Reimbursement Recommendation

Lebrikizumab (Ebglyss)

Indication: For the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Lebrikizumab can be used with or without topical corticosteroids.

Sponsor: Eli Lilly Canada, Inc.

Final recommendation: Reimburse with conditions

What Is the Reimbursement Recommendation for Ebglyss?

Canada’s Drug Agency (CDA-AMC) recommends that Ebglyss be reimbursed by public drug plans for the “treatment of moderate-to-severe atopic dermatitis [AD] in adults and adolescents 12 years of age and older with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable” if certain conditions are met.

Why Did CDA-AMC Recommend Reimbursement?

• CDA-AMC previously reviewed Ebglyss for the treatment of moderate to severe AD in adults and adolescents whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, and the recommendation issued was do not reimburse. This is a resubmission based on new information submitted by the sponsor to address evidence gaps identified in the previous recommendation.

• In this review, the Canadian Drug Expert Committee (CDEC) determined that Ebglyss demonstrates acceptable clinical value versus dupilumab, abrocitinib, and upadacitinib for the treatment of adults and adolescents with moderate to severe AD with a body weight of at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. This determination was enough for CDEC to recommend that Ebglyss be reimbursed. Given that Ebglyss is expected to be an alternative to dupilumab, abrocitinib, and upadacitinib, acceptable clinical value refers to at least comparable value versus these comparators.

• Previously reviewed evidence from 3 clinical trials showed that, over 16 weeks, Ebglyss reduced AD severity and itching compared with placebo in adults and adolescents with moderate to severe AD that was not adequately controlled with topical therapies.

• New longer-term evidence suggests that the efficacy of Ebglyss may be sustained for up to 100 weeks and there are no new safety concerns, but no firm conclusions could be drawn due to limitations of the single-arm study design.

• Although new indirect treatment comparisons (ITCs) were associated with methodological limitations and imprecision, CDEC felt the results did not demonstrate significant differences in efficacy outcomes between the treatments and found it reasonable to consider them comparable in efficacy.

• Ebglyss meets some patient needs by offering an additional treatment option that could reduce severity of AD.

Which Patients Are Eligible for Coverage?

Ebglyss should only be reimbursed to treat patients aged 12 years and older with moderate to severe AD, provided that Ebglyss is reimbursed in a similar way to other advanced systemic therapies (i.e., biologics or Janus kinase [JAK] inhibitors) currently reimbursed by public drug plans for the treatment of moderate to severe AD.

What Are the Conditions for Reimbursement?

In addition to following the pre-existing criteria for other advanced systemic therapies, Ebglyss should not be reimbursed for use in combination with other advanced systemic therapies. Ebglyss should only be reimbursed if the drug program cost of Ebglyss does not exceed the drug program cost of treatment with the least-costly advanced systemic therapy for the same indication.

Important budget impact considerations must be addressed for health systems to be able to adopt Ebglyss.

Review Background

• Disease background: AD is a chronic, relapsing, inflammatory skin disease characterized by pruritus and eczematous skin lesions, pain, tenderness, and skin dryness that contribute to significant physical, psychological, and quality-of-life burden for both patients and caregivers. International survey data suggest that the prevalence of AD in Canada was approximately 4% among adults in 2016 and approximately 15% among children in 2019.

• Indication and reimbursement request: Lebrikizumab has been approved by Health Canada “for the treatment of moderate-to-severe AD in adults and adolescents 12 years of age and older with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Lebrikizumab can be used with or without topical corticosteroids [TCS].” The sponsor is seeking reimbursement for this patient population.

• Drug under review: Lebrikizumab is an immunoglobulin G4 monoclonal antibody that inhibits interleukin-13. It is available as a 250 mg per 2 mL solution administered by subcutaneous injection. The recommended dosage in the product monograph is an initial dose of 500 mg (two 250 mg injections) injected subcutaneously at week 0 and week 2, followed by 250 mg (1 injection) every 2 weeks until week 16. Once clinical response is achieved, the recommended maintenance dosage is 250 mg every 4 weeks starting at week 16.

• Treatment costs: At the submitted price of $1,949.90 per prefilled pen or prefilled syringe with needle shield (250 mg per 2 mL), the annual cost of lebrikizumab is expected to be $37,048 per patient in the first year and $25,349 in subsequent years based on the Health Canada–recommended dosage.

• Submission history: Lebrikizumab for the treatment of moderate to severe AD in adults and adolescents aged 12 years and older with a body weight of at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable was previously reviewed by CDA-AMC and received a recommendation not to reimburse from CDEC on October 9, 2024. The initial review of lebrikizumab included 3 pivotal randomized controlled trials (RCTs), 1 long-term extension (LTE) study, 1 network meta-analysis (NMA), and 4 studies addressing gaps in the evidence. Key reasons for the recommendation included:

  • insufficient evidence that lebrikizumab would address the unmet needs of patients because of the uncertainty around the benefit of lebrikizumab versus appropriate comparators and its effectiveness in patients with prior exposure to dupilumab or JAK inhibitors

  • no evidence was submitted that directly compared lebrikizumab to currently available treatments for AD and the certainty of evidence from the submitted ITCs was limited

  • the safety and effects on health-related quality of life (HRQoL) of lebrikizumab relative to other treatments for AD is unknown because no comparative evidence was submitted

  • longer-term safety and efficacy were uncertain because of limitations of the study designs and analysis with the available evidence.

• Basis of resubmission: This resubmission is based on new evidence submitted by the sponsor (1 LTE study with extended follow-up, 1 updated NMA, and 2 new matching-adjusted indirect comparisons [MAICs]). These data provide longer-term efficacy and safety results for lebrikizumab and indirect comparative efficacy and safety of lebrikizumab relative to other advanced AD therapies in the short term and longer term.

Highlights of Input From Interested Parties

The patient groups (Canadian Skin Patient Alliance [CSPA] in collaboration with Eczéma Québec and the Eczema Society of Canada) noted the following regarding impacts of the disease, unmet needs, and important outcomes:

• Patients with moderate to severe AD experience persistent itch, pain, sleep disturbance, and visible skin changes that substantially impair daily functioning, emotional well-being, and social participation. These ongoing symptoms and frequent flares contribute to significant physical, psychological, and quality-of-life burden for both patients and caregivers. They reported persistent symptoms, side effects, burdensome treatment routines, and inequitable access due to cost and reimbursement barriers with existing treatments. There is also limited access to phototherapy and specialist care. They highlighted the need for more effective, well-tolerated, and accessible treatment options.

• They emphasized treatment outcomes, such as sustained symptom control, reduction of flares, improved quality of life, and fewer side effects as well as access to therapies that are affordable, practical to use, minimize reliance on topical treatments, and do not require injections.

The clinician groups (Fraser Health Dermatology Group, Atlantic Dermatology Group, and a group of clinicians who frequently work with Indigenous patients and communities) and the clinical experts consulted by CDA-AMC noted the following regarding unmet needs arising from the disease and place in therapy for the drug under review:

• Despite the availability of multiple systemic therapies for AD, a subset of patients continue to experience inadequate or nondurable response, including incomplete skin clearance. Existing treatments are associated with adverse events (AEs). Some patients are unable to be treated with JAK inhibitors due to comorbid conditions or contraindicated concomitant medications. Conventional immunosuppressants are generally less effective and not suitable for long-term use because they are associated with frequent AEs and laboratory monitoring requirements. Access to phototherapy is also limited, especially in remote or rural communities. The clinical experts indicated that a clear unmet need still remains for additional therapies that improve both efficacy and tolerability compared to existing treatments for moderate to severe AD.

• The clinician groups and clinical experts indicated that lebrikizumab shares a similar place in therapy as existing biologics: as a first-line advanced therapy in patients with moderate to severe AD whose disease is inadequately controlled with topical therapies or when such therapies are not advisable. Additionally, the clinical experts noted lebrikizumab could be considered for patients experiencing refractory disease or with an intolerance to existing advanced therapy.

The participating public drug programs raised potential implementation issues related to therapy initiation and prescribing.

Recommendation

With a vote of 10 in favour to 2 against, CDEC recommends that lebrikizumab be reimbursed for the “treatment of moderate-to-severe AD in adults and adolescents 12 years of age and older with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable” only if the conditions listed in Table 1 are met.

This recommendation supersedes the CDEC recommendation for this drug and indication dated October 9, 2024.

Table 1: Reimbursement Conditions and Reasons

AD = atopic dermatitis; CDA-AMC = Canada’s Drug Agency; JAK = Janus kinase.

Rationale for the Recommendation

Clinical Value

Based on the totality of clinical evidence, CDEC concluded that lebrikizumab demonstrates acceptable clinical value compared with appropriate comparators, including dupilumab, abrocitinib, and upadacitinib, for the treatment of moderate to severe AD in adults and adolescents aged 12 years and older with a body weight of at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Given that lebrikizumab is expected to be an alternative to dupilumab, abrocitinib, and upadacitinib, acceptable clinical value refers to at least comparable value versus these comparators.

In the previous recommendation, CDEC concluded that, based on evidence from 3 pivotal phase III RCTs (ADvocate 1: N = 424; ADvocate 2: N = 427; Adhere: N = 211), lebrikizumab induction therapy (with or without TCS) provided clinically meaningful improvements in physician-assessed Eczema Area and Severity Index (EASI) and Investigator Global Assessment (IGA) scores and reduced patient-reported itch symptoms compared with placebo at 16 weeks in adults and adolescents with moderate to severe AD that was not adequately controlled with topical therapies. Additional evidence previously reviewed by CDEC included 1 LTE study (ADjoin) assessing the long-term efficacy and safety lebrikizumab in adults and adolescents with moderate to severe AD, 1 NMA (comparing lebrikizumab with dupilumab, abrocitinib, and upadacitinib), and 4 other studies addressing evidence gaps (ADvantage, ADore, ADopt-VA, ADhere-J). The ADvantage RCT provided support for the efficacy and safety of lebrikizumab in combination with TCS relative to placebo in adults and adolescents with moderate to severe AD that was not adequately controlled with cyclosporine or for whom cyclosporine was not medically advisable, with results generally consistent with the pivotal RCTs.

Evidence informing this resubmission presented new clinical information to support the efficacy and safety of lebrikizumab for the treatment of AD and to address several limitations identified in the initial submission, which included uncertainty in longer-term outcomes and comparative effectiveness versus other treatments and a lack of comparative evidence for HRQoL and safety outcomes. The new evidence included longer-term data from the ADjoin study (N = 1,153) up to 100 weeks as well as ITCs versus dupilumab 300 mg, abrocitinib 100 mg and 200 mg, and upadacitinib 15 mg and 30 mg from an updated NMA assessing additional outcomes (EASI, HRQoL, and harms) at week 16, and 2 new MAICs providing comparative evidence at approximately 52 weeks. There remains a lack of direct comparative evidence between lebrikizumab and other advanced therapies. Results from the ADjoin study suggest that the efficacy of lebrikizumab may be sustained for up to 100 weeks with no new safety concerns; however, no firm conclusions could be drawn due to the absence of a comparator arm. Results from the new indirect evidence suggest that upadacitinib 30 mg may be favoured over lebrikizumab for percent change from baseline in EASI at week 16. In contrast, lebrikizumab may be favoured over abrocitinib 100 mg in achieving EASI 75 (≥ 75% improvement from baseline in EASI score), IGA 0 or 1 (patients with clear or almost clear skin), and EASI 90 responses (≥ 90% improvement from baseline in EASI score), and favoured over dupilumab 300 mg in achieving an IGA 0 or 1 response at week 52. All other comparative efficacy estimates, including alternate doses of upadacitinib and abrocitinib, were imprecise with 95% credible intervals including the potential that either lebrikizumab or the comparators could be favoured or that there was no difference between the treatments. For overall AEs, results at week 16 generally favoured lebrikizumab over the comparators within the monotherapy network while, at week 52, lebrikizumab was favoured over upadacitinib 30 mg and abrocitinib 100 mg and 200 mg. Although the ITCs were associated with methodological limitations and imprecision, CDEC felt the results did not demonstrate significant differences in efficacy outcomes between the treatments and found it reasonable to consider them comparable in efficacy.

Further information on the committee’s discussion regarding clinical value is provided in the Summary of Deliberation section.

Developing the Recommendation

The determination of acceptable clinical value was sufficient for CDEC to recommend reimbursement of lebrikizumab. As part of the deliberation on whether to recommend reimbursement, the committee also considered unmet clinical need, unmet nonclinical need, and health inequity. Information on this discussion is provided in the Unmet Clinical Need and Distinct Social and Ethical Considerations domains in the Summary of Deliberation section.

Because CDEC recommended that lebrikizumab be reimbursed, the committee also deliberated on whether reimbursement conditions should be added to address important economic considerations, health system impacts, or social and ethical considerations, or to ensure clinical value is realized. The resulting reimbursement conditions, with accompanying reasons and implementation guidance, are presented in Table 1.

Summary of Deliberation

CDEC considered all domains of value of the deliberative framework before developing its recommendation: clinical value, unmet clinical need, distinct social and ethical considerations, economic considerations, and impacts on health systems. For further information on the domains of value, refer to Expert Committee Deliberation at Canada’s Drug Agency.

The committee considered the following key discussion points, organized by the 5 domains of value.

Clinical Value

• Appropriate comparators: CDEC noted that dupilumab, abrocitinib, and upadacitinib are appropriate comparators for lebrikizumab in the population under review.

• Place in therapy: Currently, dupilumab, abrocitinib, and upadacitinib are reimbursed by the public drug programs in patients with disease that is not adequately controlled with, or who have contraindications to, systemic immunosuppressants. Although CDEC acknowledged that clinical practice guidelines have evolved, with advanced therapies now recommended as first-line systemic treatment in patients whose disease is not adequately controlled with topical therapies, the committee noted that lebrikizumab should have the same place in therapy as other biologics and that the reimbursement criteria for lebrikizumab should be aligned with other advanced therapies.

• Efficacy versus placebo: Three pivotal RCTs in the initial submission assessed the use of lebrikizumab monotherapy (ADvocate 1: N = 424; ADvocate 2: N = 427) or in combination with TCS (Adhere: N = 211) in adults and adolescents with moderate to severe AD not adequately controlled with topical therapies. Between 43% and 56% of patients had previously received treatment with systemic immunomodulatory drugs (e.g., corticosteroid, conventional immunosuppressants). The trials demonstrated that lebrikizumab induction therapy results in an increase in the proportion of patients with an IGA response, EASI 75 response, and at least a 4-point improvement in the Pruritus Numeric Rating Scale (NRS) when compared with placebo. Across the trials, the differences between lebrikizumab and placebo at week 16 were between 18.3% and 29.7% in the proportion of patients with an IGA score of 0 or 1 and there was at least a 2-point improvement from baseline in the proportion of patients with an EASI 75 response (between 26.4% and 42.0%) and in the proportion of patients with at least 4-point improvement in Pruritus NRS from baseline (between 19.2% to 32.9%). Lebrikizumab may also result in a reduction in the Patient Oriented Eczema Measure (POEM) and Dermatology Life Quality Index (DLQI) scores at week 16 compared with placebo. The evidence is very uncertain about the effect of lebrikizumab on the change in Children’s DLQI (CDLQI) when compared with placebo.

  CDEC further examined evidence from the ADvantage RCT of the initial submission, which addressed an evidence gap in adults and adolescents with moderate to severe AD that was not adequately controlled with cyclosporine or for whom cyclosporine was not medically advisable. The ADvantage study showed results consistent with the pivotal RCTs. The difference at week 16 between lebrikizumab plus TCS and placebo plus TCS in the proportion of patients with an IGA response was 27.9% (95% CI, 15.6% to 40.1%), 17.8% (95% CI, 7.0% to 28.6%) for the proportion with an EASI 75 response, and 18.2% (95% CI, 5.5% to 30.8%) for the proportion with at least a 4-point improvement in the Pruritus NRS. CDEC noted that this generally aligns with the evidence submitted for other therapies currently reimbursed for moderate to severe AD.

• Clinical importance of treatment effects: Based on the input received for this review, patients identified sustained symptom control, improved quality of life, reduced flares, fewer side effects, and minimized reliance on topical treatments as important clinical outcomes. CDEC noted that, based on the submitted pivotal RCT evidence, lebrikizumab induction treatment provided clinically important improvements in physician-assessed signs of AD and reduced patient-reported symptoms of itch compared with placebo at week 16, as measured by EASI 75, IGA 0 or 1 response, or Pruritus NRS response. However, the evidence for HRQoL and safety results was less certain.

• Certainty of the evidence: CDEC discussed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment of selected outcomes from the pivotal RCTs and noted that the certainty of the outcomes of the proportion of patients with an IGA 0 or 1 response, EASI 75 response, or at least a 4-point improvement in the Pruritus NRS score at week 16 were high. The certainty of POEM, DLQI, CDLQI, and serious AE outcomes were low to very low due to concerns with missing data, imprecision, and indirectness.

• LTE study: New evidence from the ADjoin LTE study suggested that the efficacy of lebrikizumab may be sustained for up to 100 weeks with no new safety concerns. However, there is uncertainty in the evidence due to the open-label, noncomparative design which precludes firm conclusions on the long-term effects of lebrikizumab.

• Efficacy and harms versus dupilumab, abrocitinib, and upadacitinib: No direct comparative evidence for lebrikizumab versus comparators was submitted. CDEC discussed the updated NMA which indirectly compared lebrikizumab versus dupilumab 300 mg, abrocitinib 100 mg and 200 mg, and upadacitinib 15 mg and 30 mg at weeks 16, and 2 new MAICs in the resubmission, which indirectly compared lebrikizumab versus dupilumab 300 mg, abrocitinib 100 mg and 200 mg, and upadacitinib 15 mg and 30 mg at weeks 52 in patients with moderate to severe AD that was not adequately controlled with topical therapies. Results from the new indirect evidence suggested that upadacitinib 30 mg may be favoured over lebrikizumab for percent change from baseline in EASI at week 16. In contrast, lebrikizumab may be favoured over abrocitinib 100 mg based on response rates for EASI 75, IGA 0 or 1, and EASI 90, and over dupilumab 300 mg based on IGA 0 or 1 response at week 52. All other comparative efficacy estimates involving alternate doses of upadacitinib and abrocitinib were imprecise with 95% credible intervals, including the potential that either lebrikizumab or the comparators could be favoured or that there was no difference between the treatments. For overall AEs, results at week 16 generally favoured lebrikizumab over the comparators within the monotherapy network; at week 52, lebrikizumab was favoured over upadacitinib 30 mg and abrocitinib 100 mg and 200 mg. CDEC noted that the indirect evidence was insufficient to definitively conclude the comparative effects of lebrikizumab versus dupilumab, abrocitinib, and upadacitinib, mostly due to serious imprecision and heterogeneity.

• Studies addressing gaps in the evidence: Four studies addressing evidence gaps were submitted in the initial submission. These include the previously mentioned study that assessed the effect of lebrikizumab on patients whose AD is not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable (ADvantage RCT [N = 331]), a study assessing vaccine immune response (ADopt-VA RCT [N = 254]), a study including Japanese patients (ADhere-J RCT [N = 286]), and a study in adolescents (ADore open-label, single-arm trial [N = 206]). In patients with moderate to severe AD who received induction therapy with lebrikizumab 250 mg every 2 weeks with or without TCS, the efficacy results of the supplementary trials were generally consistent with the findings of the pivotal trials. No new safety signals were detected in the single-arm study in adolescents.

• Clinical value: Based on the preceding considerations, despite limitations of the indirect evidence, the committee felt that the results did not demonstrate significant differences in efficacy outcomes between the treatments and found it reasonable to consider them comparable in efficacy and for lebrikizumab to potentially have improved safety compared to upadacitinib and abrocitinib in the longer term.

Unmet Clinical Need

• Input on unmet clinical need: Patients and clinicians noted that there is a need for additional therapies that improve both efficacy and tolerability compared to existing treatments for moderate to severe AD. Patient groups noted challenges with side effects from current treatments, limited access to phototherapy and specialist care, concerns about long-term steroid use, and inequitable access due to cost and reimbursement barriers.

• Severity of the disease: CDEC acknowledged that patients with AD experience significant physical burden and patients and caregivers experience significant psychological and quality-of-life burden due to ongoing symptoms and frequent flares.

• Availability of treatment options: Phototherapy, conventional immunosuppressants, advanced therapies (biologics and JAK inhibitors) are available to patients with moderate to severe AD that is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Limitations of existing treatments include a lack of adequate response to treatment or a disease relapse in some patients; adverse effects, such as conjunctivitis, with biologics use; contraindication and safety concerns with JAK inhibitors; limited efficacy and frequent laboratory monitoring with conventional immunosuppressants; and ineffective long-term control with phototherapy as well as limited access to phototherapy.

Distinct Social and Ethical Considerations

• Input on unmet nonclinical need: CDEC noted that monitoring and managing the side effects of conventional systemic immunosuppressants can be challenging for patients without a family physician or adequate access to laboratory and health care services, particularly in rural and remote areas. Limited access to dermatologists was identified as an additional barrier. CDEC also discussed the substantial quality-of-life burden of AD, particularly for patients with moderate to severe disease; patient group input indicated that, because AD affects up to 20% of children, this burden extends to caregivers and family members. Reducing treatment burden was identified as an important outcome to patients. CDEC noted that lebrikizumab has a less frequent maintenance dosing schedule (every 4 weeks) compared with dupilumab (every 2 weeks), which may be preferable for some patients.

• Equity considerations: CDEC noted that treatment options are limited for some patients and access to advanced therapies in Canada is uneven, especially for those without private insurance. Lebrikizumab may serve as an additional advanced therapy option for patients eligible for public drug program coverage.

Economic Considerations

• Health impacts of lebrikizumab versus relevant comparators: Because there was no direct comparison of lebrikizumab plus TCS to dupilumab plus TCS, upadacitinib (15 mg and 30 mg) plus TCS, and abrocitinib (100 mg and 200 mg) plus TCS, clinical efficacy was informed by a sponsor-submitted NMA. The sponsor conducted 2 additional MAICs; however, the data from these additional MAICs were not incorporated into the cost-utility analysis. Due to methodological limitations and imprecision associated with the sponsor’s NMA and MAICs, CDA-AMC could not draw definite conclusions on the relative efficacy and safety of lebrikizumab compared with dupilumab and JAK inhibitors.

• Cost of lebrikizumab versus relevant comparators: At the submitted price of $1,949.90 per prefilled pen or prefilled syringe with needle shield, treatment with lebrikizumab in second year onward is more costly than abrocitinib 100 mg, abrocitinib 200 mg, and upadacitinib 15 mg. Treatment with lebrikizumab in second year onward is less costly than upadacitinib 30 mg and dupilumab.

• Key findings of the economic evaluation: If decision-makers determine there are no differences in health outcomes between lebrikizumab and relevant comparators, then the total cost of lebrikizumab to the health system should not exceed that of the least-costly advanced treatment for the indicated population.

• Certainty of the evidence: The sponsor-conducted NMA and MAICs used to compare lebrikizumab to dupilumab, upadacitinib (15 mg and 30 mg), and abrocitinib (100 mg and 200 mg) did not consistently demonstrate significant differences across efficacy outcomes between the treatments. Although some analyses suggested potential differences in efficacy, the uncertainty resulted in very low confidence in any conclusions regarding comparative effects for efficacy outcomes, HRQoL, or harms.

Impacts on Health Systems

• Anticipated budget impact: CDA-AMC estimated that by year 3 of reimbursement, 83,239 patients would be eligible for lebrikizumab; of these, 6,576 patients would be expected to receive lebrikizumab. It is estimated that the budget impact of reimbursing lebrikizumab for use in the indicated population will be approximately $127 million over the first 3 years compared to the amount currently spent on comparators. The expenditure on lebrikizumab over this period is predicted to be $472 million on lebrikizumab over this period. The actual budget impact of reimbursing lebrikizumab is uncertain due to uncertainty in the market share of relevant comparators. The economic feasibility must be addressed because the predicted incremental budget impact of reimbursing lebrikizumab is predicted to be greater than $40 million in year 1 and year 3.

Sources of Information Used by the Committee

To make its recommendation, the committee considered the following information (links to the full documents for the review can be found on the project webpage):

• the CDA-AMC review of the clinical and pharmacoeconomic evidence submitted by the sponsor as well as relevant ethical issues related to lebrikizumab (refer the Main Report and Supplemental Material document)

• the sponsor’s comments on the draft report and the CDA-AMC responses

• patients’ perspectives gathered by 2 patient group submissions from CSPA in collaboration with Eczéma Québec and the Eczema Society of Canada (refer to the Patient and Clinician Group Input document)

• input from 3 clinician groups, including Fraser Health Dermatology Group, Atlantic Dermatology Group, and a group of clinicians who frequently work with Indigenous patients and communities (refer to the Patient and Clinician Group Input document)

• input from public drug programs that participate in the reimbursement review process (refer to the Supplemental Material document)

• input from 2 clinical experts consulted by CDA-AMC with expertise in the management of AD.

CDEC Information

Members of the Committee

Dr. Peter Jamieson (Chair), Dr. Kerry Mansell (Vice-Chair), Sally Bean, Daryl Bell, Dan Dunsky, Dr. Ran Goldman, Dr. Trudy Huyghebaert, Dr. Dennis Ko, Dr. Christine Leong, Dr. Alicia McCallum, Dr. Srinivas Murthy, Dr. Nicholas Myers, Dr. Krishnan Ramanathan, Dr. Marco Solmi, Carla Velastegui, Dr. Edward Xie, and Dr. Peter Zed.

Meeting date: April 22, 2026

Regrets: Four expert committee members did not attend.

Conflicts of interest: None