Independent Market Access and Reimbursement Risk Assessment.

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Deucravacitinib for treating moderate to severe plaque psoriasis

As of June 2023, MARA’s assessment finds Deucravacitinib’s reimbursement risk concentrated in clinical effectiveness and care pathway integration, with cost effectiveness a strength; the current MARA Rating and full rationale are available in the report.

The assessment also weighs evidence quality and robustness: how solid the underlying evidence is on its own terms — trial design, size and endpoints — before any question of price is reached. The strength recorded in cost effectiveness carries weight because that domain asks whether the price asked stands in a defensible relationship to the benefit delivered — the core of most European reimbursement decisions.

Dermatology

This rating sits within MARA’s Dermatology coverage, alongside 13 other independently assessed treatments in the same area.

What payers will ask

Is the clinical benefit the kind payers reward? — 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.

Does the economic case hold at the expected price? — 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.

Is there quality-of-life evidence payers weigh? — 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.

Does the safety profile hold up for payers? — 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.

Was the drug compared against what payers expect? — 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.

Is the population defined the way payers need it? — 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.

Does the drug fit how care is delivered and paid for? — 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.

Are the wider system costs understood? — 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.

Would the evidence survive payer scrutiny? — 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.

How exposed is the case to uncertainty? — 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.

Be alerted when this rating changes:

Sample two-page MARA Rating report for the fictional drug Samplinib: the rating with its decision record, and the ten graded payer questions with the reasoning behind each
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