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Indication: For the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy
CADTH recommends that Sotyktu not be reimbursed by public drug plans for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Plaque psoriasis is a skin disease that causes red, flaky, crusty patches of skin that may be itchy and painful and can lead to negative impacts on social and work life. Up to 1 million people in Canada are living with psoriasis, a third of whom have moderate to severe disease.
Although many treatments are approved in Canada for moderate to severe plaque psoriasis, some patients may not respond to these treatments. Other treatment options are needed for these patients.
Treatment with Sotyktu is expected to cost $14,409 per patient per year.
The CADTH Canadian Drug Expert Committee (CDEC) recommends that deucravacitinib not be reimbursed for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
There is a lack of robust evidence to sufficiently demonstrate that deucravacitinib exhibits a comparable therapeutic benefit relative to the treatments for plaque psoriasis that are currently used in clinical practice in Canada. Evidence from 2 double-blind, randomized controlled trials (RCTs), POETYK PSO-1 (N = 666) and POETYK PSO-2 (N = 1,020), in adults with moderate to severe plaque psoriasis showed that deucravacitinib was associated with statistically significant improvements in skin clearance (Psoriasis Area and Severity Index [PASI] score reduced by 75% [PASI 75] or 90% [PASI 90] or a static Physician’s Global Assessment [sPGA] of clear or almost clear) at week 16 versus apremilast and placebo. In the trials, 53% to 58% of patients in the deucravacitinib groups achieved a PASI 75 response, 27% to 36% achieved a PASI 90 response, and 10% to 14% achieved a PASI score reduced by 100% (PASI 100) response at week 16. However, the clinical relevance of these results within the Canadian treatment landscape is uncertain. Based on clinical expert input, although PASI 75 is accepted as a clinically relevant minimal response threshold in clinical trials, available biologics are expected to achieve a PASI 90 or PASI 100 response in clinical practice. Finally, patients in the POETYK PSO-1 and POETYK PSO-2 trials were not required to fail on conventional treatment options before enrolment, and, as a result, it is uncertain if the outcomes demonstrated in these trials can be extrapolated to the advanced treatment clinical landscape.
Direct evidence comparing newer IL-17 and IL-23 biologics and deucravacitinib was not identified by CADTH for this review. The only direct comparative evidence included deucravacitinib and apremilast. Indirect evidence from 1 sponsor-submitted network meta-analysis (NMA) suggested that deucravacitinib was less effective in producing skin improvement than several biologics (including IL-17 and IL-23 biologics) that are available and reimbursed in Canada.
Patients expressed a need for treatments that improve skin clearance, symptoms of psoriasis, and health-related quality of life (HRQoL), as well as a need for treatments that are convenient and have minimal adverse effects. CDEC concluded that there was insufficient evidence to demonstrate that deucravacitinib meets needs that are not already addressed by other available treatments.
Plaque psoriasis is a chronic inflammatory skin disease characterized by erythematous inflammatory plaques that may be itchy or painful and are usually covered by silver, flaking scales. In addition to the dermatological symptoms, plaque psoriasis is often associated with psychosocial symptoms and can impact self-esteem, interpersonal relationships, and performance at school or work. Several comorbid conditions have been linked to psoriasis, such as depression, cardiovascular disease, and psoriatic arthritis. It is estimated that up to 1 million people in Canada are living with a type of psoriasis, 90% of whom have plaque psoriasis.
Most patients with moderate to severe plaque psoriasis will require systemic therapies to control their symptoms. Traditional systemic drugs include cyclosporine, methotrexate, and acitretin. Advanced therapy, which is usually reserved for patients who fail on or are intolerant of traditional systemic therapies, include apremilast and biologic drugs (tumour necrosis factor alpha inhibitors, IL-23 inhibitors, IL-12 and IL-23 inhibitors, and IL-17 inhibitors).
Deucravacitinib is a tyrosine kinase 2 inhibitor that impedes the release of proinflammatory cytokines and chemokines. Deucravacitinib was approved by Health Canada for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is available as a 6 mg oral tablet and the dosage recommended in the product monograph is 6 mg daily.
To make its recommendation, the committee considered the following information:
Two patient groups submitted a joint input: CPN and the CAPP. The patient input was based on English and French surveys that received a total 22 responses and another survey entitled “2022 Survey of People with Psoriatic Disease in Canada and their Caregivers,” which was commissioned by the CPN and collected responses from 502 patients. The symptoms most frequently experienced by patients were flaking, itching, pain and burning, silvery scaly plaques, and dry skin that may crack or bleed. Many patients indicated that psoriasis negatively affected their mental health, self-esteem, social life, ability to exercise, and sleep. Furthermore, some patients were financially impacted and missed work due to psoriasis.
The patient groups emphasized that the complexity and chronic nature of plaque psoriasis lead to a continuing need for treatment options that consider the needs of individual patients. Regarding patients’ expectations for new medications, improved symptoms, better quality of life, and reduced side effects were mentioned. Other responses included “affordable” and “easier to take, e.g., dosing schedule, route of administration.”
According to the clinical expert consulted by CADTH, the goals of treatment are to reduce signs and symptoms of psoriasis, and to improve quality of life and function. With available treatments, 80% to 90% of patients achieve a PASI 90 response and approximately 50% to 60% achieve a PASI 100 response. About 10% of patients may not respond to initial induction therapy with a biologic (i.e., primary failure) or may lose response over time (secondary failure). The expert indicated that there is an unmet need for treatments that can be remittive and allow drug discontinuation or are intermittent (rather than continuous) therapy, as well as for treatments that can modify the disease pathophysiology and have a beneficial effect on its natural history.
The clinical expert indicated that deucravacitinib does not address any of the unmet needs in plaque psoriasis and did not anticipate that it would cause a shift in the current treatment paradigm. The expert stated that it would be difficult to define a role for deucravacitinib except as an oral alternative to the biologics for patients who prefer oral treatment.
Advanced therapy, such as deucravacitinib, should be reserved for patients who have failed first-line traditional systemics (e.g., methotrexate, acitretin, cyclosporine), according to the clinical expert. Treatment response is usually assessed after 12 to 16 weeks and then at 1 year. Deucravacitinib should be discontinued if patients experience a significant adverse effect (e.g., hypersensitivity, serious infection). In addition, the expert stated that deucravacitinib ought to be discontinued if it fails to provide at least a PASI 75 response. Like biologics, the expert stated that deucravacitinib should be prescribed by dermatologists.
No input was received from clinician groups.
Input was obtained from the drug programs that participate in the CADTH reimbursement review process. The following were identified as key factors that could potentially impact the implementation of a CADTH recommendation for deucravacitinib:
The clinical experts consulted by CADTH provided advice on the potential implementation issues raised by the drug programs.
Two 52-week double-blind RCTs met the inclusion criteria for the systematic review. POETYK PSO-1 (N = 666) and POETYK PSO-2 (N = 1,020) used a parallel study design, with POETYK PSO-2 adding a randomized withdrawal design for responders at week 24. The studies enrolled adults (≥ 18 years) who had moderate to severe plaque psoriasis and were candidates for systemic psoriasis therapy and/or phototherapy. Patients were required to have a baseline PASI score of 12 or higher, with more than 10% of body surface area affected, and with a static sPGA score of at least 3 on a 5-point scale.
Both studies randomized eligible patients (2:1:1) to deucravacitinib 6 mg daily, apremilast 30 mg twice daily, or placebo. All patients in the placebo groups switched to deucravacitinib at week 16. Both studies included a 24-week crossover to deucravacitinib for patients in the apremilast group who did not show an adequate response to therapy (i.e., did not achieve a PASI 50 response in the POETYK PSO-1 trial or a PASI 75 in the POETYK PSO-2 trial). At week 24 in the POETYK PSO-2 study, patients in the deucravacitinib group who achieved a PASI 75 response were rerandomized to placebo or to continue deucravacitinib, and patients in the apremilast group who achieved a PASI 75 response were switched to placebo.
The coprimary outcomes in both studies were the proportion of patients who achieved an sPGA score of 0 or 1 (with at least a 2-point change from baseline) and PASI 75 response at week 16, compared with placebo. The sPGA is a composite score of the physician’s assessment of the overall severity of the patient’s psoriatic lesions using a 5-point scale, described as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). PASI grades the extent and severity of psoriatic lesions and combines an assessment of the body surface area affected with the severity of desquamation, erythema, and plaque induration or infiltration. It is scored from 0 to 72, with higher scores representing more severe disease. A PASI response is the percentage improvement in PASI score, with PASI 75 considered the minimum clinically relevant change.
Key secondary outcomes included other PASI or sPGA response thresholds, HRQoL, and symptoms of psoriasis for deucravacitinib versus placebo or apremilast at week 16, 24, or 52. The POETYK PSO-2 study also evaluated the time to relapse among patients in the deucravacitinib group who achieved a PASI 75 response at week 24.
The mean age of patients enrolled in the pivotal trials ranged from 44.7 years (standard deviation [SD] = 12.1) to 47.9 years (SD = 14.0) per treatment group. The majority of patients were men (62% to 71%) and the minority were women (29% to 38%). Most patients were white (77% to 93%), with fewer patients who were Asian (3% to 21%), Black (1% to 4%), or other races (≤ 2%). The patients enrolled had been diagnosed with psoriasis for a median of 13.4 years to 18.2 years, with a mean PASI score at baseline ranging from 20.7 (SD = 8.0) to 21.8 (SD = 8.6). The majority of patients had received prior systemic therapy for psoriasis (54% to 66%), including biologics (31% to 39%).
In the POETYK PSO-1 study, 53.6%, 7.2%, and 32.1% of patients in the deucravacitinib, placebo, and apremilast groups, respectively, met the sPGA 0 or 1 response criteria at week 16. The between-group differences favoured deucravacitinib versus placebo (risk difference [RD] = 46.7%; 95% confidence interval [CI], 40.2% to 53.2%; P < 0.0001) and versus apremilast (RD = 21.4%; 95% CI, 12.7% to 30.1%; P < 0.0001). The proportion of responders was 49.5%, 8.6%, and 33.9% in the deucravacitinib, placebo, and apremilast groups, respectively, of the POETYK PSO-2 study. The between-group risk difference was 40.9% (95% CI, 35.4% to 46.4%) for deucravacitinib versus placebo and 15.8% (95% CI, 8.8% to 22.9%) versus apremilast. For both comparisons, the difference favoured deucravacitinib, with P values less than 0.0001.
The proportion of patients in POETYK PSO-1 who achieved a PASI 75 response at week 16 was 58.4%, 12.7%, and 35.1% in the deucravacitinib, placebo, and apremilast groups, respectively, with a risk difference of 46.1%, (95% CI, 38.9% to 53.2%) for deucravacitinib versus placebo (P < 0.0001) and 23.0% (95% CI, 14.1% to 31.8%) versus apremilast (P < 0.0001). The results were similar in the POETYK PSO-2 study, with 53.0%, 9.4%, and 39.8% of patients in the deucravacitinib, placebo, and apremilast groups, respectively, achieving a PASI 75 response at week 16. The risk difference was 43.7% (95% CI, 38.0% to 49.3%; P < 0.0001) for deucravacitinib versus placebo and 13.4% (95% CI, 6.2% to 20.7%; P = 0.0004) versus apremilast.
The results of the key secondary outcomes, PASI 90 and PASI 100 at week 16, favoured deucravacitinib versus placebo in both studies. In addition, the PASI 90 response also favoured deucravacitinib versus apremilast at week 16. The proportion of patients who achieved a PASI 90 response ranged from 27.0% to 35.5% in the deucravacitinib groups, 2.7% to 4.2% in the placebo groups, and 18.1% to 19.6% in the apremilast groups. Few patients in any group achieved a PASI 100 response at week 16 (deucravacitinib = 10.2% to 14.2%, apremilast = 3.0% to 4.3%, placebo = 1%), and although numerically the proportion of PASI 100 responders was higher for deucravacitinib versus apremilast, this comparison was not controlled for type I error rate.
The DLQI was used to assess the impact of treatment on HRQoL. It is a patient-reported 10-item questionnaire that covers 6 domains: symptoms and feeling, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment, each assessed over the past week. The overall DLQI score ranges from 0 to 30, with lower scores indicating better quality of life. A score of 0 or 1 may be interpreted as the disease has no impact on the patient’s HRQoL. The proportion of patients who achieved a DLQI score of 0 or 1 at week 16 was 41.0%, 10.6%, and 28.6% for POETYK PSO-1 and 37.6%, 9.8%, and 23.1% for POETYK PSO-2 in the deucravacitinib, placebo, and apremilast groups, respectively. The between-group differences favoured deucravacitinib versus placebo (POETYK PSO-1: RD = 30.5%; 95% CI, 23.4% to 37.6% and POETYK PSO-2: RD = 27.9%; 95% CI 22.2% to 33.7%), with P values < 0.0001. Although numerically more patients reported a DLQI response in the deucravacitinib groups than in the apremilast groups (RD = 12.3% and 14.6%), these comparisons were not controlled for type I error rate.
The patient-reported Psoriasis Symptoms and Signs Diary (PSSD) was used to evaluate symptom severity in both studies. PSSD symptom score includes 5 symptoms (itch, pain, stinging, burning, and skin tightness) and is scored from 0 to 100, with 0 indicating a complete absence of symptoms. Among patients who have a baseline PSSD symptom score of at least 1, the proportion of patients who had a symptom score of 0 at week 16 was 7.9%, 0.7%, and 4.4% in POETYK PSO-1 and 7.5%, 1.3%, and 4.3% in POETYK PSO-2 in the deucravacitinib, placebo, and apremilast groups, respectively. In both studies, the differences favoured deucravacitinib versus placebo (P < 0.01), but with no statistically significant difference detected for deucravacitinib versus apremilast.
The trials were 52 weeks in duration and analyzed longer-term outcomes for the randomized population (POETYK PSO-1) and for the subgroup of patients who achieved a PASI 75 response at week 24 (POETYK PSO-2). In the POETYK PSO-1 study, 56.3% of patients achieved a PASI 75 response at week 24 and week 52, in comparison to 30.5% of patients who had received apremilast (RD = 25.5%; 95% CI, 16.9% to 34.0%; P < 0.0001). Data from the POETYK PSO-2 study indicate that patients who achieved a PASI 75 response with deucravacitinib, and who remained on treatment, were less likely to relapse than patients who were switched to placebo (P < 0.0001).
During the first 16 weeks of the pivotal trials (before any treatment switching), the frequency of adverse events was generally similar across groups, with 53% and 58% of patients in the deucravacitinib groups, 42% and 54% of patients in the placebo groups, and 55% and 59% in the apremilast groups reporting 1 or more adverse event. The most commonly reported events in the deucravacitinib group were nasopharyngitis (6% to 11%), upper respiratory tract infection (5% to 6%), and diarrhea and headache (each reported in 4% to 5%). The frequency of these events was comparable in the placebo and apremilast groups, except for gastrointestinal adverse events, which appeared to be more common among patients who received apremilast.
The frequency of serious adverse events was generally low during the trials, with 2% of patients in the deucravacitinib group, 1% to 5% in the placebo group, and 0.4% to 2% in the apremilast group reporting an event during the first 16 weeks. Among patients who received deucravacitinib at any time during the 52-week trials, 3% to 6% of patients experienced a serious adverse event, compared with 1% to 4% of those who received apremilast at any time. A total of 4 patients died during the studies. One patient in the placebo group (POETYK PSO-1) died of hypertensive cardiovascular disease, 2 patients in the deucravacitinib group (POETYK PSO-2) died of heart failure and sepsis, and hepatocellular carcinoma, and 1 patient in the apremilast group (POETYK PSO-2) died of lung cancer and gastrointestinal hemorrhage.
The proportion of patients who stopped treatment due to adverse events was 2% and 3% for deucravacitinib, 4% for placebo, and 5% and 6% for apremilast during the first 16 weeks of the trials.
During the first 16 weeks of the studies, infections and infestations were reported by 26% to 31% of patients in the deucravacitinib groups, 15% to 26% in the placebo groups, and 18% to 25% in the apremilast groups. Few patients in any groups experienced an infection or infestation that was a serious adverse event, and there were no opportunistic infections or tuberculosis events reported in either study. The proportion of patients with at least a grade 2 increase in creatine kinase (CK) levels was 3% for the deucravacitinib groups, 1% to 4% in the placebo groups, and 0% to 4% in the apremilast groups during weeks 0 to 16. Over the 52-week study period, 6% of patients receiving deucravacitinib and 4% to 5% receiving apremilast reported grade 2 or higher elevated CK levels. None of these events were considered serious adverse events. In both trials, the frequency of other adverse events that may be associated with drugs that work through the Janus kinase pathway (major adverse cardiovascular events, thromboembolic events, malignancy, elevated liver enzymes, lymphopenia, or neutropenia) was generally low.
The POETYK PSO-1 and POETYK PSO-2 studies appear to have a low risk of bias with regards to randomization, allocation concealment, and blinding. In general, the baseline characteristics of patients appeared to be balanced between groups within trials. The efficacy outcomes reported were relevant to patients (i.e., skin clearance, psoriasis symptoms, and HRQoL), had evidence to support their validity, and key patient-reported outcomes were part of the statistical testing procedure to control the type I error rate. However, the coprimary outcome, PASI 75, may be considered the minimum clinically relevant response, whereas in clinical practice a PASI 90 response is generally the expected goal of therapy. Key skin clearance outcomes were analyzed based on the intention-to-treat population and using nonresponder imputation for patients who stopped treatment or with missing data. This composite estimand may be considered a conservative estimate of effects. However, up to 10% of patients were excluded from the DLQI or PSSD response end points (depending on the treatment group). The potential impact of these missing patients on the findings is unclear.
Overall, the clinical expert consulted for this review considered that the patients enrolled would represent patients with moderate to severe psoriasis who may be treated with advanced therapies in Canada, including those who had received prior systemic or biologic therapy. However, the clinical expert identified some issues with apremilast as an active comparator, including that while apremilast is another oral advanced therapy, it is infrequently prescribed in Canada for the treatment of moderate to severe plaque psoriasis. Additionally, the expert stated that the efficacy of apremilast is considered to be low for an advanced therapy, and most dermatologists would select a biologic over apremilast. Thus, based on current practice, apremilast may not be as relevant a comparator as biologics for patients with moderate to severe disease.
The sponsor-submitted ITC conducted a systematic review and used a Bayesian NMA to evaluate the relative efficacy of deucravacitinib to other comparators for the treatment of patients with moderate to severe plaque psoriasis. The NMA was based on a systematic review of the literature and data from up to 84 trials were used to inform the analyses. The main efficacy outcome of interest was PASI response.
The sponsor-submitted ITC reported that in the short-term (at 10 to 16 weeks) with 84 RCTs included, deucravacitinib was |||||||| ||||||||||||||||||||||||||||||||||||||||||||||||
The ITC reported that in the midterm (at 24 to 28 weeks) with 48 trials included, deucravacitinib |||||||||||||||||||||||||||||||||||||||||||||| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| ||||||||||||||||||||
The sponsor-submitted ITC reported that in the long-term (at 44 to 60 weeks) with 32 trials included, deucravacitinib was ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The sponsor-submitted ITC involved a rich evidence base with a large network of RCTs and sample size, which strengthened the robustness of the NMA analyses. ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Interim data for a single-arm, open-label extension study, IM011075, was submitted by the sponsor. Patients who completed the POETYK PSO-1 and POETYK PSO-2 studies were eligible to enroll. A total of 1,221 patients entered the extension study, which represented 72% of the patients randomized in the parent trials. All patients received deucravacitinib 6 mg daily. At the time of interim analysis, 90% of patients were ongoing in the study and receiving treatment, and 95%, 61%, and 20% of patients provided data at 24 weeks, 48 weeks, and 60 weeks, respectively.
In the total extension population, sPGA 0 or 1 response rates were 50.9% (95% CI, 48.1% to 53.8%; N = 1,221) at the start of the extension phase (week 0), and 56.4% (95% CI, 52.7% to 60.0%; N = 745) at week 48. PASI 75 response rates were 65.1% (95% CI, 62.4% to 67.8%) at week 0 and 75.7% (95% CI, 68.7% to 80.6%) at week 48.
Adverse events were reported by 707 of 1,211 patients (58%). The most frequently reported events were COVID-19 (9%) and nasopharyngitis (4%). Seven percent of patients experienced a serious adverse event and 2% stopped treatment due to adverse events. In total, 6 deaths occurred, including 5 due to COVID-19 and 1 due to a ruptured thoracic aortic aneurysm. Infections and infestations were reported by 29% of patients and 4% experienced serious adverse events. At the time of the interim analysis, 45 patients (4%) had at least a grade 2 increase in CK levels but only 1 patient stopped treatment due to these events. No new safety signals were identified.
Limitations of the extension study include selection bias, lack of a control group, and lack of blinding. Reporting of harms and subjective measures (such as those included in the PASI score) may be biased by knowledge of treatment received. As only descriptive statistics were published in this interim report, which were based on observed data with no imputation for missing data, and as there were no comparator groups, the interpretation of the results is limited. Moreover, there is potential for selection bias, as patients who discontinued the parent RCTs due to adverse events, lack of efficacy, or other reasons were excluded.
Summary of Economic Evaluation.
CADTH identified the following key limitations with the sponsor’s analysis: the eligible patient population was inappropriately estimated by including the pediatric population of Canada, the Non-Insured Health Benefits population was included in an inappropriate manner, and biologic therapy was assumed to be publicly funded for all patients; the model was poorly conceptualized and results did not meet face validity, which substantially overestimated the costs associated with the treatment of plaque psoriasis in Canada; response rates and discontinuation assumptions had the same limitations as outlined in the pharmacoeconomic analysis; the use of the health care payer perspective was inappropriate; the market uptake of deucravacitinib and its displacement of other comparators is uncertain; biosimilar use was underestimated; there was uncertainty in the modelling of the basket of biologics used to represent subsequent therapies; and the analysis assumes only patients who would otherwise receive a biologic will access deucravacitinib.
CADTH was unable to fully mitigate the conceptual limitations associated with the model due to structural inflexibility and nonintuitive programming. As deucravacitinib is less expensive per treatment year than most biologic therapies currently being reimbursed, its use is likely to result in cost savings to jurisdictional drug plans over the short-term (i.e., within a 3-year time horizon) as more expensive therapies would be displaced. However, due to its lower efficacy (as suggested in the sponsor’s NMA), it is likely that the use of deucravacitinib will delay rather than prevent the use of more expensive and more effective therapies, thus reimbursement may result in an overall increase in costs over the course of each patient’s life.
CADTH conducted reanalyses to adjust the eligible patient population to include only adults with plaque psoriasis, to mitigate overcounting the number of patients initiating a new therapy each year, to assume that deucravacitinib response would be assessed at 16 weeks, to exclude costs not within drug plan program budgets, to decrease the assumed uptake of deucravacitinib, to assume 100% biosimilar use where available, to equalize subsequent therapies between comparators, and to dose tildrakizumab according to its Health Canada recommendation.
CADTH exploratory analyses suggest that if deucravacitinib is reimbursed in a similar manner to the biologics available for the treatment of moderate to severe plaque psoriasis, its reimbursement might be associated with budgetary savings of $2,469,191 in year 1, $9,227,095 in year 2, and $12,766,452 in year 3, for a 3-year incremental savings of $24,462,738.
The sponsor filed a Request for Reconsideration of the draft recommendation for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In their request, the sponsor identified the following issues:
In the meeting to discuss the sponsor’s Request for Reconsideration, CDEC considered the following information:
All stakeholder feedback received in response to the draft recommendation from patient and clinician groups and the public drug programs is available on the CADTH website.
Dr. James Silvius (Chair), Dr. Sally Bean, Mr. Dan Dunsky, Dr. Alun Edwards, Mr. Bob Gagne, Dr. Ran Goldman, Dr. Allan Grill, Mr. Morris Joseph, Dr. Christine Leong, Dr. Kerry Mansell, Dr. Alicia McCallum, Dr. Srinivas Murthy, Ms. Heather Neville, Dr. Danyaal Raza, Dr. Emily Reynen, and Dr. Peter Zed.
Initial meeting date: February 22, 2023
Regrets: One expert committee member did not attend.
Conflicts of interest: None
Reconsideration meeting date: July 26, 2023
Regrets: Two expert committee members did not attend.
Conflicts of interest: None
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Indication: For the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy
Sponsor: Bristol-Myers Squibb
Final recommendation: Do not reimburse
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