Reimbursement Recommendation

Talquetamab (Talvey)

Indication: For the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on or after the last therapy

Sponsor: Janssen Inc.

Final recommendation: Reimburse with conditions

What Is the Reimbursement Recommendation for Talvey?

Canada’s Drug Agency (CDA-AMC) recommends that Talvey be reimbursed by public drug plans for the treatment of adult patients with relapsed or refractory (r/r) multiple myeloma (MM) who have received at least 3 prior lines of therapy (LOTs), including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), an anti-CD38 monoclonal antibody (mAb), and a prior B-cell maturation antigen (BCMA)-directed therapy, and have demonstrated disease progression on or after the last therapy if certain conditions are met.

Why Did CDA-AMC Recommend Reimbursement?

CDA-AMC previously reviewed Talvey for a broader population of adults with r/r MM who had received at least 3 prior LOTs and had demonstrated disease progression on or after the last therapy and issued a recommendation not to reimburse. This resubmission focuses on a narrower population who have also received prior BCMA-directed therapy and includes new evidence to address gaps identified in the previous review.

Evidence from the single-arm MonumenTAL-1 study showed that 66.7% of patients responded to Talvey, with responses lasting a median of 19.2 months. Results also suggested that Talvey may delay disease progression and help patients live longer. The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) considered the clinical experts’ input indicating that the treatment response, durability of response, and survival outcomes are clinically meaningful given the poor outcomes and limited treatment options in this population. Supportive evidence from the retrospective REALiTAL study showed generally consistent response and survival outcomes, with no new safety concerns identified. Evidence from an indirect treatment comparison (ITC) suggested that Talvey may improve survival and response compared with treatments used in clinical practice. However, confidence in the clinical value of Talvey was limited by limitations such as the phase I/II, single-arm, open-label study design of the MonumenTAL-1 trial and uncertainty about whether the treatments included in the ITC adequately represented treatment options used in Canadian clinical practice.

pERC recognized that there is a significant unmet clinical need for patients with r/r MM who have received at least 3 prior LOTs and a BCMA-directed therapy because of poor outcomes and limited effective treatment options. pERC also acknowledged the challenges in generating comparative evidence in this heavily pretreated population. Considering these and the totality of the evidence reviewed, pERC recommended that Talvey be reimbursed because it may address the significant unmet clinical need sufficiently to warrant a positive recommendation despite the uncertainty in the clinical value.

Which Patients Are Eligible for Coverage?

Talvey should only be covered for adult patients who have a documented diagnosis of r/r MM, received at least 3 prior LOTs including a PI, an ImiD, and an anti-CD38 mAb, and a BCMA-directed therapy and have demonstrated disease progression on or after the last therapy. Talvey should not be initiated in patients with active central nervous system involvement or signs of meningeal involvement, primary amyloidosis, or plasma cell leukemia.

What Are the Conditions for Reimbursement?

Talvey should be initiated at treatment centres with adequate resources to manage severe reactions, including cytokine release syndrome and neurologic toxicities, and have access to tocilizumab. Treatment should be discontinued upon the occurrence of disease progression or unacceptable toxicity due to Talvey. The total cost of Talvey should not exceed the total cost of treatment with the least costly comparator for the same indication.

Review Background

• Disease background: MM is an incurable hematological malignancy characterized by plasma cell proliferation and excessive production of abnormal immunoglobulin monoclonal protein; r/r MM refers to MM disease that progresses during or after treatment, leading to substantial symptom burden and poor survival. Key signs and symptoms of MM are fatigue, bone pain, renal or nervous system problems, recurring infections, and fever, all of which reflect the progressive and systemic nature of the disease. In Canada, an estimated 4,300 individuals were diagnosed with MM in 2025 and 1,750 died from the disease.

• Indication and reimbursement request: Talquetamab (Talvey) has been approved by Health Canada for the treatment of adult patients with r/r MM who have received at least 3 prior LOTs, including a PI, an IMiD, and an anti-CD38 monoclonal antibody (mAb), and have demonstrated disease progression on or after the last therapy. The sponsor is seeking reimbursement of talquetamab for the treatment of adult patients with r/r MM who have received at least 3 prior LOTs, including a PI, an IMiD, an anti-CD38 mAb, and a BCMA-directed therapy, and have demonstrated disease progression on or after the last therapy.

• Drug under review: Talquetamab is a bispecific antibody that targets the novel antigen GPRC5D and CD3 on T cells. It is available as a solution for subcutaneous injection, and the dosage recommended in the product monograph is 0.4 mg/kg once weekly or 0.8 mg/kg once every 2 weeks, following step-up dosing.

• Treatment costs: At the submitted price of $545.00 per 1.5 mL vial (2 mg/mL) and $7,300 per 1 mL vial (40 mg/mL), the per 28-day cost of talquetamab is expected to be $31,380 (weekly schedule) or 38,680 (biweekly schedule) per patient for the first cycle and $29,200 per patient for subsequent cycles regardless of dosing schedule based on the Health Canada–recommended dosage. Costs were calculated based on a patient weight of 76 kg.

• Submission history: Talquetamab was previously reviewed by CDA-AMC and received a pERC recommendation on February 12, 2025, not to reimburse for the treatment of adult patients with r/r MM who have received at least 3 prior LOTs, including a PI, an ImiD, and an anti-CD38 mAb and have demonstrated disease progression on or after the last therapy. The original review of talquetamab included 1 phase I/II single-arm, open-label, multicentre study (MonumenTAL-1; N = 501) in adults with r/r MM who had received T cell–redirection therapy and 3 nonrandomized comparative studies comparing talquetamab with real-world physician’s choice (RWPC) therapy, teclistamab, and ciltacabtagene autoleucel. A key reason for the previous recommendation was uncertainty in the comparative clinical benefit of talquetamab. The evidence was based primarily on the single-arm MonumenTAL-1 study; methodological limitations of the submitted ITCs limited confidence in their results.

• Basis of resubmission: This resubmission is based on new evidence for patients with r/r MM previously treated with both T cell–redirection therapy and BCMA-directed therapy, including longer-term follow-up from the MonumenTAL-1 study and a sponsor-submitted ITC comparing talquetamab with RWPC therapy.

Highlights of Input From Interested Parties

The patient group (Myeloma Canada) noted the following regarding impacts of the disease, unmet needs, and important outcomes:

• Patients with r/r MM experience a high symptom burden, including fatigue, pain, infections, bone and kidney complications, which substantially impair daily functioning and health-related quality of life (HRQoL).

• Treatment burden, frequent travel for care, and financial costs further affect patients and caregivers, particularly those in rural and underserved communities.

• The most important treatment goals for patients include prolonging survival, achieving effective and durable disease control, relieving symptoms, maintaining a manageable side effect profile, and preserving HRQoL.

• Patients also valued treatments that reduce the burden of care, including fewer in-person visits and improved access to treatment.

The clinician groups (Ontario Health [Cancer Care Ontario] [OH (CCO)] Hematology Cancer Drug Advisory Committee [DAC] and Canadian Myeloma Research Group [CMRG]) 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:

• Both clinician group input and clinical experts consulted for this review indicated that patients with triple-class exposed (TCE) r/r MM who have progressed following BCMA-directed therapy have no established treatment options and poor clinical outcomes, representing a critical unmet need.

• Prior CMRG findings in patients with TCE r/r MM show a median progression-free survival (PFS) and overall survival (OS) of 4.4 months and 10.5 months, respectively, with similarly poor outcomes expected following BCMA exposure.

• The clinician group and the clinical experts suggested that talquetamab should be primarily used in patients with TCE r/r MM after BCMA-directed therapy (i.e., fifth-line option) and is expected to be used as a monotherapy.

The participating public drug programs provided input regarding considerations for initiation, renewal, discontinuation, and prescribing of therapy.

Recommendation

With a vote of 13 in favour to 3 against, pERC recommends that talquetamab be reimbursed for the treatment of adult patients with r/r MM who have received at least 3 prior LOTs, including a PI, an IMiD, an anti-CD38 mAb, and a BCMA-directed therapy, and have demonstrated disease progression on or after the last therapy only if the conditions listed in Table 1 are met.

This pERC recommendation for talquetamab is for adult patients with TCE r/r MM and prior BCMA-directed therapy who have demonstrated disease progression on or after the last therapy and is not for the broader Health Canada indication.

Table 1: Reimbursement Conditions and Reasons

BCMA = B-cell maturation antigen; CNS = central nervous system; CRS = cytokine release syndrome; IMiD = immunomodulatory drug; LOT = line of therapy; mAb = monoclonal antibody; MM = multiple myeloma; pERC = pan-Canadian Oncology Drug Review Expert Review Committee; PI = proteasome inhibitor; r/r = relapsed or refractory.

Rationale for the Recommendation

Clinical Value

This resubmission focused on evidence from the MonumenTAL-1 study in adults with r/r MM who had received at least 3 prior LOTs, including a PI, an IMiD, an anti-CD38 mAb, and a BCMA-directed therapy, and whose disease had progressed on or after the last therapy. The resubmission involved a larger sample size and included updated evidence from a longer follow-up of the MonumenTAL-1 study, a sponsor-submitted ITC evaluating talquetamab versus RWPC treatment, and a supportive retrospective study (REALiTAL). Based on the totality of the clinical evidence, pERC concluded it is uncertain whether talquetamab demonstrates acceptable clinical value compared with available treatment options for adult patients with r/r MM who have received at least 3 prior LOTs, including a PI, an IMiD, an anti-CD38 mAb, and a BCMA-directed therapy, and have demonstrated disease progression on or after the last therapy. Although pERC acknowledged that patients with TCE r/r MM whose disease has progressed following BCMA-directed therapy have no established effective treatment options, they noted that current available treatment options include pomalidomide plus cyclophosphamide plus dexamethasone (PCd), pomalidomide plus dexamethasone (Pd), carfilzomib plus cyclophosphamide plus dexamethasone (KCd), carfilzomib plus dexamethasone (Kd), and selinexor plus bortezomib plus dexamethasone (SVd). Given that talquetamab is expected to be a treatment option following BCMA-directed therapy, acceptable clinical value was considered relative to available treatment options in the Canadian context for this heavily pretreated population.

Evidence from 1 ongoing phase I/II, single-arm, open-label study (MonumenTAL-1) demonstrated that after a median duration of treatment of 30.3 months with talquetamab in patients with TCE r/r MM whose disease has progressed following BCMA-directed therapy, the overall response rate (ORR) was 66.7%, with a median duration of response (DoR) among patients who responded of 19.2 months. The median PFS was 7.7 months, and the median OS was 28.3 months. pERC acknowledged the clinical experts’ observation that although the single-arm design of the MonumenTAL-1 study precluded conclusions about the comparative effects of talquetamab relative to available treatment options, the observed response and survival outcomes as well as the durability of response were clinically meaningful, particularly given the poor prognosis, limited treatment options after BCMA-directed therapy, and poor outcomes in patients who have been heavily pretreated. The committee also noted that the supportive retrospective REALiTAL study showed generally consistent response and survival outcomes with talquetamab in a real-world clinical setting and did not identify any new safety concerns. However, pERC observed that the evidence was limited by the study’s retrospective, noncomparative design.

Evidence from the sponsor-submitted ITC evaluating the effect of talquetamab versus RWPC using individual patient data from the MonumenTAL-1 study and observational data from the LocoMMotion and MoMMent studies suggested that talquetamab was associated with longer OS and PFS and higher ORR and very good partial response (VGPR) or better response rates compared with RWPC treatment. However, HRQoL and safety outcomes were not assessed. The confidence in the ITC findings was limited because of important methodological limitations, including the small sample size, risk of residual confounding, and heterogeneity in the RWPC regimens, Also, because the RWPC treatment did not include all the available treatment options (PCd, Pd, KCd, Kd, and SVd) in the Canadian context, its relevance as a comparator in the ITC is uncertain.

pERC considered and discussed the uncertainties in the submitted evidence due to the limitations, including the single-arm design of the MonumenTAL-1 study. pERC acknowledged that patients identified a need for more effective treatment options with a manageable side effect profile that prolongs survival, provides durable disease control, relieves symptoms, and preserves HRQoL. pERC determined that the available evidence suggests that talquetamab meets some needs, such as prolonging survival and maintaining disease control. The committee also considered the clinical experts’ input indicating that the observed OS, PFS, ORR, and DoR were clinically meaningful in this heavily pretreated population with limited effective treatment options. Therefore, pERC concluded that, although the evidence suggests talquetamab has uncertain clinical value due to the limited treatment options and poor outcomes in this heavily pretreated population, the drug may address a significant unmet clinical need to a degree that justifies a positive recommendation despite the uncertainty in the clinical value.

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

Considering Significant Unmet Clinical Need

pERC noted that patients and clinicians identified prolonging survival, achieving effective and durable disease control, and relieving symptoms and preserving HRQoL as important treatment goals. pERC acknowledged that clinician groups and the clinical experts consulted by CDA-AMC highlighted the absence of established effective treatment options, the prevalence of poor clinical outcomes, and the diminishing effectiveness and durability of available treatments with successive lines. pERC acknowledged that there is a significant unmet clinical need for patients with r/r MM who have received at least 3 prior LOTs and prior BCMA-directed therapy. pERC also acknowledged the challenges in generating comparative evidence in this late-line population because of the difficulty in selecting an appropriate comparator for randomized trials in patients who have received multiple prior therapies.

Further information on the committee’s discussion around unmet clinical need is provided in the Summary of Deliberation section.

Considering Significant Unmet Nonclinical Need or Health Inequity

pERC acknowledged that there are unmet nonclinical needs related to treatment and caregiver burden, including hospitalization during step-up dosing, intensive monitoring, and travel requirements, which may particularly affect patients living in rural, remote, or underserved communities. pERC also acknowledged that MM disproportionately affects Black individuals, who were underrepresented in the clinical evidence for talquetamab. However, pERC concluded that the submitted evidence did not address these identified unmet nonclinical needs or health inequities.

Further information on the committee’s discussion around unmet nonclinical need is provided in the Distinct Social and Ethical Considerations domain in the Summary of Deliberation section.

Developing the Recommendation

Due to the uncertainty in clinical value, pERC could not recommend whether to reimburse talquetamab based on clinical value alone. Therefore, they also considered whether talquetamab addresses a significant unmet clinical need. pERC concluded that talquetamab addresses a significant unmet clinical need with an acceptable level of certainty. Based on the preceding considerations, pERC recommends that talquetamab be reimbursed. As part of the deliberation on whether to recommend reimbursement or not, the committee also considered unmet nonclinical need and health inequity. Information on this discussion is provided in the Distinct Social and Ethical Considerations domain in the Summary of Deliberation section.

Because pERC recommended that talquetamab 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 stated in Table 1.

Summary of Deliberation

pERC 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: pERC acknowledged that there is no established standard treatment for r/r MM following BCMA-directed therapy, and treatment selection is individualized based on prior therapies, treatment sequencing, patient fitness and comorbidities, and access to available therapies. However, pERC noted that PCd, Pd, KCd, Kd, and SVd are relevant treatment options used in Canadian clinical practice for patients with r/r MM who have received 3 prior LOTs and a BCMA-directed therapy, although they are reported to have limited effectiveness. No head-to-head comparative evidence between talquetamab and these treatment options was available in the submitted evidence.

• Efficacy of talquetamab: Evidence from the ongoing phase I/II single-arm, open-label MonumenTAL-1 study included 78 patients previously treated with T cell–redirection therapy who were heavily pretreated, with a median of 6 prior LOTs. At a median follow-up of 30.3 months, the ORR was 66.7%, with 55.1% of patients achieving VGPR or better. Median DoR among patients who responded was 19.2 months, median PFS was 7.7 months, and median OS was 28.3 months. The ORR was █████ among patients previously treated with BCMA-directed CAR T-cell therapy and █████ among those previously treated with a BCMA-directed bispecific antibody. pERC noted that these results suggest that talquetamab demonstrated clinically meaningful antimyeloma activity in this heavily pretreated population. However, the single-arm design of the MonumenTAL-1 study precluded conclusions regarding the comparative clinical benefit of talquetamab relative to relevant treatment options. The REALiTAL study (N = 93) provided supportive real-world evidence for talquetamab. The results showed generally similar response and survival outcomes with talquetamab in a real-world setting, including among 49 patients previously treated with BCMA-directed therapy. Among these patients, the ORR was █████, median DoR was ████ ██████, median PFS was █████████, and median OS was ████ ██████, with no new safety concerns identified. However, because of its retrospective, noncomparative design, the study did not address the uncertainty in the comparative clinical evidence.

• Clinical importance of treatment effects: pERC considered the response and durability of response observed with talquetamab to be clinically meaningful in this heavily pretreated population. Patients identified prolonged survival, durable disease control, maintenance of HRQoL, symptom relief, and manageable side effects as important treatment outcomes. The clinical experts considered the observed ORR, depth and durability of response, PFS, and OS to be clinically meaningful given the poor prognosis and limited treatment options following BCMA-directed therapy. pERC acknowledged that despite the uncertainty in the evidence, talquetamab may address an important unmet clinical need by providing an additional treatment option for patients whose disease has progressed following BCMA-directed therapy.

• Efficacy versus RWPC: Results from the sponsor-submitted ITC favoured talquetamab over RWPC for OS, PFS, ORR, and VGPR or better response. The adjusted hazard ratio for OS was 0.37 (95% confidence interval, 0.20 to 0.70) in favour of talquetamab. However, pERC noted substantial uncertainty in the comparative estimates because of the nonrandomized and unanchored comparison, small sample size, risk of residual confounding, heterogeneity in RWPC regimens, and uncertainty regarding the relevance of these regimens to Canadian clinical practice. The ITC did not provide separate comparisons with PCd, Pd, KCd, Kd, or SVd, and comparative evidence for HRQoL and harms was not available.

• Certainty of the evidence: pERC considered the certainty of the evidence from the MonumenTAL-1 study to be very low, primarily because of its single-arm design, which precluded conclusions regarding the comparative clinical benefit of talquetamab. Additional uncertainty arose from the small, exploratory subgroup of patients previously treated with BCMA-directed therapy and substantial missing HRQoL data. The ITC also provided very low certainty comparative evidence because it was based on nonrandomized data and had an unanchored design, a small sample size, heterogeneity, and a high risk of residual confounding. Overall, the comparative efficacy and safety of talquetamab relative to relevant treatment options remains uncertain.

• Prior BCMA-directed therapy and treatment sequencing: pERC discussed the role of talquetamab following BCMA-directed therapy. ████████ ████████ ████████ ████ ██████████ ██ ████████ ██████████ ███████ ████ █████████████ ██████████ ██████████ ████ ██ █████ ██████████ ███████ ████ █████████████ ███ ██████ ███████; however, these exploratory subgroup analyses were based on small numbers of patients. pERC noted that the available evidence was insufficient to determine the optimal sequencing of talquetamab relative to other T cell–redirection therapies.

• Clinical value: pERC concluded that, although the clinical value of talquetamab remains uncertain, the available evidence suggests it may address a significant unmet need in patients with TCE r/r MM given they are heavily pretreated and have limited treatment options and poor outcomes. As a result, pERC determined that despite the uncertainty in its clinical value, the potential benefits of talquetamab justify recommending that the drug be reimbursed for the treatment of adult patients with r/r MM who have received at least 3 prior LOTs, including a PI, an IMiD, an anti-CD38 mAb, and BCMA-directed therapy, and have demonstrated disease progression on or after the last therapy.

Unmet Clinical Need

• Input on unmet clinical need: Patient group input highlighted the need for treatments that prolong survival, provide durable disease control, maintain HRQoL, and have manageable side effects. Patients and clinicians noted that treatment options become increasingly limited in effectiveness with successive LOTs. Clinician group input and the clinical experts identified an unmet need for additional treatment options for patients with TCE r/r MM and have received prior BCMA-directed therapy, who experience poor outcomes and treatment and caregiver burden that remains substantial.

• Severity of the disease: pERC acknowledged r/r MM as a serious, life-threatening, and debilitating disease associated with substantial morbidity and mortality. Patients with advanced disease experience a high symptom burden, including pain and fatigue, impaired functional status, and reduced HRQoL. pERC noted that outcomes are particularly poor among heavily pretreated patients with TCE r/r MM that has progressed following BCMA-directed therapy.

• Availability of treatment options: pERC noted that treatment options for heavily pretreated r/r MM include pomalidomide- or carfilzomib-based regimens and selinexor-based combinations, with treatment selection influenced by prior therapies, treatment sequencing, patient comorbidities, and access to available therapies. According to the clinician groups and clinical experts consulted by CDA-AMC, these treatments have limited effectiveness following progression on BCMA-directed therapy, representing an important unmet treatment need.

• Significant unmet clinical need: pERC concluded that there is a significant unmet clinical need for patients with r/r MM who have received at least 3 prior LOTs and prior BCMA-directed therapy due to the severity of the disease, poor outcomes, and limited effective treatment options following disease progression. pERC also acknowledged challenges in generating comparative evidence in this late-line population due to the difficulty in selecting an appropriate comparator for randomized trials among patients with multiple prior treatment exposures. These considerations supported the determination of significant unmet clinical need as described in the recommendation framework in the Procedures for Reimbursement Reviews.

Distinct Social and Ethical Considerations

• Input on unmet nonclinical need: pERC acknowledged treatment and caregiver burden associated with r/r MM and its treatment. Patient input highlighted burdens related to frequent treatment and monitoring, travel to specialized treatment centres, and associated financial and caregiver impacts. pERC noted that talquetamab requires hospitalization during step-up dosing and ongoing monitoring, which may contribute to treatment burden, particularly for patients who must travel substantial distances to access care.

• Equity considerations: pERC acknowledged that access to specialized r/r MM treatments may be more difficult for patients living in rural, remote, or underserved communities because of travel requirements and differences in access to treatment centres. pERC also noted that MM disproportionately affects Black individuals, who were underrepresented in the clinical evidence for talquetamab, resulting in uncertainty regarding the generalizability of the evidence to this population.

Economic Considerations

• Health impacts of talquetamab versus relevant comparators: The relative impact of talquetamab on patient health compared to RWPC treatment is very uncertain due to the uncertainty associated with the ITC. There is an absence of separate comparative evidence to relevant treatment options (Kd, KCd, Pd, and PCd). Based on the evidence reviewed for this submission, there is no robust evidence to suggest that talquetamab provides greater health benefit than Kd, KCd, Pd, or PCd.

• Cost of talquetamab versus relevant comparators: Based on the submitted price of talquetamab, it is expected to increase health care system costs if reimbursed by public drug plans when compared to Kd, KCd, Pd, and PCd. Drug acquisition costs were the primary driver of incremental costs between talquetamab and these comparators.

• Key findings of the economic evaluation: The indirect evidence for talquetamab versus comparators is very uncertain and there is insufficient evidence to determine whether talquetamab provides greater health benefit over relevant comparators. Due to the lack of robust clinical evidence, no CDA-AMC base case was performed and therefore no incremental cost-effectiveness ratio (ICER) was estimated by CDA-AMC.

• Certainty of the evidence: Several limitations regarding the ITC used to inform the comparison of talquetamab versus Kd, KCd, Pd, and PCd were identified by the CDA-AMC review team, such as the nonrandomized and noncomparative nature of the clinical evidence, the heterogeneity of the treatment regimens and their relevance to clinical practice in Canada, the high risk of residual confounding, the lack of a prespecified protocol, and the relatively small sample size. Additionally, no comparative evidence was submitted for SVd. The CDA-AMC review team conducted scenario analyses to partially address the postprogression survival and subsequent therapy costs. Although the clinical experts consulted for this review believed there is potential for benefit with talquetamab versus comparators, causal interpretation of the time-to-event end points (OS, PFS) is not possible due to the methodological concerns described, leaving the comparative benefit of talquetamab versus relevant comparators very uncertain.

Impacts on Health Systems

• Anticipated budget impact: CDA-AMC estimated that 476 patients would be eligible for talquetamab over a 3-year period (year 1 = 156; year 2 = 159; year 3 = 162), of whom 326 are expected to receive talquetamab (year 1 = 78; year 2 = 119; year 3 = 129). The estimated incremental budget impact of reimbursing talquetamab is predicted to be approximately $64 million over the first 3 years (year 1 = 15.3 million; year 2 = 23.5 million; year 3 = 25.5 million), with an expected expenditure of $70 million on talquetamab. The actual budget impact of reimbursing talquetamab will depend on the number of patients eligible for treatment and duration of treatment.

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 related to talquetamab (refer to the Main Report and Supplemental Material document)

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

• patients’ perspectives gathered by 1 patient group, Myeloma Canada (refer to the Patient and Clinician Group Input document)

• input from 2 clinician groups, OH (CCO) Hematology Cancer DAC and CMRG (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 with expertise in the management of MM consulted by CDA-AMC.

pERC Information

Members of the Committee

Dr. Catherine Moltzan (Chair), Dr. Kelvin Chan (Vice‑Chair), Paul Agbulu, Dr. Phillip Blanchette, Dr. Matthew Cheung, Annette Cyr, Dr. Jennifer Fishman, Dr. Prafull Ghatage, Dr. Jason Hart, Terry Hawrysh, Dr. Yoo‑Joung Ko, Dr. Aly‑Khan Lalani, Amy Peasgood, Dr. Anca Prica, Dr. Michael Raphael, Dr. Adam Raymakers, Dr. Patricia Tang, Dr. Pierre Villeneuve, and Danica Wasney.

Meeting date: August 12, 2026

Regrets: Two expert committee members did not attend.

Conflicts of interest: None