← The record

DeucravacitinibSotyktu

Recommended DermatologyAuthority RequiredSecond-line line 💬 consumer voice

Treatment of severe chronic plaque psoriasis in patients who have not responded to or have a contraindication or demonstrated intolerance to methotrexate.

1
Submissions
2023–23
On the record
ICER range
Not modelled
Cost basis

Decisions on record

2 decisions
  • Meeting Mar 2023 Recommended Severe chronic plaque psoriasis (CPP) in patients who have not responded to or are contraindicated to methotrexate
  • Meeting Nov 2022 Deferred Severe chronic plaque psoriasis no PSD

Access path

1 submission · public record
  1. TGA registered · Sotyktu

    TGA label narrower than the PBS population

  2. Mar 2023
    Recommended · restricted

    vs apremilast

  3. PBS listing · Authority Required
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
The PBAC deferred making a recommendation for the listing of deucravacitinib for the treatment of severe chronic plaque psoriasis, to seek additional expert clinical advice on its appropriate and likely place in therapy. In deferring the matter, the PBAC was uncertain as to whether the proposed clinical place of deucravacitinib, in the same line of therapy as apremilast, i.e. after non- or inadequate 33PSD · Mar 2023
The PBAC noted the submission nominated apremilast as the primary comparator and considered that if the proposed place in therapy were accepted, apremilast was an appropriate comparator. However, the Committee considered that if deucravacitinib was more likely to be used in patients who are potentially eligible for biologics, these therapies may represent a more appropriate primary comparator.PSD · Mar 2023
Economic analysis
The submission presented a cost-utility analysis. This is consistent with the claim of superior comparative clinical effectiveness and non-inferior safety of deucravacitinib versus apremilast in patients with severe CPP.PSD · Mar 2023
Table 9 provides a summary of the key components of the model. 19PSD · Mar 2023
Clinical claim
The submission described deucravacitinib as superior in terms of efficacy compared with apremilast based on sPGA 0/1 score and PASI 75 at week 16. The ESC considered 18PSD · Mar 2023
However, in the POETYK 1 and POETYK 2 trials, 39% and 32% of patients had received prior biologic therapy, respectively, whereas the proposed Australian clinical management algorithm positions deucravacitinib before treatment with biologics.PSD · Mar 2023
Consumer comments
The PBAC noted and welcomed the input from health care professionals (3) and organisations (1) via the Consumer Comments facility on the PBS website. The comments from health professionals noted patients with chronic plaque psoriasis often have poor quality of life due to their symptoms often being uncontrolled by topical treatments, and noted deucravacitinib is considered an option for this group to manage their symptoms and improve quality of life.PSD · Mar 2023
The PBAC also noted the advice from Creaky Joints Australia, which noted the impact of plaque psoriasis on patients’ lives and shared patient experiences of living with the condition. The experiences highlighted the physical and mental impacts of plaque psoriasis, including how the visible aspect of psoriasis leads to anxiety, depression and body image problems.PSD · Mar 2023

Cost-effectiveness

ICER not stated in the public document; the economic analysis was conducted but specific ICER values for deucravacitinib versus apremilast are not reported in this PSD.

Decision context

PopulationAdults aged 18 years or older with severe chronic plaque psoriasis who have not responded to, have a contraindication to, or have demonstrated intolerance to methotrexate, with significant interference to quality of life.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Mar 2023 Recommended · restricted apremilast RCT · sPGA 0/1 and PASI 75

Consumer voice

Mar 2023

Health care professionals and organisations noted that patients with chronic plaque psoriasis often have poor quality of life due to uncontrolled symptoms with topical treatments, and that deucravacitinib offers a treatment option to manage symptoms and improve quality of life.

patients with chronic plaque psoriasis often have poor quality of life due to their symptoms often being uncontrolled by topical treatments Consumer comments · PSD
quality of lifeunmet needtreatment burdensymptom control

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to severe psoriasis with prior methotrexate failure/intolerance, whereas TGA label includes moderate-to-severe candidates for systemic therapy.