corticosteroids, or whose disease has relapsed during corticosteroid taper, if certain conditions are met. The Canadian Drug Expert Committee (CDEC) determined it is uncertain whether Kevzara demonstrates acceptable clinical value versus corticosteroid taper in adult patients with PMR whose disease has responded inadequately to corticosteroids, or whose disease has relapsed during corticosteroid taper. Given that Kevzara is expected to be an additive to corticosteroid taper, acceptable clinical value refers to added value versus corticosteroid taper alone. Evidence from 1 phase III, double-blind, randomized controlled trial (the SAPHYR trial, N = 118) demonstrated that treatment with Kevzara plus a 14-week prednisone taper may result in added clinical benefit in patients with PMR whose disease has responded inadequately or has relapsed during corticosteroid taper, compared to treatment with placebo plus a 52-week prednisone taper. Kevzara plus a 14-week prednisone taper, compared to placebo plus a 52-week prednisone taper, may lead to a clinically meaningful increase in the proportion of patients who achieve sustained remission at week 52. Despite the positive findings favouring Kevzara, there was uncertainty in the evidence due to several limitations identified in the SAPHYR trial, such as a potential prognostic imbalance between study groups, missing outcome data, and invalid assumptions for time-to-event analyses. Symptoms of PMR, such as muscle pain, fatigue, and stiffness, had an extensive impact on patients’ quality of life. Further, long duration of corticosteroid treatment is associated with an increased risk of side effects, such as infection, osteoporosis, diabetes, accelerated atherosclerosis, weight gain, adipose redistribution, cataract formation, and avascular necrosis. Kevzara plus a 14-week prednisone taper may meet some of patients’ unmet clinical needs with an acceptable level of certainty in clinical value, notably increasing sustained symptom remission and improving patients’ health-related quality of life. Based on all the preceding considerations, CDEC recommended that Kevzara be reimbursed. Kevzara should only be reimbursed if it is initiated in adults aged 50 years or older with a confirmed diagnosis of PMR who have been treated with prednisone at a dose of at least 10 mg/day (or equivalent) for at least 8 weeks, have experienced at least 1 documented PMR flare within the previous 12 weeks while tapering prednisone at a dose of at least 7.5 mg/day (or equivalent), and have evidence of active disease (erythrocyte sedimentation rate ≥ 30 mm/hour or CRP levels ≥ 10 mg/L) within the same period. Kevzara must not be used in patients with a concurrent diagnosis of giant cell arteritis. Kevzara should only be reimbursed if initiated in combination with a tapering course of corticosteroids, and if the cost of Kevzara is reduced. The recommended period for initial reimbursement is 14 weeks. Initial renewal is recommended to be based on improvements in the signs and symptoms of PMR and normalization of CRP levels (< 10 mg/L), with subsequent renewals requiring sustained improvement of signs and symptoms with resolution by 1 year and continued normalization of CRP levels. Renewal assessments should occur at least every 3 months to confirm ongoing clinical benefit. When a patient’s condition is stable, assessment for renewal should occur at least every 6 months. Reimbursement must be discontinued if there are unacceptable side effects, after 18 months of treatment, or if PMR has been in remission for at least 1 year after starting Kevzara.
Canada’s Drug Agency (CDA-AMC) recommends that Minjuvi be reimbursed by public drug plans “in combination with rituximab and lenalidomide [rituximab-lenalidomide] for the treatment of adult patients with grade 1, 2, or 3a relapsed or refractory follicular lymphoma [FL]” if certain conditions are met. Evidence from 1 clinical trial showed that Minjuvi in combination with rituximab-lenalidomide improved progression-free survival (PFS) compared with rituximab-lenalidomide alone in patients with grade 1, 2, or 3a relapsed or refractory FL. The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that adding Minjuvi to rituximab-lenalidomide provides acceptable clinical value compared with rituximab-lenalidomide alone for the treatment of grade 1, 2, or 3a relapsed or refractory FL. This determination was enough for pERC to recommend that Minjuvi be reimbursed. Given that Minjuvi is expected to be an additive treatment to rituximab-lenalidomide, acceptable clinical value refers to added benefit over rituximab-lenalidomide alone. pERC also determined that Minjuvi in combination with rituximab-lenalidomide addresses the need identified by both patients and clinicians for additional chemotherapy-free treatment options that are feasible for administration in a community setting. Minjuvi in combination with rituximab-lenalidomide should only be covered for adults with relapsed or refractory grade 1, 2, or 3a FL who have received at least 1 previous treatment with systemic anti-CD20 immunotherapy or chemoimmunotherapy for the condition. Patients should have good performance status and should not have a nonfollicular indolent lymphoma or active lymphoma in the brain. Minjuvi should only be reimbursed if treatment is started in combination with rituximab-lenalidomide, the patient is under the care of a clinician who has expertise in managing FL and supports are available for managing infusion-related reactions, and the cost of Minjuvi is reduced. Treatment should be discontinued upon completion of 12 treatment cycles or if the patient experiences disease progression or unacceptable side effects. Important budget impact considerations must be addressed for health systems to be able to adopt Minjuvi in combination with rituximab-lenalidomide.
Canada’s Drug Agency (CDA-AMC) recommends that Lunsumio be reimbursed by public drug plans “as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (Grades 1 – 3a) who have received at least two prior lines of systemic therapy,” if certain conditions are met. The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that it is uncertain whether Lunsumio demonstrates acceptable clinical value in “adult patients with relapsed or refractory follicular lymphoma (Grades 1 –3a) who have received at least two prior lines of systemic therapy.” Given that Lunsumio is expected to be an alternative option for third-line and beyond therapy, acceptable clinical value refers to at least comparable value relative to other third-line and beyond therapies relevant in the context in Canada. Direct evidence from 1 clinical trial (GO29781) showed that treatment with Lunsumio resulted in response rate benefits considered clinically meaningful and durable by the CDA-AMC consulted experts and suggested potential survival benefits. Evidence from an indirect treatment comparison (ITC) suggested that overall survival (OS) and response outcomes with Lunsumio may be broadly comparable to other third-line and beyond therapies, although results were uncertain and mixed across comparisons. Uncertainty remains due to the single-arm study design, limited comparative evidence, and imprecision in indirect estimates. pERC concluded that, although the evidence suggests mosunetuzumab monotherapy has uncertain clinical value, given the rarity and severity of the condition the drug may address a significant unmet clinical need to a degree that justifies a positive recommendation despite the uncertainty in the clinical value. pERC discussed the direct and indirect evidence and the clinical experts’ input and noted that the overall evidence suggested that Lunsumio may address a significant unmet clinical need, offering a chemotherapy-free, fixed-duration treatment with manageable safety profile that is readily available, particularly for patients with limited access to existing therapies. pERC noted that there are significant unmet nonclinical needs and health inequities for patients with relapsed or refractory follicular lymphoma (r/r FL). pERC considered the IV and subcutaneous (SC) formulations of Lunsumio to have similar efficacy and safety, and therefore preferred the SC formulation, while allowing flexibility for patient preference and for those who may need IV due to significant injection site reactions. Based on all of the preceding considerations, pERC recommended that Lunsumio be reimbursed. Lunsumio should only be covered for adults with histologically confirmed r/r FL (grades 1 to 3a) who have received at least 2 prior lines of systemic therapy, including an anti-CD20 therapy and an alkylating agent, and who have good performance status. Lunsumio should not be covered for patients with nonfollicular indolent lymphoma or a disease with central nervous system involvement. Lunsumio should be prescribed by clinicians experienced in managing hematologic malignancies and bispecific antibody-related complications, and given in settings with access to tocilizumab and appropriate supportive care. Reimbursement should be for a fixed duration of 8 or 17 cycles as per the drug’s product monograph and should be discontinued upon the occurrence of complete response, unacceptable toxicity, or disease progression. Re-treatment may be considered for patients whose disease relapses after a treatment-free interval of at least 6 months following completion of the initial treatment course. The total cost of Lunsumio should not exceed the total cost of treatment with the least costly relevant chemotherapy comparator for the same indication. Important budget impact considerations and organizational implications must be addressed for health systems to be able to adopt Lunsumio.
Canada’s Drug Agency (CDA-AMC) recommends that Ayvakyt be reimbursed by public drug plans for adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment, if certain conditions are met. The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that it is uncertain whether Ayvakyt demonstrates acceptable clinical value versus symptomatic treatments in adult patients with ISM who have moderate to severe symptoms inadequately controlled on symptomatic treatment. Therefore, the committee also considered whether Ayvakyt addresses a significant unmet clinical need. Evidence from 1 clinical trial showed that Ayvakyt in combination with symptomatic treatment may result in added clinical benefit, compared with placebo in combination with symptomatic treatment, as per the Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF) total symptom score (TSS). However, the evidence for Ayvakyt is uncertain because there were differences between groups in terms of prognostic factors as well as in the occurrence of edema, which might have allowed patients to infer treatment allocation. The effect of Ayvakyt to reduce anaphylaxis was also uncertain due to the small number of events. ISM is a rare disease that can cause life-threatening anaphylaxis. Current treatment options available to patients with ISM in Canada only palliate the symptoms. pERC determined that Ayvakyt may meet some of the unmet clinical need in terms of improving disease symptoms with an acceptable safety profile. Based on all of the preceding considerations, pERC recommended that Ayvakyt be reimbursed. Ayvakyt should only be covered when used in conjunction with symptomatic treatments in adult patients with a confirmed diagnosis of ISM with a KIT D816V mutation, and who have moderate to severe disease based on the clinician’s assessment, with no clinical improvement in at least 1 type of symptom after receiving at least 2 prior symptomatic treatments, as determined by the clinician. Ayvakyt should only be reimbursed if the treatment is initiated by a hematologist, allergist, or immunologist with expertise in the diagnosis, treatment, and response evaluation of patients with ISM, and if the cost of Ayvakyt is reduced. Reimbursement of Ayvakyt may be continued for patients with disease response to treatment, as assessed by the treating clinician every 24 weeks. Reimbursement of Ayvakyt should be discontinued in cases of unacceptable toxicity, failure to meet follow-up requirements, or lack of clinical benefit as determined by the treating clinician.
Factors Influencing Travel for Locally Available Medical Imaging Services
What Is the Issue? Access to health services in rural and remote communities is essential to the well-being of the populations living in these communities. Medical imaging is a key component of health care, as it informs clinical diagnoses, treatment, and the monitoring of therapeutic responses. Although many rural and remote health care centres offer imaging services, some individuals travel to larger urban centres for exams. Canada’s Drug Agency (CDA-AMC) was asked to explore why people living in rural or remote areas travel to urban centres for medical imaging exams that are also available closer to home. What Did We Do? To understand why some patients in Canada travel for medical imaging, we used a mixed-evidence approach, combining a targeted literature review with input from those closest to the issue: patients, caregivers, health care professionals, and administrators involved in delivering imaging services. This report aims to: understand the perceptions and experiences that shape decisions about where to seek care explore the provider and system factors that lead patients to obtain care at a facility other than the closest option inform approaches to more equitable access to imaging across rural, remote, and urban settings. What Did We Find? Decisions to travel for care may be shaped by factors at the patient, provider, and system levels. Our analysis identified 5 main themes that may influence travel for medical imaging that is also available locally: Accessibility and system capacity: Shorter wait times, access to advanced technologies, and perceived differences in image quality can influence where people receive care. Clinical requirements and service offerings: Referral decisions may depend on access to specialists, the range of services offered, and the complexity of a patient’s condition. Provider preferences and referral pathways: Awareness of available services and established referral practices contribute to travelling for care. Convenience and perceived quality: Perceptions about differences in quality of care between rural or remote and urban centres can contribute to travel for medical imaging. Patient circumstances and equity considerations: Past experiences and individual circumstances can also lead to travel for medical imaging. Equity-deserving groups may experience additional considerations, such as the need for culturally appropriate care. What Does This Mean? Patient travel for medical imaging reflects the complexity of how services are organized, accessed, and navigated across health systems. Key implications of travelling for medical imaging include the following: Service distribution across rural, remote, and urban settings shapes demand patterns and patient flow. Differences in capacity, referral processes, and service availability can influence where imaging is received, with potential effects on wait times. Opportunities to better align referral practices with available local capacity exist, potentially enabling more consistent and predictable care pathways. Variation in access to information and system navigation support has equity implications for different populations.
Teleaudiology can offer hearing and ear care to people, including those living in areas where there are shortages of qualified audiologists and hearing instrument practitioners. There is a need to evaluate the potential benefits and harms of teleaudiology to ensure that all people receive high-quality ear care, regardless of their place of residence. There is also a need to evaluate the diagnostic test accuracy of teleaudiology compared with in-person ear assessment across various ear conditions. Given the growing use of teleaudiology, it is also important to identify and critically assess the quality of evidence-based guidelines that provide recommendations on teleaudiology for hearing assessments. Understanding the available evidence base is essential to support evidence-informed clinical practice, support equitable access to hearing care, and guide decisions regarding the implementation and use of remote assessment technologies. Canada’s Drug Agency conducted a rapid review to identify and summarize evidence that compared the clinical effectiveness and diagnostic test accuracy of teleaudiology to in-person ear assessments. We also sought to identify and summarize evidence-based guidelines for the use of teleaudiology. We searched key resources, including journal citation databases, and conducted a focused internet search for relevant evidence published between January 1, 2016, and April 24, 2026. Importantly, the purpose of this Rapid Review is to summarize and critically appraise the available evidence on the topic, but it does not provide formal recommendations. We did not find any studies comparing comprehensive teleaudiology to comprehensive in-person ear assessments in children or adults, and we did not find any evidence-based guidelines for teleaudiology. We identified 4 studies addressing diagnostic test accuracy or related measurement agreement outcomes of teleaudiology versus in-person audiological assessment for diagnosing medical conditions of the ear: In children (1 study), teleaudiology results were similar to in-person assessment results, showing acceptable agreement for hearing tests, including air and bone conduction pure-tone audiometry, otoscopy, and tympanometry assessments. In adults (3 studies), teleaudiology produced hearing assessment results that were comparable to those of in-person testing, with similar hearing thresholds, word recognition, and speech reception results. In adults (1 study), teleaudiology showed high sensitivity and specificity for hearing loss (HL), defined as a hearing threshold of 30 dB or higher or 40 dB or higher. This means the tablet audiometer used in this study was good at correctly detecting people with HL and correctly classifying most people with normal hearing. Two included studies used devices approved for use by Health Canada for teleaudiology assessments (3 devices in total). The effectiveness of these devices across diverse settings and populations in Canada is uncertain. The included studies had important limitations, including incomplete hearing assessments, risk of bias, small sample sizes, and limited available participant characteristics. This limits the interpretation and generalizability of findings. Teleaudiology may be an accurate alternative for diagnosing HL in adults and children and for conducting otoscopy and tympanometry in some children, particularly those older than 4 years. However, due to the small number of studies, underpowered sample sizes, risk of bias, and in some cases applicability concerns, the confidence in the findings is low. Implementation should be balanced against current evidence limitations, resource implications, equity considerations, and clinical practice in the context of Canada.
Short-Stay Crisis Units in the Emergency Department: Current Landscape and Evidence on Safety and Effectiveness
Emergency departments (EDs) in Canada are experiencing ongoing overcrowding, with a growing number of visits related to mental health and substance use crises. These settings are typically not ideal for delivering mental health care due to a lack of privacy and an overstimulating environment, contributing to poor patient experiences, repeat visits, and highlighting broader gaps in accessible and effective community-based services. Short-stay crisis units (SSCUs) aim to address these challenges by providing rapid assessment and brief stabilization in a more therapeutic care setting. This report draws on evidence from a pan-Canadian survey of hospital-based, SSCUs and a rapid review of published evidence on the safety and effectiveness of these units in improving mental health outcomes and alleviating overcrowding in EDs. We searched key resources, including journal citation databases, and conducted a focused internet search for relevant evidence published since 2015. We received responses from 10 relevant units in 7 jurisdictions across Canada. The findings suggest a highly variable landscape. SSCUs in Canada differ in name, model of care, staffing, referral pathways, capacity, and length of stay targets. All units were open 24 hours a day, 7 days a week, and did not charge fees. Those who responded described clear benefits including a safer and calmer space for patients experiencing a crisis, fewer unnecessary inpatient admissions, and stronger links to community care. Common barriers included funding, space, staffing, unclear admission criteria, and pressure to repurpose beds during periods of high hospital demand. Evidence from 7 included publications suggest that SSCUs may improve some system-level outcomes, particularly wait times in EDs, length of stay in EDs, and use of restraints, but the evidence base remains limited and mixed. Findings on admissions, readmissions, and patient outcomes were less consistent, and most studies were conducted outside Canada. Overall, SSCUs appear promising, but they are not a one-size-fits-all solution. Their success likely depends on clear pathways, interdisciplinary staffing, stable funding, strong links to community resources, and careful alignment with local system needs. The findings of this report can be used as guidance for decision-makers across Canada who may be in the process of, or considering, implementing or making changes to SSCUs.
Appropriate Use of Medications in Hospitals
Efforts to improve medication prescribing practices in acute care hospitals represent an opportunity to prevent patient harms from unnecessary treatments and increase the use of effective therapies. However, the degree and impact of inappropriate medication use in acute care hospitals has not been well described in Canada because in-hospital prescribing data have not been readily accessible. In a first-of-its-kind analysis, the aim of this paper was to provide new, real-world evidence to better describe the magnitude of variation in the use of medications in acute care hospitals. Data analysis of approximately 535,000 hospitalizations across 115 hospitals in Ontario and Alberta through the VITAL research network identified substantial prescribing variation for each of the 4 key medication classes that were analyzed (antibiotics, antipsychotics, sedative-hypnotics [also referred to as sleep aids], and opioids). For example, sleep aid prescribing ranged from 12% to 81% of patients across hospitals. This is particularly striking, given recommendations against the routine use of these medications from the Canadian Society of Hospital Pharmacists, the Canadian Psychiatric Association, the Canadian Academy of Geriatric Psychiatry, and Choosing Wisely Canada, suggesting an opportunity to prevent harm from inappropriate use. Evidence-based interventions to safely reduce inappropriate prescribing already exist and have been effective in specific settings. Interventions typically involve changes to care protocols paired with practice feedback and/or clinical decision support. Examples include antibiotic stewardship programs that reduced extended-spectrum antibiotic use by 28%, and multicomponent initiatives that reduced sleep medication use by 15%. Electronic health records and hospital data-sharing networks now enable efficient measurement of in-hospital medication prescribing at a system-level scale for the first time in Canada. This creates an opportunity to identify targets for interventions, deliver point-of-care clinical decision support, and evaluate the effectiveness and safety of interventions across multiple sites. Policy-makers and hospital leaders can work together to establish networks that harness hospital electronic medical records systems to measure prescribing patterns, identify improvement opportunities, and implement quality improvement interventions. Systematically improving medication appropriateness across hospitals can help address both health care quality and financial sustainability in Canadian health care.