Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
Deucravacitinib shows moderate benefit over current care, achieving significantly more PASI 75 responses compared to placebo and apremilast in clinical trials. However, it is noted that while it is more effective than non-biological treatments, it is similarly effective to or less effective than some biological treatments, indicating a modest margin of benefit.
Cost effectiveness
The cost-effectiveness estimates for deucravacitinib are within the range that NICE considers acceptable for Healthcare resources, particularly when compared to apremilast and dimethyl fumarate. The ICERs suggest it is a cost-effective option for treating moderate to severe plaque psoriasis.
Quality of life
The evidence indicates that deucravacitinib improves quality of life as measured by the Dermatology Life Quality Index (DLQI), with significant improvements noted in clinical trials. However, the extent of these improvements is moderate and may vary among individuals.
Supporting Domains
Safety and Adverse Effects
Deucravacitinib has a very good safety profile with mostly mild to moderate adverse events reported in clinical trials. Serious adverse events are rare, indicating a favorable tolerability compared to existing treatments.
Comparator Selection
The treatment was compared against appropriate alternatives, including apremilast and dimethyl fumarate, which are relevant fourth-line treatments for moderate to severe plaque psoriasis. The committee found the comparisons to be suitable for decision-making.
Patient Population and Subgroups
The trials included a diverse population of patients with moderate to severe plaque psoriasis, and the evidence is broadly generalizable to the intended patient population. Minor subgroup gaps were noted, but overall representation is strong.
Care Pathway Integration
Deucravacitinib can be integrated into existing care pathways with minor adjustments, as it is an oral treatment that does not require refrigeration or special handling, making it easier to adopt compared to subcutaneous biological treatments.
Resource Use and Cost Implications
The resource implications of implementing deucravacitinib are manageable, with the potential for cost savings due to its oral administration and the commercial arrangement providing discounts. The budget impact is considered justifiable.
Evidence Quality and Robustness
The evidence base is supported by multiple rigorous RCTs (POETYK-PSO-1 and POETYK-PSO-2) with low bias risk. However, some methodological concerns were noted, particularly regarding the generalizability of utility values.
Uncertainty, Sensitivity, and Broader Impacts
While there are some uncertainties regarding the long-term effectiveness and cost-effectiveness in different treatment sequences, the overall context is favorable, and the unmet need for effective treatments in this patient population is significant.
