Drugs, Health Technologies, Health Systems
Indication: For the topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older
Sponsor: Arcutis Biotherapeutics, Inc.
Final recommendation: Reimburse with conditions
Summary
What Is the Reimbursement Recommendation for Zoryve?
Canada’s Drug Agency (CDA-AMC) recommends that Zoryve be reimbursed by public drug plans for the topical treatment of plaque psoriasis of the scalp and body in patients aged 12 years or older.
Why Did CDA-AMC Recommend Reimbursement?
The Canadian Drug Expert Committee (CDEC) determined that Zoryve provides clinical value compared to vehicle only, but it is uncertain whether roflumilast demonstrates acceptable clinical value versus other topical therapies used in practice in Canada — including vitamin D analogues, topical corticosteroids, fixed-dose combination products, and topical calcineurin inhibitors — in patients with plaque psoriasis of the scalp and body. Given that roflumilast is expected to be an alternative to these therapies, acceptable clinical value refers to having at least comparable value versus available treatment options.
Evidence from 1 randomized, double-blind, phase III trial demonstrated that treatment with roflumilast for 8 weeks improved disease clearance, itch severity, and scalp-specific disease severity compared with vehicle in patients with plaque psoriasis of the scalp and body. These outcomes were considered clinically meaningful because itch and visible disease are important contributors to disease burden and worsening quality of life. Evidence from 1 sponsor-submitted indirect treatment comparison suggested that roflumilast may improve certain scalp-specific outcomes compared with calcipotriol; however, the results were highly uncertain. For other relevant topical comparators, there was no evidence of a difference, although estimates were imprecise and uncertain.
The committee acknowledged that plaque psoriasis is a chronic condition associated with substantial morbidity, including persistent itch, visible lesions, and psychosocial burden. Patients and clinicians identified limitations with existing therapies, including inadequate effectiveness for some patients, tolerability concerns with long-term corticosteroid use, and challenges with applying conventional topical formulations to hair-bearing and sensitive areas. CDEC considered that roflumilast may address some of these unmet needs as a nonsteroidal topical treatment with a foam formulation suitable for scalp and body involvement.
Based on all the preceding considerations, CDEC recommended that roflumilast be reimbursed.
Which Patients Are Eligible for Coverage?
Zoryve should only be reimbursed for the topical treatment of plaque psoriasis of the scalp and body in patients aged 12 years or older in line with the Health Canada indication and only be covered for patients with plaque psoriasis of the scalp and body for whom topical therapy is appropriate.
What Are the Conditions for Reimbursement?
Zoryve should only be reimbursed if the total cost of Zoryve does not exceed the cost of treatment with the least costly topical therapy currently used to treat plaque psoriasis of the scalp and body.
Important budget impact considerations must be addressed for health systems to be able to adopt Zoryve.
Disease background: Plaque psoriasis is a chronic, immune-mediated inflammatory skin disease characterized by reddish, scaly plaques affecting the scalp and body, often associated with itch, discomfort, and substantial psychosocial burden.
Prevalence: In Canada, psoriasis affects approximately 2% to 3% of the population, with scalp involvement occurring in up to 80% of patients during the disease course.
Indication and reimbursement request: Roflumilast 0.3% foam (Zoryve) has been approved by Health Canada for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older. The sponsor is seeking reimbursement for roflumilast for the treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older, consistent with the Health Canada–approved indication.
Drug under review: Zoryve is a selective PDE4 inhibitor available as a 0.3% foam for once-daily topical administration to affected areas, as recommended in the product monograph.
Treatment costs: At the submitted price of $290.00 per pressurized aluminum can, the per episode (8-week) cost of roflumilast is expected to be $828 per patient, based on the Health Canada–recommended dosage.
The patient groups that provided input (Arthritis Consumer Experts, the Canadian Skin Patient Alliance, and Psoriasis Canada) noted the following points regarding effects of the disease, unmet needs, and important outcomes:
Plaque psoriasis, particularly involving the scalp, is associated with persistent itch, visible lesions, discomfort, and substantial psychosocial burden, including effects on self-esteem, daily functioning, and sleep.
Patients identified itch relief; visible disease clearance (especially on the scalp); and treatments that are easy to use, well tolerated, and suitable for long-term management as key unmet needs and important treatment outcomes.
The clinician groups (the Atlantic Dermatology Group, the Dermatology Association of Ontario, and the Canadian Dermatology Association) and the clinical experts consulted by CDA-AMC noted the following points regarding unmet needs and a place in therapy for roflumilast:
There remains an unmet need for effective, well-tolerated topical therapies that are practical for use on hair-bearing areas such as the scalp, as existing formulations may be difficult to apply or poorly tolerated.
Roflumilast is anticipated to be used as an additional topical treatment option for patients with mild to moderate plaque psoriasis affecting the scalp and body, particularly when existing topical therapies are ineffective, not tolerated, or impractical.
The participating public drug programs raised potential implementation issues related to considerations for initiation, renewal, and prescribing of therapy; generalizability of trial populations to broader populations; and uncertainty regarding long-term use beyond the 8-week trial duration.
With a vote of 14 in favour to 0 against, CDEC recommends that roflumilast 0.3% foam be reimbursed for the treatment of body and scalp plaque psoriasis only if the conditions listed in Table 1 are met.
Table 1: Reimbursement Conditions and Reasons
Reimbursement condition | Reason | Implementation guidance |
|---|---|---|
Initiation | ||
1. Patients must have a clinical diagnosis of plaque psoriasis of the scalp and body for which topical therapy is appropriate. | The results of the ARRECTOR vehicle‑controlled randomized controlled trial demonstrated that roflumilast foam is an effective and safe treatment for patients living with plaque psoriasis, including scalp involvement. | The committee notes that assessment of plaque psoriasis extent and severity is usually performed by clinicians without the use of formal scoring systems. Jurisdictions may align reimbursement criteria with other reimbursed topical drugs for plaque psoriasis. |
Pricing | ||
2. The cost of roflumilast should be negotiated so that it does not exceed the cost of treatment with the least costly topical therapy currently used to treat plaque psoriasis of the scalp and body. | There is insufficient evidence to support a price premium for roflumilast vs. the least costly topical therapy currently used to treat plaque psoriasis of the scalp and body. | Relevant topical therapy comparators include vitamin D analogues, topical corticosteroids, topical combinations, and topical calcineurin inhibitors. |
Feasibility of adoption | ||
3. The economic feasibility of adoption of roflumilast must be addressed. | At the submitted price, the magnitude of uncertainty in the budget impact must be addressed to ensure the feasibility of adoption, given the difference between the sponsor’s estimate and the CDA‑AMC estimate(s). | — |
CDA-AMC = Canada’s Drug Agency; vs. = versus.
Based on the totality of the evidence, CDEC concluded that roflumilast provides clinical value compared with vehicle but noted its clinical value relative to relevant topical comparators (vitamin D analogues, topical corticosteroids, topical combinations, and topical calcineurin inhibitors) is uncertain.
Evidence from 1 randomized, double-blind, phase III trial (ARRECTOR) demonstrated that treatment for 8 weeks with roflumilast resulted in added clinical benefit compared with vehicle in patients with plaque psoriasis of the scalp and body. Roflumilast improved investigator-assessed disease clearance (success on the Scalp Investigator’s Global Assessment [IGA] scale and Body IGA scale), with clinically meaningful absolute improvements, and it improved scalp and worst itch severity and scalp-specific disease severity (at least a 75% improvement in individuals’ Psoriasis Scalp Severity Index scores [PSSI-75]). These outcomes were considered important to patients and clinicians, particularly given the burden of itch and visible disease. Additionally, health-related quality of life may be positively affected by roflumilast when compared with vehicle.
Evidence from 1 sponsor-submitted indirect treatment comparison suggested that roflumilast may improve certain scalp-specific outcomes compared with calcipotriol; however, the results were highly uncertain. For other comparators, including topical corticosteroids, fixed-dose combination products, and topical calcineurin inhibitors, there was no evidence of a difference, although estimates were imprecise and uncertain. The indirect evidence was limited by sparse networks, reliance on indirect comparisons, heterogeneity across studies, and substantial imprecision, and it did not provide robust evidence of comparative efficacy versus most relevant topical therapies.
Roflumilast was generally well tolerated, with higher rates of adverse events compared with vehicle, although these were mostly mild to moderate and serious adverse events were uncommon. However, there is uncertainty regarding long-term safety and durability of effect, as the pivotal trial was limited to 8 weeks of follow-up.
Overall, while roflumilast demonstrated clinically meaningful benefit compared with vehicle, the lack of direct comparative evidence and the high uncertainty associated with indirect evidence precluded the committee from determining whether roflumilast provides comparable clinical value relative to existing topical therapies in clinical practice. CDEC considered clinical value against vehicle to be relevant for decision-making when comparator drugs are not appropriate options due to issues with efficacy, tolerability, or acceptability, which are widespread among patients with plaque psoriasis according to clinicians and patients (refer to further deliberations on unmet need). Ultimately, the committee concluded that roflumilast foam would represent an additional topical treatment for plaque psoriasis.
Further information on the committee’s discussion around clinical value is provided in the Summary of Deliberation section.
The determination of acceptable clinical value was sufficient for CDEC to recommend reimbursement of roflumilast foam. As part of the deliberation on whether to recommend reimbursement, the committee also considered unmet clinical need, unmet nonclinical need, and health inequity. Information on this discussion is provided in the Unmet Clinical Need and Distinct Social and Ethical Considerations domains in the Summary of Deliberation section.
Because CDEC recommended that roflumilast be reimbursed, the committee also considered whether reimbursement conditions should be added to address important economic considerations, health system impacts, or social and ethical considerations, or to ensure that clinical value is realized. The resulting reimbursement conditions, with accompanying reasons and implementation guidance, are stated in Table 1.
CDEC considered all domains of value of the deliberative framework before developing its recommendation: clinical value, unmet clinical need, distinct social and ethical considerations, economic considerations, and impacts on health systems. For further information on the domains of value, refer to Expert Committee Deliberation at Canada’s Drug Agency.
The committee considered the following key discussion points, organized by the 5 domains of value.
Appropriate comparators: The committee considered relevant topical therapies used in clinical practice in Canada as the most appropriate comparators, including topical corticosteroids, vitamin D analogues, fixed-dose combinations, and topical calcineurin inhibitors. However, for patients in need of better options due to lack of efficacy, tolerability, or acceptability, a comparison to vehicle would be appropriate.
Efficacy versus trial comparator (vehicle): One phase III randomized, double-blind trial (ARRECTOR; N = 432) demonstrated that treatment with roflumilast for 8 weeks resulted in clinically meaningful improvements in disease clearance compared with vehicle, as measured by Scalp IGA scale and Body IGA scale success. Absolute improvements of 37% and 25% were observed for scalp and body outcomes, respectively. Improvements were also observed in itch severity (absolute improvements of 35% in the proportions of patients achieving success using the Scalp Itch–Numeric Rating Scale and 32% using the Worst Itch–Numeric Rating Scale) and scalp-specific disease severity (absolute improvement of 38% in the proportion of patients achieving PSSI‑75).
Clinical importance of treatment effects: The committee considered these effects to be clinically meaningful, particularly for outcomes identified as important by patients and clinicians, including itch relief and visible disease clearance, especially for scalp involvement.
Certainty of the evidence: The committee considered the certainty of evidence, which was judged to be high for key efficacy outcomes versus vehicle; however, uncertainty remained regarding quality of life outcomes and longer-term effects. The short duration of follow-up (8 weeks) limited conclusions regarding durability of response and long-term safety. Evidence in adolescents was limited, reducing confidence in this subgroup.
Efficacy versus relevant comparators (ITC): Evidence from a sponsor-submitted network meta-analysis suggested that roflumilast may improve certain scalp-specific outcomes compared with calcipotriol; however, estimates for other comparisons were imprecise, resulting in high overall uncertainty. The committee also noted additional limitations, including reliance on indirect comparisons, heterogeneity across studies, and sparse networks, which limited confidence in the comparative efficacy estimates.
Safety: Roflumilast was generally well tolerated, with higher rates of treatment-emergent adverse events compared with vehicle, although these were mostly mild to moderate. The lack of long-term safety data contributed to uncertainty.
Clinical value: Based on the totality of evidence, the committee concluded that roflumilast demonstrated added clinical benefit compared with vehicle, but its clinical value relative to relevant comparators in clinical practice in Canada was uncertain.
Input on unmet clinical need: Patients and clinicians identified unmet needs related to persistent itch, visible disease, and the burden of applying treatments to hair-bearing and sensitive areas. Limitations of current therapies include inadequate effectiveness for some patients, tolerability concerns with long-term corticosteroid use, and challenges with existing formulations. Clinicians and patients indicated that a substantial proportion of patients with plaque psoriasis are unsatisfied with their current therapy and are unable to use it continuously. In particular, topical corticosteroids are generally restricted to short-term or intermittent use due to safety and tolerability considerations, limiting their ability to sustain long-term disease control and increasing the risk of persistent symptoms and recurrent flares.
Severity of the disease: The committee recognized plaque psoriasis as a chronic condition associated with substantial morbidity, including physical symptoms and psychosocial burden. The chronic nature of the disease requires therapies that can be given over the long term as needed.
Availability of treatment options: Multiple topical therapies are available and are generally effective for many patients; however, not all patients achieve adequate control, and some treatments may be impractical for scalp involvement.
Unmet clinical need: Although multiple topical therapies are available, the committee considered that there remains an unmet clinical need for patients with plaque psoriasis of the scalp and body. Patients and clinicians highlighted limitations of existing treatments, including inadequate effectiveness for some patients, tolerability concerns with long-term use of topical corticosteroids, and challenges with applying conventional formulations to hair-bearing and sensitive areas. The committee noted that these factors may contribute to suboptimal disease control and treatment burden for some patients.
Input on unmet nonclinical need: The committee noted that visible disease and symptoms such as itch may affect quality of life, social functioning, and mental well-being.
Equity considerations: No specific equity concerns were identified.
Other considerations: Roflumilast, a nonsteroidal topical therapy with a formulation suitable for hair-bearing areas, may improve treatment acceptability and ease of use for some patients.
Health impacts of roflumilast versus relevant comparators: The impact of roflumilast on patient health, relative to relevant comparators, is highly uncertain due to limitations in the sponsor’s assumptions regarding treatment pathway, potential overestimation of biologic use in subsequent therapy, and uncertainty in the efficacy estimates derived from the indirect treatment comparison. Based on evidence reviewed for this submission, there is no robust evidence to suggest that roflumilast provides greater health benefit than comparators.
Cost of roflumilast versus relevant comparators: The per episode cost of roflumilast is higher than that of topical therapies. The impact of roflumilast on health system costs, relative to relevant comparators, is highly uncertain due to limitations discussed previously in this document.
Key findings of the economic evaluation: The indirect evidence for roflumilast versus comparators is therefore highly uncertain and there is insufficient evidence to determine whether roflumilast provides greater health benefit compared with topical treatments or oral systemic treatments. Due to the lack of robust clinical evidence and limitations in the model’s flexibility, no CDA-AMC base case was performed, and therefore no increYes, mental cost-effectiveness ratio was estimated by CDA-AMC.
Certainty of the evidence: Several limitations regarding the indirect treatment comparison used to inform the comparison of roflumilast versus all comparators were identified by the review team. Additionally, the modelling approach (i.e., a scalp psoriasis treatment–driven model was used, in which the body’s psoriasis response did not influence patient movement between health states) and assumptions regarding treatment pathway (i.e., proportions of patients escalating from topical to oral systemic therapy or from oral systemic therapy to biologic therapy, and the assumption that all patients initiating biologic treatments continue to take those treatments for the remainder of the model time horizon) may not adequately reflect the clinical pathway associated with psoriasis.
Other considerations: Roflumilast cream 0.3% was previously reviewed by CDA-AMC, and it was recommended with conditions (price not exceeding the least costly topical therapy). The pan-Canadian Pharmaceutical Alliance negotiation concluded without agreement in June 2024. Additionally, the sponsor’s base case used list prices, but actual costs for biologic comparators (i.e., risankizumab, guselkumab, ixekizumab) are unknown due to confidential negotiated prices, meaning cost savings with roflumilast were likely overestimated.
Anticipated budget impact: CDA-AMC estimated that by year 3 of reimbursement, 456,184 patients would be eligible for roflumilast; of them, 114,735 patients would be expected to receive roflumilast. The estimated incremental budget impact of reimbursing roflumilast is predicted to be approximately $15.2 million over the first 3 years, with an expected expenditure of $99.8 million on roflumilast. The actual impact of reimbursing roflumilast will depend on the market share of roflumilast, the number of disease flares per year experienced by patients, and the confidential list prices of comparators. The magnitude of uncertainty in the budget impact must be addressed to ensure the feasibility of adoption, given the difference between the sponsor’s estimate and the CDA-AMC estimate (the CDA-AMC reanalysis was ≥ 2 times that of the sponsor’s budget impact analysis).
To make its recommendation, the committee considered the following information (links to the full documents for the review can be found on the project web page):
the CDA-AMC review of the clinical and pharmacoeconomic evidence submitted by the sponsor related to Zoryve (refer to the Main Report and Supplemental Material document)
the sponsor’s comments on the draft report and responses from CDA-AMC
patients’ perspectives gathered by 2 patient groups, Arthritis Consumer Experts and the Canadian Skin Patient Alliance in collaboration with Psoriasis Canada (refer to the Patient and Clinician Group Input document)
input from 3 clinician groups, the Atlantic Dermatology Group, the Dermatology Association of Ontario, and the Canadian Dermatology Association (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 plaque psoriasis consulted by CDA-AMC.
All feedback received in response to the draft recommendation is available on the CDA-AMC project web page.
Dr. Peter Jamieson (Chair), Dr. Kerry Mansell (Vice-Chair), Sally Bean, Daryl Bell, Dan Dunsky, Dr. Ran Goldman, Dr. Trudy Huyghebaert, Dr. Dennis Ko, Dr. Christine Leong, Alicia McCallum, Dr. Srinivas Murthy, Dr. Nicholas Myers, Dr. Krishnan Ramanathan, Dr. Marco Solmi, Carla Velastegui, Dr. Edward Xie, and Dr. Peter Zed.
Meeting date: April 22, 2026
Regrets: Two expert committee members did not attend.
Conflicts of interest: None
ISSN: 2563-6596
Canada’s Drug Agency (CDA-AMC) is a pan-Canadian health organization. Created and funded by Canada’s federal, provincial, and territorial governments, we’re responsible for driving better coordination, alignment, and public value within Canada’s drug and health technology landscape. We provide Canada’s health system leaders with independent evidence and advice so they can make informed drug, health technology, and health system decisions, and we collaborate with national and international partners to enhance our collective impact.
Disclaimer: CDA-AMC has taken care to ensure that the information in this document was accurate, complete, and up to date when it was published, but does not make any guarantee to that effect. Your use of this information is subject to this disclaimer and the Terms of Use at cda-amc.ca.
The information in this document is made available for informational and educational purposes only and should not be used as a substitute for professional medical advice, the application of clinical judgment in respect of the care of a particular patient, or other professional judgments in any decision-making process. You assume full responsibility for the use of the information and rely on it at your own risk.
CDA-AMC does not endorse any information, drugs, therapies, treatments, products, processes, or services. The views and opinions of third parties published in this document do not necessarily reflect those of CDA-AMC. The copyright and other intellectual property rights in this document are owned by the Canadian Agency for Drugs and Technologies in Health (operating as CDA-AMC) and its licensors.
Questions or requests for information about this report can be directed to Requests@CDA-AMC.ca.