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Indication: In combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy
What Is the CADTH Reimbursement Recommendation for Sarclisa?
CADTH recommends that Sarclisa be reimbursed by public drug plans for the treatment of relapsed or refractory multiple myeloma (MM) if certain conditions are met.
Which Patients Are Eligible for Coverage?
Sarclisa should only be covered for adult patients who have relapsed or refractory MM and who have received 1 to 3 prior treatments. Patients should show the presence of a marker called M protein in their blood or in urine and have good Performance Status. Patients must not have already had treatment with an anti-CD38 monoclonal antibody (mAb) (a type of drug that includes Sarclisa and similar medications), must not be resistant to treatment with carfilzomib (another drug used for MM), and must have acceptable heart function. To be effective, Sarclisa should be combined with carfilzomib and dexamethasone.
What Are the Conditions for Reimbursement?
Sarclisa should only be reimbursed if it is prescribed by physicians with expertise and experience in managing MM and if the cost of Sarclisa is reduced.
Why Did CADTH Make This Recommendation?
What is Multiple Myeloma?
MM is a cancer of plasma cells (the white blood cells that make antibodies) that is more common in older adults and accounts for 10% to 15% of all blood cancers. Many patients do not respond to initial treatments and their disease will relapse, so they will need to try many different treatments.
Unmet Needs in Multiple Myeloma
Treatments that are better at controlling disease and are less toxic are needed. There is a particular need for patients who are resistant to treatment as prognosis tends to be poor in these patients.
How Much Does Sarclisa Cost?
Treatment with Sarclisa is expected to cost approximately $12,126 per 28-day cycle (initial cycle = $24,253). When used in combination with carfilzomib and dexamethasone, treatment is expected to cost $27,472 per 28-day cycle (initial cycle = $36,532).
The CADTH pan-Canadian Oncology Drug Review Expert Review Committee (pERC) recommends that isatuximab combined with carfilzomib and dexamethasone (IsaKd) be reimbursed for the treatment of adult patients with relapsed or refractory MM who have received 1 to 3 prior lines of therapy only if the conditions listed in Table 1 are met.
One open-label, phase III superiority trial (IKEMA; N = 302) demonstrated that treatment with IsaKd resulted in added clinical benefit when compared to carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory MM who had been previously treated with 1 to 3 prior regimens. At the interim analysis, the IKEMA trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with IsaKd compared to Kd (hazard ratio [HR] = 0.53; 99% confidence interval [CI], 0.318 to 0.889; P = 0.0007). The PFS benefit was consistent across patient subgroups, including patients who had relapsed on or were refractory to immunomodulating agents (IMiDs) and/or proteosome inhibitors (PIs), those who had prior autologous stem cell transplant, and those who had received more than 1 line of prior therapy. Overall survival (OS) data were immature and were not compared at the interim analysis. Health-related quality of life (HRQoL) was assessed but not formally compared between the treatment groups in the trial; however, the available evidence suggested that HRQoL was maintained over time in the IsaKd group. The incidence of adverse events (AEs) was similar between the treatment groups, although there were more infusion reactions and more infections, particularly pneumonia, in the IsaKd group. Despite these increases, pERC considered the safety profile of IsaKd to be manageable.
MM is an incurable disease and pERC agreed that there is an unmet need for additional effective treatments in the relapsed and refractory setting, particularly for patients who are refractory to IMiDs and PIs. Patients identified a need for new and effective treatments that control disease, prolong remission, and improve quality of life with fewer side effects than currently available treatments. Given the totality of the evidence, pERC concluded that IsaKd meets some of these needs by improving disease control, which results in longer remission, and having manageable side effects. pERC was unable to draw definitive conclusions on the effect of IsaKd on patients’ quality of life due to limitations of the evidence.
Owing to limitations with the sponsor’s modelling approach and the lack of informative comparative data to regimens currently considered standard of care for this patient population in Canada, a base-case estimate of cost-effectiveness was unable to be determined in the Health Canada–approved indication. CADTH conducted an exploratory reanalysis and determined that the incremental cost-effectiveness ratio was likely close to $1,588,632 per quality-adjusted life-year (QALY) compared to Kd; therefore, IsaKd is not cost-effective at a $50,000 per QALY willingness-to-pay threshold. CADTH notes that this estimate may underestimate the true incremental cost-effectiveness ratio due to favourable modelling assumptions, as well as the absence of lower cost comparators that could not be considered in the analysis. Based on the exploratory analysis, a 100% price reduction for isatuximab is not sufficient to achieve cost-effectiveness at a $50,000 per QALY threshold unless the price paid by public plans for carfilzomib is also 61% lower than its list price.
Reimbursement Conditions and Reasons.
Issues that may impact the drug plans’ ability to implement a recommendation as identified by pERC and the drug programs are summarized in Table 2.
Implementation Guidance From pERC.
Isatuximab is administered as an IV infusion, at a dose of 10 mg/kg in combination with Kd and has a Health Canada indication for the treatment of adult patients with relapsed or refractory MM who have received 1 to 3 prior lines of therapy. Isatuximab is a mAb that binds to a specific extracellular epitope of CD38, triggering mechanisms that result in the death of CD38-expressing tumour cells. CD38 is a transmembrane glycoprotein with ectoenzymatic activity that is expressed in hematologic malignancies as well as other cell types and tissues. Each treatment cycle of IsaKd is 28 days; in cycle 1, isatuximab is administered on days 1, 8, 15, and 22 (weekly), and in cycle 2 and beyond it is administered every 2 weeks. Treatment is continued until disease progression or unacceptable toxicity.
To make their recommendation, pERC considered the following information:
Myeloma Canada submitted the patient input for this CADTH review. Myeloma Canada, founded in 2005, is the only national charitable organization created by and for Canadians impacted by MM. The organization is driven to improve the lives of those affected by myeloma. Information from this input was gathered through a patient survey. The survey was accessed through email and social media from April 22, 2021, to May 9, 2021. A total of 208 individuals with myeloma responded to the survey.
Most patients surveyed indicated that having access to an effective treatment was very important, as was controlling symptoms such as infections, kidney problems, mobility, neuropathy, and fatigue. Patients described impacts on their abilities to perform day-to-day activities such as working, travel, and exercise. Patients are seeking new and effective treatment options that would improve their quality of life, have maximum benefits with non-debilitating side effects, reduce their hospital visits, and help them achieve the longest remission possible in lieu of a cure. The patient group highlighted the importance of receiving information about emerging treatments and having timely access to these treatments.
According to the clinical experts consulted by CADTH, newer treatments are needed for MM that exhibit better disease control and less toxicity. In particular, needs are not being met for patients who are refractory to certain drug classes, like immunomodulators (lenalidomide) or proteasome inhibitors (bortezomib), and outcomes tend to be poor in these patients.
Isatuximab should be combined with other drugs that have unrelated mechanisms and toxicity profiles that can be used in any line of therapy. For patients with 1 prior line of therapy, an isatuximab regimen could be particularly useful if they had not received a prior anti-CD38 mAb. Whether there would be benefit for those previously treated with an anti-CD38 mAb is unknown.
There is no established method for determining which patients would most and least benefit from treatment. A clinically significant response would be improved PFS with acceptable toxicity and quality of life. Response should be assessed before each treatment cycle, and disease progression or unacceptable toxicity would warrant discontinuation of treatment.
Input was submitted by the Canadian Myeloma Research Group and the Ontario Health Cancer Care Ontario Hematology Cancer Drug Advisory Committee. There were no notable differences between the input provided by the clinical experts consulted by CADTH on this review and the clinician groups. The clinician groups did not specifically comment on their own experiences with IsaKd; however, they did note that they believed IsaKd would be useful in patients who relapsed who had progressed on lenalidomide and/or bortezomib.
The drug programs identified jurisdictional implementation issues related to considerations for initiating and prescribing of therapy, generalizability, a funding algorithm, care provision issues, and system and economic issues. pERC weighed evidence from the IKEMA trial and other clinical considerations, including input from the clinical experts consulted by CADTH, to provide responses to the drug plans’ implementation questions, which are presented in Table 3.
Responses to Questions From the Drug Programs.
The CADTH systematic review included 4 reports of 1 pivotal trial (IKEMA). No additional studies were identified from the literature. IKEMA is an ongoing, sponsor-funded, multinational (with Canadian sites), open-label, randomized controlled trial that randomized 302 adult (> 18 years) patients with relapsed and/or refractory MM and 1 to 3 prior lines of therapy, in a 3:2 manner, to either IsaKd or Kd. Patients in the IsaKd group received isatuximab 10 mg/kg by IV infusion in 28-day cycles (weekly during the first cycle, then every 2 weeks for the subsequent cycles) with carfilzomib 20 mg/m2 on days 1 and 2, then escalated to 56 mg/m2 IV for days 8, 9, 15 and 16 of cycle 1 and days 1, 2, 8, 9, 15 and 16 for the subsequent cycles, and dexamethasone 20 mg twice weekly. Patients in the Kd group received carfilzomib and dexamethasone at those same dose regimens. Patients were treated until they experienced disease progression, unacceptable toxicity, or the patient decided to discontinue study treatment. Randomization was stratified by the number of prior lines of therapy (1 versus > 1) and the Revised International Staging System score (I or II versus III versus not classified).
The primary outcome of the IKEMA trial was PFS, and the key secondary outcomes included ORR, VGPR or better rate, duration of response (DOR), time to first response (TTR), MRD negativity in patients with VGPR or better, as well as complete response (CR) rate, and OS. PFS, ORR, VGPR or better, and MRD negativity in patients with VGPR or better were included in the statistical testing hierarchy. HRQoL was assessed as an exploratory outcome. The findings in this report are from an interim analysis, which was preplanned to take place once 103 disease progression events had occurred (information fraction of 65%). Results for the final analysis, including OS data, are not expected until 2023. Harms, including AEs, SAEs, and AEs of special interest, were also measured and reported.
Patients were an average of 63.1 years of age (standard deviation [SD] = 9.9), 56% were male and 70.9% were White. The majority of patients were of the immunoglobulin G subtype (67.9%) at diagnosis, followed by immunoglobulin A (22.8%), and these percentages were similar to those observed at study entry (69.9% and 22.5%, respectively). The most common International Staging System stage at study entry was stage I (53.0%), followed by stage II (31.1%) and stage III (15.2%). The majority of patients were relapsed and refractory (71.5%), while the remainder were relapsed (28.5%). The average number of prior regimens was 3.2 (SD = 1.7) and the number of prior lines was 1.8 (SD = 0.8). Patients were most commonly refractory to an iMiD (45.0% of patients) followed by a PI (33.1%), or both (20.5%).
PFS was the primary outcome of the IKEMA trial, and at the interim analysis (median follow-up of 20.73 months), median PFS was not reached in the IsaKd group and was 19.15 months (95% CI, 15.77 to not calculable) in the Kd group, for a stratified HR of 0.531 (99% CI, 0.318 to 0.889), and a P value, according to a stratified log rank test, of P = 0.0007. In the IsaKd group, 26.8% of patients had a PFS event, while in the Kd group, 44.7% of patients had a PFS event. The results for sensitivity analyses performed for the primary outcome were consistent with the primary analysis, and preplanned subgroup analyses revealed consistent results across various subgroups of interest for this review.
OS will be assessed at the end of the study; therefore, no median OS data were available at the time of the interim analysis.
HRQoL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Cancer Specific Questionnaire with 30 items, the EORTC Quality of Life MM Specific Module with 20 items, and the EQ-5D 5-Levels instruments. Interpretation of HRQoL data were limited by the large number of withdrawals over time in the study; however, generally, for the EORTC instruments, there was little change from baseline in HRQoL scores in the IsaKd group and numerical increases from baseline over time were observed in the Kd group. An increase in score on these instruments indicates an improvement in HRQoL.
The ORR was assessed in all responders (patients achieving either a stringent complete response [sCR], CR, VGPR, or partial response) and in patients achieving a VGPR or better. An sCR was defined as patients having a CR with a normalized serum-free light chain ratio in the absence of bone marrow plasma cells when assessed by immunohistochemistry or immunofluorescence. The percentage of patients responding was 86.6% in the IsaKd group and 82.9% in the Kd group, and the between-group difference was not statistically significant (P = 0.1930). Because this was the second outcome in the statistical hierarchy, testing was to have halted for subsequent outcomes, although the sponsor continued to conduct testing and report P values for descriptive purposes. The percentage of patients achieving a VGPR or better was 72.6% in the IsaKd group and 56.1% in the Kd group. No patients achieved an sCR, while 39.7% of patients in the IsaKd group and 27.6% of patients in the Kd group achieved a CR, and 33.0% and 28.5% of patients, respectively, achieved a VGPR. MRD negativity was achieved by 29.6% of patients in the IsaKd group and 13.0% of patients in the Kd group.
The median DOR was calculated based on 155 patients in the IsaKd group and 102 patients in the Kd group. The median DOR was not yet reached in either treatment group and the HR was 0.425 (95% CI, 0.269 to 0.672). The median time to first response was 1.08 months (95% CI, 1.05 to 1.12) in the IsaKd group and 1.12 months (95% CI, 1.05 to 1.18) in the Kd group, for a stratified HR of 1.143 (95% CI, 0.888 to 1.471).
There were 97.2% of patients in the IsaKd group and 95.9% of patients in the Kd group who had at least 1 AE; 76.8% versus 67.2%, respectively, who had at least a grade 3 AE or greater; and 3.4% versus 3.3% who had a grade 5 AE. The most common AE in the IsaKd group was infusion-related reaction, which occurred in 44.6% of patients in the IsaKd group and 3.3% of patients in the Kd group. Other common AEs (IsaKd versus Kd) included hypertension (36.7% versus 31.1%), diarrhea (36.2% versus 28.7%), upper respiratory tract infection (36.2% versus 23.8%), fatigue (28.2% versus 18.9%), and dyspnea (27.7% versus 21.3%). The most common grade 3 or greater AEs (IsaKd versus Kd) were hypertension (20.3% versus 19.7%) and pneumonia (16.4% versus 12.3%).
SAEs occurred in 59.3% of patients in the IsaKd group and 57.4% of patients in the Kd group. The most common SAE was pneumonia (18.1% in the IsaKd group versus 11.5% in the Kd group).
There were 8.5% of patients in the IsaKd group and 13.9% of patients in the Kd group who had an AE leading to definitive treatment discontinuation. There was 1 patient who discontinued treatment of isatuximab due to an AE.
Among notable harms, respiratory tract infections occurred in 83.1% of patients in the IsaKd group and 73.8% of patients in the Kd group, and these were grade 3 or greater events in 32.2% versus 23.8% of patients, respectively. Cardiac disorders occurred in 7.3% of patients treated with IsaKd versus 5.7% of patients treated with Kd. Second primary malignancies (i.e., solid, non-skin) occurred in 2.8% versus 3.3% of patients in the IsaKd and Kd groups, respectively, and second primary malignancies (i.e., solid, skin) in 5.1% versus 2.5% of patients, respectively. There were no hematologic malignancies reported. Events of decreased neutrophil counts occurred in 54.8% of patients in the IsaKd group versus 43.4% of patients in the Kd group, and grade 3 or greater events occurred in 19.2% versus 7.4% of patients, respectively. Events of decreased platelet counts occurred in 94.4% of patients treated with IsaKd and 87.7% of patients treated with Kd, and these were grade 3 or greater events in 29.9% versus 23.8% of patients, respectively.
IKEMA was an open-label trial and lack of blinding may have biased results, particularly for patient-reported outcomes such as HRQoL and reporting of harms. Assessment of response was conducted by a blinded independent review committee and therefore is unlikely to have been influenced by lack of blinding.
The results of the IKEMA trial were based on a preplanned interim analysis, with an information fraction of 65%; therefore, there is a risk of over-estimation of the primary effect for PFS. However, given the statistically and clinically significant difference observed between the groups for PFS, the potential for over-estimation is unlikely to have altered the conclusions.
Multiplicity was controlled for with the use of a hierarchical testing procedure; however, early failure of the hierarchy meant that statistical testing was only conducted on the primary and first secondary outcome. This meant that there were several outcomes where no inferences could be drawn about differences between groups. HRQoL was not included in the hierarchy and differences between groups were not tested statistically; therefore, no conclusions could be drawn for this outcome.
The clinical experts consulted by CADTH noted that the patients included in the IKEMA trial were approximately 10 years younger and had a better ECOG Performance Status than patients with MM treated in clinical practice, although this is a common occurrence in clinical trials, which tend to recruit younger, healthier patients. Otherwise, the baseline characteristics and the treatment regimens used in the trial were consistent with what one would expect to see in Canadian clinical practice.
The sponsor conducted several indirect treatment comparisons that included fixed-effects NMAs and MAICs. A systematic review and feasibility assessment was done to identify studies to include in the indirect treatment comparisons. On that basis, it was determined that it was feasible to conduct an NMA that included 8 studies (||||||||||) in a connected network that incorporated IsaKd, and 4 separate MAICs based on individual-level data from the IKEMA trial and summary data from 2 studies. |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| ||||||||||||||||||||||||||||||||||||||||
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The trial populations included in the NMA were relatively homogenous in age, ECOG Performance Status, race and ethnicity, and gender; however, there were some concerns from the clinical experts regarding heterogeneity in the prior treatments received. Specifically, prior lenalidomide use is likely a large effect modifier that differs between trials and greatly increases the uncertainty in these findings. In addition, it was noted that the studies included in the NMA were conducted over a wide span of time during which the treatment approach for MM has rapidly evolved. Thus, the time span of these trials may further introduce bias to the comparisons in the NMA. Sparsity of the network meant that only a fixed-effects model could be estimated, which limits the ability to detect and/or account for heterogeneity. ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||.
In the MAICs, the assumption that all prognostic factors and effect modifiers were adequately adjusted for is unlikely to be the case. In general, the baseline characteristics differed across studies, and the variation in the prior treatments received may be a serious effect modifier that reflects differences in care over the wide time span during which the trials were conducted. Previous lenalidomide use was specifically noted as a likely effect modifier by 1 of the clinical experts, and prior treatment in general. As for the choice of the matching factors, it was based on internal expert opinion (rather than a survey of clinical experts) and availability and completeness of data in the trials (which is inconsistent with the National Institute for Health and Care Excellence’s Decision Support Unit guidelines that recommend the identification of key factors in the data). |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| |||||||||||||||||||||||||||||||||||||||||||||| The reported effective sample sizes and the skewness and outliers apparent in the visualizations of the weight distributions suggest the results may be heavily influenced by a small subset of patients from the IKEMA trial. Generalizability may also be an issue due to the small sample size remaining after exclusions and matching, as the remaining patients and weighted sample are unlikely to be representative of the entire patient population.
Cost and Cost-Effectiveness.
CADTH identified the following key limitations with the sponsor’s analysis: the number of patients eligible for IsaKd is uncertain; not all relevant comparators were included; the market uptake of IsaKd is uncertain; relative dose intensity was inappropriately used to reduce drug costs; the duration of treatment is uncertain; and there was misalignment between the sponsor’s submitted pharmacoeconomic model and the budget impact analysis for some parameters. The CADTH reanalyses included assuming a relative dose intensity of 100% for all drugs and aligning inputs with the pharmacoeconomic model where possible.
Based on the CADTH reanalyses, the budget impact of introducing IsaKd for the treatment of relapsed or refractory MM is expected to be $15,780,928 in year 1; $36,288,445 in year 2; and $65,035,119 in year 3, with a 3-year total budget impact of $117,104,492. The estimated budget impact is sensitive to the prevalence of MM, the market uptake of IsaKd, and the duration of treatment.
Dr. Maureen Trudeau (Chair), Dr. Catherine Moltzan, Mr. Daryl Bell, Dr. Jennifer Bell, Dr. Matthew Cheung; Dr. Winson Cheung, Dr. Michael Crump, Dr. Leela John, Dr. Christian Kollmannsberger, Mr. Cameron Lane, Dr. Christopher Longo, Ms. Amy Peasgood, Dr. Anca Prica, Dr. Adam Raymakers, Dr. Patricia Tang, Dr. Marianne Taylor, and Dr. W. Dominika Wranik.
Meeting date: December 1, 2021
Regrets: None
Conflicts of interest: None
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Indication: In combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy
Sponsor: Sanofi Genzyme, a division of Sanofi-Aventis Canada Inc.
Final recommendation: Reimburse with conditions
Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/
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