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Risankizumab (Skyrizi): CADTH Reimbursement Review: Therapeutic area: Crohn disease [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2023 Aug.
The executive summary comprises 2 tables (Table 1 and Table 2) and a conclusion.
Submitted for Review.
Summary of Economic Evaluation.
Evidence from the ADVANCE, MOTIVATE, and FORTIFY trials suggest that risankizumab is well-tolerated and effective compared to placebo as an induction and maintenance therapy for adults with moderate to severe Crohn disease (CD) who have previously shown intolerance or inadequate response to either conventional care or another biologic. However, due to limitations of the preliminary data from the SEQUENCE trial comparing risankizumab to ustekinumab, and the uncertainty in the sponsor-submitted network meta-analysis (NMA) due to notable heterogeneity across included randomized controlled trials and — in many cases — credible intervals affected by serious imprecision, no definitive conclusions on the efficacy and safety of risankizumab relative to active comparators in both conventional care failure and biologic failure patients with CD could be drawn.
CADTH identified several key limitations with the sponsor’s economic analysis. Specifically, there was uncertainty associated with the comparative and long-term efficacy of risankizumab; there were uncertain transition probabilities given the low sample size, low sampling frequency, and the calibration method used; there was a lack of differentiation between causes and types of surgeries and their downstream effects on quality of life and future complications; there were overly optimistic assumptions that patients on risankizumab would not require dose escalation; there was inappropriately high disutility for severe infection adverse events; and, there were errors in calculating disutility values for severe infections associated with treatment. CADTH undertook its reanalysis by correcting disutility values for severe infection adverse events and aligning dose escalation for all used biologics. Issues regarding the available comparative clinical evidence and information on the durability of effect could not be addressed.
Based on the CADTH base case, risankizumab was dominated by ustekinumab (risankizumab was more costly and less effective) in the conventional care failure group. CADTH’s base case for the biologic failure population resulted in an incremental cost-effectiveness ratio (ICER) of $535,031 per quality-adjusted life-year (QALY) gained for risankizumab compared to vedolizumab-SC. A price reduction analysis showed that a price reduction of at least 41.1% would be required for risankizumab to be cost-effective at a willingness-to-pay (WTP) threshold of $50,000 per QALY in the biologic failure group.
There remains a significant degree of uncertainty in the cost-effectiveness results, where issues regarding the available comparative clinical evidence and information on the durability of effect could not be addressed in CADTH reanalysis. No definitive conclusions can be drawn from the sponsor’s NMA — specifically, whether patients receiving risankizumab will benefit more than with other biologics. Yet the pharmacoeconomic model assumes that improvement in remission rates for risankizumab observed in the 52-week trial versus placebo would be maintained over a number of decades without waning. The clinical benefits with risankizumab are expected over a long time horizon; in the CADTH base case for the biologic failure population, 97% of the total 22.43 QALYs were estimated to occur beyond the 52-week trial period. While the cost of treatment with risankizumab is higher than currently available biologics, the benefit to patients and the overall impact on health care system costs are highly uncertain.
This section is a summary of the feedback received from the patient groups, registered clinicians, and drug plans that participated in the CADTH review process.
CADTH received patient input from 2 organizations, Crohn and Colitis Canada (CCC) and the Gastrointestinal Society. The CCC input contained information from a report published in 2018 (i.e., the Impact of Inflammatory Bowel Disease in Canada report),1 a 2022 survey involving 687 respondents with moderate to severe CD, and interviews with 3 patients with CD who participated in a risankizumab clinical trial. Both the CCC and the Gastrointestinal Society agreed that CD negatively impacts patients’ personal and social lives due to being unable to predict bowel movements and being unable to control flares. The CCC found that 6 in 10 respondents felt isolated because of having CD.
CADTH received clinical input from the Pan-Canadian Inflammatory Bowel Disease Specialist Group, which consists of specialists in gastroenterology from across Canada with experience caring for patients with CD. The group emphasized that the goal of treatment should focus on improvements in endoscopic response, endoscopic remission, and mucosal healing. The group noted that these long-term goals could not be met with the current treatment landscape, due to the lack of safe and effective treatments that rapidly improve endoscopic appearance and maintain those improvements over the long-term. The group also claimed that there was still a high rate of surgery and postoperative recurrence in CD despite current available treatment options, such as corticosteroids (e.g., prednisone, budesonide), immunomodulators (e.g., azathioprine, methotrexate), and biologics (anti–tumour necrosis factors such as infliximab and adalimumab, anti–interleukin 12 and anti–interleukin 23 drugs such as ustekinumab, and anti-integrin drugs such as vedolizumab). They recognized the potential of risankizumab in improving both clinical and endoscopic outcomes in patients with CD, and suggested the use of risankizumab in patients with moderate to severe CD as the first-line biologic, and as a second-line drug in patients still experiencing flares or inadequate response on other existing biologics.
Feedback from drug plans stated that ustekinumab is not an appropriate comparator as it is not listed under most public drug plans in Canada. They also expressed concerns with the inclusion criteria used in 2 of the trials submitted by the sponsor, where the trials only included patients with CD with a Crohn Disease Activity Index (CDAI) score between 220 and 450 at baseline. Drug plans noted that it was unclear if this criteria were appropriate to determine whether physicians should initiate treatment with risankizumab, as not all gastrointestinal specialists may use the CDAI scoring system in Canadian clinical practice.
CADTH addressed some of these concerns as follows:
CADTH was unable to address the following concerns raised from stakeholder input:
The current review is for risankizumab (Skyrizi) for adults with moderately to severely active CD who have had an inadequate response, intolerance, or demonstrated dependence to corticosteroids, or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies.
The sponsor submitted a cost-utility analysis of risankizumab compared with adalimumab, adalimumab-biosimilar, infliximab, infliximab-biosimilar, ustekinumab, vedolizumab, vedolizumab-subcutaneous (SC), and conventional care that consisted of corticosteroids (e.g., prednisone), aminosalicylates, and immunomodulators (e.g., azathioprine, cyclosporine, methotrexate, 6-mercaptopurine). The model population consisted of adults with moderately to severely active CD who have had an inadequate response to, intolerance to, or demonstrated dependence on corticosteroids, or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies. The modelled population was in line with the reimbursement request and Health Canada–indicated population.
Risankizumab is available as a 600 mg/10 mL IV infusion, and a 360 mg/2.4 mL SC injection. The recommended dosage is 600 mg IV infusion for induction therapy at week 0, week 4, and week 8, followed by maintenance therapy with risankizumab 360 mg by SC injection at week 12, and every 8 weeks thereafter. At the submitted price of $4,593.14 per 600 mg IV infusion and $4,593.14 per 360 mg SC injection, the average annual cost for risankizumab is $41,338 in the first year and $29,855 in subsequent years.
The clinical outcome was QALYs and life-years. The economic analysis was undertaken over a time horizon of 60 years from the perspective of a Canadian publicly funded health care system. Costs and QALYs were discounted at a rate of 1.5% per annum.
The sponsor submitted a model consisting of a decision tree that covered up to 2 induction periods of initial treatments and a long-term Markov model with 17 health states using 2-week cycles (Appendix 3, Figure 1 and Figure 2). The model was developed in Microsoft Excel and had 3 time periods: the primary response period (the period from treatment initiation up to initial assessment of the condition), a delayed response period (in the scenario analysis), and the maintenance period (the period following primary response). The length of the induction period differed among different biologics, based on their label. At the end of each induction period, patient response status was evaluated based on Clinical Response 100 (CR-100), which defined positive response as a drop of 100 or more points in the CDAI score from the baseline to the end of the induction period. Nonresponders were switched back to conventional care after the induction period. Patients who initiated the treatment on conventional care remained on conventional care irrespective of their response status.
Those who responded to the treatment were treated with a biologic maintenance regimen. Responders entered a Markov model and were split into different health states based on their CDAI score. The Markov model included 16 alive health states that comprised 4 health states of moderate to severe (220 ≤ CDAI < 600), mild (150 ≤ CDAI < 220), remission (CDAI < 150), and surgery, repeated for 4 sets. These 4 sets included “low dose biologics after response,” “high dose biologics after response,” “conventional care after no response,” and “conventional care after response.” In each cycle, patients could transition between different CDAI-based health states or remain in their current state. Responders stayed on the same biologic treatment unless they either discontinued the treatment or escalated their dose.
Transitions to the surgery state only came from the patients in the moderate to severe health state. After undergoing surgery, patients stayed in a postsurgery tunnel state for 8 weeks and would then return to 1 of the CDAI-based health states, unless they died.
Based on the indication, the sponsor performed the analysis and reported results separately for 2 subpopulations, conventional care failure and biologic failure.
The modelled population reflected the baseline characteristics of the risankizumab induction trials, based on a joint post hoc analysis of the MOTIVATE and ADVANCE intention-to-treat populations, the primary efficacy analysis for the MOTIVATE, ADVANCE, and FORTIFY studies (ITT1A populations). Based on these trials, the submitted model assumed a female sex for 45.1% of the population and a mean age of 38.83 years (standard error = 0.73) for the conventional care failure subpopulation, and a female sex for 47.5% of the population and a mean age of 38.20 years (standard error = 0.40) for the biologic failure subpopulation. Overall, 44.5% of the patients were assumed to have moderately severe disease (220 ≤ CDAI < 300), while 55.5% of the patients were assumed to have severe disease (CDAI 300+). The baseline sample consisted of 359 patients in the conventional care failure group and 1,060 patients in the biologic failure group.
Clinical efficacy inputs in the model included CDAI response rates (only for the induction phase), CDAI remission rates (for both the induction and maintenance phases), the classification of patients as mild or moderate based on CDAI score at the end of the induction phase, dose escalation, adverse events, discontinuation rates for the biologics, and the rate of surgery. The sponsor estimated the relative efficacy and safety of risankizumab versus other biologics during the induction and maintenance periods through an in-house Bayesian NMA. For patients in the conventional care failure group, positive CR-100 response rates after the induction period were assumed to be ||||% for risankizumab, ||||% for ustekinumab, ||||% for adalimumab, ||||% for infliximab, ||||% for vedolizumab, and ||% for conventional care, based on the NMA. There was significant uncertainty around these estimates with credible intervals overlapping when comparing treatments.2 For patients in the biologic failure group, positive CR-100 response rates after the induction period were assumed to be ||||% for risankizumab, ||||% for ustekinumab, ||||% for adalimumab, ||||% for vedolizumab, and ||||% for conventional care.2 A response rate was not estimated for infliximab in the biologic failure group but was assumed to be equal to that of adalimumab (which had |||| ||||| response rate when compared to infliximab in the conventional care failure group). There was significant uncertainty around these estimates with credible intervals overlapping when comparing treatments. Notably, all treatments were assumed to have ||||| CR-100 response in the biologic failure group compared to the conventional care failure group, with the exception of risankizumab. Similarly, the sponsor estimated |||||| remission rates (CDAI < 150) for infliximab when compared to risankizumab among the conventional care failure group, and did not estimate remission rates for infliximab in the biologic failure group due to lack of data (instead, the sponsor assumed that infliximab was equal to adalimumab and thus ||||| than risankizumab). Another clinical efficacy input was the rate of surgery; transitions to the surgery state only came from patients in the moderate to severe health state, who had an annual 7% probability of surgery based on NHS [National Health Service] Hospital Episode Statistics data. Incidence rates for adverse events (serious infections, tuberculosis, lymphoma, hypersensitivity, and skin reactions) were estimated using the induction and maintenance clinical trials as well as the published literature. Background mortality was obtained from Statistics Canada Life Tables based on a patient’s age and gender. CD was assumed to not cause any excess mortality.
Health utility values were based on 5-Level EQ-5D patient scores collected in the MOTIVATE and ADVANCE risankizumab induction trials and the FORTIFY maintenance trial. Patients were assumed to have the same health state utility values irrespective of treatment. The EQ-5D sample included 1,417 patients (mean age of 38.5, 47% female, 81% white, 15% Asian, 4% Black or African American, 1% of multiple racial background, and 0.3% Native Hawaiian or Other Pacific Islander). The mean EQ-5D score associated with each health state was estimated by fitting an ordinary least squares regression to predict EQ-5D based on CDAI health state (remission, mild CD, and moderate to severe CD). The model included utility decrements to account for the impact of adverse events. Disutility values for each adverse event were based on the literature. It was assumed surgical complications did not incur health utility decrements in the model, but only affected costs. The utility value used for surgery was assumed to be equal to the moderate to severe health state.
Costs included drug acquisition and administration, disease management, adverse events, surgery, and surgical complications. Cost inputs from previous years were inflated to 2022 values using the general consumer price index from Statistics Canada. Drug acquisition costs for biologics were sourced from IQVIA DeltaPA. The sponsor’s base case included wastage for infliximab doses. For conventional care, the sponsor consulted 4 clinical experts to determine the type and proportion of conventional drugs that patients would be typically prescribed. Costs for conventional care were sourced from the Ontario Drug Benefit Formulary. The administration cost for the initial SC dose was based on the Ontario Hospital Insurance Plan Schedule of Benefits and Fees. Subsequent SC doses were assumed to be self-injections with no administration cost. The cost for both initial and subsequent IV administrations was sourced from the literature (Hughes et al.3). Ongoing monitoring, tests, and physician visits were estimated based on a survey of 4 specialists from across Canada. Unit costs for physician visits, tests, small intestine resection and anastomosis surgery, surgical complications (including wound infection, prolonged ileus or bowel obstruction, intra-abdominal abscess, and anastomotic leak), and serious adverse events (including serious infection, tuberculosis, lymphoma, hypersensitivity, and skin reactions) were obtained from the Ontario Ministry of Health and Long-term Care’s Schedule of Benefits for Professional Services, the Ontario Ministry of Health and Long-Term Care’s Schedule of Benefits for Laboratory Services, and the Ontario Case Costing Initiative for hospitalizations.
All analyses were run probabilistically with 5,000 iterations for the base case and 1,000 iterations for scenario analyses. The deterministic and probabilistic results were similar. The probabilistic findings are presented as follows.
The sponsor reported results separately for 2 groups of patients: those who previously experienced failure with conventional care, and those who previously experienced failure with biologic therapy. Among the conventional care failure group, risankizumab was extendedly dominated by conventional care and vedolizumab-SC (refer to Table 3). Among the biologic failure group, risankizumab was associated with an ICER of $325,990 per QALY gained compared to vedolizumab-SC over a 60-year time horizon (Table 4)). Vedolizumab, adalimumab, adalimumab-biosimilar, infliximab, and infliximab-biosimilar were dominated by risankizumab as they as they were more costly and generated fewer QALYs. At a WTP threshold of $50,000 per QALY, the probability of risankizumab being cost-effective was 0% in the biologic failure group. Based on the sponsor’s base case for the biologic failure group, a price reduction of at least 31.3% is required for risankizumab to be deemed cost-effective at a WTP threshold of $50,000 per QALY.
The main cost driver was the drug acquisition cost, followed by adverse events, and surgery-related costs. In the conventional care failure group, 66% of the total cost of $652,360 for risankizumab was drug acquisition costs ($430,327). In comparison, 51% of the total cost of $499,060 for vedolizumab-SC was drug acquisition costs ($255,088). Similarly, in the biologic failure group, 66% of the total cost of $644,341 for risankizumab was drug acquisition costs ($423,524). In comparison, 44% of the total cost of $453,637 for vedolizumab-SC in the biologic failure group was drug acquisition costs ($201,464).
Given that CD was assumed to not cause any excess mortality, life-years were similar across all comparators (16.24 for the conventional care failure group and 15.60 for the biologic failure group).
Summary of the Sponsor’s Economic Evaluation Results — Conventional Care Failure Group.
Summary of the Sponsor’s Economic Evaluation Results — Biologic Failure Group.
Additional results from the sponsor’s submitted economic evaluation base case, including cost-effectiveness acceptability curves and cost-effectiveness acceptability frontiers, are provided in Appendix 3.
The sponsor performed scenario analyses that included a societal perspective, alternative discount rates, time horizons of 10 years and 20 years, alternative data sources for maintenance treatment efficacy, response criteria, alternate utility values from the literature, the separation of moderate and severe health states, the adjustment of utility values for age, and vial sharing for infliximab. Base-case results remained robust across most scenario analyses. One exception was the comparison between risankizumab and vedolizumab-SC, where risankizumab was not cost-effective in the base-case analysis but would become cost-effective when the societal cost perspective and an alternative response criterion (3 70-point decrease from baseline in CDAI score [CDAI-70]) were adopted.
In the sensitivity analysis, the conventional care Markov transition matrix, the probability of remission with low-dose risankizumab maintenance therapy, the risankizumab induction response, remission probabilities, and whether the NMA or raw efficacy data were used for induction had the greatest impact on the results.
CADTH identified several key limitations to the sponsor’s analysis that have notable implications for the economic analysis.
Additionally, the following key assumptions were made by the sponsor and have been appraised by CADTH (refer to Table 5).
Key Assumptions of the Submitted Economic Evaluation (Not Noted as Limitations to the Submission).
CADTH corrected the sponsor’s model by changing the disutility for severe infections from –0.52 in the sponsor’s base case (based on an implicit assumption that episodes of severe infections last a year) to –0.04 (based on a 4-week duration for a severe infection). The CADTH base case was derived by making changes in model parameter values and assumptions, in consultation with clinical experts. CADTH’s base case assumed that patients on a maintenance dose of all biologics have an annual dose escalation probability of 15%. The CADTH changes were unable to address several major issues of the submission — namely, the uncertainty of risankizumab’s comparative efficacy and the uncertainty of its effectiveness and safety over time.
CADTH Revisions to the Submitted Economic Evaluation.
Results from the CADTH base case suggest that in the conventional care failure group, infliximab-biosimilar was associated with higher costs ($353,316) and improved QALYs (1.878), with an ICER of $188,134 per QALY gained compared to conventional care. In the conventional care failure group, risankizumab was dominated by ustekinumab, which itself was extendedly dominated (refer to Appendix 4, Figure 4). In the biologic failure group, risankizumab was associated with higher costs ($191,541) and improved QALYs (0.358), with an ICER of $535,031 per QALY gained compared to vedolizumab-SC (refer to Figure 5 in Appendix 4 for other comparators that were dominated); risankizumab had a 0% probability of being cost-effective at a WTP threshold of $50,000 per QALY.
In the biologic failure group, of the 22.433 QALYs estimated for risankizumab compared to vedolizumab-SC in the CADTH base case, only 0.684 (3%) were estimated to occur during the pivotal trial time frame (52 weeks). Of the $644,562 total cost for patients receiving risankizumab, $423,149 (66%) was treatment acquisition costs.
Summary of the Stepped Analysis of the CADTH Reanalysis Results for Conventional Care Failure Group.
Summary of the Stepped Analysis of the CADTH Reanalysis Results for Biologic Failure Group.
Based on CADTH’s base case, a series of scenario analyses was conducted. These analyses explored the impact of setting a similar rate of serious infection adverse events for all biologics, of limiting analysis time horizon to 1 year, 5 years, and 10 years, and of considering dose escalation only for treatments that reported dose escalation rates in their pivotal trials.
For patients in the conventional care failure group, repeating the analysis with time horizons of 1 year, 5 years, and 10 years resulted in ICERs of $195,939, $154,371, and $159,112 per QALY gained, respectively, when comparing infliximab-biosimilar against conventional care. For patients in the biologic failure group, repeating the analysis with time horizons of 1 year, 5 years, and 10 years resulted in ICERs of $483,167, $476,635, and $503,814 per QALY gained, respectively, when comparing risankizumab against vedolizumab-SC. Of the total 22.435 QALYs estimated for risankizumab in the CADTH base case, 0.684 (3%) were accumulated during the first year, 3.395 (15%) were accumulated during the first 5 years, and 6.529 (29%) were accumulated during the first 10 years of follow-up. Assuming no dose escalation for vedolizumab, infliximab, and risankizumab resulted in an ICER of $533,752 per QALY for risankizumab compared to vedolizumab-SC in the biologic failure group and did not change the dominated status of risankizumab in the conventional care failure group.
A price reduction analysis was conducted for the conventional care failure group based on sponsor’s base case and CADTH’s reanalysis (refer to Table 9). The sponsor argued that conventional care should not be included in this analysis since, by definition, those in the conventional care failure group will not respond to conventional care. Therefore, compared to the second least expensive comparator, vedolizumab-SC, a price reduction of at least 33.1% (based on the CADTH base case) is required for risankizumab to be considered cost-effective at a WTP threshold of $50,000 per QALY. When conventional care is included in the price reduction analysis, the results indicate that a price reduction of at least 70.6% (based on the CADTH base case) is required for risankizumab to be considered cost-effective compared to conventional care at a WTP threshold of $50,000 per QALY.
CADTH Price Reduction Analyses for Conventional Care Failure Group.
A price reduction analysis was conducted for the biologic failure group based on the sponsor’s base case and CADTH’s reanalysis (refer to Table 10). The results indicate that a price reduction of at least 41.1% (based on the CADTH base case) is required for risankizumab to be considered cost-effective at a WTP threshold of $50,000 per QALY.
CADTH Price Reduction Analyses for Biologic Failure Group.
Evidence from the ADVANCE, MOTIVATE, and FORTIFY trials suggest that risankizumab is well-tolerated and effective compared to placebo as an induction and maintenance therapy for adults with moderate to severe CD who have previously shown intolerance or inadequate response to either conventional care or another biologic. However, due to limitations of the preliminary data from the SEQUENCE trial comparing risankizumab to ustekinumab, and the uncertainty in the sponsor-submitted NMA due to notable heterogeneity across included randomized controlled trials and — in many cases — credible intervals affected by serious imprecision, no definitive conclusions on the efficacy and safety of risankizumab relative to active comparators in both conventional care failure and biologic failure patients with CD could be drawn.
CADTH identified several key limitations with the sponsor’s economic analysis. Specifically, there was uncertainty associated with the comparative and long-term efficacy of risankizumab; there were uncertain transition probabilities given the low sample size, low sampling frequency, and the calibration method used; there was a lack of differentiation between causes and types of surgeries and their downstream effects on quality of life and future complications; there were overly optimistic assumptions that patients on risankizumab would not require dose escalation; and there were errors in calculating disutility values for severe infections associated with treatment. CADTH undertook its reanalysis by correcting disutility values for severe infection adverse events and aligning dose escalation for all used biologics. Issues regarding the available comparative clinical evidence and information on the durability of effect could not be addressed.
CADTH’s base case for the biologic failure population resulted in an ICER of $535,031 per QALY gained for risankizumab compared to vedolizumab-SC. A price reduction analysis showed that a price reduction of at least 41.1% would be required for risankizumab to be cost-effective at a WTP threshold of $50,000 per QALY in the biologic failure group.
Based on the CADTH base case, risankizumab was dominated by ustekinumab (risankizumab was more costly and less effective) in the conventional care failure group. A price reduction analysis showed that a price reduction of at least 33.1% would be required for risankizumab to be cost-effective at a WTP threshold of $50,000 per QALY in the conventional care failure group. However, if conventional care is deemed a reasonable comparator in the conventional care failure group, the price reduction would rise to 70.6%.
There remains a significant degree of uncertainty in the cost-effectiveness results, where issues regarding the available comparative clinical evidence and information on the durability of effect could not be addressed in CADTH reanalyses. No definitive conclusions can be drawn from the sponsor’s NMA — specifically, whether patients receiving risankizumab will benefit more than with other biologics. Yet the pharmacoeconomic model assumed that improvement in remission rates for risankizumab observed in the 52-week trial versus placebo would be maintained over a number of decades without waning. The clinical benefits with risankizumab are expected over a long time horizon; in the CADTH base case for the biologic failure population, 97% of the total 22.43 QALYs were estimated to occur beyond the 52-week trial period. While the cost of treatment with risankizumab is higher than currently available biologics, the benefit to patients and overall impact on health care system costs are highly uncertain.
Crohn’s and Colitis Canada
Crohn disease
Crohn’s Disease Activity Index
Clinical Response 100
incremental cost-effectiveness ratio
network meta-analysis
quality-adjusted life-year
subcutaneous
willingness to pay
Note that this appendix has not been copy-edited.
The comparators presented in the following table have been deemed to be appropriate based on feedback from clinical experts. Comparators may be recommended (appropriate) practice or actual practice. Existing Product Listing Agreements are not reflected in the table and as such, the table may not represent the actual costs to public drug plans.
CADTH Cost Comparison Table for Crohn Disease.
Note that this appendix has not been copy-edited.
Submission Quality.
Note that this appendix has not been copy-edited.
Decision Tree Model Structure.
Markov Model Structure.
Cost-Effectiveness Acceptability Frontier.
Note that this appendix has not been copy-edited.
Cost-Effectiveness Acceptability Frontier for CADTH Reanalysis of Conventional Care Failure Group.
Disaggregated Summary of CADTH’s Economic Evaluation Results — Conventional Care Failure Group.
Cost-Effectiveness Acceptability Frontier for CADTH Reanalysis of Biologic Failure Group.
Disaggregated Summary of CADTH’s Economic Evaluation Results — Biologic Failure Group.
Note that this appendix has not been copy-edited.
Summary of Key Take-Aways.
The sponsor submitted a budget impact that assess the introduction of risankizumab for the treatment of moderately to severely active CD who have had an inadequate response, intolerance, or demonstrated dependence to corticosteroids; or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies. The analysis took the perspective of CADTH-participating Canadian public drug plans using a claims-based approach and incorporated drug acquisition costs. A time horizon of 3 years was taken. The size of the target population was estimated by considering the number of patients with CD using biologic therapies by province, and the percentage of patients with CD who are covered by a provincial drug plan as specified in the IQVIA GPM database which captures patients with CD living in Canada from Q1 to 2020 to Q1 to 2022. Key inputs to the budget impact analysis are documented in Table 20.
Key assumptions included the following:
Summary of Key Model Parameters.
The sponsor’s estimated budget impact for funding risankizumab as a treatment for moderately to severely active CD who have had an inadequate response, intolerance, or demonstrated dependence to corticosteroids; or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies was $10,897,238 in year 1, $12,300,264 in year 2, and in $32,425,718 year 3, for a 3-year total of $55,623,220.
The sponsor conducted several scenario analyses testing alternative assumptions. The changes with the greatest impact on the results included a change in the mean dose per administration of infliximab (mg/kg), changes in the market penetration of risankizumab, changes in the size of the total biologic market for eligible patients, and a change in the proportion of the market eligible for public coverage.
CADTH identified several key limitations to the sponsor’s analysis that have notable implications on the results of the budget impact analysis:
CADTH identified several key limitations that could not be accounted for in a reanalysis, due to the underlying data used in the model. Therefore, there is a large degree of uncertainty when interpreting the sponsor-submitted result. As previously described the sponsor predicts a 3-year budget impact of $55,623,220.
CADTH performed scenario analyses accounting for changes to the proportion of public coverage and the price reduction to risankizumab required to be cost-effective at a $50,000/QALY WTP threshold.
Detailed Breakdown of the CADTH Reanalyses of the Budget Impact Analysis.
Copyright © 2023 - Canadian Agency for Drugs and Technologies in Health. 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).
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