Health Technology Review

Disease-Modifying Therapies for Metabolic Dysfunction–Associated Steatohepatitis

Metabolic dysfunction–associated steatohepatitis (MASH) is an increasingly prevalent liver disease in Canada. While MASH is traditionally managed with lifestyle modifications, the conditional regulatory approval of the first disease-modifying therapy in December 2025 marks a potential change in the treatment landscape. This development creates opportunities to assess the readiness of health systems for the potential adoption of disease-modifying therapies. This report outlines how the potential introduction of disease-modifying therapies into clinical care creates a timely opportunity to enhance coordinated screening, standardized care pathways, education, and equitable access.

What Is the Issue?

• Metabolic dysfunction–associated steatohepatitis (MASH), an advanced stage of metabolic dysfunction–associated steatotic liver disease (MASLD), is emerging as a leading cause of liver cancer and transplant in Canada, with prevalence projected to rise.

• Management of MASH traditionally relies on lifestyle modifications, including diet and exercise. New disease-modifying therapies (DMTs) may target underlying disease mechanisms and promote fibrosis (liver scarring) regression from moderate disease stages.

• In Canada, the first DMT for MASH — a glucagon-like peptide-1 receptor agonist — received conditional regulatory approval in December 2025. In other countries, a glucagon-like peptide-1 receptor agonist and/or a thyroid hormone receptor–beta agonist (liver-directed thyroid hormone receptor therapy) have received conditional regulatory approval.

• In 2020, the annual cost of managing MASH and MASLD in Canada was an estimated $3.76 billion, largely driven by other medical conditions such as diabetes and cardiovascular disease.

What Did We Do?

• Canada’s Drug Agency sought to assess the readiness of health care systems in Canada for the potential introduction of DMTs for MASH. We summarized evidence and experiences along the current patient pathway for MASH, including specific system-level challenges and opportunities to improve care.

• We applied a mixed-evidence approach, combining targeted literature searches on health system readiness and diagnostic accuracy of noninvasive tests. Evidence was supplemented through consultations with clinical experts and engagement with patients, carers, and Indigenous people to capture contextual insights on care pathways, equity, and cultural considerations in anticipation of the potential introduction of DMTs in Canada.

What Did Canada’s Drug Agency Find?

The introduction of DMTs into clinical care for MASH in Canada may increase pressure on existing health care systems. Evidence and insights shared from clinical providers and patients on the MASH care pathway highlight areas that may constrain care integration and the uptake of DMTs.

• MASH is a progressive, multisystem disease that often involves complex care needs and interconnected comorbidities.

• As awareness and treatment options for MASH expand, there may be a need to strengthen diagnostic capacity and improve access to specialists who typically treat advanced MASH across jurisdictions.

• Clinical guidance is evolving to support earlier risk identification and management across the disease spectrum, reflecting a shift from a historical focus on late-stage disease toward earlier intervention.

• People with low-risk MASH may be monitored. Earlier and more proactive care may help prevent or slow MASH progression.

• Emerging MASH care pathways emphasize coordinated, multidisciplinary care to support patients with complex needs across specialties.

What Does This Mean?

The report highlights system-level opportunities to improve how MASH is identified and managed in Canada as new DMTs emerge. Strengthening MASH care would require greater coordination. Processes could be standardized and consolidated to prepare for rising demand. Evidence and engagement feedback point to a few high-level priorities, including:

• strengthening awareness and education about MASH and its multisystemic nature to support early identification and reduce stigma

• increasing diagnostic testing capacity to enable earlier and timely identification

• expanding and standardizing multidisciplinary care models to improve coordination and continuity and to support patients with complex metabolic and liver needs

• embedding equity considerations across the care pathway.

Approach

Context

Defining Metabolic Dysfunction–Associated Steatohepatitis and Metabolic Dysfunction–Associated Steatotic Liver Disease

Metabolic dysfunction–associated steatohepatitis (MASH) is an advanced stage of metabolic dysfunction–associated steatotic liver disease (MASLD). It is characterized by cellular-level tissue changes, including hepatocellular ballooning (swollen, damaged liver cells) and lobular inflammation (cellular damage within specific liver structures).¹

MASLD, the broader condition, is defined by fat accumulation on the liver (steatosis) in combination with 1 or more cardiometabolic risk factors (i.e., obesity, type 2 diabetes mellitus [T2DM], dyslipidemia, or hypertension) and the absence of harmful alcohol intake.^2,3 MASLD can progress to advanced stages without ever developing into MASH.

The terms MASH and MASLD were recently introduced to replace nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) to better reflect the underlying role of metabolic dysfunction, avoid stigmatizing language, and provide clearer, more clinically meaningful definitions.⁴ A detailed overview of the updated nomenclature and diagnostic criteria is provided in Appendix 1, Table 4. The term lean is added to MASH and MASLD when these conditions occur in individuals with healthy body weights who develop the disease.^5,6 Excess weight is not required for diagnosis, but patients without excess weight may represent a distinct population.⁷

If left untreated, MASH and MASLD can progress to fibrosis (liver scarring), cirrhosis (advanced liver scarring), portal hypertension (elevated pressure in the portal vein), decompensated cirrhosis (advanced cirrhosis), and hepatocellular carcinoma (liver cancer), each associated with progressively worse outcomes and higher mortality risk. This progression is illustrated in Figure 1.^8-10

Figure 1: The Progressive Nature of MASLD — Liver Changes and the Potential Development of MASH, Cirrhosis, and Liver Cancer

MASH = metabolic dysfunction–associated steatohepatitis; MASLD = metabolic dysfunction–associated steatotic liver disease.

Source of icon: Icon Vectors by Vecteezy (https://www.vecteezy.com/free-vector/icons).

Scope and Impact of Disease

MASH increases liver cancer risk and is a primary reason for adult liver transplant worldwide.^2,11-13 In Canada, it represents approximately 25.5% of MASLD cases, affecting an estimated 6.0% of the population.^14,15 MASLD is the most common liver disease in Canada, affecting more than 1 in 5 people (about 22.2% of the population) and its prevalence is projected to increase by 20% (to approximately 26.6%) between 2019 and 2030.^14,15

Populations at Risk for MASH

MASH is a multisystemic disease linked to metabolic dysfunctions such as insulin resistance, impaired glucose regulation, abnormal lipid metabolism, and inflammation.¹⁶ It frequently co-occurs with other metabolic conditions such as obesity and T2DM.^2,11,17 Of all individuals who have T2DM, who represent almost 10% of the population, up to 70% also have MASLD.^12,18-20

Several clinical factors are associated with a higher risk of developing MASH and MASLD, as illustrated in Figure 2, including:^21-25

• dysglycemia (e.g., T2DM)

• elevated body mass index (BMI) or obesity

• presence of 1 or more cardiometabolic risk factors (e.g., dyslipidemia, high blood pressure).

Figure 2: Common Clinical Risk Factors for MASH and MASLD

MASH = metabolic dysfunction–associated steatohepatitis; MASLD = metabolic dysfunction–associated steatotic liver disease.

Beyond these metabolic risk factors,^2,17 several systemic conditions have also been linked with MASH, including cardiovascular disease (CVD), chronic kidney disease, cognitive impairment, and colorectal, breast, and pancreatic cancers.^16,26 Figure 3 depicts the interconnected multisystemic spectrum of MASH.

Figure 3: High-Level Multisystemic Connections in MASH — Metabolic, Inflammatory, and Endocrine Interactions

MASH = metabolic dysfunction–associated steatohepatitis.

The burden of MASH and MASLD varies across populations. Global and national evidence shows higher prevalence among Hispanic, Latino, and some Asian populations, including individuals at risk for lean MASLD and lean MASH.^27,28 MASH is reported to disproportionately affect communities with higher rates of poverty and food insecurity.^29-34 These structural barriers may also leave people with lower incomes, immigrant populations, and racialized groups at greater risk of undetected disease.^34,35 Further details on risk factors are outlined in Appendix 2. This underscores the diversity of clinical presentation relevant to system-level identification and response in Canada.

The annual cost of managing MASH and MASLD in Canada was estimated at $3.76 billion in 2020.³⁶ Costs were largely driven by the treatment of comorbid conditions.³⁶ Costs climb as liver damage worsens, and with obesity and T2DM increasing, health spending is expected to increase unless early detection and prevention efforts expand.³⁶

Available Treatments for MASH

Current management of MASH focuses on lifestyle modifications, weight loss, and pharmacologic treatment of associated comorbidities. In advanced stages, surgical options may include bariatric surgery (because it has been associated with sustained weight loss and potential improvements in steatohepatitis and fibrosis) and liver transplant for end-stage disease. Figure 4 illustrates the current spectrum of treatment approaches for MASH. Emerging disease-modifying therapies (DMTs), including glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) and thyroid hormone receptor (THR)–beta agonists, aim to target underlying disease mechanisms and promote fibrosis regression in people with MASH or MASLD.^37,38 In December 2025, Health Canada approved the first pharmacologic therapy for patients with MASH, a GLP-1 RA.³⁹

Figure 4: Current Treatment Options for MASH in Canada

MASH = metabolic dysfunction–associated steatohepatitis.

The introduction of DMTs into clinical care could have important implications for health systems, as DMTs may require expanded capacity for diagnosis, monitoring, and coordinated clinical follow-up to support their appropriate and equitable use. Considerations related to access and coverage would also influence how these therapies would be integrated into care.

MASH and Health System Readiness

MASH is progressive, common, and increasingly treatable. The potential introduction of DMTs into clinical care presents an opportunity to assess the readiness of health systems for their adoption. This report presents evidence along the patient care pathway and identifies system-level opportunities to support earlier detection, coordinated care, and sustainable integration of emerging therapies.

Objectives

This report assesses the readiness of health care systems in Canada for the introduction of pharmacologic DMTs for MASH.

We summarize the current patient pathway for MASH to:

• describe the underlying care infrastructure and processes across the clinical pathway

• identify the incremental capabilities required to enable the adoption of DMTs.

Methods

A mixed-evidence approach was used to inform this assessment, drawing on systematic searches of the literature, targeted consultations with clinical experts, engagement with people with lived and living experience of MASH, and contextual knowledge shared by members of Indigenous communities.

Literature Search

An information specialist conducted targeted literature searches, balancing comprehensiveness with relevance, of multiple sources (including grey literature). Two searches were completed for:

• the diagnostic accuracy of noninvasive tests, conducted on July 4, 2025

• health system readiness, conducted on July 10, 2025.

Health system readiness literature was reviewed for relevance and used to describe current care pathways, disease risk factors, available and emerging treatments, and equity considerations. Regular alerts updated the database literature searches until the final draft of the report. Detailed methods are provided in Appendix 3.

Evidence on the diagnostic accuracy of noninvasive tests was sought to inform a broad understanding of existing and recommended tools and their ability to detect MASH. Rapid review methods were used to identify, review, and extract information from systematic reviews considered by the team from Canada’s Drug Agency (CDA-AMC) to be of moderate to high methodological quality. The results were supplemented with input from clinical experts on tools currently used in Canada. Detailed methods for the rapid review are provided in Appendix 4, with full results provided in Appendix 5.

Engagement With Clinicians, Patients, Carers, and Indigenous Communities

To complement published literature, CDA-AMC engaged clinical experts, individuals living with MASH, carers, patient group representatives, and Indigenous people. These participants provided contextual insights in the following areas:

• diagnostic processes

• patient needs and priorities

• treatment practices

• therapeutic readiness

• health system use

• ethics and equity considerations.

Clinician Engagement

Consultations with clinicians were conducted between August and October 2025 with 6 clinicians from the specialties of gastroenterology and hepatology (2), diagnostic pathology (1), endocrinology (1), radiology (1), and primary care (1). The clinicians were from Nova Scotia (1), Ontario (2), Alberta (1), and British Columbia (2).

Patient Engagement

We engaged people living with MASH and patient group representatives to capture lived experiences with MASH care, including perspectives on current and future patient pathways, treatment acceptability, accessibility, and equity considerations. Outreach activities included:

• a statement of interest published on the CDA-AMC website

• outreach to patient groups and clinical societies

• social media promotion.

A total of 6 individuals participated in this engagement activity: 4 people with lived experience of MASH and 2 patient group representatives (1 of whom also had lived experience). Participants lived in Newfoundland and Labrador (1), Ontario (3), and Alberta (2). Engagement questions explored participants’ experiences with accessing health care providers, diagnostic services, and currently available treatments as well as care pathway and treatment expectations for the potential adoption of DMTs in MASH care.

Engagement With Indigenous Communities

Historical and ongoing colonial policies underpin inequities in infrastructure and resource distribution and availability, which may contribute to a disproportionate impact of MASH in First Nations, Inuit, and Métis populations. Confirming the prevalence of MASH and the impact on communities through published scientific studies may not be feasible or appropriate.⁴⁰ The lived experience and insights of individuals in Indigenous communities provides contextualized knowledge that reaches beyond colonial scientific measures.⁴¹ This knowledge is highly important and can help inform decisions and actions.⁴² Research involving Indigenous Peoples must be guided by relevant frameworks such as:^43-45

• First Nations Ownership, Control, Access, and Possession (OCAP) principles

• Métis Ownership, Control, Access, and Stewardship (OCAS) principles

• Inuit Qaujimajatuqangit.

Recognizing these considerations, CDA-AMC contracted an external consultant to engage patients living with MASH and report on findings with an Indigenous lens. The consultant contacted participants, developed questions, and organized and facilitated the sessions. A member of the team at CDA-AMC attended the sessions and provided context based on an overview of MASH and the organization’s work.

CDA-AMC and Indigenous-led engagement approaches are reported according to the Guidance for Reporting Involvement of Patient and the Public (version 2) short-form (GRIPP2-SF) check list⁴⁶ available in Table 13, Appendix 6. The summary of inputs from both engagement activities are available on the project web page.

Dashboard Using Real-World Evidence

Purpose

CDA-AMC created the interactive Metabolic Dysfunction–Associated Steatohepatitis (MASH) System Readiness dashboard to complement this report and provide detailed, up-to-date decision support information for health system planning. This dashboard allows users to explore trends and visualize insights to inform planning, prioritization, and resource allocation.

Scope

The dashboard consolidates publicly available, real-world data on factors relevant to readiness for the potential introduction of MASH DMTs, including:

• diagnostic imaging capacity

• liver clinic distribution

• population health characteristics

• clinician workforce distribution at jurisdictional and national levels.

Additionally, at an international level, it provides data on DMT availability, ongoing clinical trials for DMTs for MASH, and consensus-based and evidence-based guidelines that support earlier risk identification and management across the disease spectrum. These data were gathered via literature searches and were supplemented with information from web-based sources.

Health System Readiness

Preparing Canada’s Health Systems for MASH DMTs

The recent conditional regulatory approval of a MASH DMT in Canada³⁹ provides an opportunity to review the current patient care pathway and assess readiness should MASH DMTs be adopted as part of clinical care. By outlining the steps for diagnosing and treating MASH, this report uses clinical evidence to inform system-level insights. Examining the full care pathway also highlights opportunities to strengthen the health system, including:

• optimizing resources across disease stages

• expanding diagnostic capacity

• streamlining referral pathways

• enhancing multidisciplinary care models

• strengthening treatment monitoring structures.

This report presents evidence on existing processes and care practices from diagnosis to treatment monitoring. It assesses system readiness by examining the capacity to integrate MASH DMTs into the care pathway, with the potential to improve patient care and potentially prevent or slow disease progression. A visual representation of the pathway is presented in Figure 5 and includes insights from evidence, clinical consultations, and proposed treatment steps from international clinical guidelines.

Implementation Considerations

There are several crosscutting considerations that may support efficient, patient-centred care, including with DMTs, should they become adopted in clinical practice along the care pathway, as outlined in the following points.

Disease Awareness

There is limited awareness of MASH. A survey of physicians in Canada found that 58% of primary care providers (PCPs) were somewhat familiar — or unfamiliar — with the condition.⁴⁷ Insights from CDA-AMC–led engagement with people living with MASH reinforced this finding. Targeted awareness initiatives for both providers and patients, particularly in settings with patient at high risk (e.g., diabetes and obesity clinics), may prompt patient inquiries, support clinician screening, and promote early disease detection.

“I had to explain what NASH [now referred to as MASH] was to a walk-in doctor… They’d never heard of it.”

– Participant in the CDA-AMC–led engagement who lives with MASH, describing the need for education

Stigma

MASH can be a highly stigmatized disease due to links with weight and use of the term fatty liver, as well as misconceptions that the disease is caused by excessive alcohol use, even though the disease develops independently of alcohol consumption.^48-52 In health care settings, stigma can undermine trust between patients and health care providers and is associated with delayed care seeking, reduced engagement with health services, and lower treatment uptake and adherence.^48,53 Education for physicians with accurate, nonstigmatizing information may help ensure people living with MASH are treated respectfully and receive timely, appropriate care without needing to self-advocate.

Treatment Information

First-line interventions focused on diet and exercise can improve liver outcomes and slow disease progression.^2,54-59 People living with MASH who contributed to this report described the importance of access to clear guidance from experts on recommended lifestyle adjustments that are aligned with dietary needs, cultural practices, and existing mobility or economic restrictions.

Provider Training

Many health care providers have reported having limited knowledge or training on MASH or MASLD,^60,61 including how to communicate effectively with patients about liver fibrosis. This may contribute to the inconsistent use of guideline-recommended tools and may hinder timely diagnosis and optimal patient management.^49,62-70 Expanding specialist and primary care training may support accurate and early diagnosis and effective patient management as liver disease prevalence rises.^71-73

Access to Primary Care

An estimated 17% of adults living in Canada lack a regular PCP, although access varies within and across jurisdictions.⁷⁴ Access tends to be lowest among younger adults, people with lower incomes, immigrants and newcomers to Canada, people living in northern communities, people living in rural and remote areas, and Indigenous adults (around 30% of whom report unmet primary health care needs).^75,76 Opportunities to strengthen access to primary care reported in the literature include:

• expanding provider access

• reducing wait times for appointments and services⁷⁷

• enhancing local care availability to minimize travel, including in remote and northern communities

• promoting culturally safe and inclusive care

• increasing resources and support for rural, remote, and northern areas.⁷⁸

These factors highlight opportunities to strengthen care coordination and continuity.^79-82 Across all engagement sessions, people living with MASH consistently identified delayed access to primary care as a key challenge, with many reporting having to wait several months or, in some cases, more than a year before receiving care.

Access to Specialist Care

Opportunities exist to strengthen access to specialist care and to ensure timely support for people living with MASH. Hepatologists and gastroenterologists currently focus on patients with advanced or complex cases, highlighting the potential to expand capacity and coordination across the care pathway. Improving referral systems, reducing travel requirements, and addressing socioeconomic and racial inequities could enhance timely access to and continuity of care.^79-84 Important areas for development identified in the literature and through clinical expert consultation include:

• expanding liver-focused training beyond a single pathology fellowship program currently available in Canada (based on the clinical expert consultation)

• increasing the number of radiologists and pathologists practising in Canada⁷³

• reducing geographic disparities in specialist availability.⁸³

Access to Diagnostic Testing

Improving availability and public coverage of serum-based tests (e.g., the Enhanced Liver Fibrosis [ELF] test and the Fibrosis-4 [FIB-4] test), imaging (e.g., magnetic resonance elastography [MRE], shear wave elastography [SWE] and vibration-controlled transient elastography [VCTE]), and pathology diagnostic tests (e.g., liver biopsy) could enhance consistent and equitable access across jurisdictions.^83,85-87 Such efforts should specifically consider capacity outside urban centres, especially for rural, remote, northern, and Indigenous communities.^73,83,87-94 Information on jurisdiction-specific diagnostic testing practices is provided in Appendix 1, Table 5.

Coordinated Care

Canada may be well-positioned to adopt multidisciplinary pathways that are reported to be effective internationally.⁹⁵ These approaches could support earlier intervention and may enhance continuity of care for individuals with, or at risk for, MASH. Key enablers reported in the literature include:^96,97

• standardized protocols

• clearly defined team roles

• reimbursement pathways that support diagnostic tests and treatments

• culturally safe care options.

Sustainable implementation of potential DMTs for MASH in local contexts may be supported by tailored processes and guidance that consider local infrastructures, workforce availability, and funding models. Considerations for public drug coverage may focus specifically on the need for health technology assessment (HTA) evaluation and agreement(s) on pricing.⁹⁴

Estimation of the Population With Treatable MASH

Estimation of the Patient Population With Treatable MASH and Future Demand

As the first DMT for MASH has received conditional regulatory approval in Canada, understanding the size of the population who may be eligible for treatment can help system-level planning. Estimating the number of adults with moderate to advanced fibrosis (stages F2 to F3) provides an early indication of the potential demand for diagnostic services, specialist input, monitoring capacity, and coverage considerations. These estimates help demonstrate the current burden and the potential for growing demand as prevalence rises and more patients are diagnosed over time.

An estimated 2,415,796 people in Canada are living with MASH, of whom approximately 168,449 adults currently meet criteria for treatable disease (stages F2 to F3). This highlights a substantial overall disease burden, with a smaller but sizable subgroup driving near-term demand for treatment and specialized care.¹⁵

A progressive, stepwise approach was used to estimate the population with MASH at disease stages potentially eligible for treatment (full methodology and limitations can be found in Appendix 7). Estimates were based on Canadian sources when available. Clinical experts reviewed and provided feedback on the approach and parameters; however, results should be interpreted with consideration of underlying uncertainties.

The model begins with the total population in Canada and sequentially applies estimates for MASH prevalence, fibrosis staging distribution, and adult population adjustments to arrive at an estimate of the population with treatable MASH. Using this approach, approximately 168,449 adults were estimated to be eligible for treatment in 2025, increasing to 198,731 adults by 2030, reflecting projected demographic growth and disease progression (Table 1). These estimates should be interpreted as indicative rather than definitive and likely represent a lower-bound estimate of the true eligible population.

Table 1: Summary of the Estimated Population With Treatable MASH in Canada

MASH = metabolic dysfunction–associated steatohepatitis.

Clinical experts consulted for this report indicated that the estimated population with treatable MASH is likely underestimated. This potential underestimation may reflect:

• limited early identification and diagnosis of disease

• reliance on historical obesity trends, which may not capture recent trends

• not fully accounting for the high prevalence of related conditions, including diabetes and CVD^24,25,98,99

• incomplete accounting for individuals with lean MASH, who are estimated to compose about 20% to 50% of all MASLD cases^98,99

• a large undiagnosed population.

Taken together, these factors suggest the true number of patients who may be eligible for treatment could be meaningfully higher than modelled estimates, particularly as awareness, screening, and diagnostic capacity improve over time.

Describing the Care Pathway for MASH in Canada

Assessment and Diagnosis

Social Factors That Affect the Care Pathway

Population groups experiencing multiple, intersecting structural and social determinants of health appear to experience a higher burden of MASH. These patterns can be understood through a framework of intersectionality, which outlines how social determinants of health categories such as race, class, and gender interact with broader social and institutional structures to shape differential outcomes, in this case disparities in MASH risk.¹⁰⁰ Evidence suggests that disease progression to advanced fibrosis, cirrhosis, and cardiovascular complications are more common among groups facing overlapping structural and social disadvantages. Specific examples of how MASH burden and progression vary across populations due to interacting demographic, clinical, behavioural, and structural risk factors are described in Appendix 2.

Insights from individuals living with MASH who participated in the Indigenous-led and CDA-AMC–led engagement activities described experiences of inequity across the care pathway. Across engagement sessions, participants highlighted several system-level considerations, including:

• low awareness of MASH in standard care practices throughout the system

• stigma and assumptions about alcohol use and body weight

• limited access to local testing in rural and remote areas.

Participants in the Indigenous-led engagement activities additionally emphasized:

• frequent diagnostic delays attributed to racism and misattributed symptoms.

Entry Point Into the Care Pathway

Early-stage disease is often asymptomatic. People living with MASH may present with nonspecific symptoms such as fatigue, weakness, abdominal discomfort, and bloating.¹⁰¹ Because of the multisystem nature of MASH and lack of clear early indicators, identifying MASH early can be challenging.

Participants in the Indigenous-led and CDA-AMC–led engagement activities described a lack of disease awareness. They emphasized the need for self-directed education and advocacy with health care providers to receive testing for a diagnosis. Participants reported that delays in accessing testing and diagnosis contributed to worsening symptoms as well as to heightened anxiety and stress, negatively affecting both physical and emotional well-being.

“If I don’t take charge of this, then I am going to be in trouble.”

– Participant in the CDA-AMC–led engagement who lives with MASH, describing a need to advocate for themselves

Liver disease may be identified through multiple entry points in the health system, including:

• primary care assessment in which routine blood work may reveal elevated liver enzymes or incidental imaging findings suggest steatosis (fat accumulation) or fibrosis (scarring)

• screening programs for MASH that often target patients managing comorbid conditions with increased liver disease risk¹⁴

• emergency department visits in which individuals seek care for complications of advanced disease or decompensated cirrhosis

• specialist care referral for which individuals are referred for liver assessment by a specialist in another discipline, such as cardiology, endocrinology, or internal medicine

• recognition by allied health professionals who are increasingly positioned to identify patients at risk and initiate referral for further screening.

Improving disease awareness in Canada may help improve MASH care by equipping health care providers with training on early identification and effective communication, particularly at the entry point of the health care pathway.

Participants in the Indigenous-led and CDA-AMC–led engagement activities reported experiencing vague symptoms, limited access to primary care, long wait times for imaging and specialist follow-up, minimal diagnostic communication with care providers, confusion about their diagnosis, and substantial travel and cost burdens for testing, especially for those living in remote regions.

“Pain… A lot of pain and suffering.”

– Participant in the Indigenous-led engagement, describing when their MASH was first identified in a late disease stage

Additionally, competing health priorities and stigma may hinder early identification of MASH or timely engagement with the health care pathway.

Competing Health Priorities

Patients with MASH often manage multiple comorbid conditions, which may take precedence over liver disease, particularly when MASH is asymptomatic.¹⁰² Clinicians may also underrecognize or underprioritize MASH amid competing health demands and limited time for complex care decisions.^101,103

Participants in the Indigenous-led and CDA-AMC–led engagement activities noted that MASH risks, symptoms, and management were often not discussed while they were being monitored for associated comorbidities like obesity and T2DM. They also described receiving information about their condition only when it became clinically necessary. Together, these factors may contribute to delayed identification of MASH, particularly among populations at high risk.

“They told me it’s nothing to worry about.”

– Participant in the CDA-AMC–led engagement who lives with MASH, describing when their mild liver fibrosis was first identified

Stigma

MASH-related stigma can arise from multiple sources, including outdated disease terminology, risk factors such as body weight and alcohol use, and social determinants of health categories such as race, gender, and age.⁴⁸ This stigma can contribute to moral judgment, misattribution of symptoms, and reduced care seeking.^49-52 Although efforts to reduce stigma — such as replacing terms like nonalcoholic and fatty liver disease— have been made, some patients continue to identify the condition as fatty liver disease, which can perpetuate feelings of shame and disengagement.⁴

All participants in the Indigenous-led and CDA-AMC–led engagement activities highlighted stigma around liver disease. Many noted that people, including health providers, often assumed their liver issues were caused by alcohol. One Indigenous participant shared that clinicians immediately questioned their alcohol history, even after clarifying their condition was metabolic. Other Indigenous participants echoed that community members asked if they “used to drink a lot.”

Clinical Practice Guidelines for MASH

Several clinical practice guidelines (CPGs) have been developed for MASLD and MASH. Recent Canadian evidence-based and consensus-based guidelines provide national guidance.^104-106 As well, health organizations within certain jurisdictions have developed management pathways tailored to local contexts, including Kingston Health Sciences Centre in Ontario, Shared Health in Manitoba, and Alberta Health Services.^107-109

Many physicians in Canada also refer to guidance from international groups. These international guidelines are briefly described in Appendix 2. Canadian and international guidelines are consistent in several key areas. They recommend assessing MASH in individuals with T2DM or abdominal obesity plus 1 additional metabolic risk factor, or when liver function test results are abnormal.^2,3,14,105 They also suggest that potential alternative causes of liver disease should be evaluated alongside MASLD. These conditions can co-occur, mimic, or mask MASH on imaging and laboratory testing, adding diagnostic and treatment uncertainty or complexity.^2,3,14,105 These may include:

• alcohol consumption patterns

• drug-induced liver disease

• viral hepatitis

• extrahepatic and hepatic autoimmune diseases

• certain genetic conditions

• endocrine disorders

• environmental toxins

• nutritional-related causes.

Guidelines are also aligned on the populations at risk of developing MASH, how to assess fibrosis risk, and the use of dietary and behavioural interventions as first-line treatments. However, they differ on the specific techniques used for fibrosis staging, current recommendations for pharmacologic treatment, and their integration of DMTs. Details on the alignment of Canadian and international guidelines are provided in Appendix 1, Table 6 and Table 7. Additional information on available guidelines is also presented in the dashboard under the Guidelines tab.

Baseline Fibrosis Staging and Assessment in the Care Pathway

Fibrosis Staging System

Fibrosis severity is a key marker of MASH progression and a strong predictor of mortality. Given that emerging DMTs target specific fibrosis stages (F2 to F3), these stages are often grouped into 3 clinically relevant categories, from F0 to F4:³⁸

• F0 to F1 — early-state disease

• F2 to F3 — moderate to advanced fibrosis

• F4 — cirrhosis.

Liver Biopsy

MASH is characterized by specific histological features that can only be definitively diagnosed through liver biopsy, a procedure in which tissue samples are collected for microscopic assessment.¹¹⁰ Although biopsy is the definitive test for MASH and MASLD, its use is limited because it is invasive, costly, time consuming to perform, and carries the risk for potential complications. These factors make routine biopsy impractical for large patient populations, particularly given the high prevalence of MASH and MASLD. As a result, noninvasive tests (NITs) are increasingly relied on for disease staging and risk stratification.^110-112

The types of invasive and noninvasive tests are illustrated in Figure 6.

Figure 6: Diagnostic Tools for Detecting MASH and MASLD

MASH = metabolic dysfunction–associated steatohepatitis, MASLD = metabolic dysfunction–associated steatotic liver disease; SOC = standard of care.

NITs for Fibrosis Assessment

NITs have been developed as practical alternatives to biopsy to help with the staging and detection of fibrosis.^104,105,113 These tests allow clinicians to align results with the fibrosis staging system and stratify patients’ disease into low-, intermediate-, and high-risk categories for fibrosis and high-risk MASLD or MASH.^105,114

All evidence- and consensus-based CPGs mentioned previously recommend a stepwise approach to fibrosis assessment using NITs. Figure 7 illustrates this pathway, with recommendations to begin with simple, low-cost tools for initial risk stratification and progress to more advanced imaging for confirmation when needed.

• Initial risk stratification uses the FIB-4 index.

• Secondary staging tests include the ELF score, VCTE, or SWE.^14,104-106

Figure 7: Current Recommended Pathway for Assessment of Fibrosis in Patients

ELF = Enhanced Liver Fibrosis; FIB-4 = Fibrosis-4; MRE = magnetic resonance elastography; NIT = noninvasive test; SWE = shear wave elastography; T2DM = type 2 diabetes mellitus; TE = transient elastography.

Notes: For adults aged older than 65 years, an indeterminate FIB-4 threshold is between 2.0 and 2.67. Thresholds presented in Figure 7 are for patients aged between 35 years and 65 years.

Thresholds for secondary NITs (e.g., kPa levels) are for VCTE measurements. Alternative tests (e.g., SWE, MRE, ELF) may have adapted or alternative thresholds.

Sources: European Association for the Study of the Liver, European Association for the Study of Diabetes, European Association for the Study of Obesity;² Sebastiani and Cinque;⁵⁹ and Wilson et al.¹⁰⁵

Reviewing Evidence on NITs for Accuracy and Reliability

NITs are increasingly used to support the assessment and staging of MASH. While NITs reduce reliance on biopsy, evidence shows variation in diagnostic performance across settings, disease stages, and patient populations. Because current diagnostic pathways were largely developed to identify high-risk advanced disease, earlier stages may be underdetected. As a result, diagnostic pathways may inadvertently limit detection of patients with early and moderate fibrosis who could benefit from emerging therapies. Reviewing the evidence on NIT performance provides context for understanding the current testing landscape and identifying gaps that may affect early patient identification.

Scope of the Rapid Review

CDA-AMC conducted a rapid review of recent systematic reviews and meta-analyses investigating the diagnostic accuracy of NITs. Six reviews considered to be of moderate or high methodological quality were included (full methods are available in Appendix 3 and results are available in Appendix 4).

To ensure practical relevance, the synthesis focused on the most commonly used tools referenced in CPGs (refer to Table 2). While this overview cannot fully resolve all remaining uncertainties in the diagnostic evidence, it provides critical context on:

• how these tools are currently applied

• where evidence gaps remain

• what considerations may influence future diagnostic pathways.

Key Findings From the Rapid Review

The rapid review found few large-scale (adequately powered) studies and noted inconsistencies (heterogeneity) across available evidence. Further, no NIT — or combination of NITs — demonstrated sensitivity and specificity (reflecting how well they correctly detect people who have the disease while accurately excluding those who do not) higher than 0.80 across multiple studies for detecting MASH.

Summary of NITs: Strengths, Limitations, and Key Characteristics

The NITs referenced here reflect those most frequently cited in Canadian CPGs and current care pathways. Practical considerations — such as accessibility, cost, and technical requirements — that influence their use in clinical settings are outlined in Table 2. Further details on each tool’s main characteristics are provided in Appendix 2, and Table 11 in Appendix 5 provides reported sensitivity and specificity from evidence included in the rapid review.

Table 2: Summary of Strengths and Limitations of Common NITs

CAP = controlled attenuation parameter; CSPH = clinically significant portal hypertension; ELF = Enhanced Liver Fibrosis; FIB-4 = Fibrosis-4; MASH = metabolic dysfunction–associated steatohepatitis; MRE = magnetic resonance elastography; NIT = noninvasive test; PDFF = proton density fat fraction SWE = shear wave elastography; VCTE = vibration-controlled transient elastography.

^aSecondary NIT is a confirmatory test for patients with high-risk results on initial screening (e.g., high FIB-4 scores).

Implications for Practice

The rapid review shows substantial variability in the accuracy and performance of NITs across populations, settings, and disease stages. These findings suggest that guideline approaches that emphasize risk stratification for advanced disease may limit detection of earlier stages. These findings suggest a need for clearer diagnostic pathways and broader validation of NITs in diverse populations.

System-Level Considerations for MASH Assessment

There are system-level considerations for assessing and diagnosing MASH with NITs, which are increasingly relevant with the recent conditional regulatory approval of a DMT in Canada. Earlier sections of this report, along with insights from clinical experts and patient engagement, point to challenges in diagnostic infrastructure, workforce capacity, provider readiness, reimbursement variation, and equity. The following subsections outline these considerations in detail and describe how they may affect the ability to scale timely and equitable diagnostic pathways, should DMTs become available and integrated into clinical practice.

Diagnostic Testing Infrastructure

Considerations for diagnostic capacity include the need for equipment (i.e., imaging devices, elastography systems, and blood sample processing), skilled operators, MRI procurement requirements, and, in some cases, patent-restricted technologies.^83,88,89 Supporting appropriate access to testing — particularly in rural, remote, and northern areas — could help minimize travel burdens for patients and families who typically need to visit large urban centres for testing.

Access to Testing

Noninvasive imaging tools, including VCTE, SWE, and MRI-based modalities, are concentrated in urban areas in Canada, while 30% of the population lives in rural or remote regions.⁹² Wait times may also pose challenges; in 2024, the median wait time for an MRI in Canada was 16.2 weeks,⁷³ with the longest delays in smaller provinces and northern regions.⁸³ Clinical experts and engagement participants similarly reported limited access to elastography, ELF testing, and MRI outside major centres, contributing to delays in screening and diagnosis.

For patients in rural and remote communities, long travel distances and extended wait times may delay disease staging. Participants in Indigenous-led and CDA-AMC–led engagement activities noted long wait times led to worsening physical and emotional well-being, including worsening severity of MASH and heightened stress and anxiety. Refer to the dashboard under the Liver Clinics and Diagnostic Units for Liver Fibrosis tab for more information on the known distribution of diagnostic tools in Canada. Refer to Appendix 1, Table 5 for further diagnostic differences across specific jurisdictions.

Human Resources

Demand for imaging and other diagnostic professionals continues to rise, while workforce growth has not kept pace with demand across Canada.⁷³ Training, upskilling, and retaining staff require time and resources and may affect service capacity. Demand for radiologists and technologists is high, particularly in rural regions where recruitment and retention rates are lower than in urban centres.^73,92 These disparities may affect wait times and reduce timely access to diagnostic services for patients outside major centres.

Canada also has limited numbers of diagnostic and molecular pathologists (3 per 100,000 population in 2024), which may affect turnaround times for results and the availability of specialized interpretation.⁸⁴ Additional information on provider distribution is available in the dashboard under the tab Number of Physicians.

Clinical Readiness and Testing Coverage

Increasing disease awareness and use of consensus pathways and CPGs, including embedding the FIB-4 calculation into standard laboratory test requisitions, have been suggested to strengthen risk stratification in primary care and reduce unnecessary specialist referrals.^94,132 However, the uptake of these approaches may vary across jurisdictions. Coverage for AST testing and VCTE varies, and in some areas availability may be limited to urban centres or require out-of-pocket costs.¹⁴

Cost-Effectiveness

Evidence indicates that noninvasive screening is cost-effective, particularly for populations living with obesity or T2DM. A Canadian study on the cost-effectiveness of risk stratification strategies in the community setting (i.e., FIB-4 assessment followed by SWE or VCTE) found that the most cost-effective strategy for identifying patients with substantial fibrosis (stages F2 higher) was using SWE alone.¹³³

Additionally, a study from the UK on the use of noninvasive liver fibrosis tests in primary care found that VCTE alone was the most effective for identifying patients with severe disease, while a sequential approach using the FIB-4 index followed by ELF testing offered the greatest cost savings.¹³⁴ These differences highlight how population characteristics and system structure influence optimal screening pathways.

Equitable Assessments Using NITs

Global studies have shown that standard screening thresholds, such as BMI, waist circumference, and fibrosis indices, were developed mainly in populations of white males in Western countries. As a result, these thresholds may underestimate risk in Indigenous populations, racialized communities, and females. These limitations in the data may affect the accuracy of assessments in diverse population groups and potentially lead to misclassification of liver disease status in diverse population groups.^28,135,136 Additionally, factors such as sex and age influence liver stiffness and fat distribution, affecting test sensitivity and specificity.¹³⁷

Comorbidities such as obesity and T2DM alter biomarker levels and disease progression, requiring tailored interpretation.¹³⁸ A standardized core outcome set of NITs, inclusive of diverse population characteristics, may help ensure more accurate diagnosis and risk stratification across all patient groups, including Indigenous Peoples and racialized populations.^139-141

The potential introduction of DMTs may also increase demand for liver biopsy as a confirmatory tool, even with expanded use of NITs. Eligibility for treatment may require definitive confirmation of fibrosis stage or steatohepatitis, and NITs may be insufficient in patients with borderline or discordant cases.^110-112 This could place additional strain on already limited specialist capacity, including pathologists.^73,84

Treatment

The December 2025 conditional regulatory approval of the first DMT for MASH, a GLP-1 RA, by Health Canada,³⁹ as well as emerging THR-beta agonists, may shift treatment approaches in Canada. This report draws on international clinical guidance that incorporates DMTs to outline emerging drug treatment procedures (also visualized in Figure 5) and provides system-level context for how these therapies may potentially be integrated into care pathways in Canada.

First-Line Approach

Lifestyle modification remains the cornerstone of MASH management in Canada. Diet and physical activity aimed at weight loss — typically 7% to 10% of body weight — are associated with improved liver fibrosis, while even modest reductions can benefit lean individuals (those with BMI < 25 kg/m² or < 23 kg/m² if Asian).^142,143 Eligibility for these interventions does not require a confirmed MASH diagnosis. Dietary and lifestyle changes that may be considered include:

• Mediterranean diet^55,56

• smoking avoidance^55,57

• alcohol avoidance⁵⁵

• regular physical activity.^55,58,59

DMTs are intended to build on existing lifestyle-based strategies, forming 1 part of a layered approach to MASH management rather than replacing foundational interventions.

Education and Support for Lifestyle Change

Effective lifestyle modification depends on supports that reflect individuals’ cultural, linguistic, and personal needs. A range of supportive tools may facilitate communication and engagement with health care providers, including:

• tailored treatment plans^144-146

• culturally and linguistically appropriate education^28,147,148

• peer and community-based navigation programs¹⁴⁹

• digital tools to support adherence (e.g., mobile apps, reminders, and telehealth follow-ups).^150,151

However, these supports are not consistently available across Canada. Rural and northern communities, in particular, have infrastructure limitations, connectivity challenges, and workforce constraints that reduce access to digital and culturally grounded resources.^75,152,153 When integrated into practice effectively, these support tools can promote shared decision-making by enabling culturally and linguistically aligned communication; supporting patient understanding of treatment options; facilitating ongoing monitoring of symptoms and treatment adherence; and helping patients address individual needs, navigate real-life challenges, and maintain sustained engagement and treatment consistency.^{144-146,150,151}

Lifestyle and Behavioural Support

Sustaining lifestyle changes may require addressing systemic barriers such as limited access to healthy food, safe spaces for physical activity, childcare, or flexible work hours. Evidence suggests that personalized and culturally aligned approaches — often supported through eHealth tools like online programs, smartwatch tracking, or reminder systems — can improve engagement and behaviour change.^154,155 These considerations highlight that lifestyle-based management is not solely a clinical issue but also a structural one, underscoring the need for context-appropriate supports as part of comprehensive MASH care.

Insights From People With Lived Experience

Participants in the Indigenous-led and CDA-AMC–led engagement activities described the need for more information and guidance about MASH. They noted it was difficult to understand which lifestyle modifications and therapies were appropriate for their stages of disease or comorbid conditions.

“I felt like I was wandering in the dark.”

– Participant in the CDA-AMC–led engagement who lives with MASH, reflecting on the limited information on treatment options

Participants reported having to research information about the disease and its treatments from other sources (e.g., internet searches, community support groups), and some later shared this information with their health care providers. Those who received lifestyle advice commented that it was not tailored to their culture or dietary preferences, and many sought alternative private services with added financial cost.

Indigenous participants reported the need for:

• plain-language information on MASLD and MASH

• workshops delivered within communities

• resources available in Indigenous languages

• culturally grounded teaching.

One participant expressed a desire for sessions specifically for female patients. Further, Indigenous participants emphasized that culturally safe liver care requires acknowledging and integrating Indigenous approaches.

“[Health systems could] access the traditional Healers and get their contributions.”

– Participant in the Indigenous-led engagement who lives with MASH, reflecting on how to improve the system

These perspectives reinforce the importance of culturally informed, accessible, and community-centred approaches as DMTs for MASH may become more integrated and available in Canada.

Recent Developments in DMTs for MASH

Internationally, 2 drug classes — GLP-1 RAs and THR-beta agonists — have approved therapies for MASH (refer to Table 3). More detailed descriptions of both GLP-1 RAs and THR-beta agonists, including their mechanisms and clinical roles, as well as evidence on existing and emerging DMTs in clinical development, are included in Appendix 2, Table 8.

Table 3: Regulatory Status and Health Technology Assessment Status of DMTs for MASH in Canada and Internationally as of March 2026

DMT = disease-modifying therapy; GLP-1 = glucagon-like peptide-1; MASH = metabolic dysfunction–associated steatohepatitis; RA = receptor agonist; THR = thyroid hormone receptor.

Eligibility for MASH DMTs

Determining Eligibility and Prescribing DMTs

Emerging DMTs are indicated for people with moderate to advanced fibrosis (stages F2 to F3). In Canada, treatment with the Health Canada–approved GLP-1 RA is indicated for noncirrhotic MASH with F2 to F3 fibrosis, alongside diet and exercise.¹⁶⁵ Eligibility is therefore contingent on accurate fibrosis staging, which is typically assessed using NITs. Screening tools such as FIB-4 assist with risk stratification but do not provide the level of precision needed to confirm fibrosis stage.^2,166,167

Current Practice and Opportunities

Clinicians frequently manage MASH indirectly through cardiometabolic therapies.^63,168-178 Opportunities to strengthen the treatment pathway have been identified and include:

• standardizing fibrosis staging protocols and thresholds^167,179-181

• clarifying provider roles across disciplines^49,182-191

• addressing treatment-related stigma^{49,101-103,188,189}

• tailoring care to address structural barriers influencing access and treatment adherence.^{28,135,190-192}

Refer to Appendix 2, for detailed information on indirect prescribing practices; fibrosis staging and related equity considerations; and provider roles and scope in MASH care. Appendix 2 also provides additional context on patient perspectives, including treatment stigma, perceptions of DMTs, and structural barriers, that influence engagement with care.

Treatment Administration

Administration of DMTs may raise multiple implementation considerations including clinical protocol, patient support and accessibility, infrastructure, and care coordination. Addressing these considerations could help ensure equitable availability and use of emerging MASH DMTs, should they become widely integrated in Canada.

Practice guidance from the US provides approaches for patient eligibility assessment, noninvasive fibrosis assessment, structured monitoring, and coordinated care.^167,180,193 Clinical experts engaged for this review noted that similar guidance could help support consistent, equitable implementation in Canada.

“I don't think we should have to beg.”

– Participant in the Indigenous-led engagement activity who lives with MASH, reflecting on the need for affordable medicine

Participants from Indigenous-led and CDA-AMC–led engagement sessions shared concerns about the potential introduction of emerging DMTs in Canada, especially related to cost and coverage. Indigenous participants highlighted concerns around Non‑Insured Health Benefits coverage and related administrative processes. Participants noted uncertainty about whether the drugs would be accessible, including coverage by provincial , or federal programs; affordability concerns for people on fixed incomes; potential Non‑Insured Health Benefits delays or denials; and lack of clarity about who would ultimately qualify for treatment.

Treatment Monitoring and Life Cycle Management

Experts engaged for this review noted that effective management of patients who initiate treatment with DMTs such as GLP-1 RAs or THR-beta agonists may benefit from a structured life cycle approach. This approach could support safety, tolerability, and sustained treatment effectiveness.

While monitoring protocols are still evolving, international expert consensus and updated practice guidance provide early direction for clinical practice.^167,180,193 A structured life cycle typically includes early follow-up (within the first 3 months) to assess treatment adherence and tolerability; an effectiveness assessment at 6 to 12 months using NITs and laboratory test markers; and ongoing periodic monitoring according to disease severity and comorbidities, followed by continuation or discontinuation based on response, safety, and patient preference.^167,180,193 Clinical responses that may result in discontinuation of treatment include improvement in liver fibrosis, normalization or reductions in liver enzymes and other cardiometabolic markers, or weight loss and metabolic improvement.

A brief overview of the life cycle is visualized in Figure 8 and additional details on life cycle monitoring steps are outlined in Appendix 2.

Figure 8: Treatment Monitoring and Life Cycle Management for MASH DMTs

NIT = noninvasive test.

Sources: Bansal et al.¹⁹³ and Chen et al.¹⁸⁰

System enablers to support monitoring may include remote follow-up,^194,195 integrated clinical decision support, risk-adapted monitoring, shared care models involving nurses and pharmacists,^196,197 and multidisciplinary approaches encompassing both liver and cardiometabolic care.^198-201 Sustained access to laboratory testing and imaging is essential for repeat assessments, but capacity may be limited — particularly in Indigenous, rural, remote, and northern communities.^{95,167,180,193,202-205} Appendix 2 provides additional details on multidisciplinary monitoring approaches, coordinated access to testing, and support for treatment adherence.

Coordinating Care Pathways

Early identification and management of MASH may help prevent or slow disease progression, avoid costly complications (e.g., cirrhosis, decompensated cirrhosis, liver cancer, transplant), and improve quality of life. Canadian^14,107,108 and international^181,206 clinical practice guidance emphasize the central role of primary care in early detection and the need for coordinated care.

However, there is no standardized MASH care pathway in Canada and no clear standard regarding which health care providers or specialists should coordinate care.²⁰⁷ As a result, patients often consult multiple providers before receiving a diagnosis.²⁴ According to clinical experts consulted for this review, these unclear referral responsibilities and fragmented care processes contribute to delays in identification and treatment.

Multidisciplinary Team Roles

Advanced disease is typically managed by hepatologists; however, growing evidence supports the adoption of multidisciplinary and nurse-led collaborative models across all stages of care.^95,202 Without such coordination, patients may remain undiagnosed until advanced stages of disease, leading to higher system costs as well as higher rates of morbidity and mortality.²⁰⁸

Experts consulted for this review suggested that effective management of MASH may be achieved through collaboration models that include multiple providers:

• primary care (physicians and nurse practitioners for early detection and ongoing management)

• specialists (hepatologists, endocrinologists, gastroenterologists, and transplant teams for advanced disease)

• allied health care providers (dietitians, diabetes educators, mental health professionals, and obesity or weight management specialists)

• laboratory medicine and imaging specialists (for disease staging and monitoring)

• social workers, care coordinators, and system navigators (to address social determinants of health and connect patients to resources)

• pharmacists (for medication management and adherence).

System-Level Challenges for Integrating Care

Some system-level challenges may limit integrated care for MASH in Canada, particularly in anticipation of potential DMTs, including limited access to PCPs, specialist physicians, and coordinated care models. Additional considerations for coordinated care include integrated pathways and jurisdictional capacity.

Integrated Pathways

Currently, there are limited or no standardized referral pathways or secure digital information sharing platforms, which may limit collaboration, delay early intervention, and create workflow challenges, especially if demand for services increases.^95,209-211 According to a gastroenterologist consulted for this review, fragmentation of the health care delivery system and unclear referral responsibilities can hinder timely care, particularly when PCPs require additional knowledge or guidance in managing metabolic liver disease. Indigenous individuals living with MASH who contributed insights to this report recommended that liver assessments be integrated into existing chronic disease management (e.g., diabetes care) to support earlier detection and reduce burdens experienced by patients.

Jurisdictional Capacity

According to a pathologist consulted for this review, in smaller provinces, such as those in Atlantic Canada, limited hepatology capacity and reliance on out-of-province pathology services can delay diagnosis and disrupt care coordination. Rural areas may have limited diagnostic infrastructure as well as licensure and recruitment challenges, which have been shown to result in hepatology consultation wait times of up to a year — often longer than those experienced by people living with MASH in urban areas.^83,212 For more detailed information on capacity and staffing resources, use the dashboard to access detailed information: select the Liver Clinics and Diagnostic Units for Liver Fibrosis tab for more information on the distribution of diagnostic tools in jurisdictions in Canada and the Number of Physicians tab for information on the distribution of physicians across Canada.

Clear responsibilities and standardized MASH care pathways — supported by interoperable data systems, coordinated referral structures, multidisciplinary models, and culturally safe care approaches — could improve equity, efficiency, and outcomes across the MASH care continuum. Additional detailed findings on equity considerations, referral processes, and system navigation challenges are provided in Appendix 2.

Technologies for Integrated MASH Care

A range of technologies could support efficient, coordinated care with attention paid to building on existing infrastructure and ensuring equitable access across diverse populations.

Insights from a DocuStory film co-created with First Nations and Métis Knowledge Keepers, community advocates, and Elders highlighted the importance of understanding liver health within community and cultural contexts, reinforcing that collective well-being depends on both system and relational balance.²¹³ This emphasis on balance can guide how care is designed and how technologies are selected for integrated MASH care.

System-Level Technologies

Health care organizations and authorities are increasingly adopting digital records and supporting mobile health and telehealth programs for more efficient care delivery in Canada.^214,215 As individuals with MASH often consult multiple health care providers for metabolic, hepatic, and cardiovascular care, there may be value in coordinated care and interoperable systems.

There is an opportunity to strengthen coordination by building digital infrastructure with interoperable records, which could improve timely access, enable effective data sharing, and support patient-centred service delivery.^216,217 Such infrastructure could also facilitate rapid, consent-based information access across communities, institutions, and jurisdictions²¹⁸ to reduce redundancy, strengthen integration, and thereby help ensure that care is both efficient and responsive to patient needs.

Some technologies and strategies may offer opportunities to enhance system capacity and improve coordination of care, including:

• decentralized blockchain-based systems, which provide shared, tamperproof records managed collectively rather than by a single authority (these are being explored in the modernization of health systems in Canada, particularly for consent management, data security, and audit trails; their adoption remains exploratory and would require governance frameworks, technical standards, and phased pilot testing)^219,220

• mobile health clinics (these are used in Australia and the UK for liver disease screening and staging and could support MASH point-of-care assessment and management in Canada;²²¹ mobile programs in Canada currently offer services such as screening and vaccinations, but liver-specific care remains limited)^221-223

• telehealth (or telemedicine) to support MASH care through live video consultation, storage and forwarding of messages, and remote monitoring for both patient–provider and provider–provider communication (while used in Canada, broader adoption requires interoperable electronic records, interjurisdictional licensing, and strategies to address privacy and security risks associated with digitized health records)^224-227

• immersive training technologies (virtual reality simulations can enhance practitioners’ training through hands-on experience performing technical procedures such as percutaneous liver biopsy;²²⁸ these technologies could improve access to standardized education across the system).

Emerging MASH-Specific Technologies

Building on system-level infrastructure, targeted tools for MASH may improve access to and efficiency of diagnosis, staging, and patient-centred management.²²⁹

Emerging technologies to consider for enhancing system capacity and MASH care include the following options.

Artificial Intelligence and Machine Learning Models

Artificial intelligence (AI) and machine learning models are increasingly being applied to imaging modalities (e.g., ultrasound, MRI) for detecting, quantifying, and staging steatosis, fibrosis, and related changes.^230-232 While these tools are not currently integrated in routine clinical practice, they have the potential to improve diagnostic accuracy and efficiency.

However, AI tools trained using homogenous datasets that underrepresent diverse populations risk introducing bias.^233-235 Fair implementation requires diverse data, bias auditing, strong governance and oversight,²³⁶ secure data management,²³⁷ and coordinated infrastructure and implementation readiness.^237-239 Transparent use of AI may support, not replace, clinical interactions to build trust and meaningful care provision.²⁴⁰

Digital Pathology and Spatial Omics

Digital pathology and spatial omics allow detailed visualization of liver inflammation and fibrosis patterns in MASH. Digital pathology uses high-resolution scans of liver biopsy slides, while spatial omics maps how genes and proteins are expressed within specific areas of the tissue. Readily available digitized images may improve access, reduce turnaround times, and decrease costs.

Emerging AI-based tools include:

• PathAI’s AIM-MASH, which uses deep learning to automatically score biopsy features like ballooning and fibrosis

• HistoIndex’s qFibrosis, which quantifies tissue architecture without traditional chemical stains.^241-243

These tools may support novel biomarker discovery and improved diagnostic precision but are still in development and may require advanced equipment and standardized methods.^244,245

Multiomics and Biomarker Approaches

Multiomics and biomarker approaches (i.e., genomics, transcriptomics, proteomics, and metabolomics) provide high-throughput profiles of disease mechanisms, offer noninvasive biomarkers for diagnosis and staging, and may identify novel therapeutic targets in MASH.^246-248 Successful clinical translation will require validation in diverse populations, robust computational frameworks, and workflow integrated adoption.²⁴⁹

Decision Support Tools

Decision support tools and automatic risk flagging embedded in electronic medical record decision support tools can automatically flag patients at high risk, prompt screening (e.g., FIB-4 score calculations), and support clinician decision-making.^250-252 These tools can reduce gaps in care but depend on communication between data systems, clinician workflow integration, and equitable access.²⁵³

Endoscopic Biopsies

Endoscopic biopsies can combine multiple diagnostic procedures into a single session, reducing patient burden and improving efficiency. Ultrasound-guided endoscopic liver biopsies are conducted in some places in Canada.²⁵⁴ However, tissue samples collected using ultrasound-guided endoscopic biopsies are often smaller or fragmented, which can make it harder to accurately assess fibrosis stage or may result in diagnosing milder stages of fibrosis when the disease is, in fact, advanced.^255,256

Limitations

This report aims to provide a high-level overview of health system readiness and related considerations for the potential introduction of emerging DMTs in Canada. It does not assess the clinical effectiveness of these treatments. As of the timing of the publication of this report, 1 pharmacologic therapy for MASH has received conditional regulatory approval in Canada, a GLP-1 receptor agonist. No other treatments, including THR‑beta agonists, are currently approved or under regulatory or reimbursement review in Canada. Additional DMTs in earlier stages of development, which may involve distinct considerations, are outside the scope of this report.

This report is also limited to information publicly available online and accessible through database or manual literature searches. Given the complex nature of health care systems in Canada and of MASH care, it is possible that not all jurisdictional perspectives were captured through our expert consultations. Some of the challenges and considerations discussed in this report may only apply to certain provinces or territories, or their effects may differ in magnitude across provinces and territories. Access to provincial and territorial health systems data could provide important information around the demographic profile and clinical profiles of patients with MASH. This information, in conjunction with knowledge about the current care pathways, could be used to project MASH demographic characteristics and plan for care optimization. Similarly, not all perspectives were captured by the Indigenous-led and CDA-AMC–led engagement activities. The lack of certain perspectives (including racialized communities, individuals from 2SLGBTQ+ communities, and individuals with low incomes) may limit the breadth of considerations, especially related to equity and experiences with existing MASH care pathways. Limitations of the rapid review are detailed in Appendix 4.

Future Considerations and System Readiness for MASH Treatments

The conditional regulatory approval of the first DMT in Canada signals an opportunity to assess how MASH is identified and managed, including potential pressure points and opportunities for system change. Early identification of MASH remains critical.

When diagnosis and treatment are delayed, disease progression can lead to substantially higher burden for both individuals and the health system.²⁵⁷ Globally, more than 10% of individuals with cirrhosis are estimated to experience decompensated cirrhosis each year.²⁵⁸ Decompensated cirrhosis may cause complications such as ascites (fluid build-up in the abdomen), variceal bleeding (bleeding from veins in the esophagus), and hepatic encephalopathy (change in mental state), which are associated with high health care use and patient burden.²⁵⁹

Emerging DMTs target specific disease stages (typically F2 to F3) and therefore are intended to reduce disease progression and downstream system effects by intervening earlier in the disease course. Lifestyle modifications may also effectively slow or prevent MASH progression. Realizing these benefits, however, depends on timely, reliable, and coordinated pathways to screen for, diagnose, and treat MASH.

Indigenous participants identified specific barriers that require attention — such as travel burdens, limited availability of culturally safe care, and experiences of misattributed symptoms. Improving access to Indigenous care navigators may help strengthen trust and support more equitable navigation of MASH diagnostic and treatment pathways.

System Priorities to Strengthen the MASH Care Pathway

This assessment highlights that changes within the patient care pathway may strengthen readiness for the potential introduction of DMTs into clinical care. To support existing care while avoiding widening inequities, health systems may consider the following efforts.

Improve Early Detection and Diagnostic Infrastructure

• Launch education and awareness initiatives with destigmatized MASH information.

• Integrate screening into mobile or telehealth programs and chronic disease programs for diabetes, obesity, and cardiovascular care.

• Build capacity for noninvasive diagnostic tests, including blood tests and elastography.

• Enhance provider training for new biomarkers and NITs.

• Develop diagnostic pathways for early disease detection.

• Expand screening and staging capacity to support diagnostic efficiency.

• Ensure access to standardized blood tests for early fibrosis detection.

Support Care Coordination and Multidisciplinary Models

• Integrate multidisciplinary care providers (nurses, pharmacists, allied health care providers) with standardized approaches to reduce fragmentation.

• Workforce planning to ensure hepatologist, radiologist, and pathologist capacity can meet demand.

• Provide tailored treatment plans; culturally safe and linguistically appropriate education; and peer and community-based navigation programs.

• Develop multidisciplinary models with interoperable data systems and clear protocols.

• Embed equity considerations across diagnostic pathways and strengthen navigation and shared care models to improve continuity of care for patients from populations disproportionately affected by fragmented services and geographic barriers.

Build Capacity for Monitoring, Integrated Digital Health, and Emerging DMTs

• Build digital infrastructure with governance models for remote diagnostic and monitoring capabilities.

• Explore digital adherence tools to support shared decision-making, lifestyle changes, and treatment consistency.

• Standardize and align processes for equitable access to diagnostic tests and therapies.

• Expand culturally safe care approaches with options that consider underserved populations, including Indigenous Peoples, racialized populations, immigrants and newcomers to Canada, and people living in rural, remote, northern, and low-income settings.

• Explore future technologies, including AI-driven tools, to improve diagnostic consistency and access.

This report highlights that specific groups of people in Canada may face challenges in accessing clinicians with the knowledge to identify and diagnose MASH. The technologies and services needed to diagnose the presence and severity of the disease may be difficult to access. Some populations — including Indigenous Peoples; people living in rural, remote, and northern areas; people in low-income settings; racialized populations; and immigrants — often face obstacles when attempting to access health care systems, which can undermine efforts to achieve health equity.

Alignment in disease identification, severity assessment, and treatment protocols, along with patient and caregiver engagement, could support a patient-centred approach to the management of MASH. Such changes would require consideration of human resources, clinical training, and infrastructure needs to support sustainable, equitable care delivery. Strategies may differ among provincial and territorial health care systems, given existing local structures and population needs.

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303.Merck Sharp & Dohme LLC. NCT06465186: A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017). ClinicalTrials.gov. Accessed September 23, 2025. https://clinicaltrials.gov/study/NCT06465186

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306.Corcept Therapeutics. NCT06108219: A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH). ClinicalTrials.gov. Accessed September 23, 2025. https://clinicaltrials.gov/study/NCT06108219

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308.Boehringer Ingelheim. NCT06309992: A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight. ClinicalTrials.gov. Accessed September 23, 2025. https://clinicaltrials.gov/study/NCT06309992

309.Boehringer Ingelheim. NCT06632457: LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis. ClinicalTrials.gov. Accessed September 23, 2025. https://clinicaltrials.gov/study/NCT06632457

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Appendix 1: Nomenclature and Jurisdictional Diagnostic Pathways

Please note that this appendix has not been copy-edited.

Table 4: Changes in Nomenclature and Diagnostic Criteria Introduced by the 2023 Multisociety Delphi Consensus Redefining NAFLD as MASLD

MASLD = metabolic dysfunction–associated steatotic liver disease; NAFLD = nonalcoholic fatty liver disease.

Table 5: Jurisdictional Overview of MASH Care Pathways and Diagnostic Tools in Canada

ALT = alanine aminotransferase; AST = aspartate aminotransferase; CPG = clinical practice guideline; ELF = enhanced liver fibrosis; FIB-4 = Fibrosis-4; MASLD = metabolic dysfunction–associated steatotic liver disease; MASH = metabolic dysfunction–associated steatohepatitis; VCTE = vibration-controlled transient elastography.

^aInformation presented in this table is based on available information from targeted online searches and interviews with content experts in Canada. Content experts consulted were from British Columbia, Alberta, Ontario, and Nova Scotia. Additional jurisdictional activities or considerations may exist that are not capture herein. Additional information on the distribution of diagnostic units and liver clinics is available in the dashboard.

Table 6: Alignment of Canadian Guidelines and Pathways for MASH